摘要
Objective:To evaluate the efficacy and safety of Chinese medicine(CM)improving pregnancy outcomes after surgery for endometriosis-associated infertility.Methods:A multicenter,randomized,doubleblind placebo parallel controlled clinical trial was designed.A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017,101 patients in each group.The two groups received continuous intervention at 1–5 days after surgery,for 6 menstrual cycles.Before ovulation,the CM group was treated Huoxue Xiaoyi Granule(活血消异颗粒);after ovulation,Bushen Zhuyun Granule(补肾助孕颗粒)was involved.The control group was treated with placebo.Transvaginal ultrasonography was performed every menstrual cycle during the treatment,and female hormone levels in the follicular and luteal phases were measured during the 1 st,3 rd and 6 th menstrual cycles.The analysis was continued until pregnancy.The primary outcomes were clinical pregnancy rate and pregnancy outcome,and the secondary outcomes were follicular development and endometrial receptivity.Safety evaluations were performed before and after treatment.Results:(1)Clinical pregnancy and live birth rates:the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group[44.6%(45/101)vs.29.7%(30/101),34.7%(35/101)vs.20.8%(21/101),both P<0.05].(2)Follicle development:the incidence of dominant follicles,rate of cumulative cycle ovulation,and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group[93.8%(350/373)vs.89.5%(341/381),80.4%(275/342)vs.69.1%(253/366),65.8%(181/275)vs 56.1%(142/253),P<0.05 or P<0.01]).The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group than in the placebo group[11.7%(40/342)vs.17.8%(65/366),P<0.05).(3)Endometrial receptivity:after treatment,both endometrial types and endometrial blood flow types in the CM group were mainly types A and B,while those in the placebo group were mainly types B and C,with a significant difference between the two groups(both P<0.05).(4)Adverse events:the incidence of adverse events between the two groups was not significantly different(P>0.05).Conclusion:Strategies for activating blood circulation-regulating Gan(Liver)-tonifying Shen(Kidney)sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosis-associated infertility with qi stagnation and blood stasis after laparoscopy,improve follicular development,promote ovulation,improve endometrial receptivity,while being a safe treatment option.(Trial registration No.NCT02676713).
Objective:To evaluate the efficacy and safety of Chinese medicine(CM) improving pregnancy outcomes after surgery for endometriosis-associated infertility.Methods:A multicenter,randomized,doubleblind placebo parallel controlled clinical trial was designed.A total of 202 patients who had laparoscopy for endometriosis-associatect infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017,101 patients in each group.The two groups received continuous intervention at 1-5 days after surgery,for 6 menstrual cycles.Before ovulation,the CM group was treated Huoxue Xiaoyi Granule(活血消异颗粒);after ovulation,Bushen Zhuyun Granule(补肾助孕颗粒) was involved.The control group wa3 treated with placebo.Transvaginal ultrasonography was performed every menstrual cycle during the treatment,and female hormone levels in the follicular and luteal phases were measured during the 1 st,3 rd and 6 th menstrual cycles.The analysis was continued until pregnancy.The primary outcomes were clinical pregnancy rate and pregnancy outcome,and the secondary outcotmes were follicular development and endometrial receptivity.Safety evaluations were performed before and after treatment.Resuilts:(1) Clinical pregnancy and live birth rates:the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group [44.6%(45/101) vs.29.7%(30/101),34.7%(35/101) vs.20.8%(21/101),both P<0.05].(2) Follicle development:the incidence of dominant follicles,rate of cumulative cycle ovulation,and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group [93.8%(350/373)vs.89.5%(341/381),80.4%(275/342) vs.69.1%(253/366),65.8%(181/275) vs 56.1%(142/253),P<0.05 or P<0.01]).The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group than in the placebo group [11.7%(40/342) vs.17.8%(65/366),P<0.05).(3) Endometrial receptivity:after treatment,both endometrial types and endometrial blood flow types in the CM group were mainly types A and B,while those in the placebo group were mainly types B and C,with a significant difference between the two groups(both P<0.05).(4) Adverse events:the incidence of adverse events between the two groups was not significantly different(P>0.05).Conclusion:Strategies for activating blood circulation-regulating Gan(Liver)-tonifying Shen(Kidney) sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosisassociated infertility with qi stagnation and blood stasis after laparoscopy,improve follicular development,provnote ovulation,improve endometrial receptivity,while being a safe treatment option.(Trial registration No.NCT02676713)
基金
Supported by the Key Projects of the National Science and Technology Pillar Program during the 12th Five-Year Plan Period(No.2014BAI10B08)
