苦参通关丸治疗BPH的疗效及安全性分析

Effective and Safety Analysis of Kushen Tongguan Pills in the Treatment of Benign Prostatic Hyperplasia

目的通过苦参通关丸治疗门诊良性前列腺增生症(benign prostate hyperplasia,BPH)患者,观察其临床疗效和药物安全性。方法依据纳入和排除标准,门诊选取2021年8月至2022年8月天津中医药大学第一附属医院男科就诊的40例BPH患者为研究对象。采用随机数字表法将40例BPH患者随机分成两组,即对照组和观察组,其中每组20例。对照组采用盐酸坦索罗辛缓释胶囊进行治疗,观察组口服盐酸坦索罗辛缓释胶囊联合苦参通关丸。观察两组患者治疗前及治疗后组间最大尿流率(maximum flow rate,Qmax)、前列腺体积(prostate volume,PV)、国际前列腺症状评分(international prostate symptom score,IPSS)、生活质量(quality of life,QOL)评分及不良反应发生率。结果治疗3个月后,观察组Qmax水平高于对照组,PV小于对照组,两组数据均差异有统计学意义(P<0.05);观察组IPSS评分和QOL评分均低于对照组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论苦参通关丸联合坦索罗辛治疗良性前列腺增生症疗效显著,优于坦索罗辛单一治疗,能够显著缓解患者BPH导致的下尿路梗阻症状和膀胱刺激症状,能够有效提高患者的生活质量,且具有较好的安全性。

Objective To observe the clinical efficacy and safety of Kushen Tongguan pills in the treatment of patients with benign prostatic hyperplasia(BPH).Methods 40 patients with BPH in andrology department of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from August 2021 to August 2022 were selected as subjects according to inclusion and exclusion criteria.40 patients with BPH were randomly divided into two groups,control group and observation group,with 20 cases in each group.The control group was treated with Tamsulosin hydrochloride sustained-release capsules,and the observation group was given Tamsulosin hydrochloride sustainedrelease capsules combined with Kushen Tongguan pills.The maximum flow rate(Qmax),prostate volume(PV),international prostate symptom score(IPSS),quality of life(QOL)and the incidence of adverse reactions were observed between the two groups before and after treatment.Results After 3 months of treatment,Qmax level in the observation group was higher than that in the control group,PV was lower than the control group,and the differences were statistically significant between the two groups(P<0.05).IPSS scores and QOL scores in the observation group were lower than those in the control group,the differences were statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Kushen Tongguan pills combined with Tamsulosin has significantly efficacy in the treatment of benign prostatic hyperplasia,which is better than tamsulosin single treatment,and can significantly relieve the symptoms of lower urinary tract obstruction and bladder irritation caused by BPH in patients,effectively improve the quality of life of patients,and has high safety.