Abstract: Objective:To compare the effects of hydroxychloroquine combined with prednisone, and single use of prednisone or hydroxychloroquine, on maternal and infant outcome in pregnancy complicated with systemic lupus erythematosus (SLE) using a meta-analytic approach.Methods:A computer search of CNKI, VIP, Wanfang database, Pubmed, SinoMed, Embase, and Cochrane Library were used to retrieve and compare randomized controlled studies or controlled trials on the effect of hydroxychloroquine combined with prednisone (study group) , prednisone or hydroxychloroquine alone (control group) on maternal and infant outcomes in pregnancy with SLE. The search time ranged from the inception of each database to May 2021. Cochrane risk of bias tool was used to evaluate the risk of bias in the included studies. Stata 13.1 was used for meta-analysis processing.Results:A total of 8 research articles comprising 602 subjects were included (287 in the control group and 315 in the study group) . Our meta-analysis showed that the SLE activity in the study group was significantly lower than that in the control group ( OR=0.32, 95% CI: 0.16 to 0.63, P<0.01) . The SLEDAI score was not statistically different between the study group and the control group during first trimester ( MD=-0.17, 95% CI: -0.68 to 0.34, P=0.51) , but was significantly lower in the study group during the second trimester ( MD=-2.02, 95% CI: -2.48 to -1.55, P<0.01) and the third trimester ( MD=-2.66, 95% CI: - 3.00 to -2.31, P<0.01) of pregnancy in the study group compared with the control group. The incidence of adverse reactions during treatment was lower in the study group than that in the control group ( OR=0.53, 95% CI: 0.30 to 0.95, P=0.03) . Compared with the control group, the study group presented significantly lower rate of pregnancy termination rate ( OR=0.33, 95% CI: 0.18 to 0.60, P<0.01) , higher rate of full-term pregnancy ( OR=3.66, 95% CI: 2.30 to 5.82, P<0.01) , lower rate of preterm birth ( OR=0.36, 95% CI: 0.20 to 0.64, P<0.01) , and higher birth weight of the newborns ( MD=276.40, 95% CI: 56.96 to 495.85, P=0.01) . There were no statistically differences in the Apgar scores of newborns at 5 min ( MD=0.12, 95% CI: -0.05 to 0.28, P=0.16) and incidence of neonatal asphyxia ( MD=0.23, 95% CI: 0.05 to 1.12, P=0.07) between the study group and the control group. Conclusion:Hydroxychloroquine combined with prednisone offers favorable efficacy in the treatment of pregnancy complicated with SLE than prednisone alone. The combination therapy can effectively control the SLE activity, improve adverse pregnancy outcomes and the birth weight of newborns, and reduce adverse reactions during treatment.