Abstract:Objective:To observe the clinical effect of Shenqi Maiwei Dihuang Decoction combined with insulin on gestational diabetes mellitus (GDM) with syndrome of dual deficiency of qi and yin. Methods:A total of 98 patients with GDM with syndrome of dual deficiency of qi and yin were selected and divided into the observation group and the control group according to the random number table method, with 49 cases in each group. The control group was treated with insulin,and the observation group was given Shenqi Maiwei Dihuang Decoction combined with insulin for treatment. Both groups were treated for 4 weeks and followed up until 1 week after delivery. The curative effects of traditional Chinese medicine (TCM) syndrome were compared between the two groups. Before and after treatment,the changes of glucose metabolism indexes,adipokines and inflammation indexes in the two groups were observed;the pregnancy outcome in both groups were recorded. Results:After treatment,the total effective rate of TCM syndrome was 83.67% in the observation group,higher than that of 63.27% in the control group (P< 0.05). The levels of fast blood glucose (FBG),2-hour postprandial blood glucose (P2hBG) and (HbA1c) in both groups were decreased when compared with those before treatment (P<0.05), and the above 3 levels in the observation group were lower than those in the control group (P<0.05). The levels of serum leptin (LP) and retinol-binding protein 4 (RBP4) in both groups were decreased when compared with those before treatment (P<0.05),and the above 2 levels in the observation group were lower than those in the control group (P<0.05); the levels of serum adiponectin (ADPN) and Omentin- 1 in both groups were increased when compared with those before treatment (P<0.05),and the above 2 levels in the observation group were higher than those in the control group (P<0.05). The levels of serum tumor necrosis factor-α (TNF- α), high sensitive C- reactive protein (hs- CRP) and interleukin- 6 (IL- 6) in both groups were decreased when compared with those before treatment (P<0.05), and the above 3 levels in the observation group were lower than those in the control group (P<0.05). The incidence of adverse pregnancy outcomes was 8.16% in the observation group and 14.29% in the control group, there being no significance in the difference (P>0.05). The incidence of adverse neonatal outcomes was 6.12% in the observation group,lower than that of 26.53% in the control group (P<0.05). Conclusion:Shenqi Maiwei Dihuang Decoction combined with insulin has a significant curative effect on GDM with syndrome of dual deficiency of qi and yin, which can effectively improve the glucose and lipid metabolism of patients, control the inflammatory responses of the body and has certain preventive effects on adverse neonatal outcomes.