山海丹颗粒联合他达拉非治疗勃起功能障碍的多中心临床疗效观察  

Effect of Shanhaidan Granules combined with tadalafil on erectile dysfunction:A multi-center clinical trial

作　　者：黄燕平[1] 吴正沐[2] 杨念钦[3] 彭煜[4] 陈伟杰[5] 李莉 陈磊[7] 程怀瑾[2] 卢慕峻[1] HUANG Yan-ping;WU Zheng-mu;YANG Nian-qin;PENG Yu;CHEN Wei-jie;LI Li;CHEN Lei;CHENG Huai-jin;LU Mu-jun(Department of Urology and Andrology,Renji Hospital 9 School of Medicine,Shanghai Jiao Tong University,Shanghai 200120,China;International Peace Maternal and Child Health Hospital,China Welfare Institute,Shanghai 200030,China;Department of Urology,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Urology,Yueyang Hlospital of Integrated Traditional Chinese and Wextern Medicine,Shanghai University of Chinese Medicine,Shanghai 200437,China;Shanghai Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Chinese Medicine,Shanghai 200071,China;AcademicDepartment,Hangzhou Strong Pharmaceutical Co.LTD,Hangzhou,Zhejiang 310000,China;Longhua Hospi-tal,Shanghai University of Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海交通大学医学院附属仁济医院,上海200120 [2]中国福利会国际和平妇幼保健院,上海200030 [3]复旦大学附属中山医院,上海200032 [4]上海中医药大学附属岳阳中西医结合医院,上海200437 [5]上海中医药大学附属中医医院,上海200071 [6]杭州施强药业有限公司学术部,浙江杭州310000 [7]上海中医药大学附属龙华医院,上海200032

出　　处：《中华男科学杂志》2021年第9期819-824,共6页National Journal of Andrology

摘　　要：目的:观察山海丹颗粒联合他达拉非治疗男性勃起功能障碍(ED)的临床疗效和安全性。方法:采用开放、多中心、阳性药物对照的临床研究方法,将按标准纳入的患者分为3组:山海丹组(山海丹颗粒10 g/次,3次/d,口服)、他达拉非组(他达拉非5 mg/次,隔日晚上1次,口服)以及山海丹+他达拉非联合治疗组(上述两药同剂量联合用药)。分别记录治疗前和治疗8周后的勃起功能评分(IIEF-6与EHS评分)、中医证候评分(TCMS)以及阴茎海绵体血流参数等,同时观察药物治疗的安全性指标。通过治疗前后对比和组间差异比较,分析各组治疗的有效性和安全性。结果:共纳入247例患者,其中山海丹组74例,他达拉非组52例,联合治疗组121例。与治疗前相比,治疗后3组中IIFE-6、EHS、TCMS指标显著高于治疗前(P<0.05)。以IIEF-6作为疗效评估,3组的总体有效率分别为60.8%、67.3%、69.4%,他达拉非组及联合治疗组有效率均高于山海丹组(P<0.05);以TCMS作为疗效评估,3组总体有效率分别为40.5%、32.7%、63.6%,山海丹组及联合治疗组有效率均高于他达拉非组(P<0.05)。单中心数据显示联合治疗组和他达拉非组治疗后阴茎动脉收缩期峰值流速(PSV)显著增加(P<0.05)。在改善值方面,联合治疗组治疗后各项参数的改善值均显著高于他达拉非组和山海丹组,他达拉非组IIEF-6改善值高于山海丹组,山海丹组TCMS改善值高于他达拉非组。3组患者治疗后均未发现与药物治疗相关的不良反应事件,部分肌肉酸痛及胃肠道反应者适应后症状缓解,无血常规、尿常规及肝、肾功能指标的异常。结论:山海丹颗粒联合他达拉非可显著提高ED患者的勃起功能评分,降低中医证候评分,临床治疗安全有效。Objective:To observe the clinical effect and safety of Shanhaidan Granules(SHDG)combined with tadalafil tablets(TT)in the treatment of ED.Methods:In this open multi-center case-control clinical trial,we enrolled 247 ED patients according to the designed criteria,and treated them orally with SHDG at 10 g per time tid(n=74),TT at 5 mg per time bid(n=52),or SHDG+TT at the above doses(n=121),all for 8 weeks.Before and after medication,we recorded the IIEF-6,erection hardness scores(EHS),traditional Chinese medicine syndromes(TCMS)scores,penile cavernous blood flow parameters and adverse reactions,and compared them between the 3 groups of patients.Results:After 8 weeks of treatment,all the patients showed significantly increased IIEF-6,EHS and TCMS scores in comparison with the baseline(P<0.05).The total effectiveness rates in the SHDG,TT and SHDG+TT groups were 60.8%,67.3%and 69.4%respectively based on the IIEF-6 scores,remarkably higher in the TT and SHDG+TT groups than in the SHDG group(P<0.05),and 40.5%,32.7%and 63.6%respectively according to the TCMS scores,markedly higher in the SHDG and SHDG+TT groups than in the TT group(P<0.05).Single-center data manifested significantly increased peak systolic velocity(PSV)of the penile artery in the SHDG+TT and TT groups(P<0.05).The improvement values of relevant parameters were remarkably higher in the SHDG+TT group than in the TT and SHDG groups,so were IIEF-6 scores in the TT than in the SHDG group,and TCM syndromes in the SHDG than in the TT group.No medication-related adverse events were found in any of patients after treatment,except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases,all soon relieved,none with abnormalities in blood and urine routine tests or hepatic and renal function indicators.Conclusion:Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients,and therefore can be applied effectively and safely in clinical practice.

关 键 词：勃起功能障碍 山海丹颗粒 他达拉非 国际勃起功能评分 中医证候评分 疗效评估 

分 类 号：R698.2[医药卫生—泌尿科学]