摘要
目的:观察灵归方治疗肾虚血瘀型弱精子症的有效性与安全性。方法:本研究采用随机对照的研究方法,选取2022年9月至2023年9月于中国中医科学院西苑医院男科就诊的肾虚血瘀型弱精子症患者90例,随机数字表法将其1∶1随机分为试验组(45例)和对照组(45例)。试验组接受灵归方治疗,对照组接受左卡尼汀口服溶液治疗,疗程均为12周,随访12周。观察两组患者治疗前后的精液参数、中医证候评分、生殖激素、妊娠率与精子DNA碎片指数变化。结果: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,患者前向运动精子百分率[(19.25±3.08)%vs(38.57±4.99)%]、精子总活力[(32.29±3.64)%vs(46.50±4.77)%]、精子浓度[(83.9±37.2)×10^(6)/mlvs(95.1±34.9)×10^(6)/ml]均存在明显提升,差异具有统计学意义(P<0.05);精液量[(3.38±0.38)mlvs(3.24±0.45)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,患者前向运动精子百分率[(19.75±4.28)%vs(34.46±5.07)%]、精子总活力[(33.02±4.93)%vs(43.11±4.72)%]、精子浓度[(85.2±39.7)×10^(6)/mlvs(88.1±35.2)×10^(6)/ml]均存在明显提升,差异具有统计学意义(P<0.05);精液量[(3.46±0.52)mlvs(3.30±0.37)ml],差异不具有统计学意义(P>0.05)。治疗后试验组前向运动精子百分率、精子总活力、精子浓度的改善均优于对照组(P<0.05);试验组精液量与对照组相比差异不具有统计学意义(P>0.05)。妊娠率、生殖激素与精子DNA碎片指数方面,两组间治疗前后及各组治疗前后均未见统计学差异(P>0.05)。两组患者都未见严重不良反应。结论:灵归方可改善肾虚血瘀型弱精子症患者的精子前向运动百分率,对改善患者妊娠率具有潜在作用,安全性良好。
Objective:To observe the effect and safety of the traditional Chinese medicine(TCM)Linggui Formula(LGF)in the treatment of asthenospermia with kidney deficiency and blood stasis.Methods:This randomized controlled trial included 90 cases of asthenospermia with kidney deficiency and blood stasis treated in our hospital from September 2022 to September 2023,45 by oral medication with LGF(the trial group)and the other 45 with oral levocarnitine solution(the control group),all for 12 weeks.We followed up the patients for 12 weeks,recorded the semen parameters,TCM syndrome scores,sexual hormone levels,pregnancy rates,and DNA fragmentation index(DFI)of the patients,and compared them between the two groups before and after treatment.Results:Totally,82 of the patients completed the study,42 in the trial and 40 in the control group.After treatment,the patients in the trial group showed significant increases in the percentage of progressively motile sperm(PMS)(from[19.25±3.08]%to[38.57±4.99]%,P<0.05),total sperm motility(from[32.29±3.64]%to[46.50±4.77]%,P<0.05)and sperm concentration(from[83.9±37.2]to[95.1±34.9]×10^(6)/ml],P<0.05),and so did the controls in PMS(from[19.75±4.28]%to[34.46±5.07]%,P<0.05),total sperm motility(from[33.02±4.93]%to[43.11±4.72]%,P<0.05)and sperm concentration(from[85.2±39.7]to[88.1±35.2]×10^(6)/ml,P<0.05),all even more significant in the trial than in the control group(P<0.05).No statistically significant difference was observed in the semen volume either in the trial(from[3.38±0.38]to[3.24±0.45]ml,P>0.05)or in the control group(from[3.46±0.52]to[3.30±0.37]ml,P>0.05),or between the trial and control groups(P>0.05),or in the sexual hormone levels,pregnancy rates,and sperm DFI between the two groups before and after treatment(P>0.05).Both groups of patients had good safety profiles without serious adverse reactions.Conclusion:Linggui Formula can improve the percentage of PMS in asthenospermia patients with kidney deficiency and blood stasis,potentially enhancing pregnancy rates and
作者
郭俊
晏斌
安晓静
刘胜京
赵明
王福
郭军
GUO Jun;YAN Bin;AN Xiao-jing;LIU Sheng-jing;ZHAO Ming;WANG Fu;GUO Jun(Department of Andrology,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing,100091,China)
出处
《中华男科学杂志》
CAS
CSCD
2024年第6期525-530,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)
国家自然科学基金青年基金项目(82104674)
国家自然科学基金面上项目(82174392)。
关键词
弱精子症
男性不育症
灵归方
肾虚血瘀证
疗效观察
asthenospermia
male infertility
Linggui Formula
kidney deficiency and blood stasis syndrome