连参通淋片治疗非淋菌性尿道炎(湿热下注证)Ⅱ期临床试验

Clinical Observation of Lianshentonglin Stable in Phase Ⅱ in the Treatment of Non-gonococcal Urethritis

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法,入选221例非淋菌性尿道炎(湿热下注证)病例,随机分为连参通淋片组(4片/次,每日3次,n=110)和三金片组(3片/次,每日3次,n=111),于治疗后10天及21天,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价,同时观察临床安全性。结果:治疗10天后,试验组和对照组中医症状总有效率分别为69.8.6%、48.6%,组间比较差异有统计学意义(P<0.05);治疗21天后,试验组和对照组中医症状总有效率分别为84.9%、67.7%,组间比较差异有统计学意义(P<0.05);治疗10天及21天后,两组患者中医证候总积分比较,差异均有统计学意义(P<0.05);治疗21天后,尿沉渣及尿道拭子涂片检查多形核白细胞:定性检查结果,差异无统计学意义(P>0.05);定量检查结果:两组治疗后与用药21天后-基线差值比较,差异均有统计学意义(P<0.01),试验组优于对照组。治疗后衣原体的转阴率优于对照组。试验期间,未出现不良反应。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,可为后期确定疗程提供临床依据。

Objective：To evaluate the efficacy and safety of the I.ian shen tong lin tablet in the treatment of Nomgonococcal Ure thritis（NGU） （Damp Syndrome）. Methods： A randomized, double-blind, double dummy, parallel-controlled multi center clinical trial was conducted for treatment of 221 cases of patients with Non-gonococcal Urethritis. Patients were randomized into two group, test group to receive I.ianshentonglin tablet （4/times, three times a day, n： 110） and control group receive three gold tablet （3/ time, 3 times a day, n=111）. On the 10tb and the 21 days, to evaluate the efficacy and clinical safety from TCM syndrome effect, the efficacy of individual symptoms,the first morning urine pellet of polymorphonuclear leukoeytes or urethral swab smears leukoeyte shape change aspects, changes of etiology. Results：After 10 days of treatment, the experimental group and the control group of TCM symptoms total effective rate were 69.8.6% and 48.6%, the difference was statistically significant （P〈0.05） ;the 21 days af ter treatment, the test group and the control group of TCM symptoms total effective rate were 84.9% and 67.7%, the difference was statistically significant （P〈0.05）;after 10 days and 21 days of treatment, compared with two groups of TCM syndrome total score, the differences were statistically significant （P〈0.05） ;the 21 days after treatment, urine and urethral swab smears of polymorphonuclear leukoeytes ： qualitative examination results, no statistical significance （ P〉 0.05） ; quantitative examination results： between the two groups after treatment and medication for 21 days baseline, were statistically significant （P 〈 0.01）, the experimental group is better than the control group. After the treatment of Chlamydia negative rate than the control group. During the test, there was no adverse reaction. Conclusion ： Lianshentonglin tablet is safe and effective in treatment of noN-gonococeal urethri- tis （Damp Syndrome）,and to provide clinical evidence for the late period of treatment.