Clinical Observation On Shenqi Sishe Modified Decoction Combined With Western Medicine In Treatment Of Patients With Mild To Moderate Active Lupus Nephritis

Objective:To observe the clinical efficacy and safety of Shenqi Sishe modified decoction combined with western medicine in patients with mild to moderate active lupus nephritis,and to evaluate whether it is better than western medicine treatment alone.Methods:The 33 patients with lupus nephritis included were randomly divided into a control group and an observation group,with 16 in the control group and 17 in the observation group.Patients with immunosuporessant regimens before the two groups were enrolled,treating with the original treatment plan.The patients without treatment plan were treated with glucocorticoid+cyclophosphamide(CTX).On the same basic treatment,the control group was treated with gluc-ocorticoid+immunosuppressant,the Observation group add Shenqi Sishe modified decoction basic on the control group.Follow up for 12 weeks.To compare index change,including 24-hour urine protein quantification(24h UPQ),serum albumin(ALB),Urea,serum creatinine(SCr),serum uric acid(UA)after 4 weeks',8 weeks' and 12 weeks' treatment with before respectively,and compare these index between two groups after 4 weeks',8 weeks' and 12 weeks' treatment respectively.To compare index change,including complement C3,complement C4,anti-dsDNA antibody quantification,SLE disease activity index(SLEDAI)score after 12 weeks' treatment with before respectively,and compare these index between two groups after 12 weeks' treatment respectively.To compare index including and traditional Chinese medicine(TCM)syndromes score after 12 weeks' treatment with before respectively.And evaluate clinical efficacy,TCM syndromes efficacy and clinical safety according to these index and side-effects during the treatment.Results:The 24h UPQ in the observation group decreased at 8 weeks and 12 weeks after compared with before(P<0.05),and increased after 12 weeks' treatment in the control group(P<0.05).The 24h UPQ had no statistical difference after 4 weeks',8 weeks',12weeks'treatment between two groups(P>0.05).From the change trend of 24h UPQ,the decrease of 24h UPQ in the ohservation group was earlier than that in the control group and the decrease was more obvious.The ALB in the observation group increased at 8 weeks and 12 weeks after treatment compared with before(P<0.05),and increased after 12 weeks' treatment in the control group(P<0.05).The ALB had no statistical difference at 4 weeks,8 week,12weeks after treatment between two groups(P>0.05).There is no statistical difference in Urea,SCr,UA between pretreatment and after treatment in two groups and after treatment between two groups(P>0.05).From the change trend of the SCr,the SCr of the observation group.gradually decreased compared with pretreatment,and the SCr of the control group increased compared with pretreatment.and the gap hetween the two gradually became obvious with the extension ot the observation period.The complement C3,complement C4,anti-dsDNA antibody quan-tification and SLEDAI score in the observation group after the 12 week' treatment was significantly improved than that before(P<0.05).The complement C4,anti-dsDNA antibody quantification and SLEDAI score in the control group was significantly improved after the 12 week' treatment(P<0.05).There was no statistical difference in these index after treatment between two groups(P>0.05).There was no statistical difference in the total efficacy of western medicine,which was 88.24%in the observation group and 75.00%in the control group.The total curative rate of TCM syndromes in the observation group(82.35%)was higher than that in the control group(43.75%).There was no statistical difference in various adverse reaction rates after treatment between two groups(P>0.05).Conclusion:Compared with western medicine treatment alone,Shenqi Sishe modified decoction combined with Western medicine in treatment of patients with mild to moderate lupus nephritis have the therapeutic equivalence in reducing proteinuria levels,increasing serum albumin,stabilizing renal function,improving immune activity indicators,reducing SLEDAI scores and clinical remission rate.And the Shenqi Sishe modified decoction can more effectively alleviate the clinical symptoms of patients,improve the TCM syndrome clinical remission rate,and have the clinical safety.Further in depth research can be continued for clinical popularization and application.