葛根素注射剂与发热相关性的回顾性队列研究

目的：在病例对照研究葛根素注射剂（昔乐林）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。

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

Objective: To verify the causality association between puerarin injection ( Pulelin) and the short -term 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 AR 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.