前列腺内直接注射川参通治疗慢性非细菌性前列腺炎/慢性骨盆疼痛综合征

Efficacy and Safety of Intraprostatic Injection of Chuanshentong for Chronic Abacterial Prostatitis/Chronic Pelvic Pain Syndrome

目的 :评价经会阴注射川参通治疗慢性非细菌性前列腺炎 /慢性骨盆疼痛综合征 (CAP/CPPS)的有效性和安全性。 方法 :安慰剂对照双盲试验 ,将 38例诊断为CAP/CPPS的患者随机分为 2组。治疗组 2 4例 ,运用川参通及利多卡因注射液 6ml,经会阴注射至前列腺 ,每日 1次 ,共 6次 ;对照组 14例 ,安慰剂治疗 6次。采用美国国立卫生研究院 (NIH)制定的前列腺炎症状评分 (CPSI)标准判定疗效 ,比较治疗组治疗前后精液的主要参数。 结果 :观察 6周 ,两组各有 1例在治疗中退出试验。治疗组痊愈 13例 ( 5 6 .5 % ) ,显效 5例 ( 2 1.7% ) ,有效 4例 ( 17.4 % )。对照组无痊愈病例 ( 0 % ) ,显效 2例 ( 15 .4 % ) ,有效 3例 ( 2 3% )。治疗组痊愈率、显效率及有效率显著高于对照组 (P <0 .0 5 )。川参通治疗前后 ,CPSI疼痛评分、排尿症状评分、生活质量评分及总分均有显著改善 ( 95 %可信区间分别为 :9.83至 12 .70 ,3.15至 4 .94 ,3.95至 6 .4 8,17.97至 2 3.0 8)。对精液主要参数无显著性影响 (P >0 .0 5 )。 结论 :经会阴注射川参通治疗CAP/CPPS有效、安全。

Objective: To evaluate the efficacy and safety of intraprostatic injection of Chuanshentong in the treatment of chronic abacterial prostatitis/chronic pelvic pain syndrome(CAP/CPPS) . Methods: Randomized, double blinded, placebo controlled trials were carried out from September 2002 to March 2003. A total of 38 patients with diagnosed CAP/CPPS, 24 experimental and 14 controls, were analyzed. In the trial group, 6 ml of mixed solution of Chuanshentong and lidocaine was transperineally injected into one lobe of the prostate, once a day for 6 days. Likewise,the control group was treated with placebo containing lidocaine. The efficacy was evaluated by the NIH Chronic Prostatitis Symptom Index(CPSI) after a 6 week follow up. The main semen parameters before and after 3 month treatment were compared. Results: In the trial group, 13 cases ( 56.5 %)were completely cured, 5 cases( 21.7 %) showed remarkable effect, and 4 cases( 17.4 %) were improved. While in the control group, effectiveness was shown in only 2 cases( 15.4 %), and improvement in 3 cases(23%). CPSI scores decreased significantly after treatment(95% of confidence interval: 17.97 ～ 23.08 ). Chuanshentong solution had no obvious impact on the main semen parameters. No severe adverse effects were observed. Conclusion: Transperineal intraprostatic injection of Chuanshentong is a safe and effective method for the treatment of CAP/CPPS.