Real-world study of Bushen Yangxue Tiaojing Formula in treating PCOS of kidney deficiency and blood stasis pattern
Objective To observe the clinical efficacy of Bushen Yangxue Tiaojing Formula(BSYXTJF)in treating polycystic ovary syndrome(PCOS)in real world.Methods The clinical data of 142 PCOS patients who were treated with BSYXTJF in the First Hospital of Henan University of Chinese Medicine from September 2019 to September 2021 were collected.Based on their fertility needs and infertility status,142 PCOS patients were divided into 3 groups.Group A:PCOS patients without fertility needs;Group B:Non infertile PCOS patients with fertility needs;Group C:PCOS patients with concurrent infertility.Their menstruation,pregnancy,delivery,and neonatal weight before and after treatment were also followed up.Results The menstruation of 116 PCOS patients were improved to different degrees and the clinical effective rate was 81.69%.Among the 94 PCOS patients with no need for fertility in Group A,there were five cases of biochemical pregnancy(5.32%),five cases of clinical pregnancy(5.32%),five cases of continuous pregnancy(5.32%),four cases of live birth,and one case of pregnancy.Among the 29 non-infertility patients with need for fertility in Group B,there were eight cases of biochemical pregnancy(27.59%),seven cases of clinical pregnancy(24.14%),six cases of continuous pregnancy(20.69%),and six cases of live birth(20.69%).There were 19 PCOS patients complicated with infertility in Group C and their mean duration of infertility was(2.36±1.47)years.After treatment,there were seven cases of biochemical pregnancy(36.84%),one case of ectopic pregnancy(14.29%),six cases of clinical pregnancy(31.58%),one case of early miscarriage(16.67%),five cases of continuous pregnancy(26.32%),one case of late miscarriage(16.67%),two cases of live birth,and two cases of pregnancy.The biochemical pregnancy rate,clinical pregnancy rate,and continuous pregnancy rate were compared among the three groups of patients,and the differences were statistically significant(P<0.05).Among all the pregnant patients,there were three cases of gestational diabetes(15.00%),one case of gestational hypertension(5.00%),and two cases of subclinical hypothyroidism(10.00%).All the deliveries were full-term.Among the newborns,there was one case of macrosomia,and the body weight of remaining newborns was in the normal range.Furthermore,all the infants were in good physical condition during follow-up.None of the patients had serious adverse reactions during treatment.Conclusion BSYXTJF can obviously improve the menstruation and reproductive outcome of PCOS patients with good safety.