521 Cases of Adverse Drug Reactions of Ciwujia Injection based on 944 Studies△_Chinese Journal of Evidence-Based Medicine

Authors：

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

Corresponding author：

Keywords：

Ciwujia injection; Adverse drug reaction; Clinical study

DOI：

10.7507/1672-2531.20100383

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Objective 　To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors.
Methods 　We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed.
Results 　In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used.
Conclusion 　(1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.

Citation： HU Jing,SHANG Hongcai,LI Jing,ZHANG Li,ZHANG Junhua,ZHENG Wenke,LI Tingqian,ZHANG Boli,LI Youping. 521 Cases of Adverse Drug Reactions of Ciwujia Injection based on 944 Studies△. Chinese Journal of Evidence-Based Medicine, 2010, 10(2): 182-188. doi: 10.7507/1672-2531.20100383 Copy

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2.	雷载权, 主编. 中华临床中药学. 第1版. 北京: 人民卫生出版社, 1998, 1629.
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4.	范丽静, 蒋晓红, 姚国恩. 刺五加注射液研究进展. 中成药, 2003, 25(6): 488-490.
5.	李海兰, 李雪花, 马奎蓉. 刺五加注射液的临床应用. 时珍国医国药, 2005, 16(6): 542-543.
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7.	周践, 武晓玉, 张玉萌, 等. 5165例药品不良反应报表分析. 中国药物应用监测, 2004, 1(1): 45-47.
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10.	池锡红. 刺五加引起过敏反应导致死亡1例. 护理研究, 2003, 17(1): 67.
11.	卢先彬, 李晓红, 赵枫林. 刺五加注射液致重度过敏2例. 中国中医急症, 2006, 15(10): 1166-1167.
12.	莫文先. 125例刺五加注射液致不良反应文献分析. 时珍国医国药, 2008, 19(9): 2309-2310.
13.	荆少霞, 盛玉勤. 刺五加注射液引起过敏反应二例. 佳木斯医学院学报, 1993, 16(4): 77.
14.	高素强, 胡咏川. 中药注射剂的应用现状与上市后再评价. 中国中药杂志, 2007, 32(13): 1370-1372.
15.	舒畅, 胡晶, 商洪才, 等. 中国工程院医药卫生学部2009医学科学前沿论坛纪要——中医药临床疗效评价技术与方法进展. 中国循证医学杂志, 2009, 9(3): 365-366.
16.	欧阳荣, 廖建萍, 胡铁骊, 等. 刺五加注射液与5种药物配伍的稳定性考察. 中国中医药信息杂志, 2000, 7(12): 48-49.
17.	徐艳华, 宋艳春, 张丽英. 刺五加注射液在4种输液中与14种药物配伍理化变化. 中草药, 1998, 29(4): 239-240.
18.	田子国, 于金霞, 孙俊英. 刺五加与复方丹参配伍应用发生变态反应1例. 现代中西医结合杂志, 2004, 13(16): 2176.
19.	张丽梅, 宋畅, 张鑫. 氧氟沙星注射液与常用药物配伍的稳定性. 中国药物与临床, 2005, 5(10): 770-772.
20.	肖开芝, 马登艳, 谭其玲, 等. 常用药物的配伍禁忌及预防措施. 华西医学, 2009, 24(5): 1301-1304.
21.	温霞. 中西药物配伍的合理性与禁忌分析. 中国医药导报, 2008, 5(8): 78-79.
22.	詹思延. 药物流行病学研究的迫切性和特殊性. 中华流行病学杂志, 2001, 22(6): 403-404.

1. 吴立军, 阮丽军. 刺五加茎叶化学成分研究. 药学学报, 1993, 34(11): 839-841.
2. 雷载权, 主编. 中华临床中药学. 第1版. 北京: 人民卫生出版社, 1998, 1629.
3. 陈新谦, 主编. 新编药物学. 第16版. 北京: 人民卫生出版社, 2007, 802.
4. 范丽静, 蒋晓红, 姚国恩. 刺五加注射液研究进展. 中成药, 2003, 25(6): 488-490.
5. 李海兰, 李雪花, 马奎蓉. 刺五加注射液的临床应用. 时珍国医国药, 2005, 16(6): 542-543.
6. 周超凡, 徐植灵, 林育华. 应当重视中药注射剂上市后再评价. 中国药物警戒, 2006, 3(5): 129.
7. 周践, 武晓玉, 张玉萌, 等. 5165例药品不良反应报表分析. 中国药物应用监测, 2004, 1(1): 45-47.
8. 张清文, 孙雪峰. 刺五加注射液致过敏性休克死亡. 药物不良反应杂志, 2007, 9(1): 57.
9. 朱本浩, 胡敏. 静滴刺五加注射液致过敏反应3例报告. 中国乡村医生杂志, 1998, 10: 45-46.
10. 池锡红. 刺五加引起过敏反应导致死亡1例. 护理研究, 2003, 17(1): 67.
11. 卢先彬, 李晓红, 赵枫林. 刺五加注射液致重度过敏2例. 中国中医急症, 2006, 15(10): 1166-1167.
12. 莫文先. 125例刺五加注射液致不良反应文献分析. 时珍国医国药, 2008, 19(9): 2309-2310.
13. 荆少霞, 盛玉勤. 刺五加注射液引起过敏反应二例. 佳木斯医学院学报, 1993, 16(4): 77.
14. 高素强, 胡咏川. 中药注射剂的应用现状与上市后再评价. 中国中药杂志, 2007, 32(13): 1370-1372.
15. 舒畅, 胡晶, 商洪才, 等. 中国工程院医药卫生学部2009医学科学前沿论坛纪要——中医药临床疗效评价技术与方法进展. 中国循证医学杂志, 2009, 9(3): 365-366.
16. 欧阳荣, 廖建萍, 胡铁骊, 等. 刺五加注射液与5种药物配伍的稳定性考察. 中国中医药信息杂志, 2000, 7(12): 48-49.
17. 徐艳华, 宋艳春, 张丽英. 刺五加注射液在4种输液中与14种药物配伍理化变化. 中草药, 1998, 29(4): 239-240.
18. 田子国, 于金霞, 孙俊英. 刺五加与复方丹参配伍应用发生变态反应1例. 现代中西医结合杂志, 2004, 13(16): 2176.
19. 张丽梅, 宋畅, 张鑫. 氧氟沙星注射液与常用药物配伍的稳定性. 中国药物与临床, 2005, 5(10): 770-772.
20. 肖开芝, 马登艳, 谭其玲, 等. 常用药物的配伍禁忌及预防措施. 华西医学, 2009, 24(5): 1301-1304.
21. 温霞. 中西药物配伍的合理性与禁忌分析. 中国医药导报, 2008, 5(8): 78-79.
22. 詹思延. 药物流行病学研究的迫切性和特殊性. 中华流行病学杂志, 2001, 22(6): 403-404.

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521 Cases of Adverse Drug Reactions of Ciwujia Injection based on 944 Studies△

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