何首乌及其制剂相关肝损害国内文献回顾与分析

目的：调查何首乌及其制剂相关肝损害的临床特征和发生原因以提供预防措施。方法：检索中国期刊全文数据库、中国生物医学文摘数据库及维普中文科技期刊文献数据库,收集1996年至2009年国内文献报道的与何首乌及其制剂相关药物性肝损害病例,对患者的一般情况、用药情况、肝损害的临床表现、预后和转归进行调查分析。结果：何首乌及其制剂相关肝损害病例共35例,其中男20例,女15例,平均年龄（36.2±13.7）岁。单用何首乌中成药14例,单用何首乌饮片18例,两者兼用3例,在使用何首乌饮片的患者中用生首乌6例,制首乌2例,其余不详。35例患者中有18例再次给药后又发生肝损害,3例表现出家族性发病倾向。用药后肝损害发生时间：最短3～6d,最长〉3个月,多数1～4周,临床主要表现为黄疸和肝功能异常。有肝功能检测记录的病例如下：31例患者ALT值为102～4584U/L,平均值为1153.1U/L;25例患者AST值为61.5～1937U/L,平均值为657.4U/L;29例患者TBil平均值为134.9μmol/L;23例患者DBil平均值为97.9μmol/L。症状较轻者停药后自愈,大部分患者经保肝治疗治愈,其中好转2例,治愈33例。结论：生首乌与制首乌及其制剂可引起肝损害。临床用药前应了解患者个人及家族用药史,严格剂量,用药时应监测患者肝功能。

Liver damage related to Polygonum multiflorum and its preparations: domestic literature review and analysis

Objective：To investigate the clinical features and causes of liver damage related to Polygonum multiflorum and its preparations in order to provide the preventive measures.Methods：The Chinese Journal Full-text Database,Chinese Biomedical Literature Database,and Chinese Scientific and Technical Periodicals Database were searched,and the case reports of Polygonum multiflorum and its preparation-related liver damage published in domestic literature from 1996 to 2009 were collected.The baseline characteristics of the patients,the situation of drug use,the clinical features,prognosis,and outcome of the liver damage were analysed.Results：A total of 35 patients had liver damage related to Polygonum multiflorum and its preparations.They comprised 20 men and 15 women with average age of（36.2 ±13.7） years.Of them,14 received Chinese patent medicine alone,18 received herbal pieces alone,and 3 received both Chinese patent medicine and herbal pieces.Among the patients receiving herbal pieces,6 received raw herbal pieces,2 received processed herbal pieces,and the others were not stated.Of the 35 patients,18 experienced liver damage again after drug readministration,3 might have a familial tendency to develop this disorder.The time to liver damage onset after drug administration was as follows：the shortest was 3~6 days,the longest was 3 months,and the most was 1~4 weeks.The main clinical presentations were jaundice and abnormal liver function.The case reports of having records of liver function tests were as follows：the ALT levels in 31 patients were 102~4 584 U/L,the average level was 1 153.1 U/L;the AST levels in 25 patients were 61.5~1 937 U/L,the average level was 657.4 U/L;the average TBil levels in 29 patients were 134.9 μmol/L;the average DBil levels in 23 patients were 97.9 μmol/L.The patients with mild symptoms spontaneously recovered after drug discontinuation.Most patients were cured after receiving liver-protective treatment.Of the 35 patients,2 improved and 33 were cured.Conclusion：Both raw and processed Polygonum multiflorum and its preparations may induce liver damage.The patients＇previous history and family history of Polygonum multiflorum use should be reviewed before drug administration,the correct dose should be chosen,and the patients＇liver function should be monitored during polygonum multiflorum use.