最新刊期
卷 32 ， 期 3 ， 2021
- 摘要：OBJECTIVE：To combine with the concept of process-oriented administration ，and to provide reference for improving the process and measures of the sample retention management and evaluation in drug inspection agencies. METHODS ： From the aspects of organizational management and control measures ，the improvement measures for sample retention management system were investigated. From the aspects of warehouse-in check ，storage management and warehouse-out judgment ，warehouse management and informatization ，the improvement measures for procedures and measures about sample retention management were explored. From the aspects of evaluation content and quality control measures ，the evaluation and continuous improvement of sample retention management were investigated. RESULTS & CONCLUSIONS ：In the aspect of organizational management ，it is necessary to improve management procedures and processes ，determine sample retention objectives and plans ，improve post allocation and management ，and improve safety emergency plans. In the aspect of control measures ，it is necessary to improve the business management measures such as warehouse-in status inspection ，adjust the conditions such as warehouse space allocation ， and improve the intelligent prompt of remaining validity period of samples. The key to the three links of warehouse-in ，storage and warehouse-out are warehouse-in check ，storage space and condition control ，and warehouse-out judgement. The relevant processes and measures can be improved from these aspects. The contents of sample retention management evaluation includes management system，management measures and process ，improvement and evaluation. Plan-Do-Check-Action （PDCA）cycle is a measure to improve the efficiency and quality of sample retention management in drug inspection agencies .关键词：Process-oriented;Drug inspection agency;Sample retention;Process;Management
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the mechanism of risk sharing and transfer of drug marketing authorization holders （MAH）based on drug defects ，and to promote the smooth implementation of MAH system in China. METHODS ：Firstly，the types of drug defects in the whole drug life cycle were analyzed ，and then the sources and “fault party ”of different types of drug defects in the open commissioning environment of the industry chain under the MAH system were also analyzed. Based on it ，the mechanism of risk sharing and transfer of MAH was established combined with foreign experience and China ’s actual situation. RESULTS & CONCLUSIONS ：Drug defects were divided into design defects ，manufacturing & operation & storage & transportation quality defects and use defects ，among which design defects and manufacturing & operation & storage & transportation quality defects were the two most important defects. Design defects mainly included those caused by human factors and those could not be found by current level of science and technology ，the“fault party ”according to different circumstances may be both the research and development institutions and may be the MAH. The “fault party ”of production & operation & storage & transportation quality defects was the drug production & operation & storage & transportation enterprises. For design defects ，it was recommended to establish China ’s adverse drug reaction compensation mechanism through a combination of insurance and relief. For production & operation & storage & transportation quality defects ，it was recommended that the drug quality liability insurance as the main ，contractual agreement as the supplement ，so that the “fault party ”should assume due responsibility.关键词：Marketing authorization holders;Risk sharing;Risk transfer;Drug defects
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the cost control measures for Medicaid prescription drugs in the United States ，and to provide reference for medical insurance cost control in China. METHODS ：The policy documents ，academic papers and news reports were studied to comb the practice of drug cost control policy of Medicaid project in the United States and its impact on medical insurance costs. The suggestions were put forward for medical insurance cost control in China. RESULTS & CONCLUSIONS：The cost control measures of Medicaid prescription drugs adopted in the United States include drug utilization management and drug cost control measure. The former included the list of preferred drugs ，pre-authorization and step therapy ， prescription cost limit ，while the latter included the upper limit control of drug expenditure growth ，closed drug list management ， etc. The list of preferred drugs is the basis of a series of drug cost control measures ，which provides a policy framework for prior authorization and step therapy ；pre-authorization and step therapy are the specific ways to controlling the cost ，and the use of low-cost drugs is encouraged through the guidance of specific cases ；the prescription cost limit starts from controlling the drug cost of a single patient and saves the medical insurance expenditure from another angle ；the drug growth caps control is controlling the total cost of medical insurance expenditure from aspect of overall cost ，which is a supplement to the traditional method ；closed drug list management is a new policy attempt to break through the limitation of preferred drug list. The prescription drug cost control measures adopted by Medicaid project can effectively reduce the drug expenditure to a certain extent ，but it also has the possibility of harming the interests of patients because it can interfere with doctors ’prescription right. China should further strengthen the role of medical insurance in the medical service system ，and carefully learn from the management measures of Medicaid drug utilization in the United States ；improve the dynamic control mechanism of medical insurance expenditure ，take special measures for key drugs ； improve the drug list management mechanism ，pay attention to the three links of access， exit and dynamic adjustment ， guide medical cn institutions to use drugs rationally.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a method for de termining stiripentol （STP）concentration in plasma and brain of rats ， and to compare the concentrations of STP and its self-nanoemulsifying drug delivery system （STP-SNEDDS）in plasma and brain. METHODS：Using xanthone as internal standard ，HPLC-fluorescence（HPLC-FLR）method was adopted. The determination was performed on Diamonsil C 18 column with mobile phase consisted of acetonitrile- 25 mmol/L KH 2PO4 solution [ 44 ∶ 56（V/V），pH 2.6] at a flow rate of 1.5 mL/min；the excitation and emission wavelengths were 210 nm and 400 nm，respectively；the column temperature was 30 ℃；the sample size was 10 μL. Totally 36 rats were randomly divided into 2 groups，with 18 rats in each group. They were given STP-SNEDDS and STP suspension （40 mg/kg，by STP ）intragastrically. Blood and brain tissue samples were collected at 0.5，1，2 h after administration （6 rats in each group at different time point ）. After the protein was precipitated by acetonitrile （brain tissue should be homogenized ），the concentrations of STP were determined by the above chromatographic conditions. RESULTS ：The linear ranges of STP concentration in plasma and brain tissue were 0.02-8.00 μg/mL（r were 0.999 6， 0.999 4，respectively）. The limits of quantitation were both 0.02 μg/mL. The inter-day and intra-day RSDs were all less than 5％. The extraction recovery and method recovery were all no less than 90％. Compared with STP suspension group ，the plasma concentration（except for 1 h after administration ）and cerebral concentration （except for 2 h after administration ）of STP in STP-SNEDDS group were all significantly increased （P＜0.05），showing significant linear relationship between them （for STP-SNEDDS）. CONCLUSIONS ：Established HPLC-FLR method presents high accuracy and precision ，and can be used for the distribution of STP and STP-SNEDDS in plasma and brain.The concentration of STP in plasma and brain tissue isincreased after STP is made into SNEDDS.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To s tudy the effects of Dracocephalum moldavica total flavonoids （TFDM）on AMPK/SIRT 1/PGC-1α signaling pathway ，and to explore the mechanism of its protective effect on myocardial ischemia reperfusion injury （MIRI）rats. METHODS：Totally 50 healthy male SD rats were randomly divided into sham operation group ，model group ，TFDM group [ 60 mg/（kg·d），by extract] ，Compound C+TFDM group [ig administration of 60 mg/（kg·d）TFDM+intravenous injection of 250 μg/kg Compound C（AMPK inhibitor ）via tail vein 15 min before reperfusion] ，EX-527+TFDM group [ig administration of 60 mg/ （kg·d）TFDM+ip injection of 5 mg/kg EX- 527（SIRT1 inhibitor）20 min before reperfusion] ，with 10 rats in each group. They were given relevant medicine intragastrically ，once a day ，for consecutive 7 days. After last ig administration ，sham operation group underwent sham operation ，other 4 groups were established MIRI model by ligating left anterior descending coronary artery ， ischemia for 30 min and reperfusion for 2 h. After reperfusion ，the myocardial histopathological changes were observed by HE staining；RP-HPLC method was used to determine the contents of ATP ，ADP，AMP and NAD + in cardiac tissue. mRNA expressions of AMPK ，SIRT1 and PGC- 1α were detected by quantitative real-time PCR assay. Western blotting assay was the expressions of SIRT 1 and PGC- 1α protein in myocardium. RESULTS： Compared with sham operation group ， model group showed myocardial fib ers arranged disorder and horizontal stripes disappearance ，cell swelling burst and necrosis ，and nuclei deformation displacement ；the contents of ATP and NAD+，mRNA expression of AMPK ，SIRT1 and PGC- 1α，protein expression of SIRT 1 and PGC- 1α in cardiac tissue were decreased significantly （P＜0.05 or P＜0.01）；the contents of ADP and AMP ，the phosphorylation level of AMPK protein were increased significantly （P＜0.01）. Compared with model group ，myocardial pathological morphology were improved significantly in TFDM group ；the contents of ATP and NAD + in cardiac tissue ，mRNA expression of AMPK ，SIRT1 and PGC- 1α，the phosphorylation level of AMPK protein ，the protein expression of SIRT 1 and PGC- 1α were increased significantly（P＜0.05 or P＜ 0.01），while the contents of ADP and AMP were decreased significantly （P＜0.01）. Compared with TFDM group ，improvement effects of Compound C + TFDM group and EX- 527 + TFDM group on above indexes were reversed （P＜0.05 or P＜0.01）. CONCLUSIONS：TFDM may play a protective role on myocardium by activating AMPK/SIRT 1/PGC-1α signaling pathway and regulating energy metabolism.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To ex plore the improvement effects of small-molecule glucagon-like peptide- 1 receptor（GLP-1R） agonists（6，7-dichloro-2-methylsulfonyl-3-N-tert-butylaminoquinoxaline，DMB）on osteoporosis model mice. METHODS ：C57BL/ 6J mice were randomly divided into sham operation group ，model group ，positive control group （17β-estradiol，10 μg/kg）and DMB group （1 mg/kg），with 10 mice in each group. The sham operation group received bilateral laparotomy without ovariectomy ， and the other groups received bilateral ovariectomy to reproduce the osteoporosis model. At 4th week after operation ，sham operation group and model group were given constant volume of florence oil intragastrically ；administration groups were given relevant medicine intragastrically ，once a day ，for consecutive 8 weeks. After last medication ，Micro-CT was used to detect the femur microstructure ，bone mineral density （BMD），bone mineral content （BMC）and bone morphometric parameters [bone tissue volume fraction （BV/TV），trabecular thickness （Tb.Th），trabecular number （TB.N）and trabecular spacing （Tb.Sp）]. ELISA assay was used to detect the expression of bone formation indexes [bone specific alkaline phosphatase （BALP），osteoprotegerin（OPG）] and bone resorption indexes [tartrate resistant acid phosphatase （TRAP）and C-terminal cross-linked peptide of type Ⅰ collagen （CTX-Ⅰ）]. Three-point bending test was used to detect biomechanical parameters （maximum load ，stiffness，stress and Young ’s modulus）of femur of mice in each group. RESULTS ：In sham operation group ，trabeculae were numerous ，thick，complete in morphological structure ，well-organized and reticular ；bone Δ 基金项目：国家自然科学基金资助项目（No.81402931）；陕西省 重点研发计划项目（No.2017SF-261）；西安医学院 2016年博士科研启 microstructure and bone mass were normal. Compared with 动基金项目（No.2016DOC27） sham operation group ， the number of trabecular bone ＊讲师，博士。研究方向 ：分子药理学 。E-mail：zhouying209@ decreased，the thickness became thinner ，twisted or broken ， 163.com and the trabecular space increased ；the bone microstructure ·284· China Pharmacy 2021Vol. 32 No. 3 中国药房 2021年第32卷第3期 deteriorated and the bone m ass decreased ；BMD，BMC，BV/TV，Tb.Th，Tb.N and biomechanical parameters of femur were decreased significantly ，while Tb.Sp and serum levels of BLAP ，OPG，TRAP and CTX- Ⅰ were increased significantly （P＜0.05 or P＜0.01）. Compared with model group ，the bone mass of positive control group and DMB group were increased ，while the number，thickness and shape of trabecular bone partially recovered ；BMD，BMC，BV/TV，Tb.Th，Tb.N and biomechanical parameters of femur were increased significantly （P＜0.05 or P＜0.01）；Tb.Sp，serum levels of BLAP and OPG were increased significantly （P＜0.01）， while the levels of TRAP and CTX- Ⅰ were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS：DMB can improve osteoporosis by increasing bone mass ，improving bone microstructure ，increasing the expression of bone formation related indexes and biomechanical parameters and decreasing bone resorption related indexes.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the method for the content determination of inorganic elements in Cyperus rotundus ，and to compare the contents of 14 kinds of inorganic elements in C. rotundus from different producing areas ，and to provide theoretical basis for its quality control and high quality resources development . METHODS ：The samples were processed by microwave digestion，and ICP-MS method was used to determine the contents of Na ，Mg，K，Ca，Mn，Fe，Ni，Cu，Zn，As，Se，Sr，Cd and Pb. SPSS 23.0 software were used for principal component analysis （PCA）and cluster analysis. RESULTS ：The average contents of above 14 kinds of inorganic elements in C. rotundus from different producing areas were 168.62，753.71， 6 938.33，24.31，14.69，197.77，0.60，2.43，26.89，0.21，0.06，5.64，0.05，0.32 mg/kg，respectively. The results of PCA showed that the cumulative variance contribution rate of the first four principal components was 86.203％，which could reflect most of the information of the original data. C. rotundus from Shandong ，Jiangxi，Shanxi，Hubei and Yunnan ranked the top five places in terms of comprehensive score of inorganic element contents. The results of cluster analysis showed that the samples from 9 producing areas were clustered into 5 categories，showing the characteristics of clustering by producing area. From the perspective of inorganic elements ，the quality of C. rotundus from East China ，Central China ，North China and Southwest China was better than that from South China. CONCLUSIONS ：Essential trace elements like Na ，Mg，K，Ca，Mn，Fe，Cu，Zn，Sr are rich in C. rotundus，and there are small amounts of Ni ，As，Se，Cd，Pb elements in it. The contents difference of inorganic elements in C. rotundus from different origins may related to the geographical area it belongs to.
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发布时间：2022-06-21 - 摘要：OBJECTIVE： To establish pre- column derivatization-HPLC fingerprint of polysaccharide from Achyranthes bidentata，and to determine the contents of monosaccharide components ，so as to provide reference for quality evaluation of A. bidentata decoction pieces. METHODS ：Taking 10 batches of A. bidentata decoction pieces from different manufacturers as samples，the polysaccharides were extracted by water extraction and alcohol precipitation ，hydrolyzed by trifluoroacetic acid ，and then derivatized by 1-phenyl-3-methyl-5-pyrazolone for HPLC analysis. The determination was performed on Hanbon Hedera C 18 column with column temperature of 30 ℃ at the flow rate of 1.2 mL/min. The mobile phase consisted of acetonitrile- 0.02 mol/L ammonium acetate solution （gradient elution ）. The detection wavelength was set at 250 nm，and sample size was 20 μL. HPLC fingerprint was established and similarity evaluation was performed for 10 batches of A. bidentata polysaccharide by using TCM Chromatogramic Fingerprint Similarity Evaluation System （2012A edition ）. The common peak was identified by comparing with the reference substance ，and cluster analysis was performed by using SPSS 25.0 software. The contents of identified monosaccharides were determined by HPLC. RESULTS ：The similarity of 10 batches of A. bidentata polysaccharide were all higher than 0.95. Nine common peaks were fixed and a total of 5 common peaks were identified ，namely anhydrous glucose （peak 1）， mannose（peak 2），rhamnose（peak 4），galacturonic acid （peak 5）and arabinose （peak 7）. Results of cluster analysis showed that S1 sample was classified into one category ；S2，S5，S8 and S 9 samples were clustered into one category ；S3，S4，S6，S7 and S10 samples were clustered into one category. Results of content determination showed that the contents of anhydrous glucose in 10 batches of samples ranged from 6.17 to 17.55 mg/g；those of mannose ranged from 3.31 to 7.66 mg/g；those of rhamnose ranged from 38.80 to 73.97 mg/g；those of galacturonic acid ranged from 2.49 to 8.95 mg/g；those of arabinose ranged from 11.30 to 28.58 mg/g. CONCLUSIONS ：Established pre-column derivatization HPLC fingerprints and content determination method can provide reference for quality evaluation of A. bidentata decoction pieces.关键词：Achyranthes bidentata polysaccharide;Monosaccharide;Pre-column derivatization;HPLC;Fingerprint;Contnet
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of the main active components of Naoxintong capsule （NXTC）on the proliferation of human umbilical vein endothelial cell（HUVEC） and its key protein JAK/STAT signal pathway ， vasoactive substances ，adhesion molecules and inflammatory factors so as to clarify the m echanism of NXTC for promoting blood circulation and removing blood stasis. METHODS ：The effects of different concentration of 12 active components [caffeic acid（1.56-200 μmol/L），ferulic acid （1.56-200 μmol/L），senkyunolide H （3.125-200 μmol/L），n-butylidenephthalide（3.125-200 μmol/L），ligustilide（1.56-200 μmol/L），cryptotanshinone（0.625-80 μmol/L），tanshinol sodium （1.56-200 μmol/L），paeoniflorin （1.56-200 μmol/L），formononetin（1.56-200 μmol/L），salvianolic acid B （1.56-200 μmol/L），catechin（1.56-200 μmol/L）and astragaloside Ⅳ（1.56-200 μmol/L）] on the proliferation of HUVECs were evaluated by CCK- 8 assay. The effects of above active components（3 dose groups ，setting up 0 μmol/L blank control group，hereinafter）on mRNA expression of key proteins JAK 2， STAT3，Akt，ERK in JAK/STAT signal pathway were measured by RT-PCR. The effects of each active component on the expression of PAI- 1，VCAM-1，ICAM-1，VEGF and NF-κB p65 were detected by ELISA. RESULTS ：Ferulic acid （6.25，25-200 μg/mL），senkyunolide H （6.25-200 μmol/L），ligustilide（200 μmol/L），cryptotanshinone（10-80 μmol/L），paeoniflorin（1.56， 6.25，12.5 μmol/L），salvianolic acid B （1.56-12.5 μmol/L，200 μmol/L）and catechin （25 μmol/L）could significantly inhibit the proliferation of HUVECs ；caffeic acid （1.56，12.5 μmol/L），ligustilide（50 μmol/L），trashinol sodium （6.25 μmol/L）and paeoniflorin（1.56，100，200 μmol/L）could significantly promote the proliferation of HUVECs （P＜0.05 or P＜0.01）. Compared with blank control group ，mRNA expression of JAK 2，STAT3 and Akt were decreased significantly in some dose groups of ferulic acid，formononetin，salvianolic acid B and astragaloside Ⅳ（P＜0.05 or P＜0.01）；the expression of PAI- 1 were significantly decreased in some dose groups of caffeic acid ，ferulic acid and n-butylphthalide；the expression of ICAM- 1 and VCAM- 1 were decreased significantly in some dose groups of caffeic acid ，ferulic acid ，n-butenylphthalide，cryptotanshinone，formononetin and catechin；the expression of NF-κB p65 were decreased significantly in some dose groups of ferulic acid ，n-butenylphthalide， formononetin，salvianolic acid B and astragaloside Ⅳ；the expression of VEGF were increased significantly in some dose groups of caffeic acid and catechin （P＜0.05 or P＜0.01）. CONCLUSIONS ：The active components of Naoxintong capsule may play the role of promoting blood circulation and removing blood stasis by inhibiting the expression of JAK/STAT signal pathway key protein mRNA and PAI- 1，ICAM-1，VCAM-1，NF-κB p65 in HUVEC ，and promoting the expression of VEGF.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate inhibitory effects of Qing fei baoyu an capsule on airway inflammation in rats with chronic obstructive pulmonary disease （COPD），and its effects on NLRP 3 signaling pathway. METHODS ：Totally 60 SD male rats were randomly divided into blank control group ，model group ，dexamethasone group （positive control ，0.2 mg/kg），Qingfei baoyuan capsule high-dose ，medium-dose and low-dose groups （1 232.0，616.0，308.0 mg/kg），with 10 rats in each group. Except for blank control group ，other groups were fumigated for 28 days and given intratracheal dripping of lipopolysaccharide twice to induce COPD model. Since the 29th day after modeling ，blank control group and model group were given constant volume of normal saline intragastrically ，and administration groups were given related medicine intragastrically. The administration volume was 10 mL/kg，once a day ，for consecutive 28 days. After last administration ，the lung function was detected. The pathological changes of lung tissue were observed by HE staining. The content of interleukin- 1β（IL-1β）in bronchoalveolar lavage fluid （BALF）were detected by ELISA ，and the number of leukocytes was counted ；the expression of NLRP 3 and Cleaved caspase- 1 in lung tissue of rats were detected by Western blotting assay. RESULTS：Three，two，one，one and two rats died in model group， dexamethasone group ， Qingfei baoyuan capsule high-dose，medium-dose and low-dose groups ，respectively. Compared with blank control group ，FEV0.3/FVC of rats in # model group was significantly decreased （P＜0.01）. A large number of inflammatory cells infiltration we re found in the lung tissue ，and lung tissue lesion was obvious. The content of IL- 1β and white blood cell count in BALF，relative expression of NLRP3 and Cleaved caspase- 1 protein in lung tissue were increased significantly （P＜0.05 or P＜0.01）. Compared with model group，FEV0.3/FVC of administration groups were increased significantly （P＜0.05 or P＜0.01）；lung tissue lesion of them were improved to different extents. The content of IL- 1β and white cell count in BALF，relative expression of NLRP 3 protein（except for Qingfei baoyuan capsule low-dose group ）and Cleaved caspase- 1 protein（except for Qingfei baoyuan capsule medium-dose and low-dose groups ）in lung tissue were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：Qingfei baoyuan capsule can relieve lung tissue lesion and improve lung function in COPD model rats ，the effects of which may be associated with inhibiting inflammation reaction by inhibiting NLRP 3 signaling pathway.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the improvement effect of Shenling baizhu p owder on irritable bowel syndrome with diarrhea（IBS-D）model mice with anxiety ，and to elucidate its mechanism from the point of view of intestinal microecology. METHODS：C57 BL/6 mice were randomly divided into blank control group ，model group ，Shenling baizhu powder group （3.6 g/kg），with 8 mice in each group. Except for blank control group ，IBS-D model with anxiety was established in model group and Shenling baizhu powder group by giving corticosterone subcutaneously combined with intragastric administration of Folium Sennae decoction and chronic restraint treatment. After modeling ， blank control group and model group were given intragastric administration of normal saline ，and Shenling baizhu powder group was given relevant medicine intragastrically ，for consecutive 4 weeks. After last medication ，loose stools rate ，diarrhea index ，body weight ，sugar water preference percentage ，the times of crosssing open field center area and minimum pain threshold as well as the levels of BDNF in hippocampal tissue and 5-HT in serum were detected in each group. The cecal contents of mice in each group were extracted for microbial DNA extraction and sequencing； the abundance and diversity of intestinal microorganisms were analyzed by Alpha and Beta diversity analysis. RESULTS ： Compared with blank control group ，body weight ，sugar water preference percentage ，the times of crossing open field center area and minimum pain threshold as well as the levels of BDNF in hippocampal tissue ，relative abundance of Firmicutes phylum microorganism in intestine ， relative abundance of Lachnospiraceae_NK4A136_group genus microorganism were decreased significantly （P＜0.05）；loose stools rate，diarrhea index ，serum level of 5-HT，relative abundance of Verrucomicrobia phylum microorganism and relative abundance of Ackermann phylum microorganism were increased significantly （P＜0.05），and there were great differences in the types of intestinal microorganisms. Compared with model group ，body weight ，sugar water preference percentage ，the times of crossing open field center area ，minimum pain threshold ，BDNF level of hippocampus ，relative abundance of Firmicutes phylum microorganism，relative abundance of Lachnospiraceae_NK4A136_group genus microorganism were increased significantly （P＜ 0.05 or P＜0.01）；loose stools rate ，diarrhea index ，serum level of 5-HT，relative abundance of Verrucomicrobia phylum microorganism and relative abundance of Ackermann phylum microorganism were decreased significantly （P＜0.05），and and there were great differences in the types of intestinal microorganisms. CONCLUSION ：Shenling baizhu powder can improve the diarrhea and anxiety behavior of IBS-D model mice with anxiety ，increase the level of BDNF in hippocampus and decrease serum level of 5-HT. Its mechanism may be related to decreasing relative abundance of Verrucomicrobia phylum microorganism and Ackermann phylum microorganism ，increasing the relative abundance of Firmicutes phylum and Lachnospiraceae_NK4A136_group genus microorganism.关键词：Shenling baizhu powder;Irritable bowel syndrome with diarrhea;Anxiety;Microorganism;Intestine
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prepare Liguatrazine opthalmic liposome therm osensitive gel ，and to investigate its in vivo and in vitro characteristics. METHODS ：The ammonium sulfate gradient method was used to prepare Liguatrazine liposomes. The preparation technology was optimized by using orthogonal test. Using poloxamer P 407 as gel matrix ，Liguatrazine liposomes were prepared into thermosensitive gel. A membraneless model was used to study the dissolution and in vitro drug release of the gel. The modified Franz diffusion cell was used to investigate corneal permeability and further determine corneal hydration value. The effects of the gel on the proliferation of human corneal epithelial cell HCE-T. HE staining and Draize test were used to investigate the stimulatory effects of the gel on corneal cells of the rabbit ，and the histological changes of the eyes were observed. RESULTS ：The optimal preparation technology of Liguatrazine liposome was drug-lipid ratio of 1 ∶ 10（m/m），the ammonium sulfate concentration of 0.2 mol/L，phospholipid-cholesterol ratio of 4∶1（m/m），incubation temperature of 45 ℃. Then ligustrazine opthalmic liposome thermosensitive gel was prepared with 23％ poloxamer P 407 as gel matrix. The gel had good gelatinization temperature. The in vitro drug release and dissolution showed zero-order kinetic characteristics ，and in vitro drug release of the gel was mainly related to dissolution （R2＝0.993 4）. The cumulative transcorneal permeability of the gel was 43.3％ within 6 hours and corneal hydration value was 72.98％. Low and medium concentrations （1，5 mg/L）of Ligustrazine opthalmic liposome thermosensitive gel had no obvious proliferation toxicity to HCE-T cells ，but it showed cytotoxicity at high concentration （10 mg/L）. The mean Draize eyeirritation score of the gel on rabbit cornea was within non-stimulation，and there was no abnormal change in rabbit （No.2018001） corneal histology. CONCLUSIONS ： Prepared Ligustrazine opthalmic liposome thermosensitive gel has a suitable phase transition temperature ，good corneal permeability ，and low corneal irrit ation.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To utilize ADR signal of Paclitaxel for injection （albumin-bound type ）by using FDA adverse event reporting system （FAERS），and to provide reference for rational use of drugs in the clinic. METHODS ：The reporting odds ratio （ROR）method was used for data mining of adverse events （AEs）related to Paclitaxel for injection （albumin-bound type ）reported by FDA public data program （Open-FDA）during Jan. 1st，2004-Dec. 31th，2019. The demographic characteristics ，constituents and signals of ADR were analyzed. RESULTS ：A total of 1 659 AEs were identified for Paclitaxel for injection （albumin-bound type）. The female （1 169 cases，70.5％）was more than the male （345 cases，20.8％）. The age was mainly 45-64 years old （519 cases，31.3％）. ADR signal mainly involved nerve system ，blood and lymphatic system ，gastrointestinal system ，hepatobiliary system，respiratory system ，thoracic and mediastinal system and general ADR. Twenty positive ADR signals which were not recorded in the drug instructions were found in the study ，mainly including leucopenia ，lymphopenia，macular edema ，abdominal pain，dysphagia，shivering，jaundice，liver failure ，cirrhosis，urinary tract infection ，purulent secretion ，decreased ejection fraction，hypocalcemia，hypokalemia，hyponatremia，bone pain ，facial paralysis ，mental state change ，epistaxis，atelectasis. Among them ，lymphopenia，macular edema and mental state changes were not recorded in the drug instructions ，while others were the specific manifestations of ADR recorded in the drug instructions. CONCLUSIONS ：In the clinical application of Paclitaxel for injection（albumin-bound type ），in addition to ADR mentioned in the drug instructions ，great importance should be closely paid to neurotoxicity，lymphocyte changes ，regular eye monitoring 2021MSXM041） and mental state monitoring ，so as to avoid drug withdrawal or organ injury induced by ADR.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the clini cal features of thrombocytopenia induced by antidepressants ，and to provide reference for the rational use of clinical drugs. METHODS ：Retrieved from CNKI ，Wanfang database ，VIP，PubMed and Web of Science，during Jan. 1st in 1985 to Aug. 31st in 2020，case reports about antidepressants-induced thrombocytopenia was collected and analyzed descriptively in terms of demographic characteristics ，medication，clinical manifestations ，treatment and outcome. RESULTS：A total of 17 literatures were retrieved ，and 19 patients were included ，involving 10 male and 9 female，aged from 5 to 95 years old ，with an average of （48±24）years old. Nine kinds of drugs were involved ，including 4 cases of escitalopram ，3 cases of citalopram ，3 cases of fluoxetine ，3 cases of mirtazapine ，2 cases of amitriptyline ，1 case of sertraline ，1 case of paroxetine，1 case of mianserin and 1 case of imipramine. There were 9 cases of single drug and 10 cases of drug combination. All 19 patients suffered from thrombocytopenia at 3 d-10 years after medication ，14 of them had hemorrhage tendency. Main clinical manifestations included mucocutaneous hemorrhage ，gingival bleeding ，black stool ，hematochezia，vaginal bleeding ，ocular hemorrhage，alveolar hemorrhage. No bleeding was found in 5 cases. After drug withdrawal/changing drugs and other symptomatic treatment， platelet count of 19 patients recovered to normal ， and bleeding symptoms disappeared. CONCLUSIONS ： Thrombocytopenia caused by antidepressants has no obvious clinical features and is not easy to be found ，but it may lead to severe； bleeding symptoms if it is not found in time. The changes of platelet count should be closely monitored in clinical application of such drugs to ensure the safety of drug use.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To systematically evaluate therape utic efficacy of Yixinshu preparation combined with conventional treatment plan for angina pectoris of coronary heart disease （CHD）vs. conventional treatment plan ，and to provide evidence-based reference for clinical drug use. METHODS ：Retrieved from Cochrane library ，PubMed，Embase，CBM，CNKI，Wanfang database and VIP ，randomized controlled trials （RCTs）about Yixinshu preparation combined with conventional treatment plan （trial group ） versus conventional treatment plan （control group ）for angina pectoris of coronary heart disease were collected during Jan. 1st in 2012 to Oct. 1st in 2020. After extracting the data ，the quality of included studies were evaluated with Cochrane System Evaluator Handbook 5.3；Meta-analysis was performed by using Stata 15.0 software. RESULTS ：A total of 23 RCTs involving 2 853 subjects were included. The results of Meta-analysis showed that the efficacy of angina pectoris [RR ＝0.92，95％CI（0.87，0.97），P＜0.05]， the times of angina pectoris attack [SMD ＝－0.98，95％CI（－1.09，－0.87），P＜0.05]，the duration of angina pectoris [SMD ＝ －0.77，95％CI（－0.88，－0.67），P＜0.05]，ECG curative effect [RR ＝0.91，95％CI（0.84，0.98），P＜0.05] and the improve rate of TCM syndromes [RR ＝0.89，95％CI（0.85，0.94），P＜0.05] in trial group were all better than control group ，with statistical significance. CONCLUSIONS ：Yixinshu preparation combined with conventional treatment plan is better than conventional treatment plan in terms of improving therapeutic efficacy of angina pectoris and ECG ，TCM syndrome improvement rate ，as well as reducing the frequency of angina pectoris attack ，angina pectoris attack duration.关键词：Yixinshu;Drug combination;Coronary heart disease;Angina pectoris;Therapeutic efficacy;Meta-analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the effectiveness and safety of int ensified dose and standard dose of mycophenolic acids （MPA）for kidney transplant recipients ，and to provide evidence-based reference for clinical use of drugs. METHODS ：Retrieved from Embase ，PubMed，Cochrane library ，Clinical trials ，CNKI，Wanfang database and CBM ，randomized controlled trial （RCT） and cohort study about intensified dose and standard dose of clinical commonly used Mycophenotate mofetil （MMF） and Mycophenolate sodium enteric-coated tablet （EC-MPS）for adult kidney transplant recipients were collected during the inception to Mar. 2020. After literature screening and data extraction ，the quality of RCTs were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator manual 5.0. The quality of cohort study was evaluated by NOS scale. Meta-analysis was performed by using Rev Man 5.3 software，and sensitivity analysis was conducted. RESULTS ：A total of 8 studies were included，involving 6 RCTs，2 cohort studies ，with 1 637 patients involved. Meta-analysis results showed that ，the incidence of biopsy-proven acute rejection （BPAR）[RR＝0.65，95％CI（0.48，0.89），P＝0.007] and cytomegalovirus （CMV）infection [RR ＝ 0.39，95％CI（0.17，0.91），P＝0.03] in intensified dose groupwere significantly lower than control group. Subgroup analysis by drug showed that the incidence of BPAR in MMF intensive dose group [RR ＝0.72，95％CI（0.53，0.99），P＝0.04] and EC-MPS intensive dose group [RR ＝0.19，95％ CI （0.04， 0.81），P＝0.03] was significantly lower than that in standard zhaorongsheng@bjmu.edu.cn dose group ； there was n o statistical significance in the incidence of CMV infection in MMF intensive dose group [RR ＝0.16，95％CI（0.02，1.33），P＝0.09] and EC-MPS intensive dose group [RR ＝0.51，95％CI（0.20，1.30），P＝0.16]，compared with standard dose group （P＞0.05）. There was no significant difference in the incidence of rejection，treatment failure ，graft loss ，termination of treatment ，death，overall adverse events ， infection（overall），BK virus infection ，urinary tract infection ，hematological adverse events （overall），leucopenia，anemia， thrombocytopenia，gastrointestinal adverse events （overall），nausea，vomiting or diarrhea between 2 groups（P＞0.05）. Sensitivity analysis showed that the incidence of rejection ，CMV infection and leukopenia were generally stable. CONCLUSIONS ：The efficacy and safety of early intensive dose of MPA in adult renal transplant recipients were similar to those of standard dose ，but the incidence of rejection ，CMV infection and leucopenia should be carefully interpreted.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide evidence for promoting the scientific resea rch ability and talent team construction of hospital pharmacists. METHODS ：From Dec. 2019 to Apr. 2020，“Survey Form for Scientific Research Ability of Hospital Pharmacists”were issued to pharmacists in 62 medical institutions from 20 provinces across the country. The questionnaire was mainly based on five aspects ，i.e. general information of surveyed pharmacists ，the number of internal/external funds and patents approved in recent five years （2015-2019），the number of papers published in domestic/abroad/SCI journals ，the familiarity with scientific research projects ，the difficulties in carrying out scientific research. The collected data were summarized and analyzed with R 4.0.3 software. RESULTS ：A total of 300 questionnaires were sent out ，and 288 valid questionnaires were collected with effective recovery rate of 96％. Among surveyed pharmacists ，94 were male and 194 were female. The majority of them were 31-39 years old （52.78％）；56.25％，28.12％ and 15.63％ of them had bachelor ’s degree ，master’s degree and doctor ’s degree respectively，and 156（54.17％）had intermediate title. Totally 74.66％ of hospital pharmacists thought it was very necessary or necessary to carry out research projects （involving all doctors ，26 masters and 4 bachelors）. There were significant differences among pharmacists with different educational background in respects of the number of applications for internal and external funds and patents ，as well as the number of papers published in domestic/foreign/SCI journals ，and most of them were doctors （P＜ 0.05）. In recent five years ，most of hospital pharmacists had published 1-3 papers in domestic journals ，accounting for 44.80％， while 27.08％ had published papers in SCI journals. Totally 51.39％ of hospital pharmacists were not familiar or not very familiar with scientific research projects funding （most of them had bachelor ’s degree ）；52.43％ expressed that experimental conditions were the biggest difficulty in conducting scientific research. CONCLUSIONS：This survey shows that hospital pharmacists have a relatively positive attitude towards scientific researchprojects. Most of papers are published in domestic journals. 8804919。E-mail：songjc1234@126.com However， there are still many shortcomings in scientific research status. Scientific research capabilities need to be improved. Experimental conditions also limit the scientific research projects to a certain extent. Hospitals need to strengthen funding for pharmacist research projects ，strengthen academic exchanges ， so that pharmacists can understand scientific research projects more comprehensively and systematically.关键词：Hospital pharmacist;Scientific research capabilities;Status quo;Investigation
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To understand the current status of clinical understanding of “prohibiting”“avoiding”“using caution ” in the application of TCM ，and to provide reference for standardizing the connotation and rational application of “prohibiting” “avoiding”“using caution ”of TCM. METHODS ：Based on the theory of “knowledge-attitude-behavior”，doctor-pharmacist questionnaires and patient questionnaires were designed on the basis of literature research and clinical practice. Through the “Tencent questionnaire ”platform，800 doctor-pharmacist questionnaires were distributed to nearly 300 medical institutions from 32 provinces（cities，autonomous regions ）and 800 patient questionnaires were distributed to public patiants who had used TCM nationwide by anonymous online method. After dimensionality reduction of the questionnaire from three dimensions of cognition ， attention and behavior ，the cognition ，attention and behavior of “prohibiting”“avoiding”“using caution ”in the application of TCM were evaluated by 10 points system. RESULTS ：A total of 703 doctor-pharmacist questionnaires were collected ，including 638 valid questionnaires with recovery rate of 87.9％ and effective rate of 90.8％；Cronbach alpha coefficient was 0.90. A total of 644 patient questionnaires were collected ，including 621 valid questionnaires with recovery rate of 80.5％ and effective rate of 96.4％ . The cognition score of doctors and pharmacists to the terms of “prohibiting”“avoiding”“using caution ”in clinical application of TCM was （7.94±1.21），and that of patients was （5.64±1.54）. The score of doctors and pharmacists ’attention to the above terms was （9.47±1.15）（Spearman Rho correlation coefficient with cognition score was 0.077，P＞0.05），and the score of behavioral ability of patients was （7.01±1.71）（Spearman Rho correlation coefficient with cognition score was －0.021，P＞ 0.05）. The score of behavior ability was （7.43 ± 1.72） （Spearman Rho correlation coefficient with cognition score was 0.233，P＜0.01）. TCM textbooks （89.2％），trainingmeetings （66.5％） and herbal prescriptions （58.2％） were the main ways for doctors and pharmacists to learn the above taboos. Medical staff （74.2％）and internet （52.5％）were the main ways for patients to understand the above taboos. CONCLUSIONS ：Doctors，pharmacists and patients pay more attention to the terms of “prohibiting”“avoiding”“using caution ”in the clinical application of TCM ，but their cognition and executive power were low. Clinical cognition of “prohibiting”“avoiding”“using caution ”in the application of TCM is relatively vague，and the corresponding clinical practice behavior is lacking. It is yet to establish clinical specialist consensus in the field of TCM and publicize it actively to improve the level of clinical rational drug use.关键词：TCM;Clinical application;Taboos;Cognition;Attention;Execution power
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for the ra tional use of carbap enems in tuberculosis patients. METHODS ：Totally 12 576 tuberculosis inpatients were collected from our hospital. Multi-disciplinary team （MDT） model was adopted for carbapenems management in aspects of policy intervention ，technical support and staff training. Average hospitalization duration ， mortality，nosocomial infective rate ，use and drug resistance of carbapenems were compared before （Mar. 2016-Mar. 2017）and after management （Apr. 2017 to Mar. 2019）. Interrupted time series （ITS）analysis was used to analyze the utilization rate of carbapenems，DDDs，the proportion of carbapenems ’DDDs in the total antibiotics ’DDDs，the proportion of carbapenems ’cost in the total antibiotics ’cost before and after management. Pearson correlation analysis was conducted for DDDs of carbapenems with medical quality indicators and detection rate of carbapenems-resistant bacteria. RESULTS ：After the management ，average hospitalization stay ，the cost of antibiotics ，DDDs of carbapenems ，the proportion of carbapenems ’DDDs in the total antibiotics ’ DDDs，the proportion of carbapenems ’cost in the total antibiotics ’cost，the utilization rate of carbapenems ’，and the drug resistance rate of some bacteria to carbapenems were significantly lower than those before the management （P＜0.05）. ITS analysis results showed that after management ，the utilization rate of carbapenems ，DDDs，the proportion of com carbapenems’DDDs in the total antibiotics ’DDDs and the proportion of carbapenems ’cost in the total antibiotics ’cost hhyyzj@126.com were decrease d by 4.491％ ，220.276，6.535％ ，11.747％ ， with statistical significance （P＜0.05）. Co mpared with before management ，above indexes were decreased by 0.330％，17.625， 0.308％，0.304％ monthly，among which the utilization rate and DDDs of carbapenems were decreased significantly （P＜0.05）. Before management ，drug resistance rate of Pseudomonas aeruginosa to carbapenems was 21.80％，and those of Acinetobacter baumannii to meropenem and imipenem were both 4.60％；after management ，drug resistance rate of P. aeruginosa to imipenem was 13.00％，and those of A. baumannii to meropenem and imipenem were both 16.30％，with statistical significance before and after management （P＜0.05）. There was no statistical significance in drug resistance rate of Enterobacteriaceae （P＞0.05）. Pearson correlation analysis showed that carbapenems ’DDDs was significantly positively correlated with average hospitalization duration and antibiotics ’cost（P＜0.05）；imipenem’s DDDs was positively correlated with drug resistance rate of P. aeruginosa （P＜0.05）. CONCLUSIONS： MDT management can effectively standardize the use of carbapenem in tuberculosis patients ， shorten hospitalization duration ，and reduce drug cost ，DDDs and drug resistance rate of some bacteria.关键词：Multi-disciplinary team;Antibiotics;Carbapenems;Tuberculosis;Interrupted time series analysis;Drug resistance
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发布时间：2022-06-21
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