3种不同中医治则治疗少弱精子症患者的随机对照观察

目的评价3种不同中医治则治疗男性不育症（少弱精子症）患者的疗效及安全性。方法 128例男性不育症患者中医辨证分别为肾精亏虚证、脾肾两虚证、肾虚血瘀证。按分层随机以3∶1比例分为中药组（96例）与西药对照组（32例），中药组分别采用补益肾气、补肾健脾、补肾活血等中药治疗；西药对照组采用克罗米芬（25 mg/次，每天1次）治疗，两组连续服药3个月为1个疗程，共观察1个疗程。观察精液参数、怀孕率及不良反应等指标。结果 2组共脱落24例，其中中药组脱落17例（肾虚血瘀证9例，脾肾两虚证5例，肾精亏虚证3例），西药对照组脱落7例；与治疗前比较，2组治疗3个月时，精液量改善差异无统计学意义（P>0.05）；而精液密度、A级精子、A+B级精子、1 h活动率改善差异有统计学意义（P<0.05）；其中肾虚血瘀证改善最明显，脾肾两虚证、肾精亏虚证次之，西药对照组改善最弱。治疗3个月组间比较，2组改善精液量、精液密度、A级精子、1 h活动率差异均无统计学意义（P>0.05）；而在改善A+B级精子方面，肾虚血瘀证提高明显，与其他两证及西药对照组比较，差异均有统计学意义（P<0.05，P<0.01）。治疗期间2组均未出现明显的不良反应。结论补肾活血法在提高男性不育症（少弱精子症）精子密度，改善精子的活动方面优于补肾健脾及补益肾气法。

英文摘要:

Objective To assess the efficacy and safety of three different Chinese medical principles in treating patients with male infertility （oligospermia/asthenozoospermia）. Methods Totally 128 patients with male infertility were classified into 3 groups， i.e.， Shen essence deficiency syndrome， Pi Shen deficiency syndrome， Shen deficiency blood stasis syndrome. They were assigned to the Chinese medical treatment group （96 cases） and the Western medical treatment group （32 cases） by stratified randomization in the ratio of 3∶1. Those in the Chinese medical treatment group were treated with Chinese drugs for Shen invigorating and blood activating， Shen invigorating and Pi supplementing， Shen qi benefiting. Those in the Western medical treatment group were treated with Clomifene （at the daily dose of 25 mg per day， once daily）. Three months consisted of one therapeutic course. The parameters of semen， the pregnancy rate， and adverse reactions were observed. Results Totally 24 patients dropped out in the two group， 17 in the Chinese medical treatment group （9 patients of Shen deficiency blood stasis syndrome， 5 of Shen Pi deficiency syndrome， and 3 of Shen essence deficiency syndrome） and 7 in the Western medical treatment group. Compared with before treatment， there was no statistical difference in the improvement of semen amount at 3 months after treatment between the two groups （P>0.05）. There was statistical difference in the improvement of semen density， class A semen， class A+B semen， and 1 h activity ratio （P<0.05）. The improvement was most obvious in Shen deficiency blood stasis syndrome， followed by Shen Pi deficiency syndrome and Shen essence deficiency syndrome. The improvement was the weakest in the Western medical treatment group. There was no statistical difference in the improvement of semen amount， semen density， class A semen， or 1h activity ratio at 3 months after treatment between the two groups （P>0.05）. Best effect was obtained in improving class A+B semen quality in patients of Shen deficiency blood stasis syndrome， showing statistical difference when compared with the other two syndrome types and the Western medical treatment group （P<0.05，P<0.01）. No obvious adverse reaction occurred in the two groups during the treatment course. Conclusion Shen invigorating and blood activating method could improve the semen density and semen activities， and it was superior to other therapeutic methods.

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