中药栓剂联合益肾通络清抗汤治疗免疫性不育的临床疗效

Clinical Efficacy of Traditional Chinese Medicine Suppository Combined with Yishen Tongluo Qingkang Decoction in Treatment of Immune Infertility

目的:评价中药栓剂联合益肾通络清抗汤治疗免疫性不育的临床疗效及安全性。方法:将116例符合本研究纳入标准的患者随机分为观察组及对照组各58例。观察组采用中药栓剂联合益肾通络清抗汤治疗,对照组给予醋酸泼尼松片。两组均治疗12周,并于治疗结束后6个月随访。收集治疗前后入组患者的精液标本,比较两组患者的配偶受孕情况,精浆抗精子抗体(AsAb)转阴率,精子浓度、活动率、前向运动精子百分率、精子顶体酶活性和不良反应发生情况。结果:共有104例患者完成研究,其中观察组53例,对照组51例。治疗前,两组患者基线资料均衡。治疗后,观察组总有效率为92.45%(49/53),高于对照组的76.47%(39/51),差异具有统计学意义(P<0.05)。观察组AsAb转阴率为62.26%(33/53),高于对照组的49.02%(25/51),但差异无统计学意义。与治疗前比较,治疗后两组患者的精子活动率、前向运动精子百分率及精子顶体酶活性均明显提高(P<0.05),观察组的精子浓度明显提高(P<0.05),而对照组精子浓度差异无统计学意义。与对照组治疗后比较,观察组患者的精子浓度、活动率、前向运动精子百分率及精子顶体酶活性改善程度优于对照组(P<0.05)。试验期间,观察组不良反应发生率低于对照组(P<0.05)。结论:中药栓剂联合益肾通络清抗汤能够显著提高免疫性不育患者的AsAb转阴率,改善精液质量,有较好的临床疗效及安全性。

Objective:To evaluate the clinical efficacy and safety of traditional Chinese medicine(TCM)suppository combined with Yishen Tongluo Qingkang decoction in the treatment of immune infertility.Method:A total of 116 patients meeting the inclusion criteria of this study were randomly divided into an observation group(58 cases)and a control group(58 cases).The observation group was treated with TCM suppository combined with Yishen Tongluo Qingkang decoction,and the control group was treated with prednisone acetate tablets.Both groups were treated for 12 weeks and followed up six months after treatment.Semen samples of the patients were collected before and after treatment,and the pregnancy status of their spouses,negative conversion rate of seminal plasma anti-sperm antibody(AsAb),sperm concentration,motility,percentage of forward motile sperm,sperm acrosin activity,and incidence of adverse reactions were compared between the two groups.Result:A total of 104 patients completed the study,including 53 cases in the observation group and 51 cases in the control group.Before treatment,the baseline data of the two groups were balanced.After treatment,the total effective rate of the observation group was 92.45%,which was higher than that of the control group(76.47%)(P<0.05),and the negative conversion rate of AsAb in the observation group was higher than that in the control group,but the difference was not statistically significant.After treatment,the sperm motility,percentage of forward motile sperm,and sperm acrosin activity increased in the two group(s P<0.05),and the sperm concentration in the observation group increased(P<0.05).There was no significant difference in sperm concentration in the control group.After treatment,the sperm concentration,motility,percentage of forward motile sperm,and acrosin activity in the observation group were better than those in the control group(P<0.05).During the trial,the incidence of adverse reactions in the observation group was lower than that in the control group(P<0.05).Conclusion:TCM suppository combined with Yishen Tongluo Qingkang decoction can significantly increase the negative conversion rate of AsAb and improve the quality of semen in patients with immune infertility.