龙金通淋胶囊治疗Ⅲ型前列腺炎的疗效与安全性研究

Efficacy and safety of Longjintonglin Capsule for the treatment of type Ⅲ prostatitis

目的:探讨龙金通淋胶囊治疗Ⅲ型前列腺炎(慢性前列腺炎/慢性骨盆疼痛综合征,CP/CPPS)的疗效与安全性。方法:选择符合美国国立卫生研究院(NIH)诊断标准的Ⅲ型前列腺炎患者240例,口服龙金通淋胶囊,3粒/次,3次/d,疗程12周。以NIH慢性前列腺炎症状指数(NIH-CPSI)、中医证候评分、前列腺按摩液(EPS)中白细胞计数为疗效指标,进行治疗前后疗效比较。结果:完成治疗的228例患者(ⅢA型108例,ⅢB型120例)中,ⅢA型前列腺炎患者在治疗前与治疗4、8和12周后,CPSI总评分分别为(23.12±6.99)、(18.22±6.39)、(14.12±5.88)和(12.36±6.04)分(P均<0.01),中医证候评分分别为(52.12±13.08)、(48.13±12.11)、(43.05±11.19)和(40.78±10.59)分(P均<0.01),EPS中白细胞计数分别为(26.09±21.55)/HP、(23.02±18.61)/HP、(18.25±17.79)/HP和(15.36±16.38)/HP(P均<0.01);ⅢB型前列腺炎患者在治疗前与治疗4、8和12周后,CPSI总评分分别为(22.01±6.28)、(17.56±5.89)、(13.67±5.18)和(11.45±5.22)分(P均<0.01),中医证候评分分别为(53.02±12.12)、(49.32±12.78)、(44.01±11.79)和(39.67±10.26)分(P均<0.01)。试验中未见肝、肾功能异常及不良事件发生。结论:龙金通淋胶囊治疗Ⅲ型前列腺炎安全、有效,无明显不良反应,值得临床推荐使用。

Objective ： To study the therapeutic effect and safety of Longjintonglin Capsule in the treatment of type Ⅲ prostatitis （ chronic prostatitis / chronic pelvic pain syndrome, CP/CPPS）. Method： We selected 240 patients with type m prostatitis according to the diagnostic standards of the American National Institute of Health （NIH） and treated them with Long/intonglin Capsule orally 3 capsules once tid for 12 weeks. Based on the NIH chronic prostatitis symptom index （NIH-CPSI） , traditional Chinese medicine （TCM） syndrome score, and leukocyte count in the expressed prostatic secretion （EPS）, we evaluated the results of treatment. Results： Totally 238 patients completed the treatment, including 108 ⅢA and 120 Ⅲ B prostatitis cases. Before and after 4, 8, and 12weeks of treatment, the total NIH-CPSI scores were 23.12 ±6.99, 18.22 ±6.39, 14.12 ±5.88, and 12.36 ±6.04 （P 〈0.01 ） in the IliA prostatitis patients and 22.01±6.28, 17.56 ±5.89, 13.67 ±5.18, and 11.45 ±5.22 in the ⅢB prostatitis patients （P 〈 0.01 ）, the TCM syndrome scores were 52.12 ±13.08, 48. 13 ±12.11, 43.05 ±11. 19, and 40.78 ±10.59 in the former （P 〈 0.01 ） and 53.02 ±12.12, 49.32 ±12.78, 44.01 ±11.79, and 39.67 ±10.26 in the latter （ P 〈 0.01 ）, and the leukocyte counts were 26.09 ±21.55, 23.02 ±18.61, 18.25 ±17.79, and 15.36 ±16.38 in the m A cases （P 〈 0.01 ）. Neither abnormalities in liver and renal function nor obvious adverse events were observed during the experiment. Conclusion ： Longjintonglin Capsule, with its advantages of safety, effectiveness, and no obvious adverse reactions in the treatment of type m prostatitis, deserves to be recommended for clinical application.