疏肝补肾毓麟汤联合维生素E软胶囊治疗肝郁肾虚型弱精子症不育症45例多中心随机对照试验

Treatment of Asthenospermia and Infertility with Liver Constraint and Kidney Deficiency in 45 Cases by Shugan Bushen Yulin Decoction(疏肝补肾毓麟汤)and Vitamin E Soft Capsules:A Multicenter Randomized Controlled Trial

目的观察疏肝补肾毓麟汤治疗肝郁肾虚型弱精子症不育症的临床疗效及安全性。方法采取多中心、随机、对照临床研究设计,在华中地区三所医院招募肝郁肾虚型弱精子症不育症患者95例,按照随机数字表法将患者分为治疗组47例和对照组48例。对照组给予维生素E软胶囊(每日2次,每次100 mg)口服,治疗组在对照组的基础上给予疏肝补肾毓麟汤(每日1剂,早晚饭后30 min,每次约200 ml)口服,两组治疗疗程均为12周。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(PR)、总精子活动率[PR+非前向运动精子百分率(NP)]并判断临床疗效,比较治疗前后中医证候评分(包括6个单项症状评分及中医证候总积分)及抑郁-焦虑-压力量化评分表(DASS-21)评分(包括抑郁、焦虑、压力评分)。随访6个月比较两组患者配偶妊娠情况。记录两组患者试验期间不良事件发生情况及生命体征判定安全性。结果治疗组脱落2例,对照组脱落3例,最终两组各45例进入统计分析。两组临床疗效比较,治疗组总有效率86.67%(39/45),对照组为73.74%(33/45),治疗组高于对照组(P<0.05)。两组治疗后PR、PR+NP均较本组治疗前升高,且治疗后治疗组PR、PR+NP高于对照组(P<0.05)。治疗后治疗组腰膝酸软,情志不畅,精冷滑泄,胸胁、少腹胀痛,善太息评分及中医证候总积分均较治疗前降低(P<0.05);治疗后治疗组腰膝酸软,情志不畅,胸胁、少腹胀痛,善太息评分及中医证候总积分均低于对照组(P<0.05)。治疗后治疗组DASS-21评分中抑郁、焦虑、压力评分均较治疗前降低,且治疗后治疗组抑郁评分较对照组降低(P<0.05)。经6个月的随访,治疗组5例和对照组3例患者配偶妊娠,两组比较差异无统计学意义(P>0.05)。治疗过程中两组患者均未发生不良事件,生命体征平稳。结论疏肝补肾毓麟汤可明显提高肝郁肾虚型弱精子症患者总精子活动率,有效改善临床症状及焦虑抑郁情绪,且安全性好。

Objective To observe the clinical efficacy and safety of Shugan Bushen Yulin Decoction(疏肝补肾毓麟汤,SBYD)in the treatment of asthenospermia and infertility with liver constraint and kidney deficiency.Methods A multicenter,randomized,controlled clinical study was conducted in three hospitals in central China.Totally 95patients with asthenospermia and infertility were controlled.According to random number table,the patients were divided into treatment group(47 cases)and control group(48 cases).The control group was given vitamin E soft capsules(100 mg per time,twice daily)orally,and the treatment group was given SBYD(one dose daily,30 min after breakfast and dinner,about 200 ml each time)orally.The course of treatment was 12 weeks in both groups.After the treatment,the sperm concentration,percentage of forward motile sperm(PR),and percentage of total sperm activity,that is PR+percentage of non-progressively motile sperm(NP)were compared between groups,and the clinical efficacy was judged.Traditional Chinese medicine(TCM)syndrome score(inlcuding 6 single symptom scores and total symptoms score)and 21-item depression,anxiety,and stress scale(DASS-21)scores(including depression,anxiety and stress scores)were compared between the two groups before and after treatment.The patients were followed up for 6 months,and the pregnancy status of spouse between groups was compared.The occurrence of adverse events and vital signs during the trial were recorded for safety assessment.Results Two cases in the treatment group and three cases in the control group dropped out.Finally,45 cases in each group were included in the statistical analysis.The total effective rate was 86.67%(39/45)in the treatment group,significantly higher than 73.74%(33/45)in the control group(P<0.05).After treatment,PR and PR+NP significantly increased in both groups,and were much higher in the treatment group than in the control group(P<0.05).The scores of lumbar and knee soreness,emotional disturbance,cold sperm,chest and rib-side and lesser abdomen distension and pain,frequent sighing,and the total TCM syndrome score in the treatment group decreased after treatment(P<0.05);and except for cold sperm,the scores of other symptoms mentioned above as well as the total TCM syndrome score in the treatment group were lower than those in the control group(P<0.05).The scores of depression,anxiety and stress of DASS-21 in the treatment group decreased after treatment,and were lower than those in the control group(P<0.05).After 6 months of follow-up,the spouses of 5 patients in the treatment group and 3 patients in the control group got pregnant(P>0.05).No adverse events occurred in both groups during the treatment,and their vital signs were stable.Conclusion SBYD can obviously improve sperm vitality and effectively improve the clinical symptoms,anxiety and depression,and is safe in treating asthenospermia and infertility with liver constraint and kidney deficiency.