| 陈文康;陈亚洲;陈志威;邹和德;宋春生;王福;赵家有.通脉方治疗肝郁脾虚型精索静脉曲张致少弱精子症随机对照研究[J].中国中西医结合杂志,2023,43(12):1448-1453 |
| 通脉方治疗肝郁脾虚型精索静脉曲张致少弱精子症随机对照研究 |
| Randomized Controlled Trial of Tongmai Formula in Treating Varicocele-Induced Oligoasthenospermia Patients with Gan Depression and Pi Deficiency Syndrome |
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| DOI：10.7661/j.cjim.20230918.250 |
| 中文关键词: 通脉方 精索静脉曲张 少弱精子症 肝郁脾虚证 中药复方 随机对照试验 |
| 英文关键词:Tongmai Formula varicocele oligoasthenozoospermia Gan depression and Pi deficiency Chinese herbal compound randomized controlled trial |
| 基金项目:北京市中医药科技发展资金项目（No.JJ-2020-81）;中国中医科学院科技创新工程-重大攻关项目（No.CI2021A02207）;国家自然科学基金项目（No.82274337）;首都卫生发展科研专项（No.首发 2022-2-4271） |
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| 中文摘要: |
| 目的 评价通脉方治疗精索静脉曲张致少弱精子症（肝郁脾虚型）的安全性和有效性。方法 采用随机、对照的临床试验方法，选取2020年12月—2021年11月期间中国中医科学院西苑医院男科门诊就诊的精索静脉曲张致少弱精子症（肝郁脾虚型）患者94例，随机分为试验组（47例）和对照组（47例）。试验组给予通脉方颗粒，对照组给予迈之灵片，治疗12周，随访4周。以精子浓度、前向运动精子（PR）、前向运动精子+非前向运动精子（PR+NP）作为主要疗效指标；以中医证候评分、精索静脉最大内径、配偶受孕情况作为次要疗效指标；以血、尿常规，肝、肾功能，心电图作为安全性指标。结果 试验组完成44例，对照组完成43例。与本组治疗前比较，试验组治疗12周精子浓度，治疗4、8、12周PR，治疗8、12周PR+NP升高，治疗8、12周及随访中医证候评分降低（P＜0.01，P＜0.05）；对照组治疗12周PR、PR+NP升高（P＜0.05）。与对照组同期比较，试验组治疗12周精子浓度，治疗8、12周PR、PR+NP升高，治疗8、12周及随访中医证候评分降低（P＜0.01）。两组受试者双侧精索静脉最大内径、配偶受孕率及安全性指标比较，差异均无统计学意义（P>0.05）。结论 通脉方能改善精索静脉曲张致少弱精子症（肝郁脾虚型）患者精液质量及中医证候评分。 |
| 英文摘要: |
| Objective To evaluate the safety and efficacy of Tongmai Formula in treating varicocele-induced oligoasthenozoospermia（Gan depression and Pi deficiency）. Methods A randomized，controlled clinical trial was conducted. Totally 94 varicocele-induced oligoasthenozoospermia（Gan depression and Pi deficiency） patients who visited department of andrology，Xiyuan Hospital of China Academy of Chinese Medical Sciences，from Dec，2020 to Nov，2021 were included. The patients were randomly assigned to the experimental group （47 cases） and the control group （47 cases）. The experimental group received Tongmai Formula granules，while the control group received MaiZhiling tablets，the treatment course was 12 weeks，and follow-up time was 4 weeks. The primary efficacy indicators included sperm concentration，progressive sperm（PR），and progressive sperm combined with non-progressive sperm（PR+NP）. The secondary efficacy indicators included Chinese medicine （CM） syndrome score，maximum inner diameter of the varicocele，and partner pregnancy rates. Safety indicators comprised blood and urine routine，liver and renal function，and electrocardiogram. Results Totally 44 cases in the experimental group and 43 cases in the control group completed the study. Compared with baseline，the sperm concentration at 12th week of treatment，PR at 4th，8th，and 12th week， PR+NP at 8th and 12th week increased，CM symptom scores at 8th，12th week and follow-up decreased in the experimental group（P＜0.01，P＜0.05）. PR and PR+NP at 12th week increased in the control group（P＜0.05）. Compared with control group at the same time，sperm concentration at 12th week，PR and PR+NP at 8th and 12th week increased，CM symptom scores at 8th，12th week and follow-up time decreased in the experimental group（P＜0.01）.There were no statistical significance in the maximum diameter of the bilateral spermatic veins，partner pregnancy rates and safety indicators between the 2 groups（P>0.05）. Conclusion Tongmai Formula can improve semen quality and CM syndrome score in varicocele-induced oligoasthenozoospermia（Gan depression and Pi deficiency） patients. |
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