还少胶囊治疗少弱精子症的多中心临床观察

Huanshao Capsules for oligoasthenospermia: A multicentered clinical trial

目的:观察还少胶囊治疗少弱精子症(脾肾虚损证)患者的安全性和有效性。方法:采用随机、开放、多中心、阳性药物对照的临床研究方法,选取200例少弱精子症患者,治疗组和对照组各100例。治疗组患者口服还少胶囊,3粒/次(1粒=0.38 g),每日3次,对照组患者口服五子衍宗丸,6 g/次,每日2次,两组均治疗12周。治疗第4、8、12周记录精液量、精子浓度、a级精子百分率、a+b级精子百分率以及精子存活率,配偶妊娠率,中医症状评分。结果:治疗组96例,对照组94例完成了临床观察。治疗组在治疗前、用药后4周、8周和12周,精子浓度平均值分别为14.78×106/ml、15.33×106/ml、20.98×106/ml、28.78×106/ml,a级精子百分率平均值分别为12.17%、15.05%、21.17%、26.97%,a+b级精子百分率平均值分别为24.78%、28.97%、37.23%、47.67%,精子存活率平均值分别为38.64%、44.18%、51.67%、60.45%。经过8周的治疗后,与治疗前比较,两组患者的精子活率、精子浓度及a级及a+b级精子百分率具有显著改善(P<0.05),且随着治疗时间的延长,改善效果更明显;与对照组相同的时段相比,治疗组精液各参数均有显著改善(P<0.05)。对照组患者配偶妊娠率为18.09%,治疗组患者配偶妊娠率为29.17%,治疗组的患者配偶妊娠率高于对照组,差异有统计学意义(P<0.05)。两组患者治疗12周后中医症状评分均有明显下降(P<0.05),且治疗组下降更为明显(P<0.05)。结论:还少胶囊能明显提高少弱精子症患者的精液质量,提高受孕率,安全有效,值得临床推广。

Objective： To investigate the clinical efficacy and safety of Huanshao Capsules（ HSC） in the treatment of oligoasthenospermia with spleen and kidney asthenia. Methods： This randomized,open,multicentered,positive drug controlled clinical trial included 200 cases of oligoasthenospermia with spleen and kidney asthenia,which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid,respectively,both for 12 weeks.We compared the semen volume,sperm concentration,sperm count,sperm motility and percentage of progressively motile sperm（ PMS） as the main therapeutic indicators as well as the pregnancy rate as the secondary therapeutic indicator between the two groups of patients before and at 4,8 and 12 weeks after medication. Results： Totally,190 of the patients completed the clinical observation,96 in the trial and 94 in the control group. Compared with the baseline,the patients of the trial group showed significant timedependent increases at 4,8 and 12 weeks after medication in the mean sperm concentration（ 14. 78 vs 15. 33,20. 98 and 28. 78 ×10^6ml,P〈0. 05）,percentage of grade a sperm（ 12. 17% vs 15. 05%,21. 17% and 26. 97%,P〈0. 05）,PMS（ 24. 78% vs28. 97%,37. 23% and 47. 67%,P〈0. 05）,and sperm viability（ 38. 64% vs 44. 18%,51. 67% and 60. 45%,P〈0. 05）. The pregnancy rate was significantly higher in the trial than in the control group 29. 17% vs 18. 09%,P〈0. 05）. Conclusion： Huanshao Capsules can improve the semen quality and pregnancy rate in the treatment of oligoasthenospermia patients with spleen and kidney asthenia,and therefore deserves a wide clinical application.