桂益通癃方治疗中度良性前列腺增生肾虚血瘀证随机对照试验

Guiyi Tonglong Prescription for Moderate Benign Prostatic Hyperplasia Patients with Kidney Deficiency and Blood Stasis Syndrome：An Randomized Controlled Trial

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DOI：10. 7661/j. cjim. 20220213.107

中文关键词: 良性前列腺增生桂益通癃方随机对照临床试验肾虚血瘀证

英文关键词:benign prostatic hyperplasia Guiyi Tonglong prescription randomized controlled clinical trial kidney deficiency and blood stasis syndrome

基金项目:国家自然科学基金青年基金项目（No.82104880）；国家中医药管理局中医药传承与创新“百千万”人才工程岐黄学者（No.国中医药人教函〔2022〕6号）

作者	单位
郭俊，王福，杨九天，刘胜京，高庆和，郭军	中国中医科学院西苑医院男科（北京 100091）

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中文摘要:

目的评价桂益通癃方治疗中度良性前列腺增生肾虚血瘀证患者的安全性及有效性。方法选取2021年6月-2022年2月中国中医科学院西苑医院男科门诊就诊的中度良性前列腺增生肾虚血瘀证患者72例，按随机数字表法分为试验组（36例）和对照组（36例）。试验组给予桂益通癃方，对照组给予盐酸坦索罗辛缓释胶囊，疗程6周，随访2周。观察治疗前后国际前列腺症状评分（IPSS）评分、生活质量评分（QoL）、最大尿流率（Qmax）、中医证候评分、前列腺体积（PV）、残余尿（PVR）。结果最终试验组完成31例，对照组完成30例，纳入统计分析。与本组治疗前比较，两组治疗后各时间IPSS、中医证候总分、腰膝酸软、排尿困难、夜尿频数、神疲乏力、盆腔疼痛及QoL评分降低，Qmax增加（P<0.05）。与对照组同期比较，试验组在治疗4、6周以及随访第2周，IPSS、中医证候总分、盆腔疼痛评分降低，治疗4、6周QoL降低，治疗2、4周Qmax降低，治疗2、4、6周及随访2周腰膝酸软评分降低，治疗6周及随访2周神疲乏力评分降低（P<0.05）。两组均未出现明显不良反应。结论桂益通癃方在降低中度良性前列腺增生患者IPSS、中医证候评分、QoL，提升Qmax方面具有良好的有效性与安全性。

英文摘要:

Objective To evaluate the safety and effectiveness of Guiyi Tonglong prescription （GTP）in treating patients with kidney deficiency and blood stasis syndrome in moderate benign prostatic hyperplasia. Methods From June 2021 to February 2022，72 cases of moderate benign prostatic hyperplasia with kidney deficiency and blood stasis syndrome were randomly assigned to experimental group （36 cases） and control group （36 cases）. The experimental group was given GTP，while the control group was given tamsulosin hydrochloride sustained-release capsules. The course of treatment was 6 weeks，and the patients were followed up for 2 weeks. The International Prostate Symptom Score （IPSS），Quality of Life Score （QoL），maximum urinary flow rate （Qmax），Chinese Medicine Symptoms Score，prostate volume （PV） and residual urine （PVR） were observed before and after treatment. Results Totally 31 cases were completed in the experimental group and 30 cases in the control group，which were included in the statistical analysis. Compared with the group before treatment，the scores of IPSS，total Chinese Medicine Symptoms Score，soreness of waist and knees，dysuresia，increased nocturia，mental fatigue，pelvic pain score and QoL in the 2 groups decreased at each time after treatment，while Qmax increased （P<0.05）. Compared with the control group in the same period，the IPSS，Chinese Medicine Symptoms Score and pelvic pain score in the experimental group decreased at the 4th and 6th week of treatment and the 2nd week of follow-up，the Qmax decreased at the 2nd and 4th week of treatment，the waist and knee weakness score decreased at the 2nd，4th and 6th week of treatment and the 2nd week of follow-up，and the fatigue score decreased at the 6th and 2nd weeksof treatment （P<0.05）. There were no obvious adverse reactions in both groups. Conclusion GTP has clinical efficacy and safety in reducing moderate benign prostatic hyperlasia patients' IPSS scores，Chinese Medicine Symptoms Score，QoL，increasing Qmax.

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