ABSTRACT
Objective:This study aims to investigate the effect of addition and subtraction treatment to Renshen Maidongsan on metabolism of glucose， lipid and pregnancy outcome when used to gestational diabetes mellitus （GDM） with deficiency of both Qi and Yin. Method:In this study， 108 patients with GDM were randomly divided into observation group with 54 cases and control group with 54 cases. Patients in control group took Yuquan wan orally， 6 g/time， 4 times/day ， and patients in observation group were prescribed addition and subtraction treatment to Renshen Maidongsan， 1 dose/day. The course of treatment for both groups was 4 weeks. Oral glucose tolerance test （OGTT） was performed before and after treatment. Fasting blood glucose （FBG） ， 1 h our plasma glucose （1 h PG）， 2 h our plasma glucose （2 h PG）， glycosylated hemoglobin （HbA1c） and other indicators were detected to record the pregnancy outcome. Also， the levels of total cholesterol （TC）， triglyceride （TG）， high density lipoprotein cholesterol （HDL-C）， low density lipoprotein cholesterol （LDL-C）， adiponectin， serum amyloid A （SAA）， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， resistin， interleukin-1<italic>β</italic> （IL-1<italic>β</italic>） and interleukin-6 （IL-6） were detected before and after treatment. Then the safety evalution was carried out. Result:The levels of insulin resistance index （HOMA-IR）， FBG， 1 h PG， 2 h PG， HbA1c， TC， LDL-C， TG， IL-6， IL-1<italic>β</italic>， TNF-<italic>α</italic>， SAA， leptin and resistin in observation group were lower than the data checked in control group （<italic>P</italic><0.01）， and the levels of HOMA-<italic>β</italic>， insulin sensitivity index （InISI） and adiponectin were higher than the standards of from control group （<italic>P</italic><0.01）. Then the incidence of medical cesarean section， pregnancy induced hypertension， polyhydramnios， premature rupture of membranes， premature delivery and adverse pregnancy outcomes were lower than those in control group （<italic>P</italic><0.01）. Conclusion:Addition and subtraction treatment to Renshen Maidongsan can improve insulin sensitivity and islet <italic>β</italic>-cell function， regulate inflammatory factors and adipokines， improve insulin resistance （IR）， effectively regulate glucose and lipid metabolism， improve maternal and infant adverse pregnancy outcomes when used on patients with GDM and deficiency of Qi and Yin， and it was safe to use in clinic.