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目的 观察尿促卵泡素(uFSH,产品名丽申宝)治疗严重少弱精子症患者的有效性和安全性.方法 采用多中心、开放性、自身前后对照的临床研究方法,对43例严重少弱精子症患者采用丽申宝肌肉注射治疗,每3天1次注射75单位,连续治疗24周.比较治疗前及治疗后8、16、24周后患者精子浓度、前向运动精子比例等精液参数和生殖激素的变化情况,同时观察配偶妊娠情况,以评价丽申宝的治疗效果.结果 精子浓度在用药8、16、24周后分别增加了334%、258%和460%,在用药24周后精子浓度上升到(7.79 ± 8.44)×106/mL, [治疗前(1.39±1.58)×106/mL],与治疗前比较,差异具统计学意义(P<0.05);前向运动精子比例在用药8、16、24后也呈明显上升趋势(分别增加了71%、135%和143%),在用药24周后前向运动精子比例达到(18.77±17.16)%[治疗前(7.74±11.41)%],与治疗前比较,差异具统计学意义(P<0.05);精子活力和总数、血清促卵泡素(FSH)水平在治疗后也显著提高,差异均具统计学意义(P<0.05).但患者的精液量和黄体生成素(LH)、睾酮(T)等生殖激素水平在治疗前后无明显差异.1例严重少精子症患者在用药期间发生临床妊娠.结论 丽申宝可显著提高严重少弱精子症患者的精液质量,未见明显不良反应.“,”Objective To observe the efficacy and safety of LiShenBao (uFSH) in the treatment of severe oligoasthenospermia. Methods Using a multi-centered, open and self-controlled clinical trial, we treated 43 patients with severe oligoasthenospermia with LiShenBao 75 IU/3d, i.m, for 24 weeks, and evaluated the the semen parameters including sperm concentration and the percentage of progressive motile sperm, reproductive hormone, adverse reaction and pregnancy condition of their spouse at 8, 16 and 24 weeks. Results Compared with baseline, the sperm concentration was increased by 334%, 258% and 460% respectively at 8, 16 and 24 weeks, elevating from the baseline of (1.39±1.58)×106/mL to(7.79±8.44)×106/mL at 24 weeks. The percentage of progressive motile sperm was significantly improved (increased by 71%, 135% and 143% respectively at 8, 16 and 24 weeks). There was also an increase in terms of sperm motility and total number, and serum FSH, while no significant changes were observed in sperm volume, LH and T. One patient with severe oligoasthenospermia has pregnancy during the treatment. Conclusion LiShenBao can evidently improve the seminal quality of oligoasthenospermic patients with no obvious adverse events.