肾宝片治疗肾阳虚型良性前列腺增生216例疗效评价

Effect Evaluation of Shenbao Tablet on 216 Cases of Benign Prostatic Hyperplasia of Kidney Yang Deficiency Type

目的:评价肾宝片治疗肾阳虚型良性前列腺增生的有效性和安全性。方法:选择符合前列腺增生诊断标准及肾阳虚中医证候诊断标准的患者288例,随机分为观察组和对照组,其中观察组216例,口服肾宝片和右归丸模拟剂,对照组72例,口服右归丸和肾宝片模拟剂,两组均服药治疗12周。于治疗前,治疗4周、8周及12周后分别观察两组中医证候疗效、中医证候单项评分、国际前列腺症状总积分及生活质量评分的变化。结果:治疗12周后,完成实验277例,脱落11例(观察组7例,对照组4例,脱落率3.24%)。两组患者中医证候改善均较好,其中观察组总有效率达95.83%,对照组总有效率为88.89%,两组比较差异有统计学意义(P<0.05)。试验期间共发生不良事件2例,其中观察组发生1例上呼吸道感染(0.46%),对照组发生1例轻度肝功能异常(1.39%)。结论:肾宝片治疗肾阳虚型良性前列腺增生安全有效,疗效优于右归丸。

Objective:To evaluate the efficacy and safety of Shen Bao tablet in the treatment of benign prostatic hyperplasia with kidney yang deficiency.Methods:The 288 patients with benign prostatic hyperplasia with kidney yang deficiency were randomly divided into observation group and control group.216 cases of observation group were treated with Shenbao tablet and Yougui Pill simulant for 12 weeks.72 cases of control group were treated with Shenbao tablet simulant and Yougui Pill for 12 weeks.Before treatment,4 weeks,8 weeks and 12 weeks after treatment,observe the effective of TCM syndrome,single score of TCM syndrome,total score of International Prostate Symptom and quality of life score of the two groups were observed.Results:After 12 weeks of treatment,277 cases of the experiment were completed,11 cases were shed(7 cases in observation group,4 cases in control group,with a rate of 3.24%).The improvement of TCM symptoms in both groups was good,the total effective rate of the observation group was 95.83%,and that of the control group was 88.89%,the difference was statistically significant(P<0.05).2 cases of adverse events occurred during the trial,including 1 case of upper respiratory tract infection(0.46%)in observation group and 1 case of mild liver function abnormality(1.39%)in control group.Conclusion:Shenbao tablet is safe and effective in the treatment of the syndrome of benign prostatic hyperplasia with kidney yang deficiency,and the curative effect is better than Yougui Pill.