度他雄胺治疗良性前列腺增生的快速卫生技术评估  

Dutastreride in the treatment of benign prostatic hyperplasia:a rapid health technology assessment

作　　者：刘玥 赵敏 孙瑞芳 翟所迪 LIU Yue;ZHAO Min;SUN Rui-fang;ZHAI Suo-di(Department of Pharmacy,Civil Aviation General Hospital,Beijing 100025,China;Department of Pharmacy,The First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)

机构地区：[1]民航总医院药剂科,北京100025 [2]广西医科大学第一附属医院药学部,南宁530021 [3]北京大学医学部药物评价中心,北京100191

出　　处：《中国新药杂志》2021年第15期1435-1440,共6页Chinese Journal of New Drugs

摘　　要：目的:评价度他雄胺(dutastreride)治疗良性前列腺增生(benign prostatic hyperplasia,BPH)的有效性、安全性和经济性,为临床使用提供信息支持。方法:系统检索CNKI、万方、Pubmed、The Cochrane Library数据库和CRD数据库。由2名评价者(刘、赵)分别根据预设的纳入、排除标准筛选文献并提取数据,评价文献质量,并对结果进行综合分析。结果:最终纳入系统评价/Meta分析10篇,经济学评价11篇。度他雄胺单药或者联合坦索罗辛均可有效改善国际前列腺症状评分,增加峰值尿流和延缓前列腺体积的增长,可以减少急性尿储留和前列腺相关手术。与性相关的不良事件发生率更高,包括了性欲减退、勃起障碍、射精异常等。与非那雄胺相比,有效性和安全性指标差异没有统计学意义。国外研究显示度他雄胺与坦索罗辛的联合疗法比坦索罗辛单药相比具有经济性优势。国内经济性研究结果不一致。结论:度他雄胺作为治疗良性前列腺增生的药物,具有良好的有效性和安全性。但是并不比非那雄胺具有更多的优势,可靠的结论还需要更多度他雄胺和非那雄胺的头对头直接试验的支持。Objective:To evaluate the efficacy,safety and pharmacoeconomics of dutastreride in the treatment of benign prostatic hyperplasia to meet the demand of decision-making.Methods:CNKI,Wanfang,Pubmed,the Cochrane Library and CRD databases were systematically searched.Studies were selected according to the inclusion and exclusion criteria,and the data were extracted.The quality of included literature was separately evaluated and analyzed by 2 reviewers.Results:Finally,10 systematic reviews and 11 pharmacoeconomic studies were included.The results suggested that dutasteride alone or combined with tamsulosin can effectively improve International Prostate Symptom Score,increase maximum urine flow,delay the growth of prostate volume,and reduce acute urinary retention and prostate-related surgery.The incidence of sexual adverse events is higher,including decreased libido,erectile dysfunction,abnormal ejaculation and so on.Compared with finasteride,there was no significant difference in efficacy and safety.Foreign studies showed that the combination therapy of dutasteride and tamsulosin had economic advantages compared with tamsulosin alone,while domestic economic research results were inconsistent.Conclusion:As a drug treating benign prostatic hyperplasia,dutasteride has good efficacy and safety;however,it has no advantages over finasteride,and the reliable conclusion needs the support of more head-to-head direct tests of dutasteride and finasteride.

关 键 词：度他雄胺 良性前列腺增生 有效性 安全性 经济性 

分 类 号：R969[医药卫生—药理学]