摘要
目的采用队列研究调查不同种类葛根素注射剂(天保康和普润注射液)导致发热的发生率,探讨天保康和普润与发热的相关性,并比较分析《药品生产质量管理规范》(GMP)认证前后上市的不同葛根素注射剂致热发生率的差异。方法回顾性队列研究,选择2001年以后温州医学院附属第一医院、附属第二医院、附属温岭医院符合纳入条件的心脑血管疾病病例为研究对象,设立暴露组(使用天保康和普润注射液)与非暴露组(使用其他药物),分别调查两组的发热发生率,统计分析暴露的相对危险度(RR)和归因危险度(AR);分析比较制药生产与质量改进前上市(普乐林)与后上市(天保康和普润)葛根素注射剂发热发生率的差异。结果后上市的天保康(6.31%)和普润注射液(5.66%)致热发生率分别与非暴露组比较差异均无显著性(均P>0.05),提示天保康和普润注射液与其临床使用中的发热无因果联系。而天保康和普润注射液与普乐林致热发生率差异有极显著性(P<0.01)。结论未能证明随后上市的葛根素注射剂——天保康和普润注射液与临床上发热有相关性。不同年代上市的葛根素注射剂与发热的相关联系不同,提示药品质量改善可以消除某些药物的严重不良反应,提高安全性。
Objective To investigate the relationship between the Short-term Fever of Unexplained Origin （SFUO） and pulelin injection by the case-control study and retrospective cohort study, and analyze the difference between incidence of fever caused by different puerarin injections before GMP and after GMP authenticated. Methods The eligible patients with cardiaccerebrovascular disorders among the first affiliated hospital of wenzhou medical college, the second affiliated hospital of wenzhou medical college and Wenling affiliated hospital after 2001 were selected, and were divided into an exposed group （ tianbaokang and purun injections） and a non-exposed group （received other medicines）. The incidence of SFUO,the relative risk （RR） and attributive risk （AR） were calculated, respectively, and the difference of incidences of SFUO in exposed to Puerarin, tianbaokang and purun of pulelin injections were analyzed. Results There was no significant difference between tianbaokang （6.31%） and purun（ 5. 66% ） （P 〉0.05 ）, which suggested that there was no causality between SFUO and tianbaokang or purun injections. However, compared with the incidence of pulelin injection（26.73% ）,there was marked difference of SFUO between pulelin and tianbaokang or purun injections （ P 〈 0.01 ）. Conclusion No evidence could indicate that tianbaokang injection and purun injection, both were Puerarin injections resent appeared in the market, were related to SFUO. The use of the same Chinese traditional Puerarin injections from various periods could result in completely different outcomes. Therefore, the serious side effects such as SFUO could eliminate and the safety of dralgs could increase by improving pharmaceutical quality management.
出处
《医药导报》
CAS
2008年第10期1264-1266,共3页
Herald of Medicine
关键词
葛根素注射剂
发热
队列研究
药品质量管理
药物流行病学
Puerarin injection
Short-term fever of unexplained origin （SFUO）
Cohort study
Pharmaceutical quality management
Pharmacoepidemiology
