A clinical study of Guizhi-Fuling pill combined with conventional therapy for the patients with oviduct obstructive infertility / 国际中医中药杂志

ABSTRACT

Objective In order to evaluate the clinical curative effect of Guizhi-Fuling pill combined with conventional therapy for the patients with oviduct obstructive infertility.Methods In this study,102 patients with oviduct obstructive infertility (OO1) that accorded with the inclusion criteria were randomly divided into two groups according to the order of treatment.During the study,a total of 5 patients were lost in the two groups,and so 49 in the treatment group and 48 in the control group completed the protocol.The control group was given fallopian tube recanalization under the hysteroscopy,and the treatment group was given oral Guizhi-Fuling pill at day 2 after surgery on the basis of the control group treatment.Both groups were observed for 6 months.Before and after treatment,TCM symptom score was conducted,and IL-6 level was determined by radioimmunoassay;the uterine fallopian tube was examined after the 6th month of treatment,and pregnancy rate was observed and recorded.Results After treatment,abdominal pain degree (0.6 ± 0.1 vs.1.3 ± 0.1,t=3.612),the low back pain (0.9 ± 0.2 vs.1.6 ± 0.2,t=2.553),abdominal distension (0.5 ± 0.0 vs.1.0 ± 0.8,t=2.364),menstrual blood clots (0.5 ± 0.1 vs.1.0 ± 0.1,t=2.331) in the treatment group were significantly lower than those in the control group (Ps＜0.05).After treatment,the rate of oviduct patency was 75.5％ (37/49) in thetreatment group,50.0％ (24/48) in the control group,and the comparison difference between the two groups was statistically significant (x2=8.075,P=0.044).After 6 months of treatment,the pregnancy rate of the treatment group was 63.3％ (31/49),and that of the control group was 37.5％ (18/48),the difference of pregnancy rate between the two groups was statistically significant (x2=6.724,P=0.035).After treatment,serum IL-6 (31.04 ± 2.47 ng/ml vs.42.71 ± 2.52 ng/ml,t=7.593) in the treatment group was signicantly lower than the control group (P＜0.05).Conelusions Guizhi-Fuling pill combined with conventional therapy can reduce IL-6 level,promote fallopian tube recanalization,improve the intrauterine pregnancy rate,and improve the clinical symptoms of OOI patients.