中国中西医结合杂志2023，Vol.43Issue(12)：1448-1453,6.DOI:10.7661/j.cjim.20230918.250
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
摘要
Abstract
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.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Key words
Tongmai Formula/varicocele/oligoasthenozoospermia/Gan depression and Pi deficiency/Chinese herbal compound/randomized controlled trial引用本文复制引用
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):1448-1453,6.基金项目
北京市中医药科技发展资金项目(No.JJ-2020-81) （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) （No.CI2021A02207）
国家自然科学基金项目(No.82274337) （No.82274337）
首都卫生发展科研专项(No.首发2022-2-4271) （No.首发2022-2-4271）
