最新刊期
      卷 31 ， 期 10 ， 2020
      • YU Hao,PAN Yan,WU Zhi ’ang,XUE Wei,LI Kexin
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To pro vide suggestions for imp roving the quality of ethical review of drug clinical trials in China and protecting the rights and interests of subjects. METHODS ：Guided by risk management theory ，the literature research method ， expert opinion method and analytic hierarchy process method were used to sort out the ethical review process of drug clinical trials ， extract and determine the risk factors that affect the quality of ethical review ，and determine the weight of each risk factor. Suggestions were put forward improving the ethical review of drug clinical trials in China. RESULTS & CONCLUSIONS ： Established ethical review risk index system of drug clinical trials included 31 influential factors of 5 aspects；the order of importance（weights）of 5 aspects affecting the quality of ethical review of drug clinical trials was as follows ：the construction of the medical ethics committee （0.263 5），the management of review meetings （0.251 4），follow-up review （0.194 5），the acceptance and processing of review applications （0.189 2），and the management of documents and files （0.101 4）. The influential factors with high weight included “withdrawal of people with conflict of interest in the discussion and voting process （0.078 7）” “timely review or conference discussion of scheme modification ，informed consent modification ，serious adverse events ，etc. （0.070 5）”“clarification and external exhibition of the work process and time of ethical review （0.059 8）”“unified and standardized review standards and approval standards （0.052 1）”，etc. The quality of ethical review can be improved by avoiding people with conflict of interest in the discussion and voting process ，timely reviewing or holding ethics meetings on scheme modification ， informed consent modification ，serious adverse events ，etc.，clarifying the working process and time of ethical review ，and establishing unified and standardized review standards and approval standards.  
        关键词：Drug clinical trials;Ethical review;Risk manag ement;Analytic hierarchy process;Expert opinion method   
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        发布时间：2022-06-21
      • WANG Yifang,YANG Yue
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To provi de reference for establishing and improving the compensation system for vaccination abnormal reaction in China. METHODS ：By adopting the method of literature research ，the background ，institutional elements （including management system ，financing mode ，compensation scope ，compensation application conditions ，compensation expense type and standard ）and operation mechanism （including the litigation participants of compensation application ，the judgment path of causality between injuries in and out of the list of Vaccine Injury Table ，and the litigation procedure of compensation application） of Vaccine Injury Compensation Program （VICP） in the United States were summarized comprehensively. Its implementation performance ，obstacle and deficiencies were evaluated ，and suggestions were put forward for the establishment and improvement corresponding compensation system in China. RESULTS & CONCLUSIONS ：VICP management system of the United States composed of the U.S. Department of Health and Human Services （HHS），the U.S. Federal Claims Court ，and the U. S. Department of Justice. VICP adopts special fund compensation mode ，and vaccine consumption tax is levied on vaccine enterprises to establish a vaccine injury compensation trust fund ；through the establishment and continuous revision of Vaccine Injury Table ，compensation application and other procedures ，combined with the trial advantages of its judicial system ，a complete set of “no fault ”compensation mechanism is provided for vaccine victims. There were obstacle and deficiency such as compensation time out of expectation ，obscure revision standard of Vaccine Injury Table in VICP ，but it achieved the dual legislative goals of fully compensating vaccine victims and promoted the effective supply of vaccines by vaccine enterprises. Drawing on the experience of VICP in the United States ，and based on the provisions of Article 56 of the Vaccine Administration Law of China ，it is suggested to establish and improve the compensation system for vaccination abnormal reaction in China and maintain the public ’s confidence in vaccination from six aspects ，i.e. exploring the establishment of fund compensation mode ， entrusting a third party to provide compensation services ，implementing the compensation catalogue and its adjustment mechanism ， resetting the compensation application procedure ，establishing two compensation paths within and outside the catalogue ，and scientifically setting compensation standards.  
          
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        发布时间：2022-06-21
      • LI Hua,ZHANG Mingxiao,BAI Yuqi,YANG Bin
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To eva luate content constituent characteristics and antiviral activity of main flavonnoids in genuine and non-genuine Scutellaria baicalensis ，and to investigate quality-efficiency relationship and effective substance. METHODS ： Totally 8 batches of S. baicalensis from different origins （S1-S8）were collected to prepare its water extract lyophilized powder. UPLC method was used to determine the contents of baicalin ，wogonoside，baicalein and wogonin ，and calculate their content constituent ratio. According to the content constituent ratio of flavonoids in S. baicalensis from different origins ，the mixture of the above four components was prepared as the corresponding simulated sample of flavonoids （E1-E8）. Using ribavirin as positive control，MTT assay and CPE method were used to investigate half toxic concentration （TD50）of the water extract from 8 batches of S. baicalensis and their corresponding simulated samples to human laryngeal carcinoma cell Hep-2 and their half inhibition concentration（IC50）to respiratory syncytial virus （RSV）；treatment indexes （TI）were calculated. Pearson correlation analysis for the content of baicalin ，wogonoside，baicalein and wogonin with their anti-RSV activity （IC50）was performed by SPSS 17.0 software. RESULTS ：The contents of baicalin and wogonoside in sample S 4（from Hebei Chengde ）were the highest ，and the contents of baicalein and wogonin in sample S 6（from Inner Mongolia- 2）were the highest. The contents of above 4 components were the lowest in sample S 6，S6，S7（from Beijing ），S4. The contents of flavonoid glycosides in sample S 4 were relatively higher， while those of corresponding glycosides were relatively lower ；the content constituent ratio of baicalin ， wogonoside，baicalein and wogonin was 1∶0.224∶0.111∶0.013. The contents of flavonoid glycosides in sample S6 wererelatively lower ，while those of glycosides were relatively 126.com higher；the content constituent ratio of above 4 components was 1∶0.241∶0.713∶0.106. TC 50 of S. bai calensis water extracts from different origins to Hep- 2 cells was all higher than 50 μg/mL， IC50 to RSV was 11.11-51.74 μg/mL；TI was 1.86-5.20. TC 50 of corresponding simulated samples of flavonoids was 23.11-52.23 μg/mL，while IC 50 to RSV was 4.87-14.61 μg/mL；TI was 1.85-4.75. The anti-RSV effects of water extract of S 4 from genuine origins（Hebei Chengde ）and its corresponding simulated sample E 4 were the strongest. Correlation analysis showed that the correlation coefficient between the contents of 4 flavonoids and antiviral activity was less than 0.5，and there was no significant correlation between them. CONCLUSIONS ：When the content constituent ratio of 4 main flavonoids in S. baicalensis was 1∶0.224∶ 0.111 ∶ 0.013，it has a strong inhibition effect on RSV. S. baicalensis from genuine origins has better constituent characteristics of flavonoids，which may be the important material basis for the best antiviral effect of genuine medicinal material.  
          
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        发布时间：2022-06-21
      • XUE Fenglin,HONG Shijun,ZENG Xiaofeng,YANG Genmeng,ZHOU Yiqing,LI Lihua
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To stu dy the mechanism of improvement effects of Gastrodin injection on methamphetamine induced neurotoxic damage in rats via nNOS pathway. METHODS ：SD rats were randomly divided into control group ，methamphetamine group，regular-dose of gastrodin group ，double-dose of gastrodin group ，negative control （NC）adenovirus group ，NC adenovirus+ methamphetamine group ，NC adenovirus+gastrodin group and nNOS adenovirus+gastrodin group ，with 10 rats in each group. Control group was given normal saline intraperitoneally ，twice a day. Methamphetamine group was given methamphetamine intraperitoneally（7.5 mg/kg），twice a day. Regular-dose and double-dose of gastrodin groups were respectively given different doses of Gastrodin injection （10，20 mg/kg）intraperitoneally 30 min earlier ，once a day ，and then given methamphetamine intraperitoneally by the same way as methamphetamine group. NC adenovirus group was given NC adenovirus （4.8×107 PFU）3 μL once in the striatum and normal saline intraperitoneally ，twice a day. NC adenovirus+methamphetamine group was given NC adenovirus by the same way and methamphetamine （7.5 mg/kg）intraperitoneally，twice a day. NC adenovirus+gastrodin group was given NC adenovirus+methamphetamine by the same way ，meanwhile given Gastrodin injection intraperitoneally （20 mg/kg）30 min before methamphetamine ，once a day. nNOS adenovirus+gastrodin group was given nNOS adenovirus and methamphetamine by the same way ，meanwhile given Gastrodin injection intraperitoneally （20 mg/kg）30 min before methamphetamine ，once a day. Each group was given relevant medicine intraperitoneally 1 mL/100 g，for consecutive 3 days. The stereotyped behavior of rats were observed and scored ；the apoptotic rate ，the protein expression of apoptotic factors （Bcl-2，Bax，Cleaved caspase- 3），the levels of oxidative stress factors （MDA，SOD，GPx） and NO ，the protein expression of nNOS were detected. RESULTS ： Compared with control group ，stereotyped behavior score ，cell apoptosis rate of striatum ，protein expression of Bax ，Cleaved caspase-3 and nNOS ，the levels of MDA and NO were increased significantly in methamphetamine group ；while the protein expression of Bcl- 2 and the levels of SOD and GPx were decreased significantly （P＜0.05 or P＜0.01）. Compared with methamphetamine group ，stereotyped behavior score ，cell apoptosis rate of striatum ，protein expression of Bax ，Cleaved caspase- 3 and nNOS ，the levels of MDA and NO were decreased significantly in regular-dose and double-dose of gastrodin groups ；while the protein expression of Bcl- 2，the levels of SOD and GPx were increased significantly ，and most above indexes in double-dose of gastradin group were better than regular-dose of gastrodin group （P＜0.05 or P＜0.01）. Compared with NC adenovirus group ，cell apoptosis rate of striatum ，protein expression of Bax ，Cleaved caspase- 3 and nNOS ，the levels of MDA and NO were increased significantly in NC adenovirus+methamphetamine group ；while the protein expression of Bcl- 2，the levels of SOD and GPx were decreased significantly （P＜0.01）. Compared with NC adenovirus+methamphetamine group ，cell apoptosis rate of striatum ，protein expression of Bax ，Cleaved caspase- 3 and nNOS ，the levels of MDA and NO were decreased significantly in NC adenovirus+ gastrodin group ；while the protein expression of Bcl- 2，the levels of SOD and GPx were increased significantly （P＜0.01）. Compared with NC adenovirus+gastrodin group ，cell apoptosis rate of striatum ，protein expression of Bax ，Cleaved caspase- 3 and nNOS，the levels of MDA and NO were increased significantly in nNOS adenovirus+gastrodin group ；while the protein expression of Bcl- 2，the levels of SOD and GPx were decreased significantly （P＜0.01）. CONCLUSIONS ：Gastrodin injection can protect rats against neurotoxic damage induced by methamphetamine ，and the effect is related to the inhibition of nNOS-mediated apoptosis and oxidative stress.  
        关键词：Methamphetamine;Gastrodin injection;nNOS;Cell apoptosis;Oxidative stress;Mechanism   
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        发布时间：2022-06-21
      • LIANG Xinyu,ZHOU Xiaogang,HE Bing,YANG Shiyan
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To e stablish a method for simultaneous determination of 7 constituents in Xiao ’er jinqiao granules . METHODS：QAMS method was adopted. The determination was performed on Lubex Kromasil C 18 column with mobile phase consisted of acetonitrile- 0.1％ phosphoric acid solution （gradient elution ）. The detection wavelength was set at 326 nm，the flow rate was 1.0 mL/min. The column temperature was 40 ℃，and sample size was 10 µL. Using chlorogenic acid as the internal reference，the relative correction factors （RCF）of neochlorogenic acid ，cryptochlorogenic acid ，forsythiaside A ，isochlorogenic acid B ，isochlorogenic acid A and isochlorogenic acid C were calculated. The effects of different chromatogram system ， chromatogram column ，the ratio of mobile phase ，flow rate and column temperature on RCF were investigaten. According to the two-point correction method combined with the relative retention time correction of the components to be tested ，the peak location was carried out. The contents of 7 components were determined by QAMS and SCM respectively and then compared. RESULTS： The linear range of neochlorogenic acid ，chlorogenic acid ，cryptochlorogenic acid ，forsythoside A ，isochlorogenic acid B ，isochlorogenic acid A ，isochlorogenic acid C were 9.27-92.70，37.36-373.60，13.02-130.20，7.15-71.50，4.56-45.60，6.32-63.20，14.69-146.90 µg/mL （r≥0.999 7）. The limits of quantification were 1.38，1.41，1.40，1.99，1.10，1.17，1.10 ng，respectively；and the limits of detection were 0.41，0.42，0.42，0.60，0.33，0.35，0.33 ng，respectively. RSDs of precision ，repeatability and stability tests were all less than 2％；average recoveries were 98.28％-99.15％ （RSD＜2.0％ ， n＝9）. RCFs of neochlorogenic acid ， （No.2013LZLY-K61） cryptochlorogenic acid ，forsythiaside A ，isochlorogenic acid B，isochlorogenic acid A and isochlorogenic acid C relative to xinyuliang@stu.cqmu.edu.cn chlorogenic acid were 0.995，1.007，0.580，1.243，1.252 and 1.247，respectively. RSDs of RCFs were all lower than 3％ under different chromatogram conditions. Absolute value of relative error between the relative retention time of components to be tested predicted by two-point correction combined with relative retention time correction and measured value was less than 2％. The contents measured by QAMS were 2.790-3.416， 14.526-17.907，3.763-4.531，1.625-1.982，1.087-1.523，1.434-2.219，3.631-5.078 mg/g；the contents measured by SCM method were 2.811-3.438，14.512-17.893，3.739-4.508，1.656-2.012，1.108-1.544，1.460-2.245，3.597-5.045 mg/g；relative errors of the two methods were within ±2％. CONCLUSIONS ：Two-point correction method combined with relative retention time correction can accurately locate the peaks of each constituent ；established QAMS method is simple ，rapid，accurate and reliable ，it can be used for simultaneous determination of 7 constituents in Xiao ’er jinqiao granules.  
        关键词：QAMS;Xiao’er jinqiao granules;Content determination;Peak location;Two-point correction method;Relative   
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        发布时间：2022-06-21
      • ZHENG Xiaoqian,JIN Chuanshan,ZHANG Yazhong,LIU Junling,YU Nianjun,OU Jinmei
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To establish the content determination me thod of 3 mono/disaccharides in 3 kinds of medicinal Dendrobii Caulis. METHODS ：HPLC-CAD method was established. The determination was performed on Shodex Asahipak NH2P-50 4E column with mobile phase consisted of acetonitrile-water （75 ∶ 25，V/V）at the flow rate of 1.0 mL/min. The column temperature was set at 30 ℃，and sample size was 10 µL. CAD detection condition included that data acquisition frequency was 5 Hz，filter constant was 5 s，atomization temperature was 35 ℃ ，gas source was nitrogen with pressure of 4.012 × 105 Pa. RESULTS：The linear range of fructose ，D-anhydrous glucose and sucrose were 0.156 2-1.873 8 mg/mL（r＝0.999 5），0.012 7- 0.152 4 mg/mL（r＝0.999 7），0.277 6-3.331 2 mg/mL（r＝0.999 8），respectively. The limits of quantification were 0.002 61，0.004 24 and 0.005 12 mg/mL，and the limits of detection were 0.000 78，0.001 27 and 0.001 54 mg/mL，respectively. RSDs of precision ， stability，reproducibility and durability tests were all lower than 3％. The recoveries were 95.98％-98.15％（RSD＝0.83％，n＝6）， 95.64％-98.62％（RSD＝1.10％，n＝6）and 97.53％-98.94％（RSD＝0.53％，n＝6）. The contents of them were 0.28％-1.12％， 0.02％-0.13％，0.76％-2.67％，respectively. The total content was 1.38％～3.10％. The order of saccharide content in 3 kinds of Dendrobii Caulis was sucrose ＞fructose＞D-anhydrous glucose ；the order of sucrose content and total content were Dendrobium huoshanense＞D. moniliforme ＞D. officinale ；the order of D-anhydrous glucose content was D. huoshanense ＞D. officinale ＞D. moniliforme； the order of fructose content was D. moniliforme ＞D. officinale ＞D. huoshanense . CONCLUSIONS ：Established method is sensitive ，reproducible and simple in operation ，and can be used for content determination of 3 saccharides in 3 kinds of medicinal Dendrobii Caulis. There are differences in the contents of saccharide s among 3 kinds of Dendrobii Caulis.  
          
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        发布时间：2022-06-21
      • DU Guiqiang,ZHANG Yongli,HU Xiaohui
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To investigate the effects and m echanism of oleanolic acid on inhibiting the proliferation ，invasion and metastasis of human ovarian cancer SKOV 3 cells. METHODS ：CCK-8 assay was used to detect the effects of different concentrations of oleanolic acid （10，20，40，60，80，100 μmol/L）on the proliferation of ovarian cancer SKOV 3 cells at 12，24， 36 and 48 h. The effects of low-dose and high-dose of oleanolic acid （20，40 μmol/L）on the metastasis and invasion ability of SKOV3 cells for 24 h were observed in Transwell assay. Western blotting assay was used to detect the effects of low-dose and high-dose of oleanolic acid on the protein expression of NF-κB p65，PRL-3，TNF-α，IL-6 and E-cadherin in SKOV 3 cells. Through LPS induction and NF-κB p65 plasmid transfection ，Western blotting and RT-qPCR assay were used to investigate the effects of low-dose and high-dose oleanolic acid on the expression of NF-κB/PRL-3 pathway related proteins and their mRNA. RESULTS ： With the increase of the concentration and action time of oleanolic acid ，the proliferation capacity of ovarian cancer SKOV 3 cells was decreased ，the surval rates of administration groups were significantly lower than that of the control group （P＜0.05 or P＜ 0.01）. Low-dose and high-dose of oleanolic acid could significantly reduce the number of migrating and invading cells （P＜0.05 or P＜0.01）. The protein relative expression of NF-κB p65，PRL-3，TNF-α and IL-6 in SKOV 3 cells were significantly decreased ， while the protein relative expression of E-cadherin was significantly increased （P＜0.05 or P＜0.01）. After LPS induction ，protein and mRNA relative expression of NF-κB p65，PRL-3，TNF-α and IL-6 were increased significantly in LPS model group ，while protein and mRNA relative expression of E-cadherin were significantly decreased （P＜0.05 or P＜0.01）. The protein and mRNA relative expression of NF-κ B p65，PRL-3，TNF-α and IL-6 were significantly decreased ，and protein and mRNA relative expression of E-cadherin were significantly increased in low-dose and high-dose of oleanolic acid group （P＜0.05 or P＜0.01）. In SKOV3 cells with over-expressed NF-κB p65，low-dose and high-dose of oleanolic acid c ould significantly down-regulat the proteinexpression of NF-κ B p65，PRL-3，TNF-α and IL-6，while upregult the protein relative expression of E-cadherin （P＜0.05 E-mail：122821905@qq.com or P＜0.01）. CONCLUSIONS ： Oleanolic acid can inhibit SKOV3 cells proliferation，invasion and metastasis by regulating NF-κB/PRL-3 signaling pathway.  
        关键词：Oleanolic acid;Ovarian cancer;SKOV3 cell;Proliferation;Invasion;Metastasis;NF-κB;PRL-3   
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        发布时间：2022-06-21
      • LIN Huajian,ZHANG Zihao,MENG Jiang,WANG Shumei
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To evaluate the correlation between color difference values and active constituent contents of crude and processed Zingiber officinale . METHODS ：HPLC method was adopted to determint the content of 6 active constituents. The color difference values of crude and processed Z. officinale [lightness（L＊），red-green axis component （a＊），yellow-blue axis component（b＊）] were determined by chromatic aberration meter . SPSS 24.0 software was adopted for the correlation analysis between color difference values and active constituent contents. RESULTS ：The linear range of zingiberone ，6-gingerol， 8-gingerol， 6-shogaol， diacetoxy-6-gingerol and 10-gingerol were 2.65-105.90， 10.15-406.00， 4.87-194.80， 5.28-211.20， 6.14-245.70，7.02-280.80 μg/mL（r＞0.999）. The limits of quantification were 7.46，13.68，14.37，16.62，17.03，17.99 ng，and the limits of detection were 2.24，4.11，4.31，4.99，5.11，5.40 ng，respectively. RSDs of precision ，stability，and repeatability tests were all lower than 3％. The average recovery rates were 101.34％，102.14％，101.22％；103.12％，103.74％，103.54％；103.06％，properties critical for cell migration and invasion. induced EMT through downregulation of NF-κB-Snail sig- naling in breast cancer cells enchymal transition and activation of TLR 4/JNK signal - 98.55％，99.43％；99.36％，103.51％，101.21％；100.85％，99.42％，99.60％；100.39％，97.69％，103.84％（RSD were all lower than 3％，n＝3），respectively. The contents of them were 0-0.66，0.06-7.57，0.03-1.45，0.29-3.47，0.15-2.85，0.04-2.83 mg/g， respectively. L＊ and b＊ values were negative correlated with the processing degree of Z. officinale significantly（P＜0.01），a＊ showed a significantly positive correlation with the processing degree （P＜0.05）. L＊and b＊ values showed a significantly negative correlation with the content of zingiberone before and after processing ，but positively correlated with the other five components （P＜0.01）. a＊ showed a significantly positive correlation with the content of zingiberone ，but had no correlation with other five components（P＞0.05）. The crude and processed Z. officinale were positive correlated with the content of zingiberone ，negatively correlated with other five components （P＜0.01）. CONCLUSIONS ：There is a certain correlation between the color difference values of crude and processed Z. officinale and the contents of their active constituents. With the deepening of the processing ，a＊ values is increased ，L＊ values and b＊ values is decreased ；the content of zingiberone increases ，the contents of 6-gingerol， 8-gingerol，6-shogaol，diacetoxy-6-gingerol，10-gingerol reduce.  
          
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        发布时间：2022-06-21
      • ZHANG Yukun,YUAN Yin,FENG Yuenan,BIAN Jingqi,XIAO Hongbin,NIU Wenying
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To investigate the effects of Buyang huanwu decoction on lipid metabolism and hepatic tissue in hyperlipemia model rats. METHODS ：Male SD rats were randomly divided into blank control group ，model group ，positive control group （simvastatin 0.004 g/kg），Buyang huanwu decoction low-dose and high-dose groups （3.5，14.0 g/kg，by crude drugs），with 10 rats in each group. Except that blank control group was given water intragastrically ，hyperlipidemia mode of other groups was established by intragastric administration of fat emulsion according to the body weight. From the 21st day after modeling，the rats in each group were given water or fat emulsion in the morning and water or corresponding drugs in the afternoon for consecutive 20 days. After last medication ，the contents of TG ，TC，LDL-C，ALT，AST，LCAT，PLTP and HL in plasma were determined in each group ；the contents of LPL ，MTP and HMG-CoA redutase in liver tissue were also determined. The pathological changes of liver tissue were observed in each group. RESULTS ：Compared with blank control group ，the contents of TG ，TC，LDL-C，ALT and HMG-CoA reductase were increased significantly in model group （P＜0.05 or P＜0.01），while the contents of HL ，LPL and MTP were decreased significantly （P＜0.01）. Compared with model group ，the contents of TG ，TC， LDL-C and HMG-CoA reductase in administration groups as well as the contents of ALT ，AST in Buyang huanwu decoction low-dose and high-dose groups were decreased significantly （P＜0.05 or P＜0.01）；the contents of HL and MTP in administration groups as well as the content of LPL in positive control group were increased significantly （P＜0.05 or P＜0.01）. Pathological sections showed that the hepatocytes of model group were arranged irregularly ，and there was obvious cell steatosis. The hepatocytes in positive control group and Buyang Huanwu decoction high-dose group had almost no abnormal change compared with blank control gr oup，and there was a small amount of slight cell steatosis in Buyang Huanwu decoction low-dose group. CONCLUSIONS ： Buyang huanwu decoction has a 础。E-mail：zhang520-888@163.com significant lipid-lowering effect on hyperlipemia model rats ，which may be related to the regulation of lipid absorptiontransport and metabolism by regulating the expression of lipid 126.com metabolism related enzymes and transporter.  
          
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        发布时间：2022-06-21
      • LI Jiayi,ZHANG Cheng,LI Benxue,ZHANG Ye,ZHANG Xiangyan
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To study the effects of methylprednisolone sodium succinate on oxidative stress and anti-endothelial cell antibody （AECA）of autoimmune emphysema model rats. METHODS ：Male SD rats were randomly divided into control group，model group and intervention group ，with 8 rats in each group. Except that control group was given same volume of complete Freund ’s adjuvant intraperitoneally ，model group and intervention group were given the mixture of human umbilical vein endothelial cells and complete Freund ’s adjuvant intraperitoneally to establish the model of autoimmune emphysema. On 2nd day after modeling ，intervention group was intraperitoneally injected with 10 mg/（kg·d）methylprednisolone sodium succinate. Control group and model group were intraperitoneally injected the same volume of normal saline ，once a day ，for consecutive 21 days. After last medication ，the right lung tissue of rats were taken for paraffin section and HE staining in each group ，and the pathological changes of lung tissue were observed. The mean alveolar number （MAN）and mean linear intercept （MLI）were measured. The contents of MDA and GSH ，the activities of SOD and glutathione peroxidase （GSH-Px）in bronchial alveolar lavage fluid（BALF）of left lung were determined ；the contents of AECA in BALF and serum were also determined. The correlation of AECA with MDA ，GSH，SOD and GSH-Px were determined in model group by Pearson analysis. RESULTS ：Compared with control group ，the pathological changes of pulmonary emphysema were obvious in model group ，MAN decreased significantly ，and MLI prolonged significantly （P＜0.01）； GSH content ， GSH-Px and SOD activities in BALF were decreased 1100，1195） significantly，the contents of AECA in BALF and serum were increased significantly （P＜0.01）. Compared with modelgroup，the pathological changes of pulmonary emphysema was improved significantly in the intervention group ， increased significantly ，while MLI shortened significantly （P＜ ·1208；GSH content ，SOD and GSH-Px activities were increased significantly，while the contents of AECA in BALF and serum were decreased significantly （P＜0.01）. AECA in BALF of rats in model group was positively correlated with MDA （r＝0.710， P＜0.05），and the AECA were negatively correlated with GSH ，SOD and GSH-Px （r＝－0.754，－0.781，－0.736，P＜0.05）. CONCLUSIONS：Methylprednisolone sodium succinate may achieve the purpose of the prevention of autoimmune emphysema through reducing oxidative stress and inhibiting the expression of AECA.  
          
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      • WU Lihua,YANG Hui,YANG Junli,ZENG Qilu,LIU Tao,XU Yuling
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To evaluate the quality of inflorescence of Coptis chinensis from different altitude with different growth years and drying processing methods ，and to provide reference for its utilization and quality control. METHODS ：The contents of total flavonoids and berberine hydrochloride in 24 batches of inflorescence of C. chinensis （S1-S24）from different altitude with different growth years and drying processing methods were determined by UV-Vis spectrophotometry and HPLC. Using the contents of total flavonoids and berberine hydrochloride as indexes ，and taking the short drying time as the best ，the weight ratios of total flavonoids content ，berberine hydrochloride content and standardized value of drying time were 30，40 and 30，respectively；comprehensive score was calculated ，then the quality of 24 batches of samples was evaluated. Using the contents of total flavonoids and berberine hydrochloride as variables ，systematic cluster analysis was performed for 24 batches of samples by using SPSS 19.0 statistical software. RESULTS ：For inflorescence of C. chinensis with altitude about 1 200 m and the growing years of 4 years and above ，the higher the comprehensive score （84-94 score）and the better the quality were. The comprehensive score of inflorescence of C. chinensis procesed by gradient drying method was generally higher than samples processed by other methods. Results of cluster analysis showed that S 1-S4，S9，S10，S13-S18 were clustered into one category ，and other 12 batches were clustered into one category ， which were basically consistent with the results of comprehensive scoring method. CONCLUSIONS：Different altitude ，different growth years and different drying processing methods have certain effects on the quality of inflorescence of C. chinensis ，among which the samples processed by gradient drying method with growth altitude of 1 200 m，growth years of 4 years and above are the best.  
          
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      • XIAO Ying,YUAN Xiao,LIN Shunquan
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To de termine unknown impurities in Cefprozil suspension ，and to identify its structure. METHODS ： LC-HR-MS/MS method was used to detect and identify unknown impurities in Cefprozil suspension. The determination was performed on Thermo HyPURITY TM C18 with mobile phase consisted of acetonitrile- 0.013％ formic acid solution （gradient elution ） at the flow rate of 1.0 mL/min. The detection wavelength was set at 230 nm，and column temperature was 40 ℃. The sample size was 20 μL. ESI+ full scanning was carried out with electrospray ion source scanning range was mass-charge ratio （m/z）100-1 500 with spray voltage of 3.8 kV，metal capillary temperature of 320 ℃，sheath gas pressure of 60 Arb，auxiliary gas pressure of 10 Arb，spray temperature of 280 ℃. RESULTS ：Under this condition ，the detection limit of impurity K was 0.202 μg/mL. RSDs of precision and reproducibility tests were both lower than 4％. Three unknown impurities were found around impurity K ，which were isomers of each other. The retention time of ions were 17.83-19.31 min，and the secondary parent ion were all m/z 436.150 0[M+ H]+，which may be the product of ring opening and dehydration of cefpropene. CONCLUSIONS ：Three unknown impurities near impurity K in Cefprozil suspension were detected by this method.  
          
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      • ZHANG Cunyan,LIU Hongmei,WEI Ailing,YUAN Minghao,GUO Li,CHEN Hulan,YE Qiang
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To compare the c ontents of 6 kinds of ester alkaloids in raw aconite and 5 kinds of salt-processed products，and to provide reference for the optimization of salt-processing technology. METHODS ：Processed with bittern ， magnesium chloride ，sodium chloride ，calcium chloride and potassium chloride as excipients ，and HPLC method were adopted to determine the contents of 6 kinds of ester alkaloids in raw aconite and 5 kinds of salt-processed products. The effect/toxicity ratio and toxicity component index were used to evaluate the effect and toxicity of raw aconite and 5 kinds of salt-processed products. RESULTS： The linear range of benzoylneoaconitine ， benzoylhypoconitine， benzoylaconitine， neoaconitine， aconitine and hypoconitine were 2.440-24.40，2.240-22.40，2.020-20.20，2.780-27.80，2.240-22.40，2.240-22.40 μg/mL（r≥0.999 0）. RSDs of precision，stability and repeatability tests were all less than 2％. The recovery rates were 102.13％-104.87％（RSD＝0.98％，n＝ 6），100.00％-105.00％（RSD＝2.02％，n＝6），95.00％-99.29％（RSD＝1.77％，n＝6），100.41％-104.58％（RSD＝1.78％，n＝ 6），98.87％-99.90％（RSD＝0.41％，n＝6），100.20％-104.00％（RSD＝1.55，n＝6），respectively. The contents of total alkaloids in order from the largest to the smallest was as follows ：raw aconite ＞processed products of sodium chloride ＞processed products of bittern ＞processed products of potassium chloride ＞processed products of calcium chloride ＞processed products of magnesium chloride. The order of effect/toxicity ratio was processed products of potassium chloride ＞processed products of magnesium chloride＞processed products of sodium chloride ＞processed products of calcium chloride ＞processed products of bittern ＞raw aconite. The order of toxicity component index was raw aconite ＞processed products of sodium chloride ＞processed products of bittern＞processed products of calcium chloride ＞processed products of potassium chloride ＞processed products of magnesium chloride. CONCLUSIONS ：Using 5 kinds of salt as excipients ，the proce ssing technology has different degrees of “efficacy enhancing and toxicity reducing ”effect. Among them ，magne- sium chloride ，potassium chloride and calcium chloride are better for processing and can be used for processing aconite.  
          
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      • HOU Xinlian,HUANG Lu,PENG Cheng,ZHU Yaning,CAI Bangjun,ZHOU Qinmei
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To establish an HPLC fing erprint of Ginsen g Radix et Rhizoma Rubra ，and to optimize its processing technology. METHODS ：HPLC method was adopted. The determination was performed on Waters SymmetryShield TM RP18 column with mobile phase consisted of acetonitrile-water （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was set at 30 ℃，and the detection wavelength was 203 nm. The sample size was 10 μL. Using ginsenoside Rb1 as reference peak ，HPLC fingerprints of 10 batches of Ginseng Radix et Rhizoma Rubra was established. The similarity of them was evaluated by using Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 A edition ） to confirm common peak. With steaming temperature，time and drying method as factors ，using the content of ginsenoside and fingerprint similarity as index ，the processing technology was optimized with L 16（43）orthogonal test design and verified. Cluster analysis was conducted with SPSS 19.0 statistical software of 10 batches of Ginseng Radix et Rhizoma Rubra and 3 batches of optimal processed sample. RESULTS ：There were a total of 13 common peaks in the fingerprints of 10 batches of Ginseng Radix et Rhizoma Rubra. The similarity was more than 0.920；3 common peaks were identified ，such as ginsenoside Rg 1，ginsenoside Re ，ginsenoside Rb 1. The optimal processing technology included that steamed at 100 ℃ for 150 min，dried at 60 ℃. The results of validation test show that the contents of ginsenoside Rg 1，Re and Rb 1 were 0.26％-0.29％，0.17％-0.20％，0.47％-0.54％，and the similarity between 3 batches of Ginseng Radix et Rhizome Rubra optimal processed sample and the control fingerprints was more than 0.970. The results of cluster analysis showed that 10 batches of Gimseng Radix et Rhizoma Rubra and 3 batches of optimal processed sample could be clustered into two categories；HS3-HS10 could be clustered into one category ，and 3 batches of optimal processed sample ，HS1 and HS 2 be clustered into one category. CONCLUSIONS ：Established fingerprint can be used for the optimization of processing technology of Gimseng Radix et Rhizoma Rubra ，and characterize the correlation between f luctuation of technology parameter and quality of medicinal material；the optimal processing technology is reasonable an d  
          
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      • YANG Li,MEI Yong,LONG Tao,LUO Lei,CHEN Xiaoxue
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To establish the method for content determination of related substances in Paracetamol tablets. METHODS：HPLC method was adopted. The determination was performed on Agilent 5HC-C8 column with mobile phase A consisted of methanol-water-glacial acetic acid （50 ∶ 950 ∶ 1，V/V/V）and mobile phase B consisted of methanol-water-glacial acetic acid（500 ∶ 500 ∶ 1，V/V/V）（gradient elution ）at the flow rate of 0.9 mL/min. The detection wavelength was set at 254 nm，and column temperature was 40 ℃. The sample size was 5 μL. RESULTS：Under the chromatographic condition ，the resolutions of main component （paracetamol），6 known impurities （p-aminophenol，p-chloroacetanilide，impurity A ，B，D，F），3 specific excipients（methyl hydroxybenzoate ，ethyl hydroxybenzoate ，propyl hydroxybenzoate ）and 1 unknown impurity were all higher than 1.5. The linear range of 6 known impurities were 0.539-1.617，0.026-0.384，0.237-17.799，0.257-19.271，0.239-17.955， 0.246-18.462 μg/mL（r≥0.999 8），respectively. Correction factors of impurity A ，B，D，F were 2.9，1.0，1.2，6.2. The limits of detection were 0.009 6，0.024 2，0.164 0，0.051 1，0.055 9，0.422 0 ng；the limits of quantitation were 0.032 0，0.080 6，0.546 0，0.170 0，0.186 0，1.406 0 ng. Average recoveries were 95.96％-111.09％（RSDs were 0.05％-2.42％）. The RSDs precision test were low than 15％，and the durability were good. p-aminophenol（all were 0.006％），impurity B （0.016％-0.017％）and unknown impurity（0.002 0％-0.002 1％）were detected in 3 batches of sample. p-choroacetanilide，impurity A ，D and F were not detected. CONCLUSIONS：The method is specific ，accurate and suitable for the determination of related substance in Paracetamol tablets.  
        关键词：HPLC;Paracetamol tablets;Related substance;Content   
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      • YAN Yuanyuan,TANG Hongbo,YIN Chenghong,FENG Xin,ZHAO Zhigang
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To provide reference for improving safe drug use in pregnant women. METHODS ：Retrieved from as domestic and foreign literature retrieval platforms as CNKI and Web of Science ，the literatures about drug use in pregnancy period were collected and analyzed by using the literature analysis function provided by the retrieval platform and CiteSpace 5.5R2 software. The collected data of annual volume ，author，organization，keyword co-occurrence and literature co-citation analysis of domestic and foreign literatures are visualized ，and the research focus was analyzed. RESULTS ：A total of 38 946 foreign literatures and 698 domestic literatures were included ，and domestic literatures were less than foreign literatures ；the literature volume on pregnancy drug use were increasing year by year at abroad，but the volume of domestic literatures fluctuates greatly and increased slowly. Foreign institutions and scholars worked closely together ，and built a close cooperation network ，especially in the United States. However ，the author team of domestic research was relatively scattered as a whole ，and the cooperation between researchers was less ，so a large cooperation team had not yet been formed. The most frequently cited literatures in the world were randomized controlled studies and large-scale cohort studies，the keyword “Risk”appears most frequently ，indicating that it focuses on the effects of pregnancy medication on pregnancy outcomes and offspring. The effects of antiepileptic drugs ，antidepressants and opioids used in pregnancy on pregnancy outcomes and child development were currently a research hotspot abroad. However ，there was a lack of large-scale sample and high-quality clinical research in China ，high-frequently keywords in domestic literatures indude “fetus”“hypertension in pregnancy ”etc.，which focused on the treatment of combined diseases in pregnancy and paid little attention to the long-term effects of medication in pregnancy. CONCLUSIONS：More and more attention had been paid to the study of drug use in pregnancy period. Domestic research needs to seize the international cooperation communication ，learns from the excellent experience of foreign research team ，and establishes domestic specific pregnancy medication research team. Relevant departments should introduce measures as soon as possible ，support medical institutions and drug production and developmententerprises to do a good job in the registration of pregnancy medication，establish the database of pregnancy medication inChina as soon as possible ，and improve the medication safety of pregnant patients.  
        关键词：Pregnancy;Research status;CiteSpace;Safety of drug use   
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      • CHEN Bo,BAI Bo,LI Guanghong,HUANG Xueliang,LUO Huiling,HUANG Huiyi
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To observe the ef fectiveness and safety of bosentan in the treatment of hypoxic pulmonary hypertension（HPH）in neonates. METHODS ：From Jan. 2014 to Mar. 2019，a total of 82 HPH neonates hospitalized in the department of neonatology of our hospital were selected as research subjects. According to whether or not receiving bosentan therapy，50 cases were included into bosentan group and 32 cases into non-bosentan group. Meanwhile ，another 25 non-HPH neonates with serum sample retention time and general information such as gestational age at birth and day age matching the HPH group were selected as the control group. All neonates with HPH were given continuous intravenous infusion of Dopamine hydrochloride injection 5 mg/（kg·min）until PASP was normal. On this basis, neonates in the bosentan group were additionally given Bosentan tablets 1 mg/kg（fed after dissolving with appropriate amount of water for injection ）for q 12 h，72 h. The relationship between serum ET- 1 levels of neonates with HPH and PASP was analyzed ，as well as PASP before and after treatment and therapeutic efficacy between bosentan and non-bosentan groups ，the changes of arterial blood gas indexes and ADR in 3 groups were compared. RESULTS ：Before treatment ，the serum ET- 1 levels of bosentan group was （164.3±115.3）pg/mL，which was significantly higher than （41.9±3.7）pg/mL of control group and positively correlated with PASP level （r＝0.864，P＜0.001）. Total response rate of bosentan group was 90.00％，which was significantly higher than 71.88％ of non-bosentan group （P＜0.05）. After 72 h of treatment ，PASP of 2 groups was decreased significantly ，compared with before treatment （P＜0.001），and the bosentan group was significantly lower than the non-bosentan group （P＜0.05）. The PaO 2，SaO2，PaCO2 and OI in 3 groups was significantly improved compared with that before treatment （P＜0.001），and the PaO 2，SaO2 and OI in the bosentan group was significantly higher than that in the non-bosentan group （P＜0.05）. During the treatment period of bosentan and within one week after drug withdrawal，there was no significant change in serum LDH ，AST，ALT and Scr levels in neonates. There was no statistically significant difference in the incidence of feeding intolerance ，anemia，reduced WBC and reduced PLT in 3 groups（P＞0.05）. CONCLUSIONS： Bosentan can improve the oxygenation status of neonates with HPH, reduce PA SP，and short-termmedication is safe. com  
          
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      • LI Xiao,GUO Caihui,ZHAO Na,DING Congyang,MENG Lu,LI Yin g,DONG Zhanjun
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To provid e reference for hospital decision-maker to select and use repaglinide and naglinide reasonably. METHODS ：Through reviewing literautre ，guideline and instruction ，full score system was estalished for comunni- cation between pharmacists and physicians ；from the aspects of clinical necessity ，effectiveness，safety，economy，medical insu- rance attribute ，essential medicine attribute ，original research attribute ，drug packaging attribute ，drug market and enterprise attributes，the Mini health technology assessment （Mini HTA ）was carried out for repaglinide and nateglinide ，and scored on the basis of weight value. RESULTS ：Repaglinide and naglinide ’s final score were 77 and 74，respectively. For type 2 diabetes，both of them could reduce postprandial blood glucose ，and had less side effect and good safety. They were both included in the medical insurance list. Both of them were original varieties ，easy to store and had a long period of validity. Although they were expensive in the treatment of type 2 diabetes，their manufacturers had a good reputation and were widely used in the world ，which was a good choice for patients with type 2 diabetes. But they were different to certain extent ；repaglinide could be used in patients with poor renal function [eGFR ＜30 mL/min] without dose adjustment ；nateglinide should be adjusted according to eGFR for renal excretion. Repaglinide was essential medicine but nateglinide wasn ’t；repaglinide didn ’t need shading storage but nateglinide did. In addition ， a variety of liver drug enzyme inducers or inhibitors may interact with the two drugs ，and special groups should be used with. CONCLUSIONS ：Mini HTA provide reference for the selection and rational use of repaglinide and nateglinide ；patients with type 2 diabetes can select suitable drug according to their own conditions and needs. When combined with other drugs ，blood glucose should be closely monitored to prevent the occurrence of hypoglycemia.  
        关键词：Mini health technology assess ment;Drug selection;Repaglinide;Nateglinide;Safety;Effectiveness   
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      • LIU Di,WU Hui,YANG Jun,YANG Jian,DING Jiawang,FAN Zhixing,YANG Chaojun
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To syst ematically evaluate the effectiveness and safety of ticagrelor versus clopidogrel in the treatment of acute coronary syndrome （ACS）patients in East Asia ，and to provide evidence-based references for clinical drug use. METHODS：Retrieved from Cochrane Library ，PubMed，Embase，CNKI，Wanfang database ，etc.，randomized controlled trials （RCTs）about ticagrelor （trial group ）versus clopidogrel （control group ）in the treatment of ACS patients in east Asia were collected. After literature screening and data extraction ，the quality of included literatures was evaluated by using biasrisk evaluation tool recommended by Co chrane system evaluation manual 5.1.0，and Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS ：A total of 5 RCTs were included ，with a total of 4 511 cases. Meta-analysis showed that the incidence of major adverse cardiovascular events [OR ＝0.85，95％CI（0.68，1.04），P＝0.12]，the incidence of death from cardiovascular causes [OR ＝0.76，95％CI（0.57，1.03），P＝0.08] and the incidence of stroke [OR ＝0.77，95％CI（0.48，1.24），P＝0.28]， without statistical significance. The incidence of major bleeding events [OR ＝1.54，95％CI（1.19，1.99），P＝0.001] and minor bleeding events [OR ＝1.80，95％ CI（1.40，2.32），P＜0.000 01] in trial group were significantly higher than control group. CONCLUSIONS：Ticagrelor is comparable to clopidogrel in reduce the major adverse cardiovascular events，death from cardiovascular causes and stroke in ACS patients in East Asian ，but it can increase the risk of major and minor bleeding events.  
        关键词：Acute coronary syndro me;East Asia;Ticagrelor;Clopidogrel;Meta-analysis;Efficacy;Safety   
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      • LIU Xin,ZHONG Xiaoyan,XU Changjing,ZHAO Danjie,FAN Qingze,YU Bin,HUANG Yilan
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To systematically evaluate the efficacy and safety of guselkumab in the treatment of moderate-to- severe plaque psoriasis ，and to provide evidence-based reference for the clinical treatment. METHODS ：Retrieved from PubMed ， Embase，Cochrane Library ，CNKI，VIP，Wanfang database during inception to Oct. 2019，randomized controlled trials （RCTs） about guselkumab versus placebo/positive control in the treatment of moderate-to-severe plaque psoriasis were collected. After literature screening and data extraction ，quality evaluation was performed by using the bias risk evaluation tool recommended by the Cochrane System evaluator manual 5.1.0. Meta-analysis was performed by using Stata 16.0 software. RESULTS ：Eight RCTs with a total of 3 488 patients were included. The results of Meta-analysis indicated that the proportion of patients who achieved 90％ reduction or more from baseline of psoriasis area and severity index （PASI）in guselkumab group was significantly higher than that placebo group [RR ＝26.72，95％CI（15.98，44.70），P＜0.001]，adaliumumab group [RR ＝1.45，95％CI（1.32，1.59）， P＜0.001] and secukinumab group （P＜0.000 1）. The proportion of patients with Investigator ’s Global Assessment （IGA）score of 0 or 1 in guselkumab group was significantly better than placebo group [RR ＝11.15，95％ CI（8.22，15.14），P＜0.001] and adaliumumab group [RR ＝1.27，95％CI（1.19，1.35），P＜0.001]. The proportion of patients with IGA score of 0，the proportion of patients who achieved 75％ reduction or more from baseline of PASI ，dermatology life qu ality index score of 0 or 1 in guselkumab group were signifi cantly superior than placebo group and adaliumumab gr oup，the proportion of patients who achieved 100％ reduction from baseline of PASI in guselkumab group Lewx- was significantly superior than placebo group （P＜0.05）， inn@outlook.com there was no significant difference compared with adaliumumab group （P＞0.05）. There was no statistical significance in the proportion of patients with IGA score of and other secondary outcome indicators between guselkumab and secukinumab group （P＞0.05）. In the safety indicators as total incidence rate of ADR ，rate of withdrawl due to ADR ，etc. ，there was no statistical significance between guselkumab and placebo/ adalimumab groups （P＞0.05）. CONCLUSIONS ：Guselkumab is superior to placebo ，adaliumumab and secukinumab in improving the symptoms of moderate-to-severe plaque psoriasis with good safety .  
        关键词：Guselkumab;Moderate-to-severe plaque psoriasis;Efficacy;Safety;Systematic review;Meta-analysis   
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      • XIE Kai,LI Zhiping,YANG Yang,XIE Bixiang,XUE Ruzeng
        Vol. 31, Issue 10, (2020)
        摘要：OBJECTIVE：To investiga te the role of clinical pharmacists in drug therapy for patients with severe pemphigus. METHODS：Clinical pharmacists participated in drug therapy for a patient with severe pemphigus. Clinical pharmacist adjusted the doctor’s medication plan in time according to the symptoms and adverse reactions of the patients. In view of several new blisters on the hand palms and back that may be caused by hormone reduction ，the clinical pharmacist suggested that the dosage of Prednisone acetate tablets should be adjusted to 70 mg before administration ，once a day. For poor infection control ，it was recommended to adjust the dose of minocycline to 100 mg，bid；for hypokalemia ，the clinical pharmacist advised the patients to take potassium orally，and added it into juice ，milk or honey for taking ；in order to prevent osteoporosis caused by glucocorticoid ，the clinical pharmacist suggested that patients supplement Calcium carbonate and vitamin D 3 chewable tablets and Alendronate sodium and vitamin D 3 tablets 70 mg at the same time ，once a week. For Candida albicans in patient ’s oral mucosa ，according to the results of drug sensitivity test ，the clinical pharmacists suggested that Itraconazole capsules should be adjusted to Fluconazole capsules 50 mg，once a day. At the same time ，pharmacist paid close attention to the adverse reactions after the infusion of Rituximab injection and pharmaceutical care was provided ，such as ADR monitoring ，discharge medication education. RESULTS ：The doctors took all the advice of clinical pharmacists. The patient recovered and was discharged 47 days later. CONCLUSIONS ：During drug therapy for the patient with severe pemphigus. Clinical pharmacists can help doctors improve the treatment plan so as to ensure the effectiveness and safety of patients ’medication.  
        关键词：Pemphigus;Severe;Pharmaceutical care;Clinical pharmacist   
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