舒泌通胶囊治疗良性前列腺增生湿热蕴结证的临床观察

目的观察舒泌通胶囊治疗湿热蕴结证良性前列腺增生症的临床疗效。方法将120例良性前列腺增生症患者按2:1随机分为治疗组80例,对照组40例。治疗组应用舒泌通胶囊治疗,每次4粒,日3次;对照组应用癃闭舒胶囊,每次3粒,每日2次。2组均连续用药8周为1疗程。观察治疗前后患者国际前列腺症状评分(I-PSS)、生活质量(QoL)评分、最大尿流率(Q max)、膀胱残余尿量、中医证候积分、前列腺体积,并观察不良反应。结果治疗组总有效率为治疗组总有效率为87.5%(70例),其中显效率为27.5%;对照组总有效为77.5%(31例),其中显效率为15%,2组比较差异有统计学意义(P<0.01)。2组患者治疗后I-PSS、QoL、Q max、膀胱残余尿量、中医证候积分均较治疗前有明显改善(P<0.01),而前列腺体积治疗前后无明显变化。2组患者治疗前后中医证候疗效比较:2组患者治疗后中医证候均较治疗前有明显改善,治疗组总有效率为87.6%,单项证候疗效总有效率为93.8%,对照组总有效率为77.5%,单项证候总有效率为87.5%。经χ2检验进行组间比较,治疗组在改善BPH患者I-PSS、QoL、Q max,中医证候积分方面疗效较佳,在减少膀胱残余尿量和减小前列腺体积方面,2组差异无统计学意义。结论应用具有清热解毒、利尿通淋、软坚散结功效的舒泌通胶囊治疗湿热蕴结证良性前列腺增生症可显著改善BPH引起的下尿路症状,是一个安全有效的制剂,为BPH临床治疗提供了新证据。

Clinical Observation of Shubitong Capsule in the Treatment of Benign Prostatic Hyperplasia Patients with Damp-Heat Syndrome

Objective:To observe the clinical effect of Shubitong Capsule in the treatment of benign prostatic hyperplasia(BPH)patients with damp-heat syndrome.Methods:120 BPH patients were randomly divided into a treatment group(80 cases)and a control group(40 cases)in a 2:1 ratio.The treatment group was treated with Shubitong Capsules,4 capsules each time,3 times daily and the control group was treated with Longbishu capsules,3 capsules each time,2 times daily.Both groups were treated continuously for 8 weeks as a course of treatment.The international prostate symptom score(I-PSS),quality of life(QoL)score,maximum urine flow rate(Q max),bladder residual urine volume,TCM syndrome score,and prostate volume of the two groups were observed before and after treatment and their adverse reactions were observed as well.Results:The total effective rate in the treatment group was 87.5%(70 cases),with a marked effective rate of 27.5%.The total effective rate in the control group was 77.5%(31 cases),with the marked effective rate of 15%.In comparison of the two groups the difference was statistically significant(P<0.01).After treatment,the I-PSS,QoL,Q max,bladder residual urine volume and TCM syndrome scores of the two groups were significantly improved compared with those before treatment(P<0.01),while the prostate volume did not change significantly before and after treatment.In comparison of the curative effect of TCM syndromes before and after treatment,the TCM syndromes of the two groups were significantly improved after treatment.The total effective rate of the treatment group was 87.6%and the total effective rate of the single syndrome was 93.8%.The effective rate is 77.5%,and the total effective rate of the single syndromes was 87.5%.The comparison between groups byχ2 test showed the treatment group had better effect in improving I-PSS,QoL,Q max and TCM syndrome score of BPH patients.There is no statistical difference between the two groups in reducing residual bladder volume and reducing prostate volume.Conclusion:With the functions of heat-clearing and detoxifying,promoting diuresis to relieve stranguria and resolving hard lump,Shubitong Capsules has a better effect on the treatment of BPH patients with damp-heat syndrome and can significantly improve the lower urinary tract symptoms caused by BPH,which provides new evidence for the clinical treatment of BPH patients.