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·循证药学·
补肾类中成药联合 PDE5 抑制剂治疗勃起功能障碍有效性与安
全性的网状Meta分析 Δ
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王 真 ,张丽娟 ,李绪杰 ,周梓洋 ,李苗秀 ,王从安 ,王永泉 (1. 山东中医药大学针灸推拿学院,济南
1*
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250355;2.山东第一医科大学附属颈肩腰腿痛医院中医骨伤科,济南 250000;3.山东中医药大学附属医院中
医科,济南 250014)
中图分类号 R979.9 文献标志码 A 文章编号 1001-0408(2022)18-2271-06
DOI 10.6039/j.issn.1001-0408.2022.18.19
摘 要 目的 系统评价补肾类中成药联合5型磷酸二酯酶(PDE5)抑制剂治疗勃起功能障碍(ED)的有效性和安全性,为临床用
药提供循证参考。方法 计算机检索PubMed、Embase、Cochrane Library、Web of Science、维普网、中国生物医学文献数据库、中国
知网、万方数据,收集补肾类中成药联合PDE5抑制剂(试验组)对比单用PDE5抑制剂或补肾类中成药(对照组)的随机对照试验
(RCT),检索时限为建库起至2022年2月15日。筛选文献、提取资料后采用Cochrane系统评价员手册6.1.0推荐的偏倚风险评价
工具对纳入文献质量进行评价;采用 Stata 16.0 软件进行网状 Meta 分析;采用倒漏斗图进行发表偏倚分析。结果 共纳入 23 项
RCT,共计2 417例患者,涉及苁蓉益肾颗粒、蚕茸柱天胶囊、复方玄驹胶囊、还少胶囊、山海丹颗粒、生精胶囊、十三味滋阴壮阳胶
囊、疏肝益阳胶囊 8 种中成药。网状 Meta 分析结果显示,在总有效率方面,以复方玄驹胶囊联合 PDE5 抑制剂、生精胶囊联合
PDE5抑制剂、疏肝益阳胶囊联合PDE5抑制剂的总效率较高;在国际勃起功能障碍指数评分方面,以复方玄驹胶囊联合PDE5抑
制剂、苁蓉益肾颗粒联合PDE5抑制剂、蚕茸柱天胶囊联合PDE5抑制剂的评分较高;在安全性方面,以还少胶囊、山海丹颗粒、疏
肝益阳胶囊的不良反应发生率较低。结论 补肾类中成药联合 PDE5 抑制剂可改善 ED 患者的勃起功能,减少不良反应的发生。
在疗效和安全方面,以复方玄驹胶囊联合PDE5抑制剂最佳。
关键词 勃起功能障碍;补肾类中成药;5型磷酸二酯酶抑制剂;Meta分析;有效性;安全性
Efficacy and safety of kidney-tonifying Chinese patent medicine combined with PDE5 inhibitor in the
treatment of erectile dysfunction:a network meta-analysis
WANG Zhen ,ZHANG Lijuan ,LI Xujie ,ZHOU Ziyang ,LI Miaoxiu ,WANG Cong’an ,WANG Yongquan(1.
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College of Acupuncture and Massage,Shandong University of Traditional Chinese Medicine,Jinan 250355,
China;2. Dept. of Chinese Osteo-traumatology,Neck,Shoulder,Waist and Leg Pain Hospital Affiliated to
Shandong First Medical University,Jinan 250000,China;3. Dept. of Traditional Chinese Medicine,the
Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250014,China)
ABSTRACT OBJECTIVE To systematically review the efficacy and safety of kidney-tonifying Chinese patent medicine
combined with phosphodiesterase type 5(PDE5)inhibitors in the treatment of erectile dysfunction(ED),and to provide evidence-
based reference for clinical medication. METHODS Retrieved from PubMed,Embase,Cochrane Library,Web of Science,VIP,
China Biomedical Literature Database,CNKI and Wanfang database,randomized controlled trials (RCTs) of kidney-tonifying
Chinese patent medicine combined with PDE5 inhibitors(trial group)versus PDE5 inhibitors or kidney-tonifying Chinese patent
medicine alone(control group)were collected. The search period was from the establishment of the database to February 15,2022.
After literature screening and data extraction,the risk of bias assessment tool recommended in Cochrane System Reviewer’s
Handbook 6.1.0 was used to evaluate the quality of the included literature;Stata 16.0 software was used for network meta-analysis;
and the funnel plot was used for publication bias analysis. RESULTS A total of 23 RCTs were included,with a total of 2 417
patients, involving 8 kinds of Chinese patent medicines,
Δ 基金项目 国家自然科学基金资助项目(No.82004495);山东省
including Congrong yishen granule,Canrong zhutian capsule,
自然科学基金资助项目(No.ZR2020QH318)
Compound xuanju capsule, Huanshao capsule, Shanhaidan
*第一作者 硕士研究生。研究方向:针药结合治疗内科疾病。E-
mail:1163294641@qq.com granule, Shengjing capsule, Shisanwei ziyin zhuangyang
# 通信作者 主任医师,硕士生导师,硕士。研究方向:针药结合治 capsule,Shugan yiyang capsule. The results of network meta-
疗内科疾病。E-mail:3053451770@qq.com analysis showed that in terms of total effective rate,
中国药房 2022年第33卷第18期 China Pharmacy 2022 Vol. 33 No. 18 ·2271·