中国新药杂志

度他雄胺治疗良性前列腺增生的快速卫生技术评估

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刘玥 ¹ , 赵敏 ² , 孙瑞芳 ¹ , 翟所迪 ³

中国新药杂志 | 药物安全与合理应用 2021,30(15): 1435-1440

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中国新药杂志 |药物安全与合理应用 2021 , 30 (15) : 1435 -1440

度他雄胺治疗良性前列腺增生的快速卫生技术评估

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刘玥¹, 赵敏², 孙瑞芳¹, 翟所迪³

作者信息

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

通讯作者:

翟所迪，男，博士生导师，教授，主要从事临床药学与循证药物评价研究。E-mail：zhaisuodi@163.com。

作者简介:

刘玥，女，硕士研究生，主要从事老年医学科的临床药学工作。E-mail：liuyue0923@163.com。

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

Yue LIU¹, Min ZHAO², Rui-fang SUN¹, Suo-di ZHAI³

Affiliations

¹Department of Pharmacy, Civil Aviation General Hospital, Beijing 100025, China

²Department of Pharmacy, The First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China

³Institute for Drug Evaluation, Peking University Health Science Center, Beijing 100191, China

出版时间: 2021-08-15

文章导航

摘要

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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。

关键词

度他雄胺 / 良性前列腺增生 / 有效性 / 安全性 / 经济性

Abstract

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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.

Key words

dutastreride / benign prostatic hyperplasia / efficacy / safety / economic

引用本文

刘玥, 赵敏, 孙瑞芳, 翟所迪. 度他雄胺治疗良性前列腺增生的快速卫生技术评估. 中国新药杂志, 2021 , 30 (15) : 1435 -1440 .

Yue LIU, Min ZHAO, Rui-fang SUN, Suo-di ZHAI. Dutastreride in the treatment of benign prostatic hyperplasia: a rapid health technology assessment[J]. Chinese Journal of New Drugs, 2021 , 30 (15) : 1435 -1440 .

参考文献

收起

文献

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参考文献引证文献

排序方式：

[1]

中华医学会老年医学分会, 中华老年医学杂志编辑委员会. 老年人良性前列腺增生症/下尿路症状药物治疗共识(2015)[J]. 中华老年医学杂志, 2015, 34(12): 1380-1387.

[2]

门鹏, 唐惠林, 翟所迪. 药品卫生技术评估的步骤与方法[J]. 中国医疗保险, 2015(10): 57-59.

[3]

SHEA BJ, GRIMSHAW JM, WELLS GA, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews[J]. BMC Med Res Methodol, 2007, 7(1): 10.

[4]

HUSEREAU D, DRUMMOND M, PETROU S, et al. Consolidated health economic evaluation reporting standards (CHEERS) statement[J]. Int J Technol Assess Health Care, 2013, 29(2): 117-122.

[5]

FANG QH, CHEN PY, DU NC, et al. Analysis of data from breast diseases treated with 5-alpha reductase inhibitors for benign prostatic hyperplasia[J]. Clin Breast Cancer, 2019, 19(5): e624-e636.

[6]

ZHOU Z, SONG S, GAO Z, et al. The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis[J]. Clin Interv Aging, 2019, 14(2): 399-406.

[7]

CORONA G, TIRABASSI G, SANTI D, et al. Sexual dysfunction in subjects treated with inhibitors of 5α-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis[J]. Andrology, 2017, 5(4): 671-678.

[8]

JUN JEJ, KINKADE A, TUNG ACH, et al. 5α-reductase inhibitors for treatment of benign prostatic hyperplasia: a systematic review and meta-analysis[J]. Can J Hosp Pharm, 2017, 70(2): 113-119.

[9]

YIN T, QIAO Z, LI Y, et al. Comparisons of the efficacy and safety of finasteride and dutasteride for benign prostatic hyperplasia: a network meta-analysis[J]. Am J Ther, 2017, 24(5): e517-e523.

[10]

YUAN JQ, MAO C, WONG SY, et al. Comparative effectiveness and safety of monodrug therapies for lower urinary tract symptoms associated with benign prostatic hyperplasia: a network Meta-analysis[J]. Medicine (Baltimore), 2015, 94(27): e974.

[11]

PARK T, CHOI JY. Efficacy and safety of dutasteride for the treatment of symptomatic benign prostatic hyperplasia (BPH): a systematic review and meta-analysis[J]. World J Urol, 2014, 32(4): 1093-1105.

[12]

WU XJ, ZHI Y, ZHENG J, et al. Dutasteride on benign prostatic hyperplasia: a meta-analysis on randomized clinical trials in 6460 patients[J]. Urology, 2014, 83(3): 539-543.

[13]

马爱霞, 周清, 田磊, 等. 度他雄胺治疗良性前列腺增生安全性的Meta分析[J]. 中国药物评价, 2013, 30(6): 334-338.

[14]

LOKE YK, HO R, SMITH M, et al. Systematic review evaluating cardiovascular events of the 5-alpha reductase inhibitor-Dutasteride[J]. J Clin Pharm Ther, 2013, 38(5): 405-415.

[15]

熊效墨, 李洪超, 马爱霞. 度他雄胺与非那雄胺用于良性前列腺增生患者的药物经济学评价[J]. 中国新药杂志, 2019, 28(7): 891-896.

[16]

GUEVARA-CUELLAR CA, PARODY-RÚA E, GARCIA-PERDOMO HA,et al. Cost-effectiveness of combination therapy versus monotherapy in benign prostatic hyperplasia: a Colombian experience[J]. Value Health Reg Issues, 2018, 17(9): 174-182.

[17]

吕建林, 张春香. 基于实验的中国中老年人群良性前列腺增生药物治疗的药物经济学评价[J]. 中国新药杂志, 2018, 27(9): 1083-1088.

[18]

WU DB, YEE CH, NG CF, et al. Economic evaluation of combination therapy versus monotherapy for treatment of benign prostatic hyperplasia in Hong Kong[J]. Front Pharmacol, 2018, 9(10): 1078.

[19]

DABANOVIĆ V, KOSTIĆ M, JANKOVIĆ S. Cost effectiveness comparison of dutasteride and finasteride in patients with benign prostatic hyperplasia: The Markov model based on data from Montenegro[J]. Vojnosanit Pregl, 2016, 73(1): 26-33.

[20]

UDEH EI, OFOHA CG, ADEWOLE DA, et al. A cost effective analysis of fixed-dose combination of dutasteride and tamsulosin compared with dutasteride monotherapy for benign prostatic hyperplasia in Nigeria: a middle income perspective; using an interactive Markov model[J]. BMC Cancer, 2016, 16(7): 405.

[21]

ISMAILA A, WALKER A, SAYANI A, et al. Cost-effectiveness of dutasteride-tamsulosin combination therapy for the treatment of symptomatic benign prostatic hyperplasia: a Canadian model based on the CombAT trial[J]. Can Urol Assoc J, 2013, 7(5-6): e393-e401.

[22]

WALKER A, DOYLE S, POSNETT J, et al. Cost-effectiveness of single-dose tamsulosin and dutasteride combination therapy compared with tamsulosin monotherapy in patients with benign prostatic hyperplasia in the UK[J]. BJU Int, 2013, 112(5): 638-646.

[23]

TAKAYAMA T, ARAKAWA I, KAKIHARA H, et al. Pharmacoeconomic evaluation of combination therapy with dutasteride and α1 blocker for treatment of benign prostatic hyperplasia in Japan[J]. Hinyokika Kiyo Acta Urol Japonica, 2012, 58(2): 61-69.

[24]

ANTOÑANZAS F, BRENES F, MOLERO JM, et al. Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain[J]. Actas Urológicas Espaóolas Engl Ed, 2011, 35(2): 65-71.

[25]

BJERKLUND JOHANSEN TE, BAKER TM, BLACK LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial[J]. BJU Int, 2012, 109(5): 731-738.

[26]

DERSARKISSIAN M, XIAO Y, DUH MS, et al.comparing clinical and economic outcomes associated with early initiation of combination therapy of an alpha blocker and Dutasteride or Finasteride in men with benign prostatic hyperplasia in the United States[J]. J Manag Care Spec Pharm, 2016, 22(10): 1204-1214.

2021年第30卷第15期

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首发时间：2026-10-28
出版时间：2021-08-15

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录用日期：2020-12-10

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作者信息

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

通讯作者:

翟所迪，男，博士生导师，教授，主要从事临床药学与循证药物评价研究。E-mail：zhaisuodi@163.com。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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