氯菊酯乳膏冲洗剂上市后监测研究
Postmarketing surveillance study of permethrin creme rinse.
作者信息
Andrews E B, Joseph M C, Magenheim M J, Tilson H H, Doi P A, Schultz M W
机构信息
Burroughs Wellcome Company, Research Triangle Park, NC 27709.
出版信息
Am J Public Health. 1992 Jun;82(6):857-61. doi: 10.2105/ajph.82.6.857.
BACKGROUND
An observational, epidemiological study was undertaken to evaluate the safety of permethrin 1% creme rinse (Nix) for treatment of head lice infestations.
METHODS
Thirty-seven local public health departments enrolled a total of 38,160 patients for 47,578 treatments with permethrin or other pediculicides from September 1, 1986, through January 31, 1988. Follow-up safety information was collected between 7 and 14 days following treatment via return visit or telephone contact.
RESULTS
One hundred three adverse events were reported among 41,955 evaluable treatments. The rates of reported adverse events were 2.2 per 1000 treatments among permethrin treatments, 3.4 per 1000 treatments among lindane treatments, and 1.5 per 1000 treatments among other over-the-counter treatments. No serious, unexpected adverse events were detected in the 18,950 patients treated with permethrin.
CONCLUSIONS
This study confirmed the safety profile of permethrin in conditions of general use, as seen in clinical trials. Postmarketing safety monitoring in public health departments of drugs used to treat public health conditions was shown to be feasible.
背景
开展了一项观察性流行病学研究，以评估1%氯菊酯乳膏（虱立净）治疗头虱感染的安全性。
方法
1986年9月1日至1988年1月31日期间，37个地方公共卫生部门共招募了38160名患者，使用氯菊酯或其他杀虱剂进行了47578次治疗。治疗后7至14天通过回访或电话联系收集随访安全信息。
结果
在41955次可评估治疗中报告了103起不良事件。氯菊酯治疗中报告的不良事件发生率为每1000次治疗2.2起，林丹治疗中为每1000次治疗3.4起，其他非处方治疗中为每1000次治疗1.5起。在18950名接受氯菊酯治疗的患者中未检测到严重、意外的不良事件。
结论
本研究证实了氯菊酯在一般使用情况下的安全性，如临床试验中所见。结果表明，在公共卫生部门对用于治疗公共卫生疾病的药物进行上市后安全监测是可行的。
Zotero 插件