OBJECTIVES: We conducted a literature review on adverse drug reactions (ADRs) related to 33 kinds of traditional Chinese medicine injections (CMIs) on China's National Essential medicines List (2004 edition). We aimed to retrieve basic ADR information, identify trends related to CMIs, and provide evidence for the research, development, and application of CMIs. METHODS: We electronically searched the Chinese Biomedical Literature Database (CBM, January 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, January 1979-April 2009), the Chinese Science and Technology Periodical Database (January 1989-April 2009) and the Traditional Chinese Medicine Database (January 1984-April 2009). We used the terms of 'adverse drug reaction', 'adverse event', 'side effects', 'side reaction', 'toxicity', and 'Chinese medicine injections', as well as the names of the 33 CMIs to search. We also collected CMI-related ADR reports and regulations from the Chinese Food and Drug Administration's 'Newsletter of Adverse Drug Reactions' (Issue 1 to 22). Then we descriptively analyzed all the articles by year published, periodical, and study design. We also analyzed regulations relevants to ADRs. RESULTS: (1) We found 5405 relevant citations, of which 1010 studies met the eligibility criteria. (2) The rate of publishing of research articles on CMI-linked ADRs has risen over time. (3) The included 1010 articles were scattered among 297 periodicals. Of these, 55 journals on pharmaceutical medicine accounted for 39.5% of the total (399/1010); the 64 journals on traditional Chinese medicine, accounted for only 19.5% (197/1010). Only 22 periodicals with relevant articles were included on the core journals of the Beijing University List (2008 edition); these published 129 articles (12.8% of the included articles). (4) The relevant articles consisted of 348 case reports (34.5%), 254 case series (25.2%), 119 reviews (11.8%), 116 randomized controlled trials (11.5%), 78 cross-sectional studies (7.7%), 61 literature analyses of ADR (6.0%), and 28 non-randomized controlled clinical studies (2.8%). (5) Three journals, Adverse Drug Reactions Journal, China Medical Herald, and Chinese Pharmaceuticals, together published 12.3% of the included literature. (6) The most commonly-reported CMI-related ADRs were to Shuanghuanglian, Qingkailing, and Yuxingcao injections, each of which had ADRs mentioned in more than 200 articles. Four of the five CMIs with the most ADR reports (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) had been suspended use or sale in the market. CONCLUSIONS: (1) Articles published on CMI-related ADRs increased over time, but overall the research is of low quality and is scattered through a large number of sources. (2) Four CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) had been suspended for clinical use or sale. (3) There is an urgent need for a clear standard to grade ADRs of CMIs in order to better risk manage. (4) It is necessary to continually re-evaluate the safety of CMIs and to promote rational use of CMIs.
OBJECTIVES: We conducted a literature review on adverse drug reactions (ADRs) related to 33 kinds of traditional Chinese medicine injections (CMIs) on China's National Essential medicines List (2004 edition). We aimed to retrieve basic ADR information, identify trends related to CMIs, and provide evidence for the research, development, and application of CMIs. METHODS: We electronically searched the Chinese Biomedical Literature Database (CBM, January 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, January 1979-April 2009), the Chinese Science and Technology Periodical Database (January 1989-April 2009) and the Traditional Chinese Medicine Database (January 1984-April 2009). We used the terms of 'adverse drug reaction', 'adverse event', 'side effects', 'side reaction', 'toxicity', and 'Chinese medicine injections', as well as the names of the 33 CMIs to search. We also collected CMI-related ADR reports and regulations from the Chinese Food and Drug Administration's 'Newsletter of Adverse Drug Reactions' (Issue 1 to 22). Then we descriptively analyzed all the articles by year published, periodical, and study design. We also analyzed regulations relevants to ADRs. RESULTS: (1) We found 5405 relevant citations, of which 1010 studies met the eligibility criteria. (2) The rate of publishing of research articles on CMI-linked ADRs has risen over time. (3) The included 1010 articles were scattered among 297 periodicals. Of these, 55 journals on pharmaceutical medicine accounted for 39.5% of the total (399/1010); the 64 journals on traditional Chinese medicine, accounted for only 19.5% (197/1010). Only 22 periodicals with relevant articles were included on the core journals of the Beijing University List (2008 edition); these published 129 articles (12.8% of the included articles). (4) The relevant articles consisted of 348 case reports (34.5%), 254 case series (25.2%), 119 reviews (11.8%), 116 randomized controlled trials (11.5%), 78 cross-sectional studies (7.7%), 61 literature analyses of ADR (6.0%), and 28 non-randomized controlled clinical studies (2.8%). (5) Three journals, Adverse Drug Reactions Journal, China Medical Herald, and Chinese Pharmaceuticals, together published 12.3% of the included literature. (6) The most commonly-reported CMI-related ADRs were to Shuanghuanglian, Qingkailing, and Yuxingcao injections, each of which had ADRs mentioned in more than 200 articles. Four of the five CMIs with the most ADR reports (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) had been suspended use or sale in the market. CONCLUSIONS: (1) Articles published on CMI-related ADRs increased over time, but overall the research is of low quality and is scattered through a large number of sources. (2) Four CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) had been suspended for clinical use or sale. (3) There is an urgent need for a clear standard to grade ADRs of CMIs in order to better risk manage. (4) It is necessary to continually re-evaluate the safety of CMIs and to promote rational use of CMIs.