复方玄驹胶囊治疗少弱精子症患者的多中心临床研究

Multi-centered Clinical Trial of Fufang Xuanju Capsule for Oligoasthenospermia

目的:观察复方玄驹胶囊治疗少弱精子症患者的疗效。方法:采用多中心、开放性、自身前后对照的临床研究方法,对120例少弱精子症患者采用口服复方玄驹胶囊(3粒,3次/d)治疗12周。以精子密度和(a+b)级精子为主要疗效指标,以a级精子、精子活动率及精液量为次要疗效指标,评价复方玄驹胶囊治疗效果。结果:有107例患者完成了临床研究,与治疗前相比,除精液量仅在治疗12周后明显增加(P<0.01)外,精子密度、a级精子和(a+b)级精子及精子活动率等精液参数在治疗4、8和12周后具有显著改善(P均<0.01)。此外,与治疗4周后相比,精子密度、a级精子和(a+b)级精子及精子活动率等精液参数在治疗8周和12周后也有显著改善(P<0.05或0.01);同样,与治疗8周后相比,精液参数在治疗12周后也有显著改善(P均<0.01)。治疗12周后,精子密度增加了63.28%,达到正常标准的病例数为73例(68.22%);(a+b)级精子提高了63.17%,达到正常标准的病例数为39例(36.45%);a级精子提高了78.56%,达到正常标准的病例数为34例(31.78%);精子活动率提高了44.36%,达到正常标准的病例人数为77例(71.96%);精液量增加了18.13%。结论:复方玄驹胶囊可明显提高少弱精子症患者精液质量,未见明显不良反应。

Objective ： To observe the efficacy of Fufang Xuanju Capsule in the treatment of oligoasthenospermia. Methods ： Using a multi-centered, open and self-controlled clinical triM, we treated 120 patients with oligoasthenospermia, with Fufang Xuanju Capsule for 12 weeks, and evaluated the efficacy of the capsule with sperm concentration and vitality （a ＋ b） as the primary and the number of grade a sperm, sperm motility （a ＋ b ＋ c） and semen volume as the secondary therapeutic indexes. Results： A total of 107 patients accomplished the clinical trial. Compared with pre-treatment, sperm density, vitality and motility were significantly improved after 4, 8 and 12 weeks of Fufang Xuanju treatment （P 〈 0.01 ）. At 12 weeks, sperm concentration was increased by 63.28% , with 73 cases （68.22%） restored to normal, sperm vitality by 63. 17%, with 39 （36.45%） restored to normal, sperm motility by 44.36%, with 77 （71.96%） restored to normal, and the semen volume by 18.13%. Conclusion ： Fufang Xuanju Capsule can evidently improve the seminal quality of oligoasthenospermia patients.