Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned—the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Medicine Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
Objective Shuanghuanglian injection (SHLI) is a typical Chinese medicine injection which has been used for more than 20 years. This study aims to investigate the compatibility of SHLI with western intravenous agents. Methods An extensive literature search was executed to identify all experimental tests and clinical reports on the topics. Data on the types of infusion solutions and western medical injections, usage and dosage, outcome measures for physical and chemical properties, and changes of drug effect were searched for. The included data was analyzed and described by the category of included western drugs. Compatibility was tested through integrating the evaluations of physical properties, chemical composition, drug metabolism, and safety. Results Sixty articles (38 experimental tests and 22 clinical reports) were included after screening. Fifty–three western medical injections were identified from all the included articles. Most of the research was about the compatibility of SHLI with different types of antibiotics, including β-lactam, aminoglycoside, and quinolone etc. Thirty-one western medical injections were not recommended to be combined with SHLI. The quality of the experimental test design was low because of unbalanced evaluation indicators: more attention to physical changes than drug metabolism, effect, and safety. Conclusions A broad incompatibility exists in the combination of SHLI with western medical injections. Some results are still uncertain, but the combinations should still be avoided until researched clearly. The compatibility and interaction of Chinese herbal injections and western medicines is still a weak area. The pharmaceutical sector should strengthen post-market research to update evidence and improve its distribution.
【摘要】 目的 验证临床药师对我院中药注射剂合理使用进行干预的效果。 方法 对比分析2010年临床药师干预前后中药注射剂的合理使用情况，随机抽取2010年1-6月合格病历1 000份，设为非干预组；随机抽取2010年9月-2011年2月合格病历1 000份，设为干预组；评估临床药师的干预作用。 结果 非干预组中药注射剂的使用率为31.10%，干预组为19.00%，差异有统计学意义（χ2=38.991，P=0.000）；非干预组适应证不合理的为6.00%，干预组为2.10%，差异有统计学意义（χ2=19.570，P=0.000）；非干预组发生不良反应15例，干预组发生3例，两组不良反应发生率差异有统计学意义（χ2=8.073，P=0.004）；中药注射剂的用法用量趋于规范。 结论 临床药师对中药注射剂临床使用的干预行之有效，对促进医院安全、有效、合理使用中药注射剂起到了积极作用。【Abstract】 Objective To explore the effects of clinical pharmacists intervention on traditional chinese medicine injection. Methods Compared the rational usage of traditional Chinese medicine injection in 2010 after the intervention of clinical pharmacists. A total of 1 000 clinical case records from January to June 2010 were randomly selected and was named as the non-intervention group; another 1 000 clinical case records from September 2010 to February 2011 were randomly selected and was named as the intervention group. The effect of the clinical pharmacists were evaluated. Results The utilization rate of the Chinese medicine injection was 31.10% in non-intervention group and 19.00% in the intervention group with a significant difference between the two groups (χ2=38.991，P=0.000). The irrationality of indication was 6.00% in non-intervention group and 2.10 in the intervention group with a significant difference between the two groups （χ2=19.570，P=0.000）. The adverse reaction was found in 15 patients in non-intervention group and in three patients in the intervention group with a significant difference between the two groups（χ2=8.073，P=0.004）. The usage and dosage of Chinese traditional medicine injection was tend to be normative. Conclusion The intervention on traditional Chinese medicine injection by clinical pharmacists is effective, which is a important part in promoting the rational use of traditional Chinese medicine injection.
ObjectivesTo systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. MethodsCFDA, CNKI, VIP, WanFang Data, Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. ResultsA total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection (2.54%). The related factors of ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days, indication, dose and distribution of the tube. ConclusionsThe safety of traditional Chinese medicine injection is generally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic, and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
ObjectivesTo overview the systematic reviews of traditional Chinese herb injections for viral pneumonia.MethodsCNKI, CBM, WanFang Data, VIP, PubMed, Web of Science, The Cochrane Library and EMbase databases were electronically searched to collect systematic reviews (SRs) of traditional Chinese herb injections for viral pneumonia from inception to March 2020. Two reviewers independently screened literature and extracted data. Then, AMSTAR 2 was used to assess the methodological quality and GRADE was used to grade the outcome indicators of included SRs.ResultsA total of 10 SRs were included, containing six Chinese herb injections (Xiyanping injection, Yanhuning injection, Tanreqing injection, Reduning injection, Shuanghuanglian injection, and Chuanhuning injection). Five items of AMSTAR 2 were reported well, and two items were not reported in any of the included SRs, and the quality was unsatisfactory. The efficacy of Chinese herb injection was superior than that of western medicine in many outcome indicators, such as antipyretic time, the pulmonary rales disappearing time, and the total clinical efficiency. The quality of evidence ranged from medium to very low.ConclusionsCurrent evidence shows that the quality of SRs of Chinese herb injections for viral pneumonia requires improvement, and most of the results show that Chinese herb injections are more effective than western medicines.
The post-marketing clinical safety re-evaluation studies of traditional Chinese medicine injections have obtained safety evidence of various research types such as active monitoring, passive monitoring and literature review. However, there is a lack of comprehensive evaluation methods that can effectively integrate the data of the above research types. So far, it is impossible to further produce more comprehensive and objective high-level evidence-based evidence, which seriously affects the supervision and management of traditional Chinese medicine injections and clinical rational use. The key to establishment of a comprehensive evaluation method is to first establish a comprehensive evaluation of the core indicators of the preferred method, the formation of weighted quantitative scoring model applied to the comprehensive evaluation method. Mixed methods research (MMR) can effectively and deeply integrate different types of research data and scientifically and normatively complete the screening of indicators in the evaluation model through repeated quantitative and qualitative research on data. Secondly, for the most critical index weighting and weight adjustment research in the model construction research, the author innovatively combines the analytic hierarchy process with the invariant weight sub-constraint method, and introduces the quantitative research part of the MMR design. It ensures the accurate weighting of indicators in the process of model construction. Therefore, based on the research on the core outcome set proposed for the core outcome outcomes of the effectiveness test, this paper proposes the use of MMR to carry out index screening and weight adjustment research based on multi-source complex data, and to construct a comprehensive evaluation model of post-marketing clinical safety of traditional Chinese medicine injections that integrates different research types of data. It provides measurement tools and new methods for the comprehensive evaluation of post-marketing clinical safety of traditional Chinese medicine injections.