屈螺酮炔雌醇片(Ⅱ)超说明书用药的处方调查及循证研究  

Prescription investigation and evidence-based study on off-label uses of drospirenone/ethinyl estradiol tablets(Ⅱ)

作　　者：马春来 徐静瑶 庞艳玉 陈晓晶 钟明康 MA Chunlai;XU Jingyao;PANG Yanyu;CHEN Xiaojing;ZHONG Mingkang(Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China;School of Pharmacy,Shanghai University of Medicine&Health Sciences,Shanghai 200237,China;Department of Pharmacy,Obstetrics&Gynecology Hospital of Fudan University,Shanghai 200011,China)

机构地区：[1]复旦大学附属华山医院药剂科,上海200040 [2]上海健康医学院药学院,上海200237 [3]复旦大学附属妇产科医院药剂科,上海200011

出　　处：《中国临床药学杂志》2021年第3期200-204,共5页Chinese Journal of Clinical Pharmacy

基　　金：上海市临床重点专科项目-临床药学专业(编号:shslczdzk06502);上海市优秀青年临床药师培养计划(编号:沪卫计药政[2018]1号)。

摘　　要：目的了解屈螺酮炔雌醇片(Ⅱ)的超说明书用药情况,并采用Cochrane偏倚风险评估工具评价其合理性。方法随机抽取8个城市121家各级样本医疗机构2017年1月至2019年12月门急诊患者应用屈螺酮炔雌醇片(Ⅱ)的处方。共纳入1 121张处方,根据药品说明书分析其超说明书用药情况。计算机检索Pub Med、The Cochrane Library和Embase,应用Cochrane偏倚风险评估工具Revman 5.3对筛选的RCT/CCT研究进行评价,以低度偏倚风险(A级)的文献作为超说明书使用的循证依据。结果适应证超说明书处方有1 084张(96.70%),临床诊断包括流产、异常子宫出血和多囊卵巢综合征等。经偏倚风险评估,仅有4篇多囊卵巢综合征和1篇子宫内膜异位症的临床研究为低度偏倚风险,研究质量为A级,Cochrane偏倚风险评估结果认为屈螺酮炔雌醇片(Ⅱ)用于多囊卵巢综合征有临床循证依据。结论采用Cochrane偏倚风险评估工具评价屈螺酮炔雌醇片(Ⅱ)适应证超说明书用药的临床循证依据,可以为临床合理用药提供参考。AIM To investigate the off-label uses of drospironone ethinylestradiol tablets(Ⅱ)and evaluate the rationality by using Cochrane bias risk assessment tool.METHODS A total of 1121 prescriptions of drospironone ethinylestradiol tablets(Ⅱ)were randomly selected from 121 sample medical institutions in 8 cities from January 2017 to December 2019.According to the drug instructions,the situation of off-label drug uses was analyzed.PubMed,the Cochrane Library and Embase databases were searched.Revman 5.3,a Cochrane bias risk assessment tool,was used to evaluate the selected RCT/CCT studies.Low risk(Grade A)literatures were used as the evidence for the off-label uses.RESULTS A total of 1084 prescriptions(96.70%)were in off-label uses.The clinical diagnosis included abortion,abnormal uterine bleeding and polycystic ovary syndrome.According to the bias risk assessment,only 4 clinical studies on polycystic ovary syndrome and 1 clinical study on endometriosis had low bias risk,and the research quality was grade A.The results of Cochrane bias risk assessment showed that drospironone and ethinyl estradiol tablets(Ⅱ)had clinical evidence for polycystic ovary syndrome.CONCLUSION Using Cochrane bias risk assessment tool to evaluate the clinical evidence-based basis of off-label uses of drospironone/ethinyl estradiol tablets(Ⅱ)can provide reference for clinical rational drug use.

关 键 词：屈螺酮炔雌醇片(Ⅱ) 超说明书用药 循证医学 处方分析 

分 类 号：R984[医药卫生—药品]