参芪温阳膨胀栓治疗阴道松弛症的平行、多中心、开放性、随机对照临床研究

A parallel,multicenter,open,randomized controlled clinical study of Shenqi Wenyang Expansion Supposition in the treatment of vaginal laxity

目的 探究参芪温阳膨胀栓治疗阴道松弛症的有效性与安全性。方法 选取3所医院收治的100例阴道松弛症患者为研究对象,采用随机数字表法分为对照组及研究组,每组50例。对照组采用盆底肌训练联合生物反馈电刺激治疗,研究组采用参芪温阳膨胀栓治疗,均连续治疗2个月。比较两组的阴道松弛问卷(VLQ)评分、阴道松弛症分度、盆底肌力及不良反应发生情况。结果 治疗前,两组VLQ评分比较,差异无统计学意义(P>0.05);治疗后1、2个月,研究组VLQ评分分别为(3.95±0.89)、(5.76±1.10)分,均高于对照组的(2.12±0.91)、(4.08±1.21)分,差异有统计学意义(P<0.05)。研究组阴道松弛症分度优于对照组,差异有统计学意义(P<0.05)。研究组盆底肌力Ⅲ~Ⅴ级率高于对照组,差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 参芪温阳膨胀栓治疗阴道松弛症的有效性与安全性均较好,且其有效性优于盆底肌训练联合生物反馈电刺激治疗,值得临床推广使用。

Objective To explore the efficacy and safety of Shenqi Wenyang Expansion Supposition in treating vaginal laxity.Methods A total of 100 patients with vaginal laxity treated in 3 hospitals were selected as the research objects and were divided into a control group and a study group by random number table,with 50 cases in each group.The control group was treated with pelvic floor muscle training combined with biofeedback electrical stimulation,and the study group was treated with Shenqi Wenyang Expansion Supposition,all of which were treated continuously for 2 months.The vaginal laxity questionnaire(VLQ)score,vaginal relaxation syndrome classification,pelvic floor muscle strength and the incidence of adverse reactions were compared between the two groups.Results Before treatment,there was no significant difference in VLQ scores between the two groups(P>0.05);1 and 2 months after treatment,the VLQ scores of the study group were(3.95±0.89)and(5.76±1.10)points,respectively,which were higher than(2.12±0.91)and(4.08±1.21)points of the control group,the differences were statistically significant(P<0.05).The classification of vaginal relaxation in the study group was better than that in the control group,and the difference was statistically significant(P<0.05).The rate of grade III~V pelvic floor strength in the study group was higher than that in the control group,and the difference was statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Shenqi Wenyang Expansion Supposition has good efficacy and safety in the treatment of vaginal laxity,and its effectiveness is better than that of pelvic floor muscle training combined with biofeedback electrical stimulation therapy,which is worthy of clinical application.