机构地区:[1]中国中医科学院西苑医院男科,北京100091 [2]中国中医科学院研究生院
出 处:《中国中西医结合杂志》2008年第12期1082-1085,共4页Chinese Journal of Integrated Traditional and Western Medicine
基 金:“十一五”国家科技支撑计划中医治疗常见病研究项目(No.2007BA120B044)
摘 要:目的评估滋阴通闭汤治疗良性前列腺增生症的有效性及安全性。方法采用随机、阳性药平行对照的临床观察方法。将100例良性前列腺增生患者随机分为2组,试验组(50例)服用滋阴通闭汤(由知母12 g黄柏12 g生地10 g山药15 g益智仁10 g丹参10 g三棱8 g莪术8 g桑螵蛸8 g (庶虫)虫8 g浙贝10 g夏枯草15 g等组成),每次150 mL,每天2次;对照组(50例)服用癃闭舒胶囊(由补骨脂、益母草、金钱草等组成,每粒胶囊0.3 g,石家庄科迪药业有限公司生产),每次0.9 g,每天2次;两组均4周为1个疗程。治疗前后观察中医症状(包括夜尿次数、排尿困难程度、尿线情况、腰膝酸软、少腹胀痛、神疲乏力),国际前列腺症状评分(I-PSS),最大尿流率(Qmax)值,残余尿量,前列腺体积变化。结果试验组治疗后中医症状改善与治疗前比较,差异有统计学意义(P<0.05);与对照组比较,尿线情况和小腹胀满差异亦有统计学意义(P<0.05),试验组总有效率为89.00%(43/48),对照组为73.46%(36/49),两组比较,差异有统计学意义(P<0.01);两组治疗后I-PSS评分、Qmax及残余尿差异均有统计学意义(P<0.05,P<0.01)。试验组在改善I-PSS评分,Qmax方面,疗效优于对照组(P<0.01)。两组治疗前后前列腺体积缩小差异不明显(P>0.05)。治疗组有4例、对照组有5例发生有胃部不适、口渴等轻度不良反应,但均未影响患者继续服药,亦未做纠正治疗。结论滋阴通闭汤治疗良性前列腺增生安全、有效。Objective To evaluate the efficacy and safety of Ziyin Tongbi Decoction (ZTD) in treating benign prostatic hyperplasia (BPH). Methods Adopting randomized positive controlled clinical trial method, the 100 BPH patients were assigned to two groups equally. The treatment group was medicated with ZTD, one dose per day, consisting of wild weed 12 g, yellow cocktree bark 12 g, rehmannia root 10 g, Chinese yam 15 g, bitter cardamon 10 g, red sage root 10 g, burreed tuber 8 g, tumeric rhizome 8 g, mantis egg-case 8 g, ground beetle 8 g, Zhejiang fritillary bulb 10 g, and prunella spike 15 g, etc. , by decocting with water, taking twice daily and 150 mL each time. The control group was treated by Longbishu Capsule, a product of Kedi Pharmaceutical Co. , Ltd. , consisting of psoralea fruit, motherwort, and lysimachia, etc. , twice a day, 0.9 g each time. A course of 4 weeks was given to both groups. The therapeutic efficacy was evaluated by changes in TCM symptoms after treatment (in- cluding frequency of night urination, degree of dysuria, condition of urinary thread, soreness and weakness in loin and knees, lower abdominal distention, spiritless and general weakness), the International Prostate Syndrome Score (I-PSS), maximum flow rate (Qmax), residual urine volume and prostate volume. Results The TCM symptoms were improved in the treatment group after treatment, showing significant as compared with those before treatment (P 〈0.05) ; as compared with the control group, the difference in urinary thread and lower abdominal distention in treatment group was significant improved (P 〈 0.05). The total effective rate in the treatment group was 89.00% (43/48), while that in the control group was 73.46% (36/49), showing statistically significant difference between them (P 〈0. O1 ). The efficacy in the treatment group in aspect of improving I-PSS and Qmax was better than that in the control group (P 〈 0. 05, P 〈 0. 01 ). The residual urine volume was reduced in both group, as
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