尿清舒颗粒治疗慢性非细菌性前列腺炎(湿热下注证)的有效性与安全性

Efficacy and safety of Niaoqingshu granules in the treatment of chronic pelvic pain syndrome(syndrome of dampness-heat diffusing downward)

目的:探讨应用尿清舒颗粒治疗慢性非细菌性前列腺炎(湿热下注证)的有效性与安全性。方法:采用分层区组随机、双盲双模拟、阳性药平行对照、多中心的临床试验研究方法,应用尿清舒颗粒对444例慢性非细菌性前列腺炎患者进行为期4周的治疗,其中观察组333例,给予尿清舒颗粒与前列腺胶囊模拟剂,对照组111例,给予前列腺胶囊与尿清舒颗粒模拟剂。以西医症状积分(慢性前列腺炎NIH-CPSI症状评分)、中医症候疗效和单项症状积分、前列腺触诊、前列腺液常规检查为观察指标,并观察治疗前后患者的一般体格检查、血常规、尿常规、便常规、心电图和肝肾功能以及不良反应发生率,以评价其有效性与安全性。结果:治疗4周后,观察组患者在NIH-CPSI症状评分中,优于对照组,差异有显著性统计学意义(P<0.05)。西医症状单项积分评分中,排尿症状评分两组差异有显著性统计学意义(P<0.05)。2组患者在治疗前后中医症候总积分组间比较,观察组显著优于对照组,组间比较差异具有显著性统计学意义(P<0.05),且2组在中医症候愈显率及总有效率进行组间比较,观察组与对照组差异具有显著性统计学意义(P<0.05);中医单项症候比较,在"尿急、尿痛、舌质"三个单项症状上,观察组明显优于对照组,组间比较差异具有显著性统计学意义(P<0.05),而其他单项症状比较,差异无统计学意义(P>0.05)。2组患者在前列腺触诊及前列腺液常规检查比较,差异无统计学意义(P>0.05)。两组试验前后血、尿、便常规及心、肝、肾功能检测均未发现明显异常。结论:尿清舒颗粒治疗非细菌性慢性前列腺炎(湿热下注证)疗效确切,临床服用安全,具有较好的临床应用前景,值得推广使用。

OBJECTTVE To investigate the efficacy and safety of Niaoqingshu granules in the treatment of chronic pelvic pain syndrome （syndrome of dampness-heat diffusing downward）. METHODS A stratified block randomized, double blind, double dummy, parallel controlled, multicenter trial was designed for clinical study, 444 patients with chronic pelvic pain syndrome were given Niaoqingshu granules for 4 weeks, 333 patients in treatment group were given Niaoqingshu granules and Qianliexiao cap- sule mimetic agent, and 111 cases in control group were given Qianliexiao capsules and Niaoqingshu granule mimetic agent. Western medicine symptom score （chronic prostatitis symptom NIH-CPSI scores）, curative ＂effect of Chinese medicine syndrome and the individual symptoms score were used as the main observation indexes, prostate digital examination and routine prostatic fluid test as the secondary outcomes. General physical examination, blood routine, urine routine, and stool routine, electrocardio- gram,liver and kidney functions and incidence of adverse reactions were observed before and after treatment to evaluate the effi- cacy and safety, RSULTS Four weeks after treatment,the NIH-CPSI symptom scores of the treatment group were superior to the control group （P〈0. 05）. In western medicine single symptom score, difference of micturition symptom score was statistically significant between the two groups （P〈0. 05）. Treatment group showed superior total integral of TCM syndrome before and after treatment to the control group （P〈0. 05）, significantly different effective rate and total effective rate of syndromes than those in control group （P〈0. 05）. For single syndromes of TCM, treatment group was superior in the three individual symptoms including ＇urgent urination,odynuria, tongue nature＇ （P〈0. 05）. Two groups had no significant difference in prostate digital examina- tion and routine prostatic fluid test （P〉0. 05）. Blood routine, urine routine, stool routine, and heart, liver and renal function tests showed no obvious abnormality before and after treatment, suggesting that test drugs had better security. CONCLUSION Niaoqing- shu granules have obvious curative effects against the treatment of chronic pelvic pain syndrome （syndrome of dampness-heat diffusing downward）, good clinical safety and prospects, and is worth promoting and applying widely.