葛根素注射液所致临床发热反应的系统评价

目的在治疗心脑血管疾病方面，评价葛根素注射液与发热反应的相关性。方法计算机检索Cochrane Central Register of Controlled Trials、EMbase、Pubmed、CBM、WanFang Data和CNKI（至2013年8月）中有关葛根素注射液与发热相关性的临床试验，并手工检索相关研究及其参考文献。根据纳入和排除标准选择纳入文献、提取资料和进行方法学质量评价。在此基础上，以不良反应发生率为指标，利用系统评价的方法考察葛根素注射液与发热的相关性。结果依据纳入排除标准共纳入8项随机对照临床研究。结果显示，葛根素注射液组整体的不良反应发生率为1．20％，提示发热为葛根素注射液的常见不良反应。进一步的亚组分析结果显示，天保康葛根素注射液未见发热反应；普润葛根素注射液的发热反应发生率为0．90％，为偶见不良反应；其他产家的葛根素注射液的发热反应发生率为5．13％，为常见不良反应。葛根素注射液的发热反应发生率从2005年之前的4．04％降至2005年之后的0．32％。结论发热为葛根素注射液不良反应，除药物本身因素外，该不良反应与葛根素注射液的制备工艺具有一定的相关性。

Relationship between Puerarin Injections and Its Clinical Fever Reaction. A Systematic Review

Objective To assess the relationship between puerarin injections and its clinical fever reaction in the treatment of cardiovascular and cerebrovascular diseases. Methods The published clinical studies of puerarin injections were searched in Cochrane Central Register of Controlled Trials, EMbase, Pubmed, CBM, WanFang and CNKI （to August, 2013） as well as the further evaluation of references cited by target clinical studies to get sufficient evidences. Based on the suitable standards, the valid clinical studies were taken into further assessment followed by the extraction of information. Afterwards, the rate of adverse reaction was chosen as an index to estimate the relationship between puerarin injection and its clinical fever adverse reaction by fixed effect model and subgroup analysis. Results Eight clinical studies were considered to be effective evidences to assess the relationship between puerarin injection and its clinical fever reaction. Fixed effect model revealed that the rate of fever reaction was 1.20%, belonging to common adverse reaction. However, the subgroup analysis indicates that, in this study, the puerarin injections with unknown manufacturer had 5.13% of fever reaction comparing with 0.90% for Pu Run and none for Tian Baokang whose rates of adverse reaction were considered to be rare and none at present. In addition, more clinical fever reactions were reported before 2005 （4.04%） than after 2005 adverse reaction of puerarin technology and method. （0.32%） according to the comparison of rates. Conclusion Fever is injections, and also the rate of its fever reaction can be greatly affected characterized as an by the preparation