摘要
目的分析评估肾上腺色腙片剂及注射液的有效性与安全性。方法查阅"中文科技期刊数据库"(1989～2009年)和"中国期刊全文数据库"(1994～2009年)有关肾上腺色腙的临床研究、不良反应报道文献,分析临床研究数据,不良反应严重性。结果肾上腺色腙的临床研究涉及片剂、注射液,所有临床研究未能做到双盲随机对照,片剂文献报道临床有效率为70%～90%,注射液的报道有效率为20%。文献报道不良反应均为注射液所致,作者均推测为其中水杨酸钠所致。结论应加强肾上腺色腙临床研究的设计,肾上腺色腙注射液处方设计合理性欠充分,其不良反应的危险性超过了临床有效性,已有安全性有效性较强的产品可以替代,建议淘汰肾上腺色腙注射液制剂。
Objective To evaluate the safety and effectiveness of Carbazochrome tablet and injection.Methods Clinical trial and adverse drug reaction report articles retrieved in Chinese Science and Technology Journals Database（1989～2009） and Chinese Journals Full text Database（1994～2009） were evaluated.Results 13 clinical trials,858 patients were induced in 13 articles for carbazochrome tablet and injection,but none is randomized,controlled trial.Conclusion Study design for clinical trial of carbazochrome should be improved.The formula of carbazochrome injection is not optimized,and the ratio of risk to effectiveness of the injection is unacceptable.There has been other substitute and carbazochrome injection should be terminated.
出处
《中国药物警戒》
2010年第11期683-685,共3页
Chinese Journal of Pharmacovigilance
