乌茴止痛方治疗慢性前列腺炎寒凝肝脉兼瘀阻型患者随机对照、双盲双模拟的临床研究OA
A Randomized Controlled,Double-Blind,and Double-Dummy Clinical Trial of Wuhui Zhitong Formula in Treating Chronic Prostatitis of Accumulation of Cold in Liver Meridian and Blood Stasis
目的 观察乌茴止痛方治疗ⅢB型前列腺炎寒凝肝脉兼瘀阻型患者的临床疗效与安全性.方法 采用随机双盲双模拟对照设计,选取2025年6月—2025年11月于首都医科大学附属北京中医医院男科门诊就诊的80 例ⅢB型前列腺炎寒凝肝脉兼瘀阻证患者,按随机数字表法分为对照组和中药组,每组40 例.对照组给予盐酸坦洛新缓释胶囊联合乌茴止痛方颗粒模拟剂治疗,中药组给予乌茴止痛方颗粒联合盐酸坦洛新缓释胶囊模拟剂治疗,连续治疗8周.观察比较两组患者治疗后临床疗效、不良反应情况,治疗前后美国国立卫生院慢性前列腺炎症状指数(national institutes of health chronic prostatitis symptom index,NIH-CPSI)总分,NIH-CPSI子项(疼痛症状、排尿症状、生活质量)评分、中医证候积分.结果 治疗后,中药组总有效率91.67%(33/36)明显高于对照组62.86%(22/35),差异有统计学意义(P<0.05).两组患者治疗后NIH-CPSI总分及疼痛症状、排尿症状、生活质量评分、中医证候积分均较治疗前降低,差异有统计学意义(P<0.05);且中药组NIH-CPSI总分、疼痛症状评分、生活质量评分、中医证候积分均较对照组明显下降,差异有统计学意义(P<0.05).两组患者不良反应发生率比较,差异无统计学意义(P>0.05).结论 乌茴止痛方治疗ⅢB型前列腺炎寒凝肝脉兼瘀阻型安全有效.
Objective To observe the clinical efficacy and safety of Wuhui Zhitong Formula in treating Type ⅢB prostatitis of accumulation of cold in liver meridian and blood stasis.Methods This trial adopted a randomized,double-blind,double-dummy controlled design.From June 2025 to February 2026,eighty patients with Type ⅢB prostatitis of accumulation of cold in liver meridian and blood stasis were enrolled at the Andrology Outpatient Clinic of Beijing Hospital of Traditional Chinese Medicine,Capital Medical University.They were divided into a control group and a traditional Chinese medicine(TCM)group using a random number table,with 40 cases in each group.The control group received tamsulosin hydrochloride sustained-release capsules combined with a Wuhui Zhitong Formula granule placebo,while the TCM group received Wuhui Zhitong Formula granules combined with a tamsulosin hydrochloride sustained-release capsule placebo.After treatment for 8 weeks,clinical efficacy and adverse reactions were compared between the two groups.The following parameters were assessed before and after treatment:total National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI)scores,NIH-CPSI subdomain scores(pain or discomfort,urinary symptoms,and quality of life),and TCM syndrome scores.Results After treatment,the overall response rate was 82.5%(33/40)in the TCM group,significantly higher than 55%(22/40)in the control group(P<0.05).Both groups exhibited decreased total NIH-CPSI scores,TCM syndrome scores,as well as the scores for pain or discomfort,urinary symptoms,and quality of life(P<0.05),while these scores,except for urinary symptoms,were significantly lower in the TCM group(P<0.05).Furthermore,there was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Wuhui Zhitong Formula is safe and effective for treating Type ⅢB prostatitis of accumulation of cold in liver meridian and blood stasis.
曾银;高庆和;王任远;李江敏子;韩强
首都医科大学附属北京中医医院,北京 100010中国中医科学院望京医院,北京 100102首都医科大学附属北京中医医院,北京 100010首都医科大学附属北京中医医院,北京 100010首都医科大学附属北京中医医院,北京 100010
医药卫生
慢性前列腺炎寒凝肝脉兼瘀阻乌茴止痛方随机对照试验
chronic prostatitisaccumulation of cold in liver meridian and blood stasisWuhui Zhitong Formularandomized controlled trial
《世界中西医结合杂志》 2026 (4)
695-699,5
国家自然科学基金青年项目(82405399)北京市属医院科研培育计划项目(PZ2023016)
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