黑番茄浓缩浆治疗勃起功能障碍有效性安全性的前瞻性随机对照开放试验

Efficacy and safety of black tomato concentrate in the treatment of erectile dysfunction:A prospective randomized controlled open trial

目的:评价富含多酚类物质的黑番茄浓缩浆对于勃起功能障碍(ED)患者的有效性和安全性。方法:从2018年12月至2020年2月进行了一项前瞻性、随机、开放的临床研究,纳入ED患者150例,其中黑番茄治疗组、安慰剂组、复方玄驹胶囊组各50例。给予各组患者8周规律治疗,患者入组前、服药4、8周后分别进行勃起功能的问卷评分,包括:国际勃起功能指数(IIEF-5)问卷、阴茎勃起硬度分级(EHS)问卷、性生活日记(SEP-2,3)和总体评估问卷(GAQ-1,2),完善相关生化指标和睾酮的检测,分别对3个组进行组内和组间的疗效及安全性进行比较研究。结果:150例患者中共120例完成临床试验,其中黑番茄治疗组43例,安慰剂组37例,复方玄驹胶囊组40例。3组患者基线期IIEF-5(11.70±3.80 vs 12.03±3.50 vs 11.42±3.82)、EHS、SEP-2,3无统计学差异(P>0.05),经过为期8周的临床观察,黑番茄治疗组在IIEF-5评分(15.67±3.63)、EHS分级、SEP-2,3及GAQ-1阳性应答方面较安慰剂组均有显著改善(P<0.05),与复方玄驹胶囊相比,两者在IIEF-5评分(15.67±3.63vs15.65±3.87)、EHS分级、SEP-2,3和GAQ-1,2方面疗效相当(P>0.05)。3组不良反应发生率无明显统计学差异(黑番茄治疗组:2.7%,安慰剂组4.7%,复方玄驹组:5.0%;P>0.05),黑番茄治疗组患者建议改为餐后口服症状明显缓解,其余两组患者服用一段时间后均明显好转。结论:富含多酚类物质的黑番茄浓缩浆因其在改善ED患者IIEF-5、EHS和性生活日记方面与复方玄驹胶囊疗效相当,且优于安慰剂,同时发现其安全性良好,可作为改善ED的另一种治疗选择方案。

Objective:To evaluate the efficacy and safety of black tomato concentrate(BTC),which is rich in polyphenols,in the treatment of ED.Methods:We conducted a prospective randomized open clinical study of 150 ED patients from December 2018 to February 2020,and treated the them with placebo(n=50),BTC(n=50)and Compound Xuanju Capsules(CXC)(n=50),respectively,all for 8 weeks.Before and at 4 and 8 weeks after treatment,we obtained the scores of the patients on IIEF-5,Erection Hardness Score(EHS),Sexual Encounter Profile(SEP-2,3)and General Assessment Questionnaire(GAQ-1,2),related biochemical indexes and the T level,followed by comparison among the three groups.Results:Totally,120 of the patients completed the clinical trial,37 in the placebo,43 in the BTC and 40 in the CXC group.There were no statistically significant differences among the placebo,BTC and CXC groups in the baseline scores on IIEF-5(12.03±3.50 vs 11.70±3.80 vs 11.42±3.82),EHS,and SEP-2,3(P>0.05).At 8 weeks after treatment,the patients in the BTC group showed significant improvement in IIEF-5(15.67±3.63),EHS,SEP-2,3 and GAQ-1 positive response compared with those in the placebo group(P<0.05)and similar improvement to that in the CXC group in IIEF-5(15.67±3.63 vs 15.65±3.87),EHS,SEP-2,3 and GAQ-1,2(P>0.05).No statistically significant differences were observed in the incidence of adverse reactions among the placebo,BTC and CXC groups(4.7%vs 2.7%vs 5.0%,P>0.05),and the symptoms were significantly relieved in the BTC group after change of the administration time to after meal.Conclusion:Black tomato concentrate is comparable to Compound Xuanju Capsules and better than placebo(P<0.05)in improving the IIEF-5,EHS and SEP-2,3 scores of ED patients.And,with a high safety,it can be used as an alternative treatment of ED.