| ObjectiveTo systematically evaluate the efficacy,TCM syndrome score,SLEDAI score,24h urinary protein,complement C3 and adverse reactions of the treatment of systemic lupus erythematosus with integrated traditional Chinese and western medicine,in order to clearly understand the specific value of integrated traditional Chinese and western medicine in clinical practice,so as to further reflect the practical significance of integrated traditional Chinese and western medicine treatment scheme.MethodsRetrieved from CBM,VIP,CNKI,Wangfang Data,Embase,Medline,The Cochrance Library and other databases,the RCTs of SLE using integrated traditional Chinese and western medicine were searched by computer from January 2011 to January 2021.Literature screening,data extraction and bias risk assessment were completed independently by two reviewers and cross-checked the data.Review Manager V5.4 software was used to conduct sensitivity,publication bias and Meta analysis.ResultsForty-eight studies were included,and subgroup analysis was performed according to the stage of disease activity.The results showed as follows:(1)Clinical efficacy subgroup analysis:the effect size of remission subcombination was OR=4.96,95%CI(1.85,13.31),and the difference between groups was P=0.001;The combined effect size of the mild-to-moderate subgroup:OR=3.60,confidence interval:95%CI(2.63,4.92),inter-group difference:P<0.00001;The combined effect size of the moderate-severe subgroup:OR=4.16,confidence interval:95%CI(2.36,7.33),inter-group difference:P<0.00001;The effect size of other subcombinations:OR=3.57,confidence interval:95%CI(2.59,4.93),difference between the two groups:P<0.00001.There were significant differences within each subgroup,which indicated that the combination of traditional Chinese and western medicine could significantly enhance the curative effect.(2)The subgroup analysis of TCM syndrome score showed that the combined effect size of the mild-to-moderate subgroup:MD=-2.54,confidence interval:95%CI(-3.21,-1.88),and the difference between the two groups:P<0.00001;The combined effect size of moderate-severe subcombination:MD=-5.77,confidence interval:95%CI(-11.51,-0.03),difference between the two groups:P=0.05;The combined effect size of other subcombinations:MD=-4.77,confidence interval:95%CI(-8.08,-1.46),difference between the two groups:P=0.005.Except for the moderate and severe patients,there were significant differences in other subgroups,indicating that the combination of traditional Chinese and western medicine can significantly reduce the TCM syndrome scores of patients,but for the moderate and severe patients,the efficacy of the two therapies was basically the same.(3)SLEDAI score subgroup analysis showed that the combined effect size of the mild-to-moderate subgroup was-1.95,confidence interval:95%CI(-2.34,-1.55),difference between the two groups:P<0.00001;The combined effect size of the moderate-severe subgroup was-1.53,confidence interval:95%CI(-1.95,-1.11),difference between the two groups:P<0.00001;The combined effect size of the other subgroups MD=-2.21,confidence interval:95%CI(-2.85,-1.57),difference between the two groups:P<0.00001.There were significant differences within each subgroup,indicating that integrated traditional Chinese and western medicine could significantly reduce patients’ SLEDAI score compared with western medicine alone.(4)24h urine protein quantitative subgroup analysis showed that the combined effect size of the mild-to-moderate subgroup SMD=-1.57,confidence interval:95%CI(-2.43,-0.71),the difference between the two groups:P=0.0003;The combined effect size of the moderate-severe subgroup was SMD=-0.64,confidence interval:95%CI(-0.98,-0.29),difference between the two groups:P=0.0003;The combined effect size of other subgroups SMD=-0.80,confidence interval:95%CI(-1.10,-0.50),difference between the two groups:P<0.00001.There were significant differences within each subgroup,indicating that the combination of traditional Chinese and western medicine was more significant in reducing 24h urinary protein quantification than western medicine alone.(5)ESR subgroup analysis showed that the combined effect size of the mild-to-moderate subgroup was-6.45,confidence interval:95%CI(-9.59,-3.31),difference between the two groups:P<0.0001;MD=-7.18,confidence interval:95%CI(-12.86,-1.50),difference between the two groups:P=0.01;The combined effect size of other subcombinations MD=-15.63,confidence interval:95%CI(-21.28,-9.99),difference between the two groups:P<0.00001.There were significant differences in each subgroup,which indicated that combined traditional Chinese and western medicine could reduce erythrocyte sedimentation rate more significantly than western medicine alone.(6)Complement C3 subgroup analysis showed that the combined effect size of the mild-to-moderate subgroup SMD=0.47,confidence interval:95%CI(0.13,0.81),the difference between the two groups:P=0.007;The effect size of subcombination at moderate and severe stage was SMD=1.68,confidence interval:95%CI(0.75,2.62),difference between the two groups:P=0.0004;The combined effect size of the other subgroups was SMD = 0.70,confidence interval:95%CI(0.42,0.98),difference between the two groups:P<0.00001.There were significant differences within each subgroup,indicating that the combination of traditional Chinese and western medicine could increase C3 more clearly than that of western medicine alone.(7)Subgroup analysis of hormone dosage showed that the combined effect size of the mild-to-moderate subgroup was-4.83,confidence interval:95%CI(-8.87,-0.79),difference between the two groups:P=0.02;The differences between subgroups were significant,indicating that the combination of traditional Chinese and western medicine could reduce the use of hormones more than western medicine alone for mild and moderate patients.(8)C-reactive protein subgroup analysis showed that the combined effect size of the mild-to-moderate subgroup was-3.03,confidence interval:95%CI(-7.43,1.38),the difference between the two groups:P=0.18;The combined effect size of the moderate-severe subgroup MD=-2.47,confidence interval:95%CI(-6.1 7,1.24),difference between the two groups:P=0.19;The combined effect size of other subcombinations MD=-5.9,confidence interval:95%CI(-11.42,-0.39),difference between the two groups:P=0.04.The results showed that there was no significant difference in C-reactive protein value between combined Chinese and Western medicine and western medicine alone for patients with mild,moderate and severe stage.(9)The subgroup analysis of anti-ds-DNA concentration showed that the combined effect size of the subgroup in the mild-to-moderate stage was-5.12,confidence interval:95%CI(-12.80,2.56),and the difference between the two groups:P=0.19.There was no significant difference within the subgroup,indicating that the efficacy of combination of traditional Chinese and western medicine and western medicine alone in reducing the ds-DNA titer for mild-to-moderate patients was basically the same.The subgroup analysis of anti-ds-DNA positive rate showed that the effect size of mild to moderate subcombination was or=0.54,the confidence interval was 95%CI(0.33,0.88),and the difference between the two groups was P=0.01.There were significant differences within the subgroup,indicating that the combination of traditional Chinese and western medicine was more effective than western medicine alone in improving the positive rate of ds-DNA for mild and moderate patients.(10)Adverse reaction subgroup analysis showed that the effect size of remission subcombination was OR=0.21,confidence interval:95%CI(0.09,0.48),difference between the two groups:P=0.0003;OR=0.40,confidence interval:95%CI(0.09,1.85),difference between the two groups:P=0.24;OR=0.28,confidence interval:95%CI(0.14,0.57),difference between the two groups:P=0.0004;The effect size of other subcombinations was OR=0.24,confidence interval:95%CI(0.12,0.48),difference between the two groups:P<0.0001.Except for the mild-to-moderate stage,there were significant differences within each subgroup,indicating that in the non-mild-to-moderate stage of patients,Chinese and western medicine treatment can significantly reduce the occurrence of adverse reactions compared with western medicine,and for the mild-to-moderate stage of patients,the efficacy of the two treatment methods is equal.Sensitivity analysis showed that the sensitivity of each subgroup was low and the stability was acceptable,.ConclusionSystemic lupus erythematosus(SLE)is a complex immune inflammatory disease.The clinical manifestations are varied,the treatment methods are varied,the related clinical studies are fragmented and complex,and the specific value of integrated traditional Chinese and western medicine is fuzzy in clinical practice at present.In this study,a comprehensive collection of relevant literature and statistical methods were used to conduct the first subgroup analysis of patients in clinical randomized controlled trials based on SLE activity as a classification criterion.The results showed that:(1)for each stage of patients,the combination of traditional Chinese and western medicine can significantly improve the clinical efficacy,reduce the incidence of adverse reactions and improve some laboratory indicators,such as 24h urinary protein,C3;(2)For patients with mild to moderate and severe disease,TCM and Western medicine can further adjust the dosage of hormone and erythrocyte sedimentation rate.Therefore,the treatment of integrated traditional Chinese and western medicine is an important means to effectively help patients relieve symptoms and optimize the quality of life.However,there are some shortcomings in this study:(1)The quality of some studies is low,and some observation indicators can only be used for descriptive analysis due to a small number of included studies,which may affect the accuracy of research results;(2)The standard of TCM syndrome ty pe is different,and the treatment based on syndrome differentiation mainly depends on the subjective judgment of clinicians,which is not high in reproducibility,which may hinder the promotion of integrated TCM and Western medicine treatment.Therefore,it is expected that more high quality research reports will provide strong evidence for clinical decision making in the treatment of this disease. |
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