地柏益精方治疗男性不育症(肾精亏虚,精室湿热型)的随机平行阳性对照临床研究  

A randomized positive parallel-controlled clinical study of Dibai Yijing Formula for the treatment of male infertility with essence deficiency in the kidney and damp-heat type in the essence chamber

作　　者：吴霜 陈超乾 李云智 冯秋涧 吕珲 安晓静 郭军[3] WU Shuang;CHEN Chao-qian;LI Yun-zhi;FENG Qiu-jian;L Hui;AN Xiao-jing;GUO Jun(Graduate School of Beijing University of Chinese Medicine,Beijing 100029,China;Department of Andrology,Ningxia Traditional Chinese Medicine Hospital and Research Institute of Traditional Chinese Medicine,Yinchuan 750021,China;Department of Andrology,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing,100091,China)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]宁夏回族自治区中医医院暨中医研究院男科,宁夏银川750021 [3]中国中医科学院西苑医院男科,北京100091

出　　处：《中华男科学杂志》2024年第11期1019-1024,共6页National Journal of Andrology

基　　金：国家中医药管理局高水平中医药重点学科建设项目(zyyzdxk-2023238)。

摘　　要：目的:评估地柏益精方治疗男性不育症(肾精亏虚,精室湿热型)的有效性和安全性。方法:采用随机、对照的临床研究设计,招募本型男性不育症患者72例。根据随机数字表法将患者分为试验组(36例)和对照组(36例)。对照组口服枸橼酸氯米芬胶囊(每日1次,每次50 mg);试验组口服地柏益精方(每日1剂,早晚饭后30 min口服,每次200 ml)。两组均接受为期12周的治疗。治疗结束后,比较两组患者治疗前后精子浓度、前向运动精子百分率、精子总活率以及精液量。同时,比较治疗前后中医证候总评分、精子DNA碎片指数(DFI)和配偶妊娠情况。结果:试验组脱落3例,对照组脱落4例。两组患者治疗前精液参数比较,无统计学差异(P>0.05),试验组治疗后与治疗前相比,患者精子浓度[(19.42±5.30)×10^(6)/ml vs(10.75±2.41)×10^(6)/ml]、前向运动精子百分率[(27.72±6.62)%vs(20.04±4.10)%]、精子总活率[(49.86±10.68)%vs(33.74±5.58)%]、DFI[(12.33±3.43)%vs(15.06±3.98)%]和中医证候评分[(7.45±1.82)分vs(13.85±1.91)分]均存在明显改善,差异具有统计学意义(P<0.05);精液量[(2.93±1.29)ml vs(3.04±1.31)ml]差异不具有统计学意义(P>0.05)。对照组治疗后与治疗前相比,患者精子浓度[(19.56±5.24)×10^(6)/mlvs(11.31±2.08)×10^(6)/ml]、中医证候评分[(12.81±1.86)分vs(14.06±1.64)分]存在明显差异(P<0.05),而前向运动精子百分率[(21.75±5.93)%vs(20.05±4.67)%]、精子总活率[(34.23±7.15)%vs(32.35±4.09)%]、精液量[(3.19±1.08)ml vs(3.12±1.13)ml]和DFI[(15.11±4.76)%vs(15.51±4.35)%]未见显着性差异(P>0.05)。与对照组相比,试验组治疗后前向运动精子百分率、精子总活率、中医症状评分和DFI的改善情况均优于对照组(P<0.05);试验组精子浓度和精液量和配偶妊娠情况与对照组相比差异不具有统计学意义(P>0.05)。两组患者在治疗期间均未发生严重不良事件。结论:地柏益精方治疗肾精亏虚、精室湿Objective:This study aims to evaluate the clinical efficacy and safety of Dibai Yijing Formula(DYF)in the treatment of male infertility with essence deficiency in the kidney and damp-heat in the essence chamber(Abbreviation:kidney deficiency and damp-heat type).Methods:This study employed a randomized,controlled clinical trial design,recruiting 72 male patients with infertility due to kidney deficiency and damp-heat type.Patients were randomly assigned to an treatment group(36 patients)and a control group(36 patients)using a random number table.The control group received oral Clomiphene Citrate Capsules(50 mg,twice daily),while the treatment group received oral DYF(one dose daily,200 ml each time,30 minutes after breakfast and dinner).Both groups underwent a 12-week treatment period.After treatment,sperm concentration(SC),percentage of progressively motile sperms(PR),total sperm motility[PR+percentage of non-progressively motile sperms(NP)],and semen volume(SV)were compared between the two groups before and after treatment.Additionally,the total score of Traditional Chinese Medicine(TCM)syndrome score and sperm DNA fragmentation index(DFI)and pregnancy outcomes of the patients'spouses were compared between the two groups.Results:Three patients dropped out from the treatment group and four from the control group.There were no statistically significant differences in semen parameters between the two groups(P>0.05).After treatment,the patients in the treatment group showed significant difference in the percentage of SC([19.42±5.30]×10^(6)/ml vs[10.75±2.41]×10^(6)/ml),PR([27.72±6.62]%vs[20.04±4.10]%),PR+NP([49.86±10.68]%vs(33.74±5.58)%),DFI([12.33±3.43]%vs[15.06±3.98]%)and TCM symtom score([7.45±1.82]vs[13.85±1.91]),and the difference was statistically significant(P<0.05).The patients in the control group showed significant difference in the percentage of SC([19.56±5.24]×10^(6)/ml vs[11.31±2.08]×10^(6)/ml)and TCM symptom score([12.81±1.86]vs[14.06±1.64]).But no significant changes were observed in t

关 键 词：男性不育症 中医药 地柏益精方 肾精亏虚 精室湿热 

分 类 号：R698.2[医药卫生—泌尿科学]