摘要
目的清开灵注射液(QKL)是在中医传统古方安宫牛黄丸基础上研制而成,被广泛应用于中、西医临床治疗,本研究根据现有证据评价清开灵注射液的安全性。方法由两位研究者检索中文数据库CNKI和VIP(检索时间从1987年到2009年4月),并提取资料。结果本研究纳入1486例清开灵注射液不良反应/不良事件(ADR/AE)。由于不能获得清开灵注射液总的产量和使用量资料,无法计算ADR/AE的发生率,但根据现有资料估计,其ADR/AE发生率低。此外,清开灵注射液的一些使用方法和范围值得商榷,如在婴幼儿中使用,与有配伍禁忌的药物一起使用,在私人诊所或患者家里使用。根据发表资料尚无法鉴别ADR或AE。结论当前强度不高的证据表明,清开灵注射液的ADR/AE风险很低,但不恰当使用可能导致相当部份ADR/AE的发生。应鼓励临床工作者在医学期刊发表ADR/AE报告,并按照中药ADR报告建议规范写作和发表。
Objective Qin Kai Ling injection（QKL） is made upon traditional Chinese medicine formulation ＂An Gong Niu Huang Wan＂,is widely used to treatment a lot of diseases.This review aims to assess the safety of QKL.Methods We searched Chinese databases CNKI,VIP from 1987 to April 2009.Two authors extracted the data.Results Totally 1 486 cases were included in this review.We unable to answer the question about the incidence of adverse drug reaction/adverse event（ADR/AE） induced by QKL due to absence of total numbers of producing and market information.It was estimated based on the limited data that the possibility of ADR/AE by using QKL should be low.We found some ADR/AE may induced by incorrect use of QKL,such as used in infants,and some incompatibility drugs were used together with QKL,four patients died in private clinics or patient＇s home.We unable to distinguish the ADR or AE based on the poor reported data.Conclusion Current weak evidence shows that QKL has a low risk of ADR/AE.The use of QKL in some ADR/AE cases may be questionable.The reporting of ADR/AE needs to be much improved based on ＂Recommendation for reporting traditional Chinese medicine adverse drug reaction＂.
出处
《中国循证医学杂志》
CSCD
2010年第2期162-175,共14页
Chinese Journal of Evidence-based Medicine
关键词
清开灵注射液
不良反应
不良事件
系统评价
Qin Kai Ling injection
Adverse drug reaction
Adverse event
Systematic review
