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目的：观察连参通淋片治疗非淋菌性尿道炎(湿热下注证)的临床疗效和安全性。方法用随机、双盲双模拟、平行对照的多中心研究,入选435例病例,随机分配到连参通淋片组(4片/次,3次/d,n＝326)和三金片组(3片/次,3次/d,n＝109)疗程2 w,从中医证候疗效、单项症状疗效、晨间首次尿离心沉淀物的多形核白细胞变化或尿道拭子涂片的多形白细胞变化、病原学的变化等方面进行疗效评定,并观察临床安全性。结果治疗结束后ITT(意愿治疗Intent To Treat)中,试验组和对照组中医症状有效率分别为77.6%、66.2%,愈显率分别为52.5%、33.9%,组间比较有统计学意义(﹤0.05)；PP(符合方案Per Protocol)中,试验组和对照组中医症状有效率分别为77.4%、62.3%,愈显率分别为53.0%、62.3%,组间比较有统计学意义(﹤0.05)；试验组治疗后尿沉渣白细胞数定性、定量,治疗后支原体和衣原体的转阴率优于对照组；治疗后尿痛、尿道刺痒、尿道红肿等症状改善情况优于对照组。结论连参通淋片治疗非淋菌性尿道炎(湿热下注证)安全、有效。“,”Objective To evaluate the efficacy and safety of the Lian shen tong lin tablet in the treatment of Non-gonococcal Urethritis (NGU) (Damp Syndrome). Methods A randomized, double-blind, double-dummy, parallel-controlled multi-center clinical trial was conducted for treatment of 435 cases of patients with Non-gonococcal Urethritis . Patients were randomized into two group, test group to receive Lianshentonglin tablet (4/times, three times a day,n=326) and control group receive three gold tablet (3/time,3 times a day, n=109) for 2 weeks, to evaluate the efficacy and clinical safety from TCM syndrome effect、the efficacy of individual symptoms、the first morning urine pellet of polymorphonuclear leukocytes or urethral swab smears leukocyte shape change aspects、changes of etiology.Results After treatment, in ITT (Intent To Treat), the clinical symptoms effective rate of test group and the control group were 77.6%, 66.2%, markedly effective rate was 52.5%,33.9%, was statistically significant ( <0.05) between the two groups;in PP(Per Protocol), the clinical symptoms effective rate of test group and the control group were 77.4%, 62.3%, markedly effective rates were 53.0%, 62.3%, was statistically significant ( <0.05) between the two groups;after treatment, white blood cell count in urinary sediment qualitative and quantitative, mycoplasma and chlamydia negative conversion rate,dysuria, urethral itching, individual symptoms improved conditions in dysuria、Urethral itching,Urethra swelling, the test group is better than the control group.Conclusion Lianshentonglin tablet is safe and effective in treatment of non-gonococcal urethritis (Damp Syndrome).