前列安栓治疗慢性前列腺炎(湿热瘀血壅阻证)的安全性和有效性的Ⅲ期临床试验

目的:评价前列安栓治疗慢性前列腺炎(湿热瘀血壅阻证)的安全性和有效性。方法:随机、单盲、平行对照、多中心临床试验,467例受试者分为试验组349例、对照组118例。试验组前列安栓1粒,对照组野菊花栓1粒,肛内用药每晚1次,疗程28 d。以中医证候、美国国立卫生研究院慢性前列腺炎症状评分(NIH-CPSI)、主要临床症状及前列腺按摩液白细胞(EPS-WBC)计数为疗效评价指标。结果:试验组治疗结束时中医证候疗效临床控制率为4.4%、总显效率为58.0%、总有效率为90.7%,明显优于对照组的0.9%、33.1%、70.4%(P<0.025)。试验组的NIH-CPSI总分、疼痛与不适、排尿情况、生存质量评分的下降程度均较对照组明显(P<0.025)。试验组对主要临床症状尿急、会阴部等局部坠胀和局部疼痛有明显缓解作用,疗效优于对照组(P<0.05)。试验组EPS-WBC计数改善率为55.2%,明显优于对照组的32.4%(P<0.05)。试验组和对照组均未发生严重不良事件,试验药和对照药不良反应发生率低,分别为0.56%(2/349)和0.83%(1/118)。结论:前列安栓治疗慢性前列腺炎(湿热瘀血壅阻证)疗效肯定,临床用药安全性良好。

Safety and Efficacy of Qianliean Suppository for Chronic Prostatitis of Damp-Heat and Blood-Stasis Syndrome: A Randomized, Single-Blind, Parallel Controlled,Multi-Centered Phase m Clinical Trial

Objective: To evaluate the safety and effieaey of Qianliean Suppository in the treatment of chronie prostatitis of damp-heat and blood-stasis syndrome. Methods: We conducted a randomized, single-blind, parallel-controlled, multi-centered elinical trial among 467 subjects, who were assigned to a trial group (n = 349) and a control group (n = 118), the former treated with Qianliean Suppository anally one pill per night for 28 days and the latter given Yejuhua Suppository in the same way. The efficacy was evaluated by the TCM syndrome, NIH-CPSI, main clinical symptoms and WBC count in EPS. Results: After the treatment, the total rates of recovery, excellenee and effectiveness for the TCM syndrome were 4.4%, 58.0% and 90.7% respectively in the trial group, significantly higher than 0.9%, 33.1% and 70.4% in the control group (P < 0.025). Remarkable decreases were observed in the NIHCPSI total score and the scores on pain and discomfort, voiding symptoms and quality of life in the former group compared with the latter (P < 0.025). The trial group also showed a marked alleviation of such main chronic prostatitis symptoms as urgent micturition and perineal pain and discomfort (P < 0.05), as well as an obvious improvement (55.2%) of the WBC count in EPS as compared with 32.4% in the control group (P < 0.05). No serious adverse events occurred in either of the two groups (0.56% [2/349] vs 0.83% [1/118]). Conclusions : Qianliean Suppository is safe and effective for the treatment of chronic prostatitis of damp-heat and bloodstasis syndrome.