中西药联合治疗特发性少弱畸精子症的有效性和安全性

Study on the Efficacy and Safety of Chinese and Western Medicine in the Treatment of Idiopathic Oligoasthenospermia

目的:探讨复方玄驹胶囊联合左卡尼汀口服液治疗特发性少弱畸精子症的疗效与安全性。方法:本研究共纳入2017年10月1日至2018年9月30日佛山市妇幼保健院收治的诊断为特发性少弱畸精子症患者154例,并随机分为观察组与对照组各77例,观察组口服左卡尼汀口服液10 mL·次^-1,2次·d^-1,及复方玄驹胶囊3.78 g·次^-1,3次·d^-1,对照组服用安慰剂维生素B1为10 mg·次^-1,3次·d^-1。两组患者均规律治疗3个月。比较治疗前后观察组和对照组精液常规参数的变化以及自然妊娠结局,同时观察有无不良反应的发生。结果:治疗3个月后观察组精液质量指标包括精子浓度、前向运动精子百分率(PR)、正常精子形态率均显著高于治疗前,差异具有统计学意义(P <0.05),并且高于对照组治疗后,差异具有统计学意义(P <0.01);观察组服药期间女性配偶临床妊娠率高于对照组,组间比较,差异具有统计学意义(P <0.05)。两组患者服药后均无头痛、呕吐、过敏等严重不良反应发生。结论:复方玄驹胶囊结合左卡尼汀口服液治疗特发性少弱畸精子症疗效好,安全性高,可显著提高精子浓度、前向运动精子百分率及正常形态精子的比例,并提高患者女性配偶的自然妊娠率。

Objective To investigate the efficacy and safety of compound xuanju capsule combined with leocarnitine oral liquid in the treatment of idiopathic oligoasthenospermia. Methods A total of 154 male infertility patients with idiopathic oligoasthenospermia were included in this study, and were randomly divided into the treatment group and the control group, with 77 cases in each group. The treatment group received 10 ml of levocarnitine oral solution, twice a day, and three capsules of compound xuanju, three times a day. The control group received 10 mg of placebo vitamin B1, three times a day. Both groups were treated regularly for 3 months. The changes of semen routine parameters before and after treatment and the natural pregnancy outcome were compared between the treatment group and the control group. The adverse reactions were observed. Results After 3 months of treatment, the semen quality indicators including sperm concentration, forward motor sperm percentage(PR),and normal sperm morphology rate were significantly higher than those in the control group(P<0.05) and before the observation group, the difference was statistically significant(P < 0.01). The clinical pregnancy rate of female spouses in the observation group was higher than that in the control group, and the difference was statistically significant(P < 0.05). There were no serious adverse reactions such as headache, vomiting and allergies in the two groups after taking the drug. Conclusion Compound xuanju capsule combined with levocarnitine oral liquid has good efficacy and high safety in the treatment of idiopathic oligoasthenospermia, which can significantly improve the sperm concentration, percentage of forward motile sperm and proportion of normal sperm, and improve the natural pregnancy rate of the female spouse of the patient.