Yang Chang-Hai, Sun Zhong-Yi, Wang Bo, Wang Shun-de, Guo Jun, Wang Fu
Department of Urology, General Hospital of Tianjin Medical University, Tianjin 300050, China.
Department of Urology, Daping Hospital, Army Military Medical University, Chongqing 400020, China.
Zhonghua Nan Ke Xue. 2018 Jul;24(7):635-639.
To investigate the clinical efficacy and safety of Huanshao Capsules (HSC) in the treatment of oligoasthenospermia with spleen and kidney asthenia.
This randomized, open, multicentered, positive drug controlled clinical trial included 200 cases of oligoasthenospermia with spleen and kidney asthenia, which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid, respectively, both for 12 weeks. We compared the semen volume, sperm concentration, sperm count, sperm motility and percentage of progressively motile sperm (PMS) as the main therapeutic indicators as well as the pregnancy rate as the secondary therapeutic indicator between the two groups of patients before and at 4, 8 and 12 weeks after medication.
Totally, 190 of the patients completed the clinical observation, 96 in the trial and 94 in the control group. Compared with the baseline, the patients of the trial group showed significant time-dependent increases at 4, 8 and 12 weeks after medication in the mean sperm concentration (14.78 vs 15.33, 20.98 and 28.78 ×10⁶/ml, P < 0.05), percentage of grade a sperm (12.17% vs 15.05%, 21.17% and 26.97%, P < 0.05), PMS (24.78% vs 28.97%, 37.23% and 47.67%, P < 0.05), and sperm viability (38.64% vs 44.18%, 51.67% and 60.45%, P < 0.05). The pregnancy rate was significantly higher in the trial than in the control group 29.17% vs 18.09%, P < 0.05).
Huanshao Capsules can improve the semen quality and pregnancy rate in the treatment of oligoasthenospermia patients with spleen and kidney asthenia, and therefore deserves a wide clinical application.
探讨还少胶囊（HSC）治疗脾肾两虚型少弱精子症的临床疗效及安全性。
本随机、开放、多中心、阳性药物对照临床试验纳入200例脾肾两虚型少弱精子症患者，将其分为试验组和对照组，每组各100例。试验组患者服用还少胶囊，每次3粒，每日3次；对照组患者服用五子衍宗丸，每次6 g，每日2次。两组均治疗12周。比较两组患者用药前及用药后4、8、12周的精液量、精子浓度、精子总数、精子活力及前向运动精子百分比（PMS）等主要疗效指标，以及妊娠率等次要疗效指标。
共有190例患者完成临床观察，其中试验组96例，对照组94例。与基线相比，试验组患者用药后4、8、12周的平均精子浓度（分别为14.78 vs 15.33、20.98和28.78×10⁶/ml，P<0.05）、a级精子百分比（分别为12.17% vs 15.05%、21.17%和26.97%，P<0.05）、PMS（分别为24.78% vs 28.97%、37.23%和47.67%，P<0.05）及精子活率（分别为38.64% vs 44.18%、51.67%和60.45%，P<0.05）均呈时间依赖性显著升高。试验组妊娠率显著高于对照组（29.17% vs 18.09%，P<0.05）。
还少胶囊可提高脾肾两虚型少弱精子症患者的精液质量及妊娠率，值得临床广泛应用。
