最新刊期
卷 32 ， 期 20 ， 2021
- 摘要：OBJECTIVE：To provide reference for the related research and policy-making of drug network transaction governance model. METHODS ：Based on the highly chimerism of agile governance concept and drug network transaction ，the governance dilemma of the existing drug network transaction mode were analyzed ，and the optimization path was refined from the perspectives of governance objectives ，tools and subjects. RESULTS & CONCLUSIONS ：The unique complexity and innovation of drug network transactions had brought many challenges to the regulatory authorities ，which not only manifested that it was difficult to choose governance objectives and governance tools ，but also manifested that the addition of multiple subjects had broken the traditional single supervision mode. In order to further optimize the governance of drug network transactions ，it is necessary to adhere to the concept of agile governance ，intervene in the market with a more positive attitude ，and pursue the balance between safety and efficiency ；respond to risks with more flexible tools ，and achieve the unity of inclusiveness and prudence ；participate in governance with more diversified subjects ，and form a pattern of joint efforts of government ，enterprises and society.关键词：Agile governance;Drugs;Network transaction;Governance mode
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for the stable operation of TCM industrial technology innovation strategic alliance（called“TCM industrial alliance ”for short ）as well as the transformation and upgrading of TCM industry. METHODS ： The game theory was adopted to construct the initial game model and repeated game model of cooperative trust among the members of TCM industrial alliance under moral self-discipline ，and mixed strategy game model under external constraints. The main influential factors of trust mechanism construction for TCM industrial alliance were analyzed ，and countermeasures and suggestions were put forward for the trust mechanism construction of TCM industrial alliance in China. RESULTS & CONCLUTIONS ：Both the initial game model and the finite repeated game model showed that the strategy combination of （distrust，distrust）was the only Nash equilibrium. At this time ，the overall benefit of the alliance was the smallest ，and the innovation efficiency and stability of the alliance were very low. The infinite repeated game model showed that the strategy combination of （trust，trust）was the equilibrium path of the repeated game. The long-term benefits of both sides of the game due to trustworthiness were greater than those obtained by dishonesty. At this time ，the total benefits of the alliance were the largest ，but both sides of the game needed to have sufficient patience and enough game times. The mixed strategy game model showed that when the loss of breach of trust was large enough and there was no upper limit ，the alliance members chose to trust each other ，and the strategy of （trust，trust）was the only Nash equilibrium；when the loss of breach of trust was relatively small and closer to the upper limit ，the more reluctant the alliance members were to choose to keep faith ，and the external constraint force was weak. The number of games ，the completeness of game information and the strength of external constraints were the key factors to establish alliance trust mechanism. It is suggested that an efficient communication system ，transparent information disclosure system and perfect reward and punishment system should be established within TCM industrial alliance ，and the role of government and non-governmental third parties should be fully played to promote the stable operation of TCM industrial alliance in China.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.关键词：Drug quality sampling and inspection;Official standard;Non-standard method;Database
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects a nd mechanism of X iaozheng decoction on the proliferation and migration of uterine leiomyoma cells in rat. METHODS ：Female SD rats were randomly divided into normal control group ，model group ， chemical medicine positive control group （Mifepristone tablets ，2.25 mg/kg），TCM positive control group （Guizhi fuling capsules ， 200 mg/kg），Xiaozheng decoction low-dose ，medium-dose and high-dose groups （1.4，2.8，5.6 g/kg），with 15 rats in each group. Except for normal control group ，other groups were given intramuscular injection of estrogen and progesterone to induce uterine leiomyomas model. On the second day after modeling ，rats in administration groups were given relevant medicine intragastrically ； normal control group and model group were given constant volume of normal saline intragastrically ，once a day ，for consecutive 4 months. After last administration ，the uterus was removed and its morphology was observed ；the uterine coefficient was calculated. Uterine leiomyoma cells or uterine smooth muscle cells were isolated and cultured. The proliferation rate and migration rate of cells were detected by MTT method and cell scratch test ；flow cytometry was used to detect the cell apoptosis rate ；mRNA expression of HMGB 1 were detected by RT-qPCR. The expression of phosphorylated protein kinase B （p-Akt），nuclear factor κB inhibitor α （IκBα）and phosphorylated transforming growth factor β-activated kinase 1（p-TAK1）were detected by ELISA ；the protein expression of HMGB 1，phospholipid 3 kinase（PI3K），p-Akt in cytoplasm and nuclear factor κB p65（NF-κB p65）in nucleus were detected by Western blot assay. RESULTS ：Compared with normal control g roup，the myometrium of the model group was significantly thickened ，the number of uterine smooth muscle cells were significantly increased and the sizes were 83777930。E-mail：jianghua_ouyang@126.com different，the arrangement of muscle fibers in so me areas was disordered，the uterine coefficient ，and the relative expression of HMGB 1 mRNA and protein were increased significantly （P＜ 0.01）. Compared with model group ，the thickening of uterine myometrium and other symptoms were improved to different extents in Xiaozheng decoction groups and positive control groups ；the uterine coefficient ，cell proliferation rate ，migration rate ，mRNA and protein expression of HMGB 1，the expression of p-Akt and IκBα，protein expression of PI 3K and p-Akt （except for Xiaozheng decoction low-dose group ）in cytoplasm were all decreased significantly （P＜0.05 or P＜0.01）；the cell apoptosis rate ，the expression of p-TAK 1，protein expression of NF-κB p65 in nucleus were all increased significantly （P＜0.05 or P＜0.01）. The effects of Xiaozheng decoction showed a dose-dependent trend. CONCLUSIONS ：Xiaozheng decoction can inhibit the proliferation and migration of uterine leiomyoma cells by down-regulating the expression of HMGB 1，PI3K and p-Akt ，up-regulating the expression of NF-κB p65，so as to promote cell apoptosis.关键词：Xiaozheng decoction;Uterine leiomyoma;HMGB1;PI3K/Akt;NF-κB;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To discuss the inhibitory effect of lanthanum chloride on the calcification of vascular smooth muscle cells（VSMCs）induced by high phosphorus and its mechanism. METHODS ：On the basis of screening the action concentration and time of lanthanum chloride by MTT method ，human VSMCs were divided into control group （1 mmol/L phosphorus solution ）， lanthanum chloride high concentration control group （1 mmol/L phosphorus solution+ 60 μmol/L lanthanum chloride），model group （3 mmol/L phosphorus solution ），sodium chloride group （3 mmol/L phosphorus solution+ 180 μmol/L sodium chloride），nuclear factor κB（NF-κB）signaling pathway agonist+lanthanum chloride group （3 mmol/L phosphorus solution+ 1 μg/mL lipopolysaccharide+ 60 μmol/L lanthanum chloride），positive control group （3 mmol/L phosphorus solution+ 100 μmol/L sodium pyrophosphate），and lanthanum chloride low ，medium，and high concentration groups （3 mmol/L phosphorus solution+ 15，30，60 μmol/L lanthanum chloride）. Alizarin red S staining and Von Kossa staining were used to detect cell calcification in each group after treated with phosphorus solution for 6 d and relevant medicine for 2 d. Western blot assay was used to detect the protein expression of TNF-α receptor associated protein 6（TRAF6），nuclear factor κB inhibitor protein α（IκBα），NF-κB p65，bone morphogenetic protein 2 （BMP-2），smooth muscle 22 α（SM22α）and Runt related transcription factor 2（Runx2）. Real-time fluorescence quantitative polymerase chain reaction was used to detect mRNA expression of TRAF 6，IκBα，BMP-2，SM22α and Runx2. RESULTS ： Compared with control group ，no cell calcification was observed in the lanthanum chloride high concentration control group ，while obvious cell calcification and significant increase of OD value were observed in model group and sodium chloride group （P＜ 0.01）；protein and mRNA expression of TRAF 6 and BMP- 2 in cytoplasm as well as mRNA expression of Runx 2，protein expression of NF-κB p65 and Runx 2 in nucleus were significantly increased （P＜0.01）；protein and mRNA expression of IκBα and SM22α as well as protein expression of NF-κB p65 in cytoplasm were significantly decreased （P＜0.01）. Compared with model group，cell calcification was significantly improved in lanthanum chloride groups and positive control group ，while OD values were significantly reduced ；the expression levels of the above-mentioned protein and mRNA were reversed to varying degrees （P＜0.05 or P＜0.01）. Compared with lanthanum chloride high concentration group ，obvious cell calcification was observed in NF-κB signaling pathway agonist + lanthanum chloride group ，and OD value was significantly increased ；the above indexes were significantly reversed in cytoplasm and nucleus （P＜0.05 or P＜0.01）. CONCLUSIONS ：Lanthanum chloride can inhibit the calcification of VSMCs induced by high phosphorus ，and its mechanism may be related to the inhibition of NF-κB signaling pathway activation.关键词：Lanthanum chloride;High phosphorus;Vascular calcification;NF-κB signaling pathway;Human vascular smooth
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the repa ir，anti-inflammatory and analgesic effects of Compound crocodile oil burn ointment on superficial second-degree burned skin. METHODS ：The heated weight was attached to the right depilated skin of guinea pigs for 4 s to induce the model of superficial second-degree burn. After modeling ，guinea pigs were randomly divided into model group ， Jingwanhong ointment group （positive control ），formula Ⅰ，Ⅱ and Ⅲ groups of Compound crocodile oil burn ointment （volume fraction 1.5％，3％，4.5％，hereinafter），with 8 guinea pigs in each group. Except for model group ，other groups were smeared with 0.7 g/guinea pigs twice a day for 14 consecutive days. The wound healing was recorded every day ，the healing rate of wound was calculated. HE staining was used to observe the histopathological changes of the wound. The serum levels of EGF ，VEGF， SOD，MDA，TNF-α and IL-1 were detected by ELISA. Eighty Kunming mice were divided into 2 groups，and then sub-grouped into model group ，Jingwanhong ointment group （positive control ），formula Ⅰ and Ⅲ groups of Compound crocodile oil burn ointment，with 10 mice in each group. Then xylene auricle swelling method and acetic acid writhing method were used to investigate the anti-inflammatory and analgesic effects of Compound crocodile oil burn ointment. RESULTS ：In the burn repair experiment，after intervention of Compound crocodile oil burn ointment ，the wound area of guinea pigs gradually decreased ，and on the 14th day ，the wound had healed greatly ，and the wound healing rate increased significantly （P＜0.01）；serum levels of EGF and SOD were increased significantly （P＜0.01），while the levels of VEGF ，MDA，TNF-α and IL-1 were decreased significantly（P＜0.05 or P＜0.01）. The thick new epidermal layer was found in wound tissue ，and the connective tissue and neovascularization in the dermis increased significantly. In the anti-inflammatory and analgesic experiment ，after intervention of Compound crocodile oil burn ointment ，the degree of ear swelling and the times of writhing decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：Compound crocodile oil burn ointment shows good skin repair ，anti-inflammatory and analgesic efficacy；the mechanism may be associated with increasing the serum levels of EGF and SOD and reducing the levels of VEGF ， MDA，TNF-α，IL-1.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the fingerprint of Fritillariae thunbergii formula granules and determine the contents of 3 components. METHODS ：HPLC method was used. Using peiminine as reference ，HPLC fingerprints of 13 batches of F. thunbergii formula granules were drawn with Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 edition）. Similarity evaluation and common peak identification were conducted. The contents of peimisine ，peimine and peiminine in F. thunbergii formula granules were determined by the same HPLC method. The quality difference of samples were compared among different manufacturers. RESULTS ：There were 5 common peaks in 13 batches of F. thunbergii formula granules ，and the similarity was 0.669-0.971. Three common peaks of peimisine ，peimine and peiminine were identified. The linear ranges of peimisine ，peimine and peiminine were 30.00-180.00 μg/mL（r＝0.999 9），79.58-477.50 μg/mL（r＝0.999 6）and 97.33-584.00 μg/mL（r＝0.999 4）， respectively. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 3％. The average recoveries were 95.82％（RSD＝1.17％，n＝6），99.00％（RSD＝1.96％，n＝6）and 95.39％（RSD＝2.00％，n＝6），respectively. In the 13 batches of samples ，the content of peimisine ，peimine and peiminine were 0.17-1.02 mg/g，0.52-2.26 mg/g，and 0.70-3.50 mg/g， respectively. Their average total content was 3.62 mg/g. The average total content of manufacturer C and A was higher （5.02 mg/g and 4.61 mg/g），followed by manufacturer E and B （3.48 mg/g and 3.02 mg/g）；the lowest was manufacturer D（only 1.87 mg/g）. CONCLUSIONS：Established fingerpri nt and content determination method is simple ，feasible and reproducible ，which can be used for the quality evaluation of F. thunbergii formula granules. There are some differences in content among different manufacturers.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the c hemical components differences of Inula japonica before and after honey-frying. METHODS：UPLC-MS/MS method was adopted. The determination was performed on Waters ACQUITY UPLC BEH C 18 column with mobile phase consisted of 0.1％ formic acid-acetonitrile （gradient elution ）at the flow rate of 0.3 mL/min. The column temperature was set at 30 ℃，and sample size was 5 µL. The electrospray ion source was scanned by positive ion mode. The first order mass spectrometry scanning range was m/z 70-1 050，the second order mass spectrometry scanning range was m/z 50-1 050， and the normalized collision energy was 40，60 eV ；mass spectrum type was the peak figure ，the flow rate of sheath gas was 35 arb，the auxiliary airflow speed was 10 arb，the spray voltage was 3.80 kV，the S-lens voltage was 50 V，the heating temperature was 350 ℃，and the capillary temperature was 350 ℃. The components were identified by Qual Browser 4.1.39.1 software， referring to the online high-resolution database mzCloud and local database OTCML of high-resolution mass spectrometry of TCM ， and combined with relevant literature. The principal component analysis （PCA）and orthogonal partial least squared-discriminant analysis（OPLS-DA）of I. japonica before and after honey-fried were performed by using SIMCA 14.1 statistical software ，and variable importance projection （VIP）value greater than 1 was used as the standard to screen the differential components before and after honey-frying. RESULTS ：A total of 29 common chemical components were identified from I. japonica and honey-fried I. japonica，including 5 phenolic acids as 1-caffeoylquinic acid ，chlorogenic acid and 3，5-dicaffeoylquinic acid ，12 flavonoids as quercetin，luteolin and evamectin ，as well as 12 sesquiterpene lactones as 1-O-acetylinula diester ，inula bicolor lactone B and 1-O-acetyl-6-O-isobutyryl inulin. The results of PCA showed that I. japonica and honey-fried I. japonica were located on both sides of the score diagram respectively. The results of OPLS-DA showed that the VIP values of 7 components were greater than 1，which were peak 19（britanin），peak 6（quercetagitrin），peak 1（1-caffeoylquinic acid ），peak 21（vitexicarpin），peak 20（tomentosin）， peak 13（spinacetin）and peak 3（daphnetin）. CONCLUSIONS ：After honey-fried ，the content of chemical components of I. japonica changed and decreased to a certain extent. Britanin ，quercetagitrin，1-caffeoylquinic acid ，tomentosin，vitexicarpin， spinacetin and daphnetin may be the differential components of I. japonica and honey-fried I. japonica .关键词：Inula japonica;Honey-fried Inula japonica;UPLC-MS/MS;PCA;OPLS-DA;Chemical components
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a m ethod for simultaneous determination of neoastilbin ，astilbin，neoisoastilbin，isoastilbin， quercitrin and engeletin in Engelhardia roxburghiana，and conduct multivariate statistical analysis. METHODS ：HPLC-QAMS method was adopted. The determination was performed on Phenomenex SuperLu C 18 column with mobile phase consisted of acetonitrile-0.1％ formic acid （19 ∶ 81，V/V）at the flow rate of 1.0 mL/min. The detection wavelengths were set at 254 nm （neoastilbin，astilbin，neoisoastilbin，isoastilbin，engeletin）and 291 nm（quercitrin）. The column temperature was 30 ℃，and sample size was 10 μL. Using astilbin as internal substance，and the relative correction factors of other 5 factors were calculated. The contents of each component were calculated according to relative correction factor ，and were compared with the results of external standard method. SPSS 22.0 software was used for cluster analysis and principal component analysis. RESULTS ：The linear range of neoastilbin ，astilbin，neoisoastilbin，isoastilbin，quercitrin and engeletin were 0.007-0.311，0.871-18.184，0.002-0.119， 0.052-1.251，0.105-2.202，0.020-2.319 μg（r＞0.999），respectively. RSDs of precision ，reproducibility and stability （24 h）tests were all lower than 3％. The average recoveries were 97.32％，94.89％，97.15％，96.90％，97.52％ and 97.53％（RSDs were 1.09％ -2.60％ ，n＝6），respectively. The relative correction factors of neoastilbin ，neoisoastilbin，isoastilbin，quercitrin and engeletin were 1.252 6，1.198 3，0.958 6，0.807 1 and 1.138 1， respectively. The contents of neoastilbin ， neoisoastilbin， qq.com isoastilbin，quercitrin and engeletin measured by QAMS were 0.394 2-2.067 2，0.139 1-0.804 7，2.864 8-8.554 8，4.581 2- 11.371 1，1.028 9-13.401 5 mg/g；the contents of neoastilbin ， astilbin，neoisoastilbin，isoastilbin，quercitrin and engeletin were 0.367 2-1.925 3，46.361 1-126.342 1，0.138 1-0.798 8，2.966 2-8.857 8， 4.642 5-11.523 3，0.970 6-12.641 9 mg/g，respectively. Relative errors of two methods was lower than or equal to 3.55％. The results of cluster analysis showed that 9 batches of samples could be clustered into two categories ；S8 sample was one category and others were one category. The results of principal component analysis showed that accumulative contribution rate of former 2 principle components was 84.745％，and the results of sample classification were consistent with those of cluster analysis. CONCLUSIONS ： The established HPLC-QAMS method is accurate ，feasible and repeatable ，and can be used for simultaneous determination of 6 flavonoids in E. roxburghiana ，and it can provide reference for quality control.关键词：Engelhardia roxburghiana;HPLC;QAMS;Flavonoids;Content;Cluster analysis;Principle component analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optimize the f ormulation of docetaxel （DTX）-mPEG-PLGA-mPEG （PELGE）-nanoparticles （NPs），and to characterize it and evaluate its in vitro drug release and antitumor activity. METHODS ：PELGE were synthesized by ring-opening polymerization. DTX-PELGE-NPs were prepared by using emulsion solvent evaporation method. The content of DTX in DTX-PELGE-NPs was determined by HPLC. Box-Behnken design-response surface methodology was applied to optimize the formulation of the nanoparticles using the amount of DTX ，PELGE and poloxamer 188 as independent variable ，using entrapped efficiency as dependent variable. The particle size and Zeta-potential of DTX-PELGE-NPs were characterized by laser particle size analyzer and transmission electron microscope. The in vitro release of the DTX-PELGE-NPs was investigated by ultra-filtered centrifugation，using DTX injection as reference. In vitro cytotoxicity of the DTX-PELGE-NPs was investigated by MTT assay ， using DTX and PELGE-NPs without DTX as reference . RESULTS ：The optimal formulation included 2.80 mg DTX ，20.60 mg PELGE and 6％ poloxamer 188. The entrapped efficiency of optimized DTX-PELGE-NPs was （86.79±1.32）％；drug-loading amount was （10.21±0.78）％，and average particle size was （78.4±2.9）nm；polydispersity coeffici ent was （0.187±0.018）and Zeta potential was （－20.6±1.5）mV. Furthermore ，DTX- PELGE-NPs showed a regular spherical and uniform distribution under scanning electron microscopy. Compared with DTXinjection（accumulative release rate of 92.3％ at 4 h），DTX- PELGE-NPs had a significant sustained-release effect （accumu-lative release rate of 78.6％ at 36 h）. 0.1-50 μg/mL PELGE-NPs had no obvious cytotoxicity to human breast cancer cells MCF-7（P＞0.05）. 0.5-10 μg/mL DTX-PELGE-NPs could significantly inhibit the growth of human breast cancer cells MCF-7， and its inhibitory effect （except for DTX-PELGE-NPs 10 μg/mL group）was significantly stronger than that of DTX injection （P＜ 0.05）. CONCLUSIONS ：The optimized formulation is stable and feasible. The obtained DTX-PELGE-NPs not only have uniform particle size ，high encapsulation rate obvious slow-release effect ，but also have stronger anti-tumor effect in vitro than DTX injection.关键词：Docetaxel;mPEG-PLGA-mPEG;Box-Behnken design-response surface methodology;HPLC;Formulation
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for impro ving the quality of programmed cell death protein 1 （PD-1）/ programmed cell death 1 ligand（PD-L1）inhibitors in the treatment of non-small cell lung cancer related pharmacoeconomic studies in China. METHODS ：Retrieved from Embase ，PubMed，Medline，Cochrane Library ，CNKI，Wanfang database ，VIP and other Chinese and English database ，cost-utility studies about PD- 1/PD-L1 inhibitors in the treatment of non-small cell lung cancer published during Jan. 2016-Jan. 2021 were collected. The data of the included studies were extracted. After the quality of the included studies was evaluated by using the Consolidated Health Economic Evaluation Reporting Standards list ，the relevant data were summarized and compared from the aspects of model framework ，model parameters and uncertainty analysis. RESULTS & CONCLUSIONS：A total of 17 studies were finally included ，the overall quality of them was high but the differences in methodology were great. Markov model or partition survival model based on three states was adopted for 16 studies. The time horizon ranged from 5 years to lifetime ；the cycle length ranged from 1 week to 6 weeks. A total of 8 studies used the standard parameter distribution method for parameter fitting ，and 7 studies additionally adopted other parameters estimation methods as KM curves or spline models. Eleven studies performed the validation of model extrapolation. All studies considered the direct medical costs and reported the incremental cost-effectiveness ratio using quality-adjusted life years as the health outcome. Sixteen studies conducted the deterministic sensitivity analysis and probabilistic sensitivity analysis to improve the stability of the model. It is suggested that studies should keep the integrity of the report ； format，choose the appropriate positive comparators ，selectthe health economic model and construct reasonable assumptions according to the available data format ， use Cholesky decomposition to explore the uncertainty of the parameter fitting ， perform the validation of extrapolation combined with external data and use the appropriate indirect comparison in the absence of the head-to-head clinical trials to improve the quality of related pharmacoeconomic studies in China.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for clinical decision-making related to chemotherapy-induced nausea and vomiting（CINV）. METHODS ：The medical records of patients diagnosed as malignant tumor receiving multi-day cisplatin-containing chemotherapy in our hospital were collected by hospital information system from Jan.-Dec. 2012. The medical records were divided into tropisetron group ，ramosetron group and palonosetron group according to different schemes of 5-hydroxytryptamine-3 receptor antagonist. The covariates of 3 groups were balanced by propensity score matching method ；cost-utility analysis was conducted for the 3 matched antiemetic schemes ；one-way sensitivity analysis and sampling uncertainty analysis were also conducted. RESULTS ： The results of cost-utility analysis showed that treatment cost of one observation period of tropisetron group was 237.71 yuan and utility were 0.054 68 QALYs；that of ramosetron group was 242.37 yuan and utility were 0.055 26 QALYs，and that of palonosetron group was 319.24 yuan and utility were 0.055 76 QALYs. Compared with tropisetron group ，the ICER of palonosetron group was 75 155.69 yuan/QALY；Compared with ramosetron group ，the ICER of palonosetron group was 152 062.07 yuan/QALY. Both of them were lower than 3 times of China ’s 2020 per capita GDP （217 341 yuan/QALY）. The results of sensitivity analysis and sampling uncertainty analysis demonstrated that the results of basic analysis were robust. CONCLUSIONS ：Under the current drug price，the antiemetic regimen based on palonosetron is more economical for the prevention of CINV caused by multi-day chemotherapy containing cisplatin.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compa re the effectiveness and safety of three regimens of tiapride ，clonidine and tiapride combined with clonidine in the treatment of tic disorder （TD）in children. METHODS ：A sequential collection of 312 children with TD from the outpatient department of West China Second Hospital of Sichuan University were conducted during Jan.-Dec. 2019. They were divided into clonidine group ，tiapride group ，tiapride combined with clo nidine group ，with 104 cases in each group. Tiapride group was given Tiapride hydrochloride tablets with initial dose of 50-100 mg per day ，and the dose was gradually increased to 150-500 mg per day according to tolerance and clinical experience. Clonidine group was given Clonidine transdermal patches ，once a week ，with initial dose of 1 mg each week ，maintenance dose of 1-2 mg each week ，once a week. Tiapride combined with clonidine group was given Tiapride hydrochloride tablets （same usage and dosage as tiapride group ）+ Clonidine transdermal patches （same usage and dosage as clonidine group ）. The treatment course of 3 groups was 3 months. After the treatment ，they were followed up every 3 months（the following were expressed as 24，36 and 48 weeks after treatment ）. Yale global tie severity scale （YGTSS）scores of 3 groups were observed before treatment ，after 4，8，12，24，36，48 weeks of treatment，and the occurrence of ADR was recorded at different follow up time points. RESULTS ：Before treatment ，there was no statistical significance in YGTSS scores among 3 groups（P＞0.05）. After 4，8，12，24，36 and 48 weeks of treatment ，YGTSS scores of 3 groups were significantly lower than those before treatment （P＜0.05）. After 4，8 and 12 weeks of treatment ，YGTSS scores of tiapride combined with clonidine group were significantly lower than tiapride group and clonidine group （P＜0.05），while there was no statistical significance between tiapride group and clonidine group （P＞0.05）. At 24 weeks of treatment ，YGTSS score of children in tiopride combined with clonidine group was significantly lower than tiopride group （P＜0.05），but there were no significant differences between tiopride combined with clonidine group and tiopride group ，and between tiopride group and clonidine group （P＞0.05）. After 36 and 48 weeks of treatment ，there was no significant difference in YGTSS scores among 3 groups（P＞0.05）. After 12 weeks of treatment ，the results of P value corrected by Bonferroni method showed that YGTSS score of tiopride combined with clonidine group was significantly lower than those of tiopride group and clonidine group （P＜0.016 7）， while there was no statistical significance in the difference between tiopride group and clonidine group （P＞0.016 7）. There was no statistically significant difference in the total incidence of ADR among 3 groups（P＞0.05）. CONCLUSIONS ：Clonidine，tiapride and tiapride combined with clonidine can significantly improve the tic symptoms of TD children with good safety .关键词：Tic disorder;Children;Clonidine;Tiapride;Efficacy;Safety;Cohort study
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explo re the clinical characteristics of voriconazole-induced neurological ADR and the occurrence of hypokalemia and hyponatremia before ADR. METHODS ：The medical records of 411 patients receiving voriconazole therapy ， who admitted to our hospital from January 2018 to November 2020，were retrospectively analyzed. The general information of all patients，including sex ，age，body weight ，type of infection ，underlying disease ，type of pathogenic fungal infection and administration route of voriconazole ，maintenance dose ，blood drug concentration ，were collected. The basic information of patients with neurological ADR ，including sex ，age，types of infection ，underlying disease ，drug combination ，occurrence time and clinical manifestations ，were collected . The levels of blood potassium ，blood sodium and liver function indexes （ALT，AST， γ-GT，ALP，total bilirubin ，direct bilirubin ）within 3 days before the neurological ADR were also collected. The relationship of neurological ADR with voriconazole trough concentration ，blood potassium and blood sodium levels was analyzed. RESULTS ： Among 411 patients，31（7.54％）patients suffered from neurological ADR ，which were higher in male （64.52％）than in female （35.48％），mainly in patients aged 50 and over （74.20％）. The major infection type was lung infection （96.77％）. Among 31 patients with neurological ADR ，26 patients suffered from neurological ADR after 1-7 days after voriconazole administration ， accounting for 83.87％. Thirty patients received intravenous drip ，accounting for 96.77％. The incidence of neurological ADR in patients with voriconazole trough concentration ＞5.0 μ g/mL （8.99％）was significantly higher than that in patients with trough concentration ≤5.0 μg/mL（3.42％，χ2＝4.91，P＝0.027）. The clinical manifestations of the patients were mainly 023-68766797。E-mail：cheng7zhu@163.com hallucinations（32.35％），irritability（32.35％）and poor sleep （17.65％），etc. Within 3 days before 30 patients，receiving related indexes test ，suffered from neurological ADR ，16 patients（53.33％）had hypokalemia and 12 patients（40.00％） had hyponatremia ，which w ere significantly higher than the incidence of hypokalemia （24.74％，P＝0.001）and hyponatremia （12.89％，P＜0.001）in those without neurological ADR . There were 8，10，7，13，7 and 10 patients with ALT ，AST，ALP， γ-GT，total bilirubin and direct bilirubin increased. In 31 patients with neurological ADR ，the neurological ADR were relieved or disappeared after reducing the dosage or discontinuing voriconazole. CONCLUSIONS ：The neurological ADR of voriconazole mostly occurs 1-7 days after voriconazole administration ，mainly by intravenous drip ，mostly in male and people aged 50 and over. The occurrence of neurological ADR may be related to trough concentration of voriconazole ，and most patients suffer from hypokalemia or hyponatremia before the occurrence of ADR .关键词：Voriconazole;Neurological ADR;Trough concentration;Hypokalemia;Hyponatremia
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establis h the method for the determination of voriconazole concentration in human plasma. METHODS：After protein precipitation with acetonitrile ，using riluzole as internal standard ，plasma concentration of voriconazole were determined by HPLC method. The determination was performed on Agilent Zorbax Eclipse Plus C 18 column with mobile phase consisted of acetonitrile- 0.01 mol/L monopotassium phosphate solution （38∶62，V/V）at the flow rate of 1.0 mL/min. The column temperature was maintained at 40 ℃，and the detection wavelength was 255 nm. The sample size was 20 μL. Meanwhile，the method was applied to determine plasma concentration of voriconazole in 10 patients receiving voriconazole. RESULTS ：The liner range of voriconazole was 0.2-20.0 μg/mL（r＝0.999 6）. The lower limit of quantitation was 0.2 μg/mL. RSDs of intra-day and inter-day were both lower than 7％（n＝6 or n＝18）. Average accuracies were 98.59％-106.18％. Average extraction recoveries were 86.77％-89.86％（RSD＜4％，n＝6），and the deviations of measured results and theoretical values of stability tests were within ±15％. The plasma concentrations of voriconazole in 10 patients were 0.34-5.04 μg/mL. CONCLUSIONS：The study successfully establish a rapid and efficient HPLC method for the determination of voriconazole in human plasma.关键词：Voriconazole;HPLC;Plasma concentration
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To reeval uate the systematic review/Meta-analy sis of efficacy and safety of eplerenone in the treatment of essential hypertension. METHODS ：Retrieved from PubMed ，Embase，Cochrane Library ，Web of Science ，Wanfang database，CNKI，VIP，systematic review/Meta-analysis about eplerenone in the treatment of essential hypertension were collected from the inception to June 24th，2021. After literature screening and data extraction ，the quality of included literatures were evaluated with PRISMA statement ；methodology quality of included literatures were evaluated with AMSTAR 2 scale；GRADE method was adopted to evaluate the evidence quality of outcome measures. Efficacy and safety index evaluation of included literatures were summeried. RESULTS ：A total of 8 systematic reviews/Meta-analyses were included ，involving 5 systematic reviews and 3 Meta-analysis，including 73 outcome indicators. PRISMA scores ranged from 7.5 to 23.5，including 6 literatures （75.0％）with≤15 points，1（12.5％）with ＞15-＜21 points and 1（12.5％）with ≥21 points. The results of AMSTAR 2 evaluation indicated that the methodological quality of 2 studies was low ，and that of 6 studies was very low . GRADE quality evaluation results showed that there were 3 high quality indicators ，24 medium quality indicators and 46 low or very low quality indicators；the factors contributed to downgrading evidence quality were limitation ，inconsistency，imprecision and publication bias. In terms of efficacy ，compared with placebo ，eplerenone could significantly reduce clinical blood pressure （CBP）and 24-hour ambulatory blood pressure （ABP）. Its effect in reducing CBP was significantly better than other antihypertensive drugs or equivalent to other antihypertensive drugs. The effects of eplerenone on reducing clinical systolic blood pressure was not as good as spironolactone and enalapril ，or bett er than calcium channel blocker ，enalapril and angiotensin receptor antag onist，or equivalent to calcium channel blocker and enalapril ；the effect of eplerenone on reducing clinical diastolic blood pressure was not as good com as spironolactone ，calcium c hannel blocker and enalapril ，or as good as enalapril ，but better than angiotensin receptor antagonist. In terms of safety ，there was no significant difference in the incidence of ADR ，serious ADR or hyperkalemia caused by eplerenone ，compared with placebo ，or the incidence of ADR was higher than that of placebo. There was no statistical significance in the incidence of ADR or serious ADR ，compared with other antihypertensive drugs. CONCLUSIONS ：Efficacy and safety of eplerenone in the treatment of essential hypertension was good ，but in view of the poor methodological quality of systematic reviews or Meta-analysis and the low or very low level of outcome indicator evidence ，the authenticity and effectiveness of the conclusion will be reduced ，so that those indcaters should be interpreted carefully.关键词：Eplerenone;Essential hypertension;Efficacy;Safety;Systematic review;Meta-analysis;Reevaluation
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To summarize and analyze t he clinical characteristics of acarbose-induced skin ADR ，and to provide reference for its therapy. METHODS ：Clinical pharmacists participated in the treatment of a patient with acarbose-induced skin ADR. The patient developed erythema multiforme several days after oral administration of Acarbose tablets （100 mg/d）. After consultation by dermatology and clinical pharmacy ，considering that the adverse reaction was related to acarbose ，clinical pharmacists suggested to stop the drug. Based on the above cases ，clinical pharmacists searched Wanfang database ，CNKI， PubMed，Embase and other databases to collect case reports of skin ADR caused by acarbose ，summarize its general situation （gender，age，usage and dosage ，etc.），latency，ADR（diagnosis and manifestation ），intervention and outcome ，etc. RESULTS ： The doctor adopted the pharmacist s’advice，stopped the use of acarbose ，and gave symptomatic treatment as Methylprednisolone sodium succinate for injection 40 mg（intravenous injection ，qd）+Medloratadine tablets 8.8 mg（oral administration ，qd）+Calamine lotion（for external use ）. The patient improved and was discharged after 10 days. A total of 12 literatures involving 12 patients were retrieved. Among the 13 patients included in the analysis （including the above clinical case and 12 literature cases ），there were 8 males and 5 females，and 8 patients of them aged 50 and over；the dosage of acarb ose in most patients was within the requirements of the drug instructions. The primary diseases of 12 patients were diabetes mellitus. The latency of skin ADR in 11 patients was within 6 days of administration. Among the 13 patients，the ADR were diagnosed as rash in 4 cases，pustulosis in 3 cases， erythema multiforme in 2 cases， urticaria in 2 cases， maculopapular rash in 1 case and lip swelling in 1 case. The ADR of 1 patient improved after drug withdrawal ，and 12 patients also improved after drug withdrawal and symptomatic treatment such as glucocorticoid or antihistamine. Acarbose was re-used in 2 patients after the improvement of first skin ADR ，and skin ADR occurred again ，and the ADR were improved after drug withdrawal and symptomatic treatment. CONCLUSIONS ：Skin ADR are acarbose-induced rare ADR ，mostly within 6 days of medication ，and are more likely to occur in middle-aged and older men. When the patients suffer from ADR ，the drug should be stopped in time and given glucocorticoids or antihistamines for symptomatic treatment. Clinical pharmacists should do a good job in drug publicity and education ，remind patients to closely monitor relevant indicators and ensure drug safety.关键词：Acarbose;Skin r elated ADR;Clinical characteristics;Case analysis;Literature review;Clinical pharmacists
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide scientific basis for evaluating the burden caused by antibiotic resistance （AbR）and reference for policy making on crubing AbR in China. METHODS ：Databases including CNKI ，Wanfang database ，VIP，PubMed， Scopus，Medline and EconoLite from Jan. 1st 2016 to Aug. 10th 2020 were searched to collect studies on burden caused by AbR in China . After independent literature screening anddata extraction ，Newcastle-Ottawa scale （NOS）was used to evaluate the literature quality ，and a descriptive analysis was conduced to evaluate the health and economic burden caused by AbR. RESULTS ：A total of 27 Chinese and English literatures were included. The NOS scores of i ncluded literatures were 4-6，and all of them were retrospective case-control study ； the patients were divided into case group （resistance infection ） and control group （susceptible infection or non-infection ）； mortality，length of stay and medical expenditure were commonly applied as the measurement indexes. In the included studies ，the mortality of patients infected with AbR bacteria was 0.7-12.0 times that of patients infected with susceptible bacteria ；the mean or medium value of total length of stay was 0.9-2.5 times that of patients infected with susceptible bacteria ；the mean or medium of total medical expenditure was 1.0-2.7 times that of patients with susceptible bacteria infection. The differences in these indicators were greater between patients infected with AbR infections and those without becterial infections. CONCLUSIONS ：Bacterial drug resistance could increase the health and economic burden. However ，the existing relevant studies were mainly single center researches，the sample representation was insufficient ；the research design did not adjust for time-dependent bias ；the repeatability was low ，and the perspective of evalution was limited. It is urgent to carry out multicenter studies with higher quality to comprehensively evaluate the health and economic burden caused by AbR in China.关键词：Bacterial drug resistance;Health burden;Economic burden;Literature;Systematic review;China
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发布时间：2022-06-21
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