| Objective:The purpose of this study was to observe the effect of Langchuangjing Granule on the damage of blood system and disease activity of systemic lupus erythematosus of kidney deficiency and blood stasis toxin with mild and moderate disease activity.By observing the blood glucose,cholesterol,triglyceride,weight and other indicators before and after treatment,objectively evaluate the interventional effect of Langchuangjing granule on the side effects of glucocorticoid.Provide a clinical basis for the widespread application of Langchuangjing granule in the clinic.Methods:According to a randomized controlled trial,the 60 cases included in the study were randomly divided into a control group and a treatment group according to 1:2.The control group was taken prednisone acetate tablets(Drug dosage according to the patient's disease activity)and hydroxychloroquine sulfates tablets 0.2g orally twice daily.In the treatment group,on the basis of the control group,we added the Langchuangjing granule developed by Professor Jin Shi,and took lOg three times a day.The observation period was 12 weeks.After 12 weeks,blood system,SLEDAI score,ESR,CRP,immunoglobulin,complement C3,C4,TG,CHO,LDL,HDL,TCM syndrome score and other indexes were observed before and after treatment.Results:A total of 58 patients completed clinical observations in this study,19 in the control group and 39 in the treatment group.There was no statistical significance between the two groups in general information and various indicators(P>0.05),and they were comparable.1.Blood system:After 12 weeks of treatment,white blood cells,hemoglobin,and platelets were all higher than before treatment,the difference was statistically significant(P<0.05),and the treatment group was better than the control group,with statistical difference(P<0.05).The treatment group had better efficacy than the control group in leukopenia,hemoglobin reduction,and thrombocytopenia,and the difference was statistically significant(P<0.05).2.Disease activity and immunological indicators:After treatment,the SLEDAI scores of the two groups decreased compared with before,the difference was statistically significant(P<0.01),and the treatment group was lower than the control group,the difference was statistically significant(P<0.05).The complement C3 and C4 after treatment both were higher than before,the difference was statistically significant(P<0.05),and the treatment group was higher than the control group,the difference was statistically significant(P<0.05).After treatment,the IgG of both groups decreased compared with before,the difference was statistically significant(P<0.05);,and the treatment group was better than the control group,the difference was statistically significant(P<0.01).After treatment,IgA in the treatment group decreased compared with the previous period,which was statistically significant(P<0.05),and there was no significant change in the control group IgA(P>0.05),no significant difference between the two groups after treatment(P>0.05).After treatment,IgM had no statistical significant compared with before treatment(P>0.05),and there was no statistical difference between the two groups after treatment(P>0.05).After treatment,the anti-ds-DNA and CRP of the two groups were lower than before,the difference was statistically significant(P<0.01),and there was no statistical difference between the two groups after treatment(P>0.05).After treatment,the ESR of both groups decreased compared with before,the difference was statistically significant(P<0.05),and the treatment group was better than the control group,the difference was statistically significant(P<0.05).3.Glucocorticoid dosage:After treatment,the dosage of glucocorticoid in both groups decreased compared with before,the difference was statistically significant(P<0.01),and the dosage of glucocorticoid in the treatment group was less than the control group,the difference was statistically significant(P<0.05).4.Side effects of glucocorticoids:After treatment,the GLU,CHO,and TG of the control group were higher than before,and the difference was statistically significant(P<0.01).The GLU,CHO,and TG of the treatment group were not statistically significant(P>0.05).The GLU and TG of the treatment group were lower than those of the control group,the difference was statistically significant(P<0.05),and there was no statistical difference between the two groups of CHO after treatment(P>0.05).After treatment,the HDL of the control group was unchanged(P>0.05),and the HDL of the treatment group was higher than before(P<0.05),but there was no statistical difference between the two groups after treatment(P>0.05).After treatment,the LDL of both groups was higher than before,the difference was statistically significant(P<0.05),and there was no statistically significant difference between the two groups after treatment(P>0.05).After treatment,the weight of the two groups increased compared with before,with statistical difference(P<0.01),but the weight gain of the treatment group was smaller than that of the control group,the difference was statistically significant(P<0.05).5.TCM syndromes:After treatment,the two groups had significant improvement in the main symptoms and secondary symptoms,and the difference was statistically significant(P<0.05).However,the treatment group was better than the control group in terms of facial erythema,fever,vertigo and tinnitus,the weakness of waist and knees and feverishness in palms and soles.The difference was statistically significant(P<0.05).There was no significant difference between the two groups in terms of joint swelling and pain,purple petechia and ecchymosis around the nails or limbs(P>0.05).6.Efficacy of TCM syndromes:There were 19 cases in the control group.After treatment,13 cases were effective(68.4%)and 6 cases were ineffective(31.6%).There were 39 cases in the treatment group.After treatment,2 cases(5.1%)were clinically cured,28 cases were markedly effective(71.8%),5 cases were effective(12.8%),and 4 cases were ineffective(10.3%).The curative effect of the treatment group was better than that of the control group,with statistical significance(P<0.01).7.Safety:During the 12-week observation period,there were no serious adverse reactions in both groups.Conclusion:Langchuangjing granule combined with Western medicine group can significantly improve the blood system damage of mild to moderate systemic lupus erythematosus of kidney deficiency and blood stasis toxin,reduce disease activity of SLE,improve immunological indicators and TCM symptoms and signs,and reduce side effects of glucocorticoids.Langchuangjing granule plays a role in enhancing efficacy and reducing side effects. |
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