葛根素注射剂与发热相关性的回顾性队列研究

Retrospective Cohort Study of the Relationship Between Short-term Fever of Unexplained Origin And Puerarin Injections (PuLeLin)

目的:在病例对照研究葛根素注射剂(普乐林)与发热有相关性结论的基础上。进一步验证两者的因果联系。方法:采取回顾性队列研究,选择温州医学院附属第一医院1995-1997年住院的符合纳入标准的心脑血管病病例为调查对象,设立暴露组(使用普乐林)与非暴露组(使用其它药物),调查普乐林致热发生率,统计分析暴露的相对危险度(RR)和特异危险度(AR),揭示普乐林注射液暴露致热的剂量反应关系。结果:普乐林致热发生率达26.73%,与非暴露组差异有显著性(P<0.001),RR为6.568,AR达21.47%,而男女性别发生率差异无统计学意义(P=0.535)。暴露于普乐林注射液致发热发生率和体温均存在剂量反应关系。结论:普乐林注射液与不明原因短期发热存在强因果联系,有剂量反应关系,临床使用时应注意用药疗程和剂量。

Objective： To verify the causality association between puerarin injection （Pulelin） and the shortterm fever of unexplained origin （SFUO） , which was deduced by the case-control study. Method ： The retrospective cohort study was adopted to select investigational inpatients with cardiac-cerebrovascular disorders in the First Affiliated Hospital of Wenzhou Medical College from 1995 to 1997, They were divided into an exposing group and a non-exposing group according to whether Pulelin injection was used or not. The incidence rate of the SFUO was calculated, and the relative risk（RR） , and attributive risk （AR） could be concluded for the exposed factor of Pulelin injection. The dose-effect relationship between the SFUO and Pulelin injection could be indicated too. Result： The exposing group showed that the incidence rate of the SFUO was equal to 26.73% ,the RR was 6. 568 （95% CI：3. 437-12.551 ）, and the A R was 21.47%. There were marked differences of incidence rates between the two groups（P〈0.001 ） , but no statistical significance for sex incidence rates （P=0.535 ）. The dose -effect relationship existed. Conclusion： Pulelin injection and the first Puerarin injection on the market confirmed the cause of the SFUO at that time. There was indeed a strong association. Attention should be paid to the reasonable dosage and course since the dose-effect relationship has been found.