灵泽片治疗肾虚血瘀湿阻型BPH的单臂、开放、多中心Ⅳ期临床研究及安全性评价

Lingze Tablets for BPH with kidney-deficiency,blood stasis and dampness resistance:A phase-Ⅳopen-label single-arm multicenter clinical study and safety evaluation

目的:评价灵泽片广泛使用情况下治疗肾虚血瘀湿阻型良性前列腺增生(BPH)的疗效及安全性。方法:符合纳入标准BPH受试者口服灵泽片治疗:4片/次,3次/d,疗程为8周。观察纳入对象治疗前后国际前列腺症状评分(IPSS)、生活质量指数评分(QOL)、中医证候分级评分(TCM clinical symptoms scores)变化。结果:共纳入符合条件的BPH患者235例,其中24例脱落,211例完成整个疗程。治疗前IPSS为(18.28±5.29)分,治疗4周后为(12.82±4.66)分,治疗8周后IPSS为(9.23±4.21)分;治疗前后比较,差异有非常显著性(P<0.01);治疗前QOL(6.44±1.99)分,治疗4周后为(4.95±1.64)分,治疗8周后为(3.16±1.53)分,治疗前后比较,差异有非常显著性(P<0.01);治疗前中医证候分级评分(17.49±5.30)分,治疗4周后评分为(12.45±3.74)分,治疗8周后评分为(9.17±3.24)分,治疗前后比较,差异有非常显著性(P<0.01);试验药物不良反应/不良事件发生率低,未见器官功能损害。结论:灵泽片对肾虚血瘀湿阻型BPH患者疗效显著,安全性高。

Objective:To evaluate the efficacy and safety of Lingze Tablets in the treatment of BPH with kidney deficiency,blood stasis and dampness resistance.Methods:Totally 235 eligible BPH patients,aged 50-80 years and meeting the inclusion criteria,were enrolled and treated with Lingze Tablets orally,4 tablets per time,tid.Before and after an 8-week course of medication,IPSS,quality of life(QOL)and TCM syndromes scores were obtained from the patients.Results:Of the total number of patients,211 completed the whole course of treatment.Compared with the baseline,the IPSS was dramatically reduced after 4 and 8 weeks of medication(18.28±5.29 vs 12.82±4.66 and 9.23±4.21,P<0.01),and so were the QOL scores(6.44±1.99 vs 4.95±1.64 and 3.16±1.53,P<0.01)and TCM syndromes scores(17.49±5.30 vs 12.45±3.74 and 9.17±3.24,P<0.01).The incidence rates of adverse events and drug-related adverse reactions were 15.2%and 1.9%,respectively,and no organ function impairment was observed.Conclusion:Lingze Tablets are definitely effective and safe for the treatment of BPH with kidney deficiency,blood stasis and dampness resistance.