生殖医学杂志

目的 评价金龟毓麟方治疗特发性弱精子症(肾虚肝郁型)的有效性与安全性。方法 收集2019年12月至2020年12月就诊于中国中医科学院西苑医院男科门诊的特发性弱精子症(肾虚肝郁型)患者为研究对象，共纳入患者124例。采用随机、对照试验，按1∶1随机分为研究组(62例)和对照组(62例),研究组给予金龟毓麟方治疗，对照组给予左卡尼汀口服液治疗，两组均用药12周，随访4周。主要疗效指标包括前向运动精子(PR)、精子总活力[PR+非前向运动精子(NP)];次要疗效指标包括中医证候评分、精子浓度、精液量、配偶受孕率；安全性指标包括血常规、尿常规、肝肾功能、心电图。结果 本研究共入组患者124例，脱落11例(研究组脱落4例，对照组脱落7例),研究组58例和对照组55例纳入最终分析。(1)组内比较，对照组治疗8周、12周后PR及PR+NP精子比例显著提高(P<0.05);研究组在治疗4周、8周、12周后PR及PR+NP精子比例显著提高(P<0.05)。(2)组间比较，研究组治疗8周、12周后，在提高PR及PR+NP精子比例方面均显著优于对照组(P<0.05);研究组治疗4周、8周、12周后在降低中医证候评分方面均显著优于对照组(P<0.05)。在治疗4周、8周、12周后两组间精子浓度、精液量、配偶受孕率比较均无统计学差异(P>0.05)。结论 金龟毓麟方在提高特发性弱精子症PR和PR+NP精子比例及降低中医证候评分方面均优于左卡尼汀口服液，且未见明显不良反应，表明金龟毓麟方在治疗肾虚肝郁型特发性弱精子症方面安全有效。

Objective:To evaluate the efficacy and safety of Jingui Yulin prescription in treatment of idiopathic asthenospermia(kidney deficiency and liver depression type).Methods:A total of 124 patients with idiopathic asthenospermia who visited the andrology department of Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine from December 2019 to December 2020 were collected as the research objects. They were randomly divided into study group and control group according to the ratio of 1∶1,62 patients for each group. The patients in study group were treated with Jingui Yulin formula and the patients in control group were treated with levocarnitine oral liquid. The patients in the two groups were treated for 12 weeks and followed up for 4 weeks. The main efficacy indicators included forward motile sperm(PR),total sperm motility(PR+NP). The secondary efficacy indicators included Traditional Chinese Medicine(TCM) syndrome score, sperm concentration, semen volume, and pregnancy rate. Safety indicators included blood routine, urine routine, liver and kidney function and electrocardiogram.Results:A total of 124 patients were enrolled in this study, and 11 patients were withdrawn, including 4 patients in the study group and 7 patients in the control group. Fifty-eight patients in the study group and 55 patients in the control group were included in the final analysis.(1) Intra-group comparison: the PR and PR+NP of the control group significantly increased after 8 and 12 weeks of treatment(P<0.05). The treatment of study group significantly improved PR and PR+NP after 4,8 and 12 weeks of treatment(P<0.05).(2)Inter-group comparison: the study group was superior to the control group in improving PR and PR+NP after 8 and 12 weeks of treatment(P<0.05). The study group was superior to the control group in reducing TCM syndrome scores after 4,8 and 12 weeks of treatment(P<0.05). There were no significant differences in sperm concentration, semen volume and pregnancy rate between the two groups after 4,8 and 12 weeks of treatment(P>0.05).Conclusions:Jingui Yulin prescription is superior to levocarnitine oral liquid in improving the PR and PR+NP of idiopathic asthenospermia and reducing the TCM syndrome score, and there is no obvious adverse reaction, indicating that Jingui Yulin prescription is safe and effective in treating idiopathic asthenospermia of kidney deficiency and liver depression type.