七子填精口服液治疗男性不育安全性及有效性临床研究  

Clinical study on the efficacy and safety of Qizi Tianjing oral liquid in the treatment of male infertility

作　　者：王传航[1] 戴继灿[2] 谢建兴[3] 丘勇超[3] 周少虎[3] 周强[1] 李兰群[1] 陈铭[3] 刘保兴[1] 黄坚[3] 周小廉[2] 李治平[3] 姚怀国[1] 王鑫[1] 张培伦[1] 柯明辉[1] 

机构地区：[1]北京中日友好医院男科,北京100029 [2]上海交通大学医学院附属仁济医院 [3]广州中医药大学第一附属医院

出　　处：《中国男科学杂志》2012年第11期40-44,共5页Chinese Journal of Andrology

摘　　要：目的探讨七子填精口服液治疗男性不育的安全性及有效性。方法多中心、随机、安慰剂对照临床设计。160例肾虚型男性不育患者随机分为试验组和对照组。试验组98例，口服七子填精口服液20ml／次，tid。对照组62例，口服五子衍宗口服液，10m1／次，bid，疗程3个月，以精子质量、中医证候评分为主要疗效评价指标，以血尿常规、生化、心电图为主要安全性评价指标。结果治疗3个月后，两组的精子浓度、精子总数、前向运动精子百分率、前向运动精子总数、精子总活力、正常形态精子百分率均较治疗前有显著提高（P〈0．05），而治疗后的试验组前向运动精子百分率及数量高于对照组（P〈0．05）。试验组总有效率为81．4％，高于对照组的66．7％，P〈0．05。两组的中医证候积分均明显降低，有效率分别为85．6％、82．1％，P〉0．05。治疗后，未出现与药物有关的不良反应，未出现有临床意义的指标变化。结论七子填精口服液与五子衍宗口服液均能显著提高男性不育患者的精子质量，改善肾虚症状，且能长期安全使用。而七子填精口服液增加前向运动精子的效果更佳，值得在临床上推广。Objective To evaluate the efficacy and safety of Qizi Tianjing oral liquid in the treatment of male infertility. Methods A multi-central,randomized,controlled trial was carried out. A total of 160 patients diagnosed as male infertility with the type of deficiency of kidney were divided randomly into two groups. Patients in the trial group were treated with Qizi Tianjing oral liquid for 3 months（20ml,three times daily）, and patients in the control group treated with Wuzi Yanzong oral liquid for 3 months（10ml,twice a day）.The efficacy was evaluated by semen quality and the syndrome index of Chinese medicine. The safety was evaluated by blood and urine routine index, biochemical index, and electrocardiogram. Results After 3 months, treatment, the semen density, sperm amount, rate and sum of progressive motility of sperm, motility and morphology of sperm of patients in both groups were all improved significantly, while the proportion of progressive motility sperm of the trial group was higher obviously than that of the control group. The total effective rate was 81.44% in the trial group, higher than that of control group（66.7%）. The syndrome scores of Chinese medicine of both groups were all deceased, the total effective rates were similar, 85.6% VS 82.1%. No adverse events related to medicine were found. Conelusion Qizi Tianjing oral liquid and Wuzi Yanzong oral liquid all improved the semen quality and allievated syndromes of male infertility with the type of deficiency of kidney, but Qizi Tianjing oral liquid was betterin increasing progressive motility of sperm.

关 键 词：不育 男性 七子填精口服液 

分 类 号：R698.2[医药卫生—泌尿科学]