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Chinese Journal of Pharmacovigilance
15 November 2021, Volume 18 Issue 11

15 November 2021, Volume 18 Issue 11 Previous Issue   
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Practice and Exploration of Uniformity about Medical Device Evaluation Criterion
ZHANG Shiqing, WANG Yingjun
2021, 18(11): 1001-1003. 
DOI: 10.19803/j.1672-8629.2021.11.01

Abstract ( 46 )   PDF (1187KB) ( 41 )  
Objectiv eTo outline the practice and exploration carried out by the Center for Medical Device Evaluation, NMPA(CMDE) in the unified evaluation criterion so as to provide a reference for relevant parties. Methods The existing problems in the system and the measures taken were analyzed, and the case of uniformity about medical device safety in CMDR was introduced. Results The CMDE further improved the quality management system, and carried out a number of useful explorations on the unified evaluation scale. Conclusion The unification of criterion is an important basis for ensuring the stability and repeatability of the evaluation, and the improvement of the system can effectively promote the unification of the evaluation criterion.
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Prevention and Control of Safety Risks of Traditional Chinese Medicine Based on Indirect Knowledge of Toxicity
GAO Yunjuan, ZHAO Xu, BAI Zhaofang, WANG Jiabo, ZHAN Xiaoyan, GUO Yuming, XIAO Xiaohe
2021, 18(11): 1004-1008. 
DOI: 10.19803/j.1672-8629.2021.11.02

Abstract ( 59 )   PDF (1233KB) ( 46 )  
For a long time, our knowledge of and research on the safety of traditional Chinese medicine(TCM) have been confined to the inherent toxicity of drugs. However, safety incidents of non-toxic traditional Chinese medicine have been frequently reported in recent years. It is often difficult to make scientific explanations and formulate effective prevention and control measures by evaluating inherent toxicity or direct toxicity alone. Based on the current knowledge and research findings of indirect toxicity of TCM, we recommended strategies for prevention and control of safety risks. We focused on explanation of the difference between indirect toxicity and intrinsic toxicity or immunogenicity. We also discussed how to evaluate and prevent safety risks of TCM effectively in order to provide new ideas and countermeasures for guiding clinical safety and rational use of medicines and promoting the healthy development of traditional Chinese medicine.
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Chronic Phenotypes of Drug-induced Liver Injury Based on Clinical Cohort
XU Wentao, WANG Ruilin, BAI Zhaofang, GUO Yuming, ZHANG Fan, WANG Jiabo, NIU Ming, ZOU Zhengsheng, XIAO Xiaohe, JING Jing
2021, 18(11): 1009-1013. 
DOI: 10.19803/j.1672-8629.2021.11.03

Abstract ( 39 )   PDF (1324KB) ( 29 )  
Objectiv eTo evaluate and analyze different clinical phenotypes and characteristics of chronic drug-induced liver injury (DILI). Methods The clinical data on 1 656 patients with DILI who met the inclusion criteria was retrospectively analyzed, and the clinical phenotypes and characteristics of 286 patients with chronic DILI were evaluated. Results The ratio of males to females was 1∶1.92, and the median age was 49.03 yrs. According to the dynamic changes of liver function and development of the disease, chronic DILI could be divided into the persistent type (n=159, 55.6%), recurrent type (n=31, 10.8%), slow recovery type (n=27, 9.4%), and first onset cirrhosis type (n=69, 24.1%). 204 of these cases were able to provide detailed information about medication. 97.7% of the cases of the first onset cirrhosis type were caused by two or more drugs, and the proportion was significantly higher than that of other types (P=0.015). Compared with other types, the MELD score of the first onset cirrhosis type was higher while the prognosis was worse (P<0.05). Conclusion The chronic process of DILI can be divided into four types, the main clinical phenotype of DILI is the persistent type, and the prognosis of the first onset of DILI of the cirrhosis type is poor, which deserves attention in clinic.
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The Mechanism of Psoralea Fructus Induced Idiosyncratic Liver Injury Based on Metabolomics
WANG Xiaoyan, LI Weixia, ZHANG Hui, ZHANG Mingliang, WU Yali, CAO Zhanxia, NI Wenjuan, CHEN Yulong, LI Kun, FENG Keran, TANG Jinfa
2021, 18(11): 1014-1019. 
DOI: 10.19803/j.1672-8629.2021.11.04

Abstract ( 26 )   PDF (2174KB) ( 19 )  
Objectiv eTo study the mechanism of Psoralea Fructus induced idiosyncratic injury based on metabolomics, and to screen related biomarkers and metabolic pathways. Methods A rat model of idiosyncratic liver injury was induced by caudal vein injection of LPS (LPS). Rats were randomly divided into the control group (CMC group), Psoralea Fructus group (BGZ group), lipopolysaccharide group and BGZ+LPS group. The serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities were analyzed. Global metabolomics profiling of the serum was detected by UPLC-QTOF/MS. The characteristic biomarkers and corresponding metabolic pathways were analyzed by Progenesis QI (v2.4), SIMCA v13.0, MetaboAnalyst v 5.0 and other software. Results Compared with the control group, there were no significant changes in ALT or AST in the BGZ group, but there was an increase in ALT and AST in the BGZ+LPS group. Furthermore, serum metabolite spectra in the CMC, BGZ, LPS and BGZ+LPS groups were significantly separated from OPLS-DA. Fourteen potential metabolomics biomarkers were screened that were associated with Psoralea Fructus induced idiosyncratic injury, involving seventeen pathways. Conclusion Psoralea Fructus induced liver injury is idiosyncratic liver injury, and its mechanism is possibly related to the regulation of sphingolipid metabolism, tyrosine metabolism and other metabolic pathways.
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Clinical Characteristics and Rationality of Drug Usage in Antibiotic Agents Related Liver Injury
LI Jiayi, GE Feilin, CAO Junling, ZHOU Xiaochun, GAO Yunjuan, MU Guangdi, ZHAO Xu, CAO Boya, GUO Yuming
2021, 18(11): 1020-1024. 
DOI: 10.19803/j.1672-8629.2021.11.05

Abstract ( 63 )   PDF (1743KB) ( 68 )  
Objectiv eTo investigate the potential risk signals of liver injury in order to provide data for rational use of antibiotic agents. Methods ADR reports on liver injury related to antibiotic agents and collected between January 1, 2012 and December 31, 2016 were retrospectively analyzed to find the main clinical characteristics and ways in which these drugs were used. The reporting odds ratio (ROR) method was used to analyze the risk stratification. Results There were 2 938 ADR reports and male patients outnumbered female ones (1.83∶1) in our study. The median age of these patients was 53. The largest proportion (25.73%) of these patients was 45-60 years old. Moreover, the top five antibiotic agents were lactams, cephalosporins, quinolones, antifungals and macrolactones. The highest ROR in children aged 0 to 14 versus the entire population was observed for erythromycin (ROR, 11.19; 95% CI: 4.33~28.92) and mezlocillin (ROR, 5.07; 95% CI: 1.43~18.04) in penicillins and macrolides agents. The highest ROR in patients aged 45 to 59 was observed for ceftazidime (ROR, 1.80; 95% CI: 1.07~3.04) in cephalosporins. The highest ROR in patients aged 60 to 74 was observed for piperacillin-sulbactam (ROR, 1.64; 95% CI: 1.069~2.53) in lactams. Conclusion Antibiotic agents related liver injury is more common in elder patients. However, the risk of liver injury caused by different categories of antibiotics varies in different age groups. The risk difference in clinical use of drugs should be fully assessed for the sake of safety.
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Application of Real-World Study Designs in Post-Marketing Evaluation of Drug Safety
XUE Xue, JIN Xinyan, LU Chunli, DAI Ning, LIU Jianping
2021, 18(11): 1025-1028. 
DOI: 10.19803/j.1672-8629.2021.11.06

Abstract ( 77 )   PDF (1127KB) ( 80 )  
Objectiv eTo explore the applicability of real-world study designs in post-marketing drug safety evaluation so as to improve the rationality of clinical drug use and ensure drug safety. Methods Theories on real-world study were used. The applications of commonly used study designs in post-marketing evaluation of drug safety were described in detail along with case analysis. Results In post-marketing evaluation of drug safety, the most commonly used type of design of experimental studies was the pragmatic randomized controlled trial. Common types of design of analytical studies included cohort study, nested case-control study and case-control study. Common types of design of descriptive studies included cross-sectional survey, case series and case reports. Among these types of design, the pragmatic randomized controlled trial, cohort study, and nested case-control study could be used to infer the causal relationships between drug exposure and medical events. Other types of design could do nothing more than establish hypotheses for causal associations due to their weak validity. Conclusion Real-world study designs have been widely used in post-marketing evaluation of drug safety. Compared with explanatory randomized controlled trials, they are closer to the real clinical environment and attaches more importance to drug safety so as to ensure the safety of medication.
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Progress in Methods of Research into Clinical Interactions between Traditional Chinese Medicine and Chemical Medicine
YANG Ming, LUO Hui, LIU Jianping
2021, 18(11): 1029-1033. 
DOI: 10.19803/j.1672-8629.2021.11.07

Abstract ( 22 )   PDF (1297KB) ( 26 )  
The combined application of traditional Chinese medicine and chemical medicine in clinical practice is very common, so drug interactions deserve attention. This article describes the basic concepts about and research progress in drug interactions, and summarizes the types of clinical research design for observational studies and interventional studies. Based on the complexity of components of traditional Chinese medicine, the similarities and differences between traditional Chinese medicine and chemical drugs and between drug interactions are compared. The research progress in clinical evaluation methods of interactions between traditional Chinese medicine, herbal medicine or natural products and chemical drugs is reviewed. On the basis of research methods currently available, new methods of CYP450 enzyme phenotype detection, metabolomics and imaging applied to the evaluation of clinical research outcomes of drug interactions are described prospectively in order to provide ideas and reference for clinical research of traditional Chinese medicine-chemical drug interactions.
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Opportunities and Challenges of Pharmacovigilance in Cancer Treatment
ZHANG Xiaowen, HOU Wenbin, YANG Ming, LIU Jianping
2021, 18(11): 1034-1038. 
DOI: 10.19803/j.1672-8629.2021.11.08

Abstract ( 59 )   PDF (566KB) ( 76 )  
Objectiv eTo introduce domestic and foreign pharmacovigilance systems and review the research progress in pharmacovigilance in the field of cancer treatment at home and abroad. Methods A comprehensive research was conducted in CNKI and PubMed from inception to May 31, 2021. Articles about pharmacovigilance in cancer treatment were reviewed, while the number of factors that made this sphere complicated were analyzed. Current opportunities as well as challenges were outlined. Results There was an increase in the demand for pharmacovigilance, IT could help reveal the potential connections between drugs and events, and patients'participation in adverse reaction reporting could add a new dimension to information collection, all of which could accelerate personalized cancer treatment. Conclusion Pharmacovigilance research in oncology will be oriented to risk prediction and personalized management of adverse drug reactions. The establishment of a better pharmacovigilance system is conducive to the safety of patients in drug use.
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Risk Assessment and Determination of Hepatotoxic Pyrrolizidine Alkaloids in Senecionis Cannabifolii Herba
ZAN Ke, ZHOU Ying, PANG Yu, LI Yaolei, WANG Ying, JIN Hongyu, ZUO Tiantian, MA Shuang-cheng
2021, 18(11): 1039-1042. 
DOI: 10.19803/j.1672-8629.2021.11.09

Abstract ( 12 )   PDF (761KB) ( 14 )  
Objectiv eTo analyze the contents of hepatotoxic pyrrolizidine alkaloids in Senecionis cannabifolii Herba, and to carry out preliminary risk assessment based on the research results. Methods A UPLC-MS/MS method was established to determine the contents of jacoline, jacoline N-oxide, jacobine, jaconine and jacobine N-oxide. According to the content determination results, the risk was assessed using the margin of exposure (MOE) method. Results The contents of jacoline, jacoline N-oxide, jacobine, jaconine, and jacobine N-oxide in six batches of Senecionis cannabifolii Herba were 0.23-0.85, 0.25-0.98, 0.85-2.65, 0.37-1.85 and 2.32-7.58 μg/g, respectively. The MOE values ranged from 2 131 to 4 845. Conclusion The method established in this study provides data for quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloids in Senecionis cannabifolii Herba.
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Toxicity and Mechanism of Pyrazinamide in Human Hepatocyte L02
LIU Mengxing, LIU Yuan, SUN Hui, LIU Xing, YANG Min, PENG Jiangli, CHEN Jie
2021, 18(11): 1043-1047. 
DOI: 10.19803/j.1672-8629.2021.11.10

Abstract ( 12 )   PDF (2577KB) ( 7 )  
Objectiv eTo evaluate the liver toxicity of pyrazinamide and to explore its mechanism of liver injury. Methods L02 cells were divided into the control group, PZA group (25, 125, 625, 3 125 µg/mL), and N-acetlg-L-cysteine (NAC) (10 mmol/L) + PZA (25, 125, 625, 3 125 µg/mL) group. The corresponding culture medium and different concentrations of PZA and NAC were given respectively. Flow cytometry was used to quantitatively detect the degree of apoptosis and intracellular mitochondrial membrane potential (MMP) of L02 cells. The Western-blot method was used to detect the protein expressions of Fas, Fas-related protein (FADD), cytochrome C (Cyt-c), and activated caspase-3 (Cleaved caspase-3). Results Compared with the control group, the proportion of apoptotic cells in the PZA administration group at each concentration was significantly increased, and the proportion of cells at the mid-late stage of apoptosis was significantly higher than that of cells at the early stage of apoptosis. MMP in the 25 and 125 µg/mL PZA administration groups was decreased by 32.23% and 24.79%, respectively, compared with 31.40% in the 3 125 µg/mL PZA administration group. The expression of Fas protein in the 3 125 µg/mL PZA administration group increased, so did the expression of Cleaved caspase-3 protein in the 125, 625 µg/mL PZA administration group. After PZA was combined with NAC, the proportion of apoptotic cells in each concentration group was not only lower than that of the PZA alone group, but decreased significantly in the 25, 125 and 3 125 μg/mL groups. Compared with the PZA alone group, MMP was increased by 21.95%, 33.48%, and 22.33% respectively in the 25, 625, and 3 125 µg/mL groups. Compared with the PZA alone group, Fas protein expression decreased by 47.50% in the 3 125 µg/mL group. The expression of Cleaved caspase-3 protein in the 125, 625, 3 125 µg/mL groups decreased by 66.13%, 73.91%, and 41.67%, respectively. Conclusion PZA may induce apoptosis of L02 cells through the death receptor pathway and mitochondrial pathway, resulting in liver injury. The combination with NAC can significantly alleviate liver injury induced by PZA.
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Network Pharmacological Mechanisms of Weixuening Granules in the Treatment of Immune Thrombocytopenia
HUANG Wei, LUO Yaqin, WANG Xiao
2021, 18(11): 1048-1054. 
DOI: 10.19803/j.1672-8629.2021.11.11

Abstract ( 20 )   PDF (4022KB) ( 10 )  
Objectiv e To explore the mechanism of Weixuening granules in the treatment of immune thrombocytopenia (ITP) using network pharmacology. Methods The main active ingredients of Weixuening granules were screened using the pharmacological database and analysis platform (TCMSP) of the Chinese Medicine System. Drugbank database was used for target prediction, while Cytoscape 3.7.1 software was used to build a chemical composition-target network. Online Mendelian Inheritance in Man (OMIM), the Human Gene Database (Gene Cards), and Drugbank were searched for the related target genes of ITP. The targets of active ingredients of drugs were mapped to the ITP targets to obtain the intersection targets, which were the predicted targets for ITP of Weixuening granules. The STRING database was used to construct an intersection target protein interaction network (PPI) online before the CytoHubba and MCODE plug-ins in the Cytoscape 3.7.1 software were used to screen out key target genes. Gene ontology (GO) analysis and enrichment analysis based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) were used to analyze intersection targets using DAVID 6.8 and online tools. Results A total of 64 chemical components and 229 potential targets in Weixuening granules, 1 746 related targets in ITP disease, and 120 common targets in Weixuening granules- ITP disease were found. Quercetin, kaempferol, and luteolin regulated most of the targets associated with ITP, involving 47, 60 and 56 targets respectively. GO biological function analysis showed that such biological processes were involved as RNA polymerase II promoter, apoptosis, inflammation, aging, cell proliferation and signal transduction. KEGG pathway enrichment results showed 118 signaling pathways, mainly related to pathways in cancer, hepatitis B, and PI3K-Akt signaling pathway. Conclusion Weixuening granules combat ITP by the complex mechanism of multiple components, multiple targets and multiple pathways. The core targets are TP53, AKT1, VEGFA, CASP3, IL6, JUN, TNF, MAPK1, MYC and STAT3. The regulation mechanism involves regulation of inflammation, immunity and related signal transduction pathways.
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Considerations about MedDRA Coding in Adverse Drug Reaction Reports
LIU Cuili, TIAN Chuanhua, XIA Dongsheng, ZHU Lan, LIU Hongliang, SHEN Changhui, QI Yan, WANG Tao
2021, 18(11): 1055-1057. 
DOI: 10.19803/j.1672-8629.2021.11.12

Abstract ( 88 )   PDF (1181KB) ( 100 )  
Objectiv eTo make comments on MedDRA coding in case reports of Chinese drugs in order to provide reference for Chinese marketing authorization holders (MAHs) in the process of reporting adverse reactions with the Medical Dictionary for Regulatory Activities (MedDRA) as the standard term set. Methods The essential conditions, general principles and considerations related to MedDRA coding in adverse reaction reports were specified, and recommendations were made on MedDRA coding. Result and Conclusions With the extensive use of MedDRA in China, it is recommended that drug regulatory authorities release unified principles on the use of MedDRA in China in conjunction with the related requirements on term selection by the Maintenance and Support Services Organization(MSSO).
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An Overview of EudraVigilance and Implications for China
HOU Yongfang, LIU hongliang, QI Yan
2021, 18(11): 1058-1061. 
DOI: 10.19803/j.1672-8629.2021.11.13

Abstract ( 59 )   PDF (1435KB) ( 65 )  
Objectiv eTo offer some tips about upgrading adverse drug reaction monitoring systems in China by analyzing the EU's drug safety monitoring system (EudraVigilance). Methods EudraVigilance was studied from three perspectives: case reporting, data management, and data analysis. The key functions and methods of implementation of EudraVigilance were analyzed. Results EudraVigilance collected individual case safety reports(ICSR) through gateway reporting and web reporting. Methods of data quality control in EudraVigilance included MedDRA, drugs dictionaries, case recoding and monitoring of duplicates. Conclusion It is recommended that the Chinese counterpart learn from EudraVigilance to improve adverse drug reaction monitoring systems in China by establishing gateway reporting, web reporting and other reporting channels, improving data quality using terminology dictionaries and duplicate monitoring, and establishing a data warehouse to support risk signal identification.
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Clinical Evaluation of Medical Devices Seen from International Coordination Documents
JU Shan, LIU Yinghui, WANG Yawen, TENG Yingying, JIANG Yan, DENG Gang, SUN Lei
2021, 18(11): 1062-1065. 
DOI: 10.19803/j.1672-8629.2021.11.14

Abstract ( 20 )   PDF (1286KB) ( 15 )  
Clinical evaluation is critical to the determination of whether the risk benefit of medical devices meets the criteria for marketing authorization. The clinical evidence generated from clinical evaluation can be used as supporting evidence for regulatory decision-making. The clinical evaluation of medical devices is a top priority for domestic and foreign regulatory authorities, medical device manufacturers and stakeholders. The Medical Device Clinical Evaluation Working Group was established by the International Medical Device Regulators Forum (IMDRF) Management Committee in March 2018. It is a working group led by the Center of Medical Device Evaluation of the National Medical Products Administration. This working group drafted clinical evaluation-related documents after 18 months of research and discussion, which were approved and released by the IMDRF Management Committee in September 2019. The contents and main ideas of the three documents are summarized in this article. The progress in the clinical evaluation of medical devices in China and the implications of the three documents for clinical evaluation in China are discussed, and the challenges facing clinical evaluation in China are mentioned. This article is intended to provide reference for future research on clinical evaluation methods that are practical in China.
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Modern Clinical Applications and Analysis of Linggui Zhugan Decoction
WANG Luyao, DENG Zhe, XIAO Suping, ZHANG Quan, OUYANG Luodan, CHEN Meng, ZHOU Haiyan, WANG Jiyong, DU Jie
2021, 18(11): 1066-1069. 
DOI: 10.19803/j.1672-8629.2021.11.15

Abstract ( 24 )   PDF (1254KB) ( 19 )  
Objective To find out about the clinical profiles and targeted diseases of Linggui Zhugan decoction in order to provide reference for the development and application of Linggui Zhugan decoction and to inspire ideas for modern clinical applications of other classical prescriptions. Methods Related literature that was published between January 1, 1979 and February 11, 2020 was searched for from CNKI, VIP, Wanfang and other databases, Excel 2010 was used to sort out and statistically analyze such key information as the indications, number of cases, composition of medicine, characteristics of prescriptions, dosage, usage, efficacy and adverse reactions. The clinical applicability and targeted diseases of Linggui Zhugan decoction were studied based on data. Results A total of 543 pieces of literature met the inclusion criteria. It was found that Linggui Zhugan decoction was used against various indications, the number of cases ranged from 50 to 99, the total effective rate was over 90% and that few adverse reactions occurred. Heart failure was one of the targeted diseases of this decoction and the composition of this decoration was still based on the original prescription. The dosage varied considerably. This decoration was prepared by boiling the ingredients in water. 100-200 mL was taken each time, two or three times a day. Other herbs, which could benefit qi, activate blood and facilitate urination, were added. Conclusion This paper is expected to provide clinical data for more extensive use of Linggui Zhugan decoction and guide its industrialized clinical application.
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Compliance of Patients with Hyperlipidemia in Taking Statins and Risk Prediction
CHEN Jie, WU Lei, WU Yangxia, PAN Mi, DUAN Zihao, ZHU Zhixiang
2021, 18(11): 1070-1074. 
DOI: 10.19803/j.1672-8629.2021.11.16

Abstract ( 20 )   PDF (1591KB) ( 27 )  
Objectiv eTo explore the influencing factors of drug compliance in hyperlipidemia patients treated with statins, and to establish a nomogram model to predict the risk of poor compliance. Methods One hundred and sixty patients with hyperlipidemia treated in our hospital were selected between January 2018 and September 2019. These patients were divided into the good compliance group (84 cases) and poor compliance group (76 cases) according to the results of a questionnaire survey. Logistic regression analysis was used to screen independent risk factors. A linear prediction model was established by including the selected independent risk factors before the predictability and accuracy of the model were verified. Results According to logistic regression analysis of the general clinical data and related complications of the two groups, age (OR= 6.517, 95% CI: 1.986~21.39), lifestyles (OR=0.130, 95% CI: 0.039~0.429), medical expenses (OR=0.162, 95% CI: 0.058~0.452), doctor-patient relationships (OR=15.017, 95% CI: 4.991~45.181), follow-up (OR=7.889, 95% CI: 2.668~23.323), dietary habits (OR=5.187, 95% CI: 1.839~14.634) and adverse reactions of statins (OR=0.316, 95% CI: 0.110~0.904) were independent risk factors for poor drug compliance of patients with hyperlipidemia. The predictability of this model was basically consistent with the measured value. In addition, this model was verified by the Bootstrap internal verification method. The C-index was as high as 0.934(95% CI: 0.896-0.972), indicating the precision of the model. Conclusion It is of great clinical significance to evaluate the incidence of poor drug compliance in hyperlipidemia patients by taking into consideration age, lifestyles, medical expenses, doctor-patient relationships, follow-up, eating habits, adverse reactions of statins and other diseases.
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Availability and Affordability of National Medical Insurance Negotiated Innovative Anticancer Drugs in Changzhou
JIANG Huiqun, LI Xin, HAN Feng
2021, 18(11): 1075-1079. 
DOI: 10.19803/j.1672-8629.2021.11.17

Abstract ( 23 )   PDF (1578KB) ( 24 )  
Objectiv eTo understand the availability and affordability of national medical insurance negotiated innovative anticancer drugs in Changzhou, and to provide evidence for formulating and completing related policy.Methods WHO/HAI standard survey method was adopted to investigate on the availability and affordability of national medical insurance negotiated innovative anticancer drugs in Changzhou, and analyze the factors that affect the results.ResultsThe overall availability of these drugs is really high, with a large number of available varieties, but the access is mainly concentrated in tertiary general hospitals.The affordability of innovative anticancer drugs investigated in this study has been significantly improved after entering medical insurance list, but there is still a large space for improvement.ConclusionThe availability and affordability of these drugs were affected by many factors, including policies, the medical level of hospitals, market requirement, characteristics of tumor epidemiology, generics, etc.In order to further improve the availability and affordability of national medical insurance-negotiated innovative anticancer drugs, it is suggested that it is better to implement and promote the national medical policy, strengthen the management of medical and health institutions, and play further positive role of retail pharmacies.
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Safety Risks of Somatostatin for Injection
WANG Chunting, MA Minkang, ZHENG Mingjie
2021, 18(11): 1080-1082. 
DOI: 10.19803/j.1672-8629.2021.11.18

Abstract ( 23 )   PDF (1302KB) ( 30 )  
Objectiv eTo analyze the risks of somatostatin for injection so as to provide reference for clinical rational drug use. Methods The related adverse drug reaction reports in WHO VigiAccess and China adverse drug reaction database were analyzed. The cases of adverse drug reactions caused by somatostatin for injection reported in China were summarized. Instructions for somatostatin for injection and risk control measures and were statistically analyzed. Results Adverse drug reactions of somatostatin for injection involved multiple systems or organs, including gastrointestinal system damage, skin and accessory damage, cardiovascular system damage, metabolic and nutritional disorders. The main serious adverse drug reactions were allergic reactions, which could lead to allergic shock. Conclusion The serious allergic reactions induced by somatostatin for injection deserve more attention. Drug instructions should be made more specific while clinical safe and rational drug use should be ensured.
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Prevention of Adverse Reactions of Antibiotics in a Respiratory Department
WEI Yuanyuan, LI Fang, TAO Xiaomei, GU Hongyan
2021, 18(11): 1083-1086. 
DOI: 10.19803/j.1672-8629.2021.11.19

Abstract ( 45 )   PDF (1328KB) ( 46 )  
Objectiv eTo analyze the adverse drug reaction (ADR) that occur in a respiratory department and recommend precautions for the sake of rational use of antibiotics in clinic. Methods ADR reports of antibiotics in a hospital between January 31, 2016 and August 31, 2018 were retrospectively analyzed. The incidence of antibiotics-related ADR in different age groups, drug varieties, the time adverse reactions occurred, systems and organs involved and clinical manifestations were analyzed.A total of fifty-one ADR cases were included in this study. The characteristics of three cases of serious ADR were studied.ResultsElderly patients were more vulnerable to ADR in wards of a respiratory department. Levofloxacin, piperacillin-tazobactam and voriconazole were the top three drugs that were responsible for ADR. Most of the ADR were found within one day of treatment. Clinical pharmacists suggested precautions against ADR. Conclusion We should strengthen ADR monitoring of key drugs and elderly patients in order to ensure medication safety of patients by selecting the right drugs.
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Evaluation of Potentially Inappropriate Medications in Elderly Outpatients
ZHANG Jie, MAO Qiantai, AI Chao
2021, 18(11): 1087-1090. 
DOI: 10.19803/j.1672-8629.2021.11.20

Abstract ( 39 )   PDF (1366KB) ( 38 )  
Objectiv eTo evaluate the potentially inappropriate medications (PIM) in elderly outpatients, and recommend ways to improve the safety of medication for the elderly. Methods According to the 2017 edition of criteria for potentially inappropriate medications for older adults in China, medications for 2 411 elderly outpatients aged 60 or above were analyzed. Results The average age of the 2 411 enrolled outpatients was with random 30-day prescriptions from August to October 2018 (71.06±8.13) years and the average number of types of diseases was (6.59±5.16). For each patient, (2.96±2.30) types of medicines were being used. 507 patients (21.03%) experienced 584 PIM, and there were 46 cases of PIM (1.91%) related to diseases. Conclusion PIM are becoming more prevalent in elderly patients. Pharmacists should pre-examine prescriptions for the elderly more prudently and give more guidance to the elderly. We should also focus on patients who are elderly, suffer from multiple diseases, and use multiple drugs so as to avoid the risk of drug use and ensure the rational use of drugs by the elderly.
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Research Progress in the Influence of Proton Pump Inhibitors on Absorption of Oral Targeted Antitumor Drugs
XU Yinying, LU Zihong, LI Qi, LU Mudan, JIANG Sunmin
2021, 18(11): 1091-1096. 
DOI: 10.19803/j.1672-8629.2021.11.21

Abstract ( 31 )   PDF (1563KB) ( 49 )  
Proton pump inhibitors (PPIs), also called H+/K+-ATPase inhibitors, not only affect the efficiency and safety of drugs due to their inhibition of gastric acid secretion, resulting in the increase of pH in the stomach, but also hinder the dissolution and absorption of drugs. Oral targeted anticancer drugs are first-line treatment against tumors. Some cancer patients take PPIs and oral targeted anti-tumor drugs at the same time, making it necessary to study the effect of PPIs on the absorption of oral targeted anti-tumor drugs for the sake of effective and safe cancer treatment. In order to provide reference for clinical use, promote rational use of drugs and improve clinical efficacy, this paper collected the related literature and summarized the influence of PPIs on the absorption of oral targeted anti-tumor drugs.
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Research Progress in Methods of Risk & Benefit Assessment of Vaccines
LIU Chunguang, LIANG Gongshan, XU Changqing
2021, 18(11): 1097-1100. 
DOI: 10.19803/j.1672-8629.2021.11.22

Abstract ( 53 )   PDF (1531KB) ( 68 )  
The way in which the risk & benefit of vaccines are assessed has become an important means by which regulators and vaccine manufactures assess vaccines. Currently, foreign methods of assessment of the risk & benefit of vaccines are not yet full-fledged and there are no universally-used ones. The methods of quality-adjusted life years and multi-criteria decision-making method were prevalent. the World Health Organization (WHO) developed the Global Benchmark Tool for the national regulatory system for medical products to assess national regulatory systems for vaccines, including requirements related to the risk & benefit assessment of vaccines. China is to gradually establish and improve methods of assessment of the risk & benefit vaccines. Meanwhile, regulatory authorities, public health institutions and vaccine manufacturers should build a shared data platform to provide more evidence, promote vaccine assessment and improve China's vaccine regulatory systems.
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