葛根素注射剂与发热相关性的病例对照研究

Case-control Study of the Relationship Between the Short-term Fever of Unexplained Origin and the Puerarin Injections (PuLeLin)

目的:探讨不明原因短期发热(SFUO)的危险因素,论证最早上市的葛根素注射剂——普乐林与发热的相关性。方法:采取1:2匹配病例对照,选择温州医学院附属第一医院1995-1997年住院的心脑血管病病例为调查对象,将符合SFUO标准的45例纳入病例组,对照组为相匹配的90例病例。选取普乐林、其他活血化瘀中药、抗生素、生物制品、其他西药注射剂、阿司匹林服用、过敏史、微侵袭手术、重大精神刺激等9项候选危险因素,进行调查分析,筛选出危险因素。结果:单因素条件logistic回归分析将“使用普乐林”筛选为发热的危险因素,比值比(OR)为13.772,P<0.001;多因素条件logistic回归分析显示,最终有统计学意义的只有普乐林注射液,OR值10.947。结论:最早上市的葛根素注射剂——普乐林的使用是SFUO的独立危险因素,两者存在相关性。

Objective： To reveal the risk factors of the short-term fever of unexplained origin（SFUO） and demonstrate the relationship between the SFUO and Pulelin（ the first puerarin injection on the market）. Method： l to 2 standard matches were adopted to select investigational patients in hospital with cardiac-cerebrovascular disorders in the First Affiliated Hospital of Wenzhou Medical College from 1995 to 1997. The case group contained 45 instances coincided with the diagnostic criteria for SFUO. The control group contained 90 instances with the essential matching conditions. Nine probable risk factors of the two groups selected to investigate were： the old Puerarin （ Pulelin injection）, Chinese medicine injections, antibiotics, biological agents, Western medicine injections, aspirin, allergic history, micro - invasion operation and serious mental stimulus history. The obtained data were investigated, and the risk factor was screened out. Result： The study showed that the Pulelin injection was screened as the valid risk factor of the SFUO with odds ratio （OR） of 13. 772, tested by the conditional logistic regression analysis, P 〈 O. OOl. The result of the multivariate conditional logistic regression analysis indicated that the Pulelin injection was the only one with statistical significance with OR 10. 947. The course, dosage and total amount of the Pulelin injection were closely associated with SFUO, and the total amount of treatment was the most correlated one. The tites of OR were 2. 864,3. 670,and 4.212, respectively. Conclusion： The Pulelin injection,the first Puerarin injection on the market, was proved to be the independent risk factor of SFUO at that time. They were correlated. SFUO was related to the dosage, course and total amount. The total amount was the most important factor.