双黄连注射剂与西药配伍研究的系统评价

Systematic Review on the Compatibility of Shuanghuanglian Injection Combined with Western Medical Injections

目的探讨研究双黄连注射剂与西药注射剂和配伍宜忌,为双黄连注射剂的临床合理使用提供依据。方法全面收集双黄连注射剂(水针和粉针)与西药注射剂配伍的实验室和临床研究,提取有关双黄连剂型与用量、配伍药物及用量、输液类型、配制液理化检测指标以及药物代谢、药效指标和不良反应等数据,按照配伍药物的类别进行分类,描述性分析其物理性状、化学成分、药物代谢和安全性等,并据此评价配伍的宜忌。结果共纳入60篇文献,其中实验研究38篇,1999～2002年间发表者占总数的50%。所有研究共涉及西药注射剂53个,并以与β内酰胺类、氨基甙类及喹诺酮类抗生素配伍的研究为多,共发现31个配伍禁忌。本系统评价结果还显示,现有实验研究指标选择片面,在今后的研究设计中应予注意。结论双黄连注射剂与西药针剂存在广泛配伍禁忌,在没有研究清楚前,不可盲目配伍使用。现有中药注射剂与其他药物配伍的基础研究还很薄弱,企业应加强组织研究,主动收集上市后研究的数据,不断完善说明书。

Objective Shuanghuanglian injection（SHLI） is a typical Chinese medicine injection which has been used for more than 20 years.This study aims to investigate the compatibility of SHLI with western intravenous agents.Methods An extensive literature search was executed to identify all experimental tests and clinical reports on the topics.Data on the types of infusion solutions and western medical injections,usage and dosage,outcome measures for physical and chemical properties,and changes of drug e ect were searched for.The included data was analyzed and described by the category of included western drugs.Compatibility was tested through integrating the evaluations of physical properties,chemical composition,drug metabolism,and safety.Results Sixty articles（38 experimental tests and 22 clinical reports） were included after screening.Fifty-three western medical injections were identi ed from all the included articles.Most of the research was about the compatibility of SHLI with di erent types of antibiotics,including β-lactam,aminoglycoside,and quinolone etc.Thirty-one western medical injections were not recommended to be combined with SHLI.The quality of the experimental test design was low because of unbalanced evaluation indicators：more attention to physical changes than drug metabolism,e ect,and safety.Conclusions A broad incompatibility exists in the combination of SHLI with western medical injections.Some results are still uncertain,but the combinations should still be avoided until researched clearly.The compatibility and interaction of Chinese herbal injections and western medicines is still a weak area.The pharmaceutical sector should strengthen post-market research to update evidence and improve its distribution.