查询《中国药典》2015年版和《中华人民共和国卫生部药品标准》（中药成方制剂1~20册）中所有含何首乌生品和炮制品的中成药，运用中国知网检索上述制剂的不良反应报道，并针对中药炮制、处方药味数、功能主治等中医特色，运用统计学手段对其不良反应情况进行系统分析。含何首乌生品中成药已有不良反应报道的品种有13种，其不良反应发生依次为胃肠道反应、口干、肝损伤、过敏反应、心悸，主要发生在治疗高脂血症、冠心病、痹症的中成药中；含何首乌炮制品的中成药已有不良反应报道的品种为37种，其不良反应报道主要有肝损伤、胃肠道反应、过敏反应等，多在治疗白发、脱发、体虚、血虚、肾虚、冠心病、脑血管等疾病时发生；双变量相关分析显示含生首乌制剂不良反应与处方药味数量之间没有相关性，而含制首乌制剂不良反应与处方药味数量之间呈一定的负相关。总之，含何首乌中成药不良反应发生率较高，但尚缺乏明确证据证明其不良反应与何首乌毒性相关，应对其进行系统安全性研究，为客观评价何首乌及含何首乌制剂安全性，提高临床安全用药水平提供客观依据。

All the Chinese patent medicines (CPMs) containing raw and processed products of Polygoni Multiflori Radix (PMR) in Chinese Pharmacopoeia and Drug Standard of Ministry of Public Health of the Peoples Republic of China were inquired and adverse drug reactions of the CPMs were searched in CNKI. And then a systematic analysis about adverse drug reactions accroding to processing, compatibility, and indication was conducted by statistical approach. The CPMs with adverse drug reactions were composed of 13 preparations containing raw products of PMR and 37 processed products containing processed products of PMR. The common adverse drug reactions of preparations containing raw products of PMR were gastrointestinal reaction, dry mouth, liver damage, allergic reactions, and palpitations, and these reactions mostly happened when these preparations were used in the treatment of hyperlipidemia and coronary heart disease. The common adverse drug reactions of preparations containing processed products of PMR were liver damage, gastrointestinal reaction, and allergic reactions, and these reactions mostly happened when these preparations were used in the treatment of white hair, hair loss, alopecia areata, weakness, anemia, coronary heart disease, and cerebrovascular disease. There was a certain negative correlation between number of herbs and incidence of adverse reaction. To sum up, incidence of adverse reactions of CPMs containing raw and processed products of PMR is high, but still lacks a clear evidence of the association between adverse reaction of preparations and the toxicity of PMR. A systematic research on the safety of CPM included PMR is needed.

国家公益性行业专项：基于临床的何首乌肝损害易感人群筛查及防控对策研究（201507004-4）；山东省自主创新和成果转化项目（2014ZZCX02104）；国家重点基础研究发展计划（“973”）中医基础理论专项资助项目（2009CB522802）；山东省泰山学者工程专项经费资助（Ns201511107）