蜂花前清茶(方)治疗良性前列腺增生症45例临床随机对照研究

Randomized controlled trial on fenghuaqianqing tea in treatment 45 cases with benign prostatic hyperplasia

目的评价蜂花前清方治疗前列腺增生症(BPH)的临床疗效及安全性。方法采用随机对照、多中心临床研究方法,共纳入96例,其中治疗组48例,对照组48例。治疗组给予蜂花前清方冲服,2袋/次,早晚服用;对照组给予马沙尼口服,睡前服用1片。8周为1个疗程,停药随访2周,同时记录不良反应。结果治疗组完成45例,脱落3例;对照组完成45例,脱落3例。治疗组总有效率为73.3%,其中显效率为11.1%;对照组总有效率为51.1%,其中显效率为4.4%,两组疗效比较差异具有统计学意义(P<0.05)。两组治疗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(Qmax)、膀胱残余尿量方面改善比较差异具有统计学意义(P<0.05),而前列腺体积无明显变化。组间比较显示:治疗组在改善BPH患者I-PSS、Qo L、Qmax方面优于对照组(P<0.05);I-PSS单项积分中,治疗组在改善间断性排尿、尿线变细现象、用力及使劲才能开始排尿方面优于对照组(P<0.05)。对照组停药2周后I-PSS变化与治疗组比较差异有统计学意义(P<0.05)。结论蜂花前清方可明显改善BPH临床症状,提高患者生活质量,而且具有一定的停药稳定性,同时治疗BPH较为安全,具有很好的应用开发前景。

Objective To evaluate the efficacy and safety of Fenghuaqianqing Tea in treatment of benign prostatic hyperplasia. Methods A randomized control and multi-center clinical trial was applied. The patients were divided into observation group（ 48 cases） and control group（ 48 cases）. The control group were treated with Fenghuaqianqing Tea（ 2 bags/time,bid,po）,while the observation group received Terazosin Hydrochloride Tablets（ 1 tablet,qn,po）. A course of treatment last 8 weeks including the one observation course. Then there would be a 2-week follow-up visit and the adverse drug reactions were statistically collected. Results Treatment group,45 cases completed,detached 3 cases,control group,45 cases completed,3 cases lost. The total effectiveness rate of treatment group was 73. 3% with significant efficiency rate of 11. 1% and that of control group was 51. 1% with significant efficiency rate of 4. 4%. There were significant differences in clinical efficacy between the two groups（ P〈0. 05）. The I-PSS,Qo L,Qmax and residual urine volume were obviously improved in both groups after treatment（ P〈0. 05）,In I-PSS single integrals,the treatment group was superior to the control group（ P〈0. 05） in the improvement of intermittent urination,the appearance of the urine line,and the Urination difficulty. whereas no changes were found in prostate gland volume; Compared with control group,treatment group was better in the improvement of I-PSS,Qo L,Qmax（ P〈0. 05）,but there was no significant difference in reducing residualvolume and prostate gland volume between the 2 groups. Drug withdrawal two weeks later,Comparing the curative effect for effective cases,The treatment group patients score on I-PSS,which has no statistical difference compared with 2 weeks ago（ P〈0. 05）; The control group patients score on I-PSS,which has statistical difference compared with 2 weeks ago（ P〈0. 05）. Comparison between groups,the treatment group patients and the control group was statistically difference on I-PSS score（ P〈0. 05）. Conclusion Fenghuaqianqing Tea can significantly improve clinical syndromes caused by BPH and preferably maintenance treatment effect,which is a safe and effective medicine in treating BPH with broad development and application prospects.