Randomized Controlled Study of Disease-syndrome Combination Therapy for Anovulatory Infertility / 广州中医药大学学报

ABSTRACT

Objective To investigate the clinical effectiveness of disease-syndrome combination therapy for anovulatory infertility through randomized controlled trial, thus to provide high-level evidence-based medical reference for the diagnosis and treatment of WHO typeⅡovulation disorder infertility. Methods Eighty-six patients with WHO typeⅡovulation disorder infertility were randomized into treatment group and control group , 43 cases in each group. Both groups were given the treatment for correcting endocrinic disorder if necessary. Additionally, by following the principle of combination of disease differentiation and syndrome differentiation , Zhuyun Recipe 1, Zhuyun Recipe 2, and Zhuyun Recipe 3 were separately given orally to the patients with kidney-yang deficiency (WHO type Ⅱ ovulation disorder without PCOS), patients with liver-kidney insufficiency(WHO typeⅡovulation disorder complicated with hyperandrogenitic lean-PCOS),and patients with kidney-deficiency complicated with phl egm-dampness (WHO type Ⅱ ovulation disorder complicated with insulin-resistant obesity-PCOS) in the treatment group respectively. The patients in the control group was given oral use of the first-rate ovulation induction drug Clomiphene. The treatment covered 3 menstruation cycles. Ovulation rate,pregnancy rate and alive fetus rate were used as the indicators for evaluating the effectiveness,and the safety was also monitored. Results(1)Of the 86 cases,5 cases dropped out(loss to follow-up or being excluded),with the drop-out rate being 6%. Of the 5 drop-out cases,3 were from the control group,and 2 were from the treatment group. (2)Ovulation rate of the treatment group was 70.7%,and that of the control group was 85.0%. The ovulation rate of the two groups was enhanced,but the difference between the two groups was insignificant(P > 0.05).(3)Pregnancy rate of the treatment group was 51.2%,and that of the control group was 30.0%, the differen ce being significant between the two groups(P < 0.05).(4)Alive fetus rate of the treatment group was 45.2%,and that of the control group was 22.5%,the difference being significant between the two groups(P < 0.05).(5)No adverse reaction was found in the two groups during the treatment. Conclusion The disease-syndrome combination therapy for WHO type Ⅱanovulatory infertility shows the advantages of higher pregnancy rate and alive fetus rate, which makes up for the disadvantages of low pregnancy rate and high abortion rate of Clomiphene.