Adverse Drug Reactions of Shuanghuanglian Injection: A Systematic Review of Public Literatures△_Chinese Journal of Evidence-Based Medicine

Authors：

CHENG Lan ^1,2# , WANG Li ^1# , YUAN Qiang ^1,2 , CUI Xiaohua ^1,2 , SHANG Hongcai ³ , ZHANG Boli ³ ,  LI Youping ¹

1. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;2. West China School of Medicine, Sichuan University, Chengdu 610041, China;3. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Shuanghuanglian injection; Adverse drug reaction; Systematic review

DOI：

10.7507/1672-2531.20100344

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Objectives 　To systematically evaluate the clinical characteristics of adverse drug reactions (ADRs) caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI.
Methods 　We searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979.1-2009.9), the Chinese Science and Technology Journal Full-text Database (VIP, 1989.1-2009.9), and the Chinese Biomedical Disc (CBMdisc, 1978.1-2009.9). 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 accounted for 84.51%. According to 31165 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 accounted 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, 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 lt;0.05) in the rate of ADR caused by SHLI in power form (2.25%) and as a solution (4.14%).
Conclusion 　The 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.

Citation： CHENG Lan,WANG Li,YUAN Qiang,CUI Xiaohua,SHANG Hongcai,ZHANG Boli,LI Youping. Adverse Drug Reactions of Shuanghuanglian Injection: A Systematic Review of Public Literatures△. Chinese Journal of Evidence-Based Medicine, 2010, 10(2): 140-147. doi: 10.7507/1672-2531.20100344 Copy

1.	颜敏, 吴晔, 郭小昕. 药品上市后再评价技术规范及评价模式探讨. 药物流行病学杂志, 2003, 12(6): 286-289.
2.	国家食品药品监督管理局. 第一期《药品不良反应信息通报》. [2009-12-5] http:// www.cdr.gov.cn/gxzy/ ypblfytb/1373.shtml.
3.	国家食品药品监督管理局. 第二十二期《药品不良反应信息通报》. [2009-12-5] http://www.cdr.gov.cn/ gxzy/ ypblfytb/8701. shtml.
4.	国家食品药品监督管理局. 卫生部办公厅、国家食品药品监督管理局办公室关于立即暂停使用和销售黑龙江乌苏里江制药有限公司佳木斯分公司生产的双黄连注射液的紧急通知. [2009-12-5] http://www.sda.gov.cn/WS01/CL0056/35813.html.
5.	国家食品药品监督管理局. 国家食品药品监督管理局要求暂停销售使用标示为多多药业有限公司双黄连注射液. [2009-12-5] http://www.cdr.gov.cn/xwdt/gnxw/11152.shtml.
6.	袁强, 王莉, 成岚, 等. 国家基本药物目录（2004年版）33种中药注射剂不良反应/不良事件文献分析. 中国循证医学杂志, 2010, 10(2): 132-139.
7.	周践, 武晓玉, 张玉闷, 等. 5165例药品不良反应报表分析. 中国药物应用监测, 2004, 1(1): 54-47.
8.	赵冬梅, 吕镇东. 双黄连致过敏性休克2例. 医药导报, 1994, 13(1): 41-41.
9.	张国华, 汪德文, 陈怀芳. 静滴双黄连粉针剂引起过敏性休克尸检一例. 中国法医学杂志, 1996, 11(4): 203.
10.	雷华国. 双黄连注射液静滴致死1例. 急诊医学, 2000, 9(6): 366.
11.	李桂英, 王跃波. 双黄连粉针药物过敏致死1例. 中国药事, 2001, 15(2): 143-144.
12.	谷兰卿. 双黄连致过敏性休克死亡1例. 临沂医专学报, 2001(3): 221.
13.	陈志刚. 静滴双黄连注射液致休克死亡1例. 滨州医学院学报, 2002, 25(1): 28.
14.	杜一顺, 周建, 侯胡玲, 等. 静脉滴注清开灵、双黄连引起过敏性休克2例. 中国法医学杂志, 200, 17(2): 84.
15.	鞠忠玲, 赵小玲, 罗德劲. 双黄连粉针剂致严重过敏反应2例. 山西中医, 2002, 18(6): 41.
16.	吴玉坤, 付玉娟, 陈艳霞. 静脉输入双黄连注射液诱发心肌梗死发作致死1例. 中国乡村医药杂志, 2002, 9(12): 41.
17.	郑增春, 孙向梅. 静滴双黄连过敏致死1例. 中国乡村医药杂志, 2002, 9(3): 35.
18.	艾尼, 卡米力江. 双黄连注射液致过敏性休克3例. 中国基层医药, 2004, 11(7): 817.
19.	尹爱群, 王军栋, 安勤玲. 双黄连注射剂不良反应致死1例. 中国药事, 2007, 21(10): 864.
20.	李阳革. 两种不同剂型双黄连不良反应类型临床分析. 中国现代药物应用, 2009, 3(1): 136-137.
21.	孙宝恩, 杨建宁, 唐桂荣. 医院内上呼吸道感染的易发人群调查分析. 张家口医学院学报, 2000, 17(3), 48-49.
22.	吴嘉瑞, 张冰. 双黄连注射剂不良反应文献的数据挖掘研究. 药物警戒, 2008, 5(3), 139-143.
23.	张力, 冯巧巧, 杨晓辉. 中药注射剂不合理使用相关不良事件案例分析与探讨. 中国药物警戒, 2009, 6(10): 598-602.
24.	曹海山, 何鹏彬, 杨莉珠. 288例中药注射剂致过敏性休克分析. 药物流行病学杂志, 2006, 15(1): 26-27.
25.	吴晔, 任经天, 颜敏, 等. 六省市2001-2002年双黄连注射剂的临床使用情况调查. 中国药物警戒, 2004, 1(2): 21-24.
26.	吴嘉瑞, 张冰. 双黄连注射剂致过敏性休克流行病学特点. 中成药, 2007, 29(5): 638-641.
27.	杨丽甲, 宋红儒, 储雪蓉, 等. 双黄连注射剂不溶性微粒考察. 中华中西医学杂志, 2007, 5(10): 12-14.
28.	杨翠平. 双黄连及清开灵注射液与葡萄糖及氯化钠注射液配伍后不容性微粒情况的观察. 河南中医学院学报, 2004, 19(5): 18.

1. 颜敏, 吴晔, 郭小昕. 药品上市后再评价技术规范及评价模式探讨. 药物流行病学杂志, 2003, 12(6): 286-289.
2. 国家食品药品监督管理局. 第一期《药品不良反应信息通报》. [2009-12-5] http:// www.cdr.gov.cn/gxzy/ ypblfytb/1373.shtml.
3. 国家食品药品监督管理局. 第二十二期《药品不良反应信息通报》. [2009-12-5] http://www.cdr.gov.cn/ gxzy/ ypblfytb/8701. shtml.
4. 国家食品药品监督管理局. 卫生部办公厅、国家食品药品监督管理局办公室关于立即暂停使用和销售黑龙江乌苏里江制药有限公司佳木斯分公司生产的双黄连注射液的紧急通知. [2009-12-5] http://www.sda.gov.cn/WS01/CL0056/35813.html.
5. 国家食品药品监督管理局. 国家食品药品监督管理局要求暂停销售使用标示为多多药业有限公司双黄连注射液. [2009-12-5] http://www.cdr.gov.cn/xwdt/gnxw/11152.shtml.
6. 袁强, 王莉, 成岚, 等. 国家基本药物目录（2004年版）33种中药注射剂不良反应/不良事件文献分析. 中国循证医学杂志, 2010, 10(2): 132-139.
7. 周践, 武晓玉, 张玉闷, 等. 5165例药品不良反应报表分析. 中国药物应用监测, 2004, 1(1): 54-47.
8. 赵冬梅, 吕镇东. 双黄连致过敏性休克2例. 医药导报, 1994, 13(1): 41-41.
9. 张国华, 汪德文, 陈怀芳. 静滴双黄连粉针剂引起过敏性休克尸检一例. 中国法医学杂志, 1996, 11(4): 203.
10. 雷华国. 双黄连注射液静滴致死1例. 急诊医学, 2000, 9(6): 366.
11. 李桂英, 王跃波. 双黄连粉针药物过敏致死1例. 中国药事, 2001, 15(2): 143-144.
12. 谷兰卿. 双黄连致过敏性休克死亡1例. 临沂医专学报, 2001(3): 221.
13. 陈志刚. 静滴双黄连注射液致休克死亡1例. 滨州医学院学报, 2002, 25(1): 28.
14. 杜一顺, 周建, 侯胡玲, 等. 静脉滴注清开灵、双黄连引起过敏性休克2例. 中国法医学杂志, 200, 17(2): 84.
15. 鞠忠玲, 赵小玲, 罗德劲. 双黄连粉针剂致严重过敏反应2例. 山西中医, 2002, 18(6): 41.
16. 吴玉坤, 付玉娟, 陈艳霞. 静脉输入双黄连注射液诱发心肌梗死发作致死1例. 中国乡村医药杂志, 2002, 9(12): 41.
17. 郑增春, 孙向梅. 静滴双黄连过敏致死1例. 中国乡村医药杂志, 2002, 9(3): 35.
18. 艾尼, 卡米力江. 双黄连注射液致过敏性休克3例. 中国基层医药, 2004, 11(7): 817.
19. 尹爱群, 王军栋, 安勤玲. 双黄连注射剂不良反应致死1例. 中国药事, 2007, 21(10): 864.
20. 李阳革. 两种不同剂型双黄连不良反应类型临床分析. 中国现代药物应用, 2009, 3(1): 136-137.
21. 孙宝恩, 杨建宁, 唐桂荣. 医院内上呼吸道感染的易发人群调查分析. 张家口医学院学报, 2000, 17(3), 48-49.
22. 吴嘉瑞, 张冰. 双黄连注射剂不良反应文献的数据挖掘研究. 药物警戒, 2008, 5(3), 139-143.
23. 张力, 冯巧巧, 杨晓辉. 中药注射剂不合理使用相关不良事件案例分析与探讨. 中国药物警戒, 2009, 6(10): 598-602.
24. 曹海山, 何鹏彬, 杨莉珠. 288例中药注射剂致过敏性休克分析. 药物流行病学杂志, 2006, 15(1): 26-27.
25. 吴晔, 任经天, 颜敏, 等. 六省市2001-2002年双黄连注射剂的临床使用情况调查. 中国药物警戒, 2004, 1(2): 21-24.
26. 吴嘉瑞, 张冰. 双黄连注射剂致过敏性休克流行病学特点. 中成药, 2007, 29(5): 638-641.
27. 杨丽甲, 宋红儒, 储雪蓉, 等. 双黄连注射剂不溶性微粒考察. 中华中西医学杂志, 2007, 5(10): 12-14.
28. 杨翠平. 双黄连及清开灵注射液与葡萄糖及氯化钠注射液配伍后不容性微粒情况的观察. 河南中医学院学报, 2004, 19(5): 18.

Chinese Journal of Evidence-Based Medicine

Adverse Drug Reactions of Shuanghuanglian Injection: A Systematic Review of Public Literatures△

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