李外

摘要：目的 探讨壮骨关节丸致肝损伤的临床特点及发生规律，为临床合理用药提供参考。方法 通过检索1993-2015年国内文献，收集壮骨关节丸致肝损伤15例，应用药物流行病学方法对资料进行归纳分析。结果 壮骨关节丸致肝损伤的临床表现多为全身乏力、食欲下降、恶心、厌油腻、皮肤瘙痒，尿色深如浓茶、皮肤及巩膜黄染。经停药及对症治疗后，患者均痊愈。结论 壮骨关节丸导致肝损伤的因果联系确切；该药处方无配伍禁忌及毒性药物，其肝损伤是可逆的，预后良好，建议临床应用该药应严格辨证，控制疗程；另外，建议该药的制剂工艺做适当修改，避免将乳香、没药等研成粉末，未经提取精制而直接做丸剂。

关键词：壮骨关节丸；肝损伤；文献分析

DOI：10.3969/j.issn.1005-5304.2017.05.030

中图分类号：R288 文献标识码：A 文章编号：1005-5304（2017）05-0122-02

Literature Analysis on Liver Damage Induced by Zhuanggu Guanjie Pills LI Wai （Outpatient Pharmacy， Chinese PLA General Hospital， Beijing 100853， China）

Abstract： Objective To investigate clinical features and regularity of liver damage induced by Zhuanggu Guanjie Pills； To provide references for rational medication. Methods By searching for domestic papers from 1993 to 2015， 15 cases of liver damage caused by Zhuanggu Guanjie Pills were collected. The data were analyzed by the method of medicine epidemiology. Results The main clinical manifestations of liver injury caused by Zhuanggu Gujie Pills were general malaise， loss of appetite， nausea， aversion to greasy food， pruritus， deep dark urine like tea， yellow skin and sclera. After withdrawal and symptomatic treatment， patients were cured. Conclusion It is clear that Zhuanggu Guanjie Pills would lead to liver damage. The prescription of Zhuanggu Guanjie Pills is safe， without incompatibility and toxicity. The liver damage was converse， and the patients were recovered. It is suggested that Zhuanggu Guanjie Pills should be taken differencially and according to course of treatment. It is suggested that the preparation process of Zhuanggu Guanjie Pills should be modified. Olibanum and myrrha should be extracted and refined， and should not be made pills directly.

Key words： Zhuanggu Guanjie Pills； liver damage； literature analysis

壮骨关节丸主要成分为狗脊、淫羊藿、独活、骨碎补等，其功能为补益肝肾、养血活血、舒筋活络、理气止痛，主要用于肝肾不足、血瘀气滞、脉络痹阻所致骨性关节炎、腰肌勞损等。近年来，随着临床广泛应用，有关其不良反应的报道也逐渐增多。为此，笔者就壮骨关节丸致肝损伤的国内文献进行分析，为临床合理用药提供参考。

1 资料与方法

检索中国知识资源总库（1993年1月-2015年12月）和中文科技期刊数据库（重庆维普，1993年1月-2015年12月），以“壮骨关节丸”“肝损伤”等为检索词，下载病例报告原文，剔除综述、重复病例和年龄、性别、用药剂量等情况不明的病例报告后，最终获得有分析价值的文献11篇，共计15例病例。……