康乐方治疗肝郁肾虚型勃起功能障碍的临床疗效观察

Kangle Decoction for erectile dysfunction with liver-qi stagnation and kidney deficiency

目的:观察康乐方治疗肝郁肾虚型勃起功能障碍(ED)的临床疗效。方法:将79例肝郁肾虚型ED患者随机分为试验组和对照组,年龄分别为(36.62±8.05)岁和(37.44±8.10)岁(P>0.05),病程分别为(18.15±6.41)个月和(17.51±6.79)个月(P>0.05)。试验组给予康乐方口服,每天1剂分2次口服;对照组给予他达拉非口服,每次10 mg,1次/2 d。两组均连续治疗8周。分别于治疗前,治疗后4周、8周和停药后4周观察每组患者的国际勃起功能指数-5评分(IIEF-5)、勃起功能障碍治疗满意度(EDITS)与简化心理和人际关系评分(SFPAIRS)。结果:试验组、对照组患者IIEF-5治疗前分别为(10.78±2.28)、(10.77±2.33)分,治疗4周后分别为(13.40±2.42)、(16.00±2.68)分,治疗8周后分别为(18.60±3.50)、(18.59±3.80)分,停药4周后分别为(17.00±3.05)、(13.95±2.61)分;治疗后IIEF-5均较治疗前明显改善(P<0.05),停药4周后,试验组IIEF-5显著高于对照组(P<0.05)。试验组、对照组患者EDITS评分治疗4周后分别为(28.88±3.31)、(28.90±3.31)分,治疗8周后分别为(29.68±3.30)、(29.13±3.32)分,停药4周后分别为(29.20±2.92)、(26.82±3.23)分;停药4周后,试验组EDITS显著高于对照组(P<0.05)。治疗后两组患者性自信指数、性自然指数和性时间顾虑指数与治疗前相比均显著改善(P<0.05);停药4周后,试验组的改善程度要明显优于对照组。结论:康乐方疗效确切、不良反应小,停药后疗效持久,因而对于肝郁肾虚型ED患者具有较高的应用价值。

Objective： To observe the clinical efficacy of Kangle Decoction in the treatment of erectile dysfunction（ED） with liver-qi stagnation and kidney deficiency. Methods： A total of 79 ED patients with liver-qi stagnation and kidney deficiency were randomly assigned to an experimental group（ aged [36. 62 ± 8. 05] yr and with a disease course of [18. 15 ± 6. 41] mo） and a control group（ aged [37. 44 ± 8. 10]yr and with a disease course of [17. 51 ± 6. 79]mo）,the former treated orally with Kangle Decoction at0. 5 dose bid while the latter with Cialis at 10 mg qd alt,both for 8 weeks. Before treatment,after 4 and 8 weeks of medication,and at 4 weeks after drug withdrawal,we obtained the scores of the patients in the International Index of Erectile Function-5（ IIEF-5）,Erectile Dysfunction Inventory of Treatment Satisfaction（ EDITS）,and Short-Form Psychological and Interpersonal Relationship Scales（SF-PAIRS）,and compared the indexes between the two groups of patients. Results： The IIEF-5 score was dramatically increased in both the treatment and control groups after 4 weeks（13. 40 ± 2. 42 and 16. 00 ± 2. 68） and 8 weeks of medication（18. 60 ± 3. 50 and18. 59 ± 3. 80） and at 4 weeks after drug withdrawal（17. 00 ± 3. 05 and 13. 95 ± 2. 61） as compared with the baseline（10. 78 ± 2. 28 and 10. 77 ± 2. 33）（ P〈0. 05）,even higher in the treatment than in the control group after drug withdrawal（ P〈0. 05）. The EDITS scores in the treatment and control groups were（28. 88 ± 3. 31 and 28. 90 ± 3. 31） after 4 weeks of intervention,（29. 68 ± 3. 30 and29. 13 ± 3. 32） after 8 weeks of intervention,and（29. 20 ± 2. 92 and 26. 82 ± 3. 23） at 4 weeks after drug withdrawal,all significantly higher in the former than in the latter group after drug withdrawal（ P〈0. 05）. The sexual self-confidence score（ SSCS）,sexual spontaneity score（ SSS）,and sexual time-concern score（ STCS） were all improved in the treatment and control groups after medication as compared with the baseline（ P〈0. 05）,even higher in the former than in the latter group after drug withdrawal（P〈0. 05） Conclusion：Kangle Decoction has a definite efficacy in the treatment of ED with liver-qi stagnation and kidney deficiency,with few adverse reactions and long-term post-withdrawal effect,and therefore deserves a wide clinical application.