• Li Wang, Lan Cheng, Qiang Yuan, Xiaohua Cui, Hongcai Shang, Boli Zhang, and Youping Li.
• West China Hospital, Sichuan University, Chengdu 610041, China. cochrane@163.com
• J Evid Based Med. 2010 Feb 1; 3 (1): 18-26.

ObjectivesTo systematically evaluate the clinical characteristics of ADRs caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI.MethodsWe searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979-2009.9), the Chinese Science and Technology Journal Full-text Database (VIP, 1989-2009.9), and the Chinese Biomedical Disc (CBMdisc, 1978-2009.9). ADR cases were analyzed according to occurrences categorized. Available data was assessed using the Chi-square test including relative ratios (RR) with 95% confidence intervals (95%CI). Different medicine combinations and comparisons between SHL powder injection and SHL injection were calculated using the statistical software Stata 9.1.Results(1) A total of 452 articles were included with a total of 2,799 ADR cases reported. Case reports were the main design type of included literature, which account for 84.51%. According to 31,165 cases of SHLI treatment and 1,013 corresponding ADRs, the incidence of SHLI ADR was calculated as 3.25%. (2) The ratio of male to female in the reported ADR cases was 1.13:1. (3) Allergy to Penicillin, which account for 13.38% of the total cases, was at the top for past allergic history, followed by sulfonamides and asthma (2.68%). (4) In terms of disease treated respiratory disease accounted for 91.75% of all cases of SHLI ADRs, followed by digestive diseases (5.17%), and urinary diseases (1.11%). (5) Penicillins were the most common combination choice with SHLI, and such combination showed higher ADR risk than SHLI used alone (RR = 3.14, 95%CI 2.58 to 3.81). (6) Multiple systems/organs were involved in SHLI ADRs, and were ranked downwards according to proportion as: skin, digestive system, general reactions, respiratory system, nervous system, cardiovascular system, local reactions, urinary system, hematologic system and others. (7) According to the WHO ADR Classification Criteria, ADR cases were divided into four grades. There were 6.36%, 5.48%, 45.62%, and 2.12% cases of Grade I, II, III, and IV respectively. And the prognoses of the rest 52.42% cases were reported unclearly. (8) All cases of death were caused by allergic shock, except for one, which was caused by myocardial infarction induced by pain at the injection site. The fastest ADR case occurred 1 minute after being injected. (9) There was a remarkable difference (P < 0.05) in the rate of ADR caused by SHLI in power form (2.25%) and as a solution (4.14%).ConclusionThe clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions. There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics. Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance. We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs.© 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

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