Objective: To evaluate the clinical efficacy and safety of Qilin Pills in the treatment of oligoasthenospermia in infertile men.
Methods: This multi-centered randomized double-blind controlled clinical trial included 216 infertile males with oligoasthenospermia, 108 in the trial group and the other 108 in the control, the former treated with Qilin Pills at the dose of 6 g tid while the latter with Wuziyanzong Pills at 6 g bid, both for 12 weeks. We examined the total sperm count, sperm motility and the count of progressively motile sperm of the patients before and at 4, 8 and 12 weeks after medication and evaluated the safety of the drug based on the adverse events and the laboratory results of blood and urine routine examinations and liver and kidney function tests.
Results: Compared with the baseline, the patients in the trial group showed a significant time-dependent improvement after 4, 8 and 12 weeks of medication in sperm motility (21.75% vs 27.54%, 29.04% and 32.95%, P <0.05), total sperm count (156.27 ×106 vs 177.33, 188.18 and 205.44 ×106, P <0.05), and the count of progressively motile sperm (32.08 ×10⁶/ml vs 46.33, 50.98 and 61.10 ×10⁶/ml, P <0.05). The three parameters above were also improved in the controls, but more significantly in the trial group (P <0.05).
Conclusions: Qilin Pills can evidently improve the semen quality of oligoasthenospermia patients with no obvious adverse events.
目的： 评价麒麟丸治疗男性不育患者中特发性少弱精子症的疗效和临床应用的安全性。方法： 以五子衍宗丸为阳性对照药物，进行多中心、随机双盲对照临床研究，共216例男性不育患者入选临床试验，实验组和对照组各108例。试验组患者口服麒麟丸,每次 6 g ,3次/d ,对照组患者口服五子衍宗丸 ,每次 6 g ,2次/d,两组以12周为1个疗程，治疗结束后以精子活力、精子总数和前向运动精子数量为主要疗效指标, 评价麒麟丸治疗效果；通过试验过程中不良事件的随访及检测治疗前后患者血、尿常规及肝肾功能指标评估其安全性。结果： 实验组在治疗前、用药后4周、8周和12周的精子活力平均值分别为21.75%、27.54%、29.04％和32.95%，在治疗前、用药后4、8和12周的精子总数平均值分别为156.27×106、177.33×106、188.18×106和205.44×106，其中前向运动的精子数量平均值分别为32.08×10⁶/ml、46.33×10⁶/ml、50.98×10⁶/ml和61.1×10⁶/ml。 经过12周的治疗后，与治疗前相比，两组患者的精子活力、精子总数及前向运动精子数量在治疗 4、8 和 12 周后具有显著改善(P<0.01)，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,试验组在精液各参数均有显著改善(P<0.01)。结论： 麒麟丸较五子衍宗丸能明显提高少弱精子症患者的精液质量，具有较好的疗效和临床安全性。.
Keywords: Qilin Pills; clinical efficacy; oligoasthenospermia; safety.