Objective:Observe the clinical characteristics of children with SLE,namely,to observe the symptoms and laboratory examinations,such as blood routine,blood lipid,immunoglobulin,complement,autoantibodies,serum 25(OH)D a...Objective:Observe the clinical characteristics of children with SLE,namely,to observe the symptoms and laboratory examinations,such as blood routine,blood lipid,immunoglobulin,complement,autoantibodies,serum 25(OH)D and other indicators,and to explore the clinical characteristics,the difference and the significance of vitamin D supplements between male and female SLE patients in children respectively.Methods:We enrolled 64 cases of SLE patients in children who were admitted into the department of pediatrics and rheumatology of the third affiliated hospital of sun yat-sen university in guangzhou from May 1,2011 to February 1,2019,They were analyzed retrospectively,adoptingΧ²test for statistical analysis.Results:64 cases of SLE in children,which included 10 cases of male and 54 cases of female.Clinical manifestations:facial skin rash in 48 patients(75%),fever in 38 cases(59.4%),arthritis in 28 cases(43.8%),oral ulcer in 18 cases(28.1%),serositis in13 cases(20.3%),and the sun allergy in 9 cases(14.1%),the damage of central nervous system in 7 cases(10.9%).Laboratory examination:30 cases of leukopenia(46.9%),anemia in 30 cases(46.9%),thrombocytopenia in 12 cases(18.8%),hematuria in 18 cases(28.1%),proteinuria in 33 cases(51.2%),6 patients with renal impairment(9.4%),antinuclear antibody positive in 63 cases(98.4%),anti-double-stranded DNA(dsDNA)antibody positive in 48 cases(75%),anti SSA antibody positive in 44 cases(68.7%),SSB antibody positive in 33 cases(51.6%),Sm antibody positive in 40 cases(62.5%),nucleosome antibody positive in 28 cases(43.8%).Among these children,male SLE patients were higher than female children with SLE in the damage of kidney,Sm antibodies and resisting nucleosome antibody positive rates(Χ²=4.451,8.336,6.803,P<0.05),the female children with SLE was higher than male SLE Children in the anti-SSB antibody positive rate(Χ²=4.945,P<0.05).In 64 cases of SLE children,which included 52 cases were lower than the normal level of serum 25(OH)D measurements,12 cases were in the normal lower limit of serum 25(OH)D measurements,at the same time,the female SLE.Patients was higher than male children with SLE in the reduce rate of serum 25(OH)D(Χ²=8.351,P<0.05).Conclusion:Male SLE patients which appeared damage of kidney easier than female patients,the proteinuria was the most common in the damage of kidney.Resistance to Sm antibodies which was the risk factor of renal injury with higher incidence in male children with SLE;Anti nucleosome antibody which was the risk factor for the disease activity in male children with SLE were higher than female children with SLE.It was estimated that the risk of Sjogren’s syndrome appeared in female with SLE were higher than that in male SLE children.In this retrospective study,the serum 25(OH)D levels were significantly lower in children with SLE,and vitamin D supplementation was required.展开更多
Background： SmD1-amino-acid 83-119 peptide （SmD183-119） is the major epitope of Smith （Sm） antigen, which is specific for adult systemic lupus erythematosus （SLE）. The anti-SmD183-119 antibody has exhibited hig...Background： SmD1-amino-acid 83-119 peptide （SmD183-119） is the major epitope of Smith （Sm） antigen, which is specific for adult systemic lupus erythematosus （SLE）. The anti-SmD183-119 antibody has exhibited higher sensitivity and specificity than anti-Sm antibody in diagnosing adult SLE. However, the utility of anti-SmD183-119 antibodies remains unclear in children with SLE （cSLE）. This study aimed to assess the characteristics of anti-StuD 183-119 antibody in the diagnosis of cSLE. Methods： Samples from 242 children with different rheumatological and immunological disorders, including autoimmune diseases （SLE [n = 46] and ankylosing spondylitis [AS, n = 11]）, nonautoimmune diseases （Henoch-Schonlein purpura [HSP, n = 60], idiopathic thrombocytopenia purpura [n = 27], hematuria [n = 59], and arthralgia [n = 39]） were collected from Shanghai Children＇s Medical Center from March 6, 2012 to February 27, 2014. Seventy age- and sex-matched patients were enrolled in this study as the negative controls. All the patients＇ sera were analyzed for the anti-SmD 183-119, anti-Sm, anti-U 1-nRNP, anti-double-stranded DNA （dsDNA）, anti-nucleosome, anti-SSA/Ro60, anti-SSA/Ro52, anti-SSB, anti-Scl-70, and anti-histone antibodies using the immunoblotting assay. The differences in sensitivity and specificity between anti-SmD183-119 and anti-Sm antibodies were compared by Chi-square test. The correlations between anti-SmD183-119 and other auto-antibodies were analyzed using the Spearman＇s correlation analysis. A value of P 〈 0.05 was considered statistically significant. Results： Thirty-six out of 46 patients with cSLE were found to be positive for anti-SmD183-119, while 12 patients from the cSLE cohort were found to be positive for anti-Sm. Compared to cSLE, it has been shown that anti-SmD183-119 was only detected in 27.3% of patients with AS and 16.7% of patients with HSP. In comparison with anti-Sm, it has been demonstrated that anti-StuD 183-119 had a higher sensitivity （78.3% vs. 26.1%, 2＇2 = 25.1, P 〈 0.05） and a lower specificity （90.8% vs. 100%, x^2 = 13.6, P 〈 0.05） in the diagnosis of cSLE. Further analysis revealed that anti-StuD 183-119 antibodies were positively correlated with anti-dsDNA, anti-nucleosome, and anti-histone antibodies in cSLE. Moreover, it has been clearly shown that anti-SmD183-119was more sensitive than anti-Sm in discriminating autoimmune diseases from nonautoimmune disorders in patients with arthralgia or hematuria. Conclusions： Measurement of anti-SmD183-119 in patients with cSLE has a higher sensitivity and a marginally lower specificity than anti-Sin. It has been suggested that inclusion of anti-SmD183-119 testing in the integrated laboratory diagnosis ofcSLE may significantly improve the overall sensitivity in child populations.展开更多
BACKGROUND Systemic lupus erythematosus(SLE)is the most frequent and serious systemic connective tissue disease.Nowadays there is no clear guidance on its treatment in childhood.There are a lot of negative effects of ...BACKGROUND Systemic lupus erythematosus(SLE)is the most frequent and serious systemic connective tissue disease.Nowadays there is no clear guidance on its treatment in childhood.There are a lot of negative effects of standard-of-care treatment(SOCT),including steroid toxicity.Rituximab(RTX)is the biological B-lymphocyte-depleting agent suggested as a basic therapy in pediatric SLE.AIM To compare the benefits of RTX above SOCT.METHODS The data from case histories of 79 children from the Saint-Petersburg State Pediatric Medical University from 2012 to 2022 years,were analyzed.The diagnosis of SLE was established with SLICC criteria.We compared the outcomes of treatment of SLE in children treated with and without RTX.Laboratory data,doses of glucocorticosteroids,disease activity measured with SELENA-SLEDAI,RESULTS Patients,treated with RTX initially had a higher degree of disease activity with prevalence of central nervous system and kidney involvement,compared to patients with SOCT.One year later the disease characteristics became similar between groups with a more marked reduction of disease activity(SELENA-SLEDAI activity index)in the children who received RTX[-19 points(17;23)since baseline]compared to children with SOCT[-10(5;15.5)points since baseline,P=0.001],the number of patients with active lupus nephritis,and daily proteinuria.During RTX therapy,infectious diseases had three patients;one patient developed a bi-cytopenia.CONCLUSION RTX can be considered as the option in the treatment of severe forms of SLE,due to its ability to arrest disease activity compared to SOCT.展开更多
BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve dis...BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve disease outcomes.AIM To assess the differences in the outcomes of different types of rituximab administration(early and late).METHODS In this retrospective cohort study,the information of 36 children with SLE with administration(LRA)was analyzed.We compared initial disease characteristics at onset,at baseline(start of rituximab),and at the end of the study(EOS)at 12 months,as well as outcomes and treatment characteristics.RESULTS The main differences at baseline were a higher daily median dose of corticosteroids,increased MAS frequency,and a higher Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)in the ERA group.No differences in the main SLE outcomes between groups at the EOS were observed.The part of lupus nephritis patients who achieved remission changed from 44%to 31%in ERA and 32%to 11%in the LRA group.Patients with ERA had a shorter time to achieve low daily corticosteroid dose(≤0.2 mg/kg)at 1.2(0.9;1.4)years compared to 2.8(2.3;4.0)years(P=0.000001)and higher probability to achieve this low dose[hazard ratio(HR)=57.8(95%confidence interval(CI):7.2-463.2),P=0.00001 and remission(SLEDAI=0);HR=37.6(95%CI:4.45-333.3),P=0.00001].No differences in adverse events,including severe adverse events,were observed.CONCLUSION ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity,except for lupus nephritis.Further investigations are required.展开更多
Objective:To objectively evaluate the effectiveness of psychological interventions for improving health-related quality of life in patients with systemic lupus erythematosus(SLE).Design and review methods:Databases in...Objective:To objectively evaluate the effectiveness of psychological interventions for improving health-related quality of life in patients with systemic lupus erythematosus(SLE).Design and review methods:Databases including Ovid-Medline,PubMed,Web of Science,EBSCOhost,the Cochrane Library and Embase were electronically searched to identify randomized controlled trials published from inception through November 2013 involving psychological intervention in SLE patients.Studies that measured physiological function,life vitality,depression,pain degree,disease activity,severity of fatigue,and physical and mental component summaries as outcomes were included.Trials involving patients with multiple diseases or received simultaneous psychological interventions or combinations of other interventions were excluded.Two independent investigators screened the identified articles,extracted the data,and assessed the methodological quality of the included studies.Qualitative descriptions were conducted and quantitative analysis was performed with RevMan software(version 5.2).Results:A total of six randomized controlled trials comprising 394 participants were included in the study.Meta-analyses showed that psychological interventions significantly reduced the degree of depression(standard mean difference=-0.44,95%confidence interval[CI]:-0.78-0.10;P=0.01]and improved the status of the physical health component summary(mean difference=8.85,95%CI:3.69-14.00;P=0.00]in SLE patients.However,there was no significant effect of psychological intervention on disease activity,degree of pain,fatigue or the mental health component summary.Conclusions:The results show that psychological interventions can effectively improve the health-related quality of life in patients with SLE.The full benefit and clinical performance of psychological care requires further investigation by a series of multicenter,large-sample size randomized controlled trails.展开更多
Background:Zhibai Dihuang pill(ZBDH),a Chinese herbal formula,has been widely used as an adjunctive therapy to help reduce the patient’s steroid dose and maintain low disease activity in systemic lupus erythematosus(...Background:Zhibai Dihuang pill(ZBDH),a Chinese herbal formula,has been widely used as an adjunctive therapy to help reduce the patient’s steroid dose and maintain low disease activity in systemic lupus erythematosus(SLE).Objective:This systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE.Search strategy:A systematic literature search was carried out using seven databases,including PubMed,Embase,Cochrane Central Register of Controlled Trials,Chinese Biomedical Literature Database,Chinese National Knowledge Infrastructure,Chinese VIP Information and Wanfang Database,from their inception to June 1 st,2019.The search terms included‘‘systemic lupus erythematosus,"‘‘Chinese medicine"and‘‘clinical trial,"and their synonyms.Subject headings matching the above terms were also used.Inclusion criteria:This meta-analysis included randomized controlled trials that evaluated the reduction of steroid dose in patients with SLE.Traditional Chinese medicine(TCM)formulas in experimental group should be prescribed based on ZBDH and used as adjunctive therapy and the comparator should contain steroids.Data extraction and analysis:Two authors independently conducted database search,study selection,data extraction and quality assessment.The extracted information contained study design,sample size,recruitment mode,diagnostic criteria,inclusion and exclusion criteria,participant characteristics,TCM patterns,TCM formulas and treatment outcomes.The primary outcome was the change of steroid dose.Secondary outcomes included SLE Disease Activity Index(SLEDAI),biomarkers of disease activity and clinical response rate.STATA 15.0 was used to analyze the pooled effects reported as weighted mean difference(WMD)or odds ratio,with a 95%confidence interval(CI).Results:In total,20 trials involving 1470 SLE patients were included.The pooled result showed that modified ZBDH taken in combination with standard care led to a larger reduction in steroid dose,compared to standard care alone(WMD:3.79;95%CI:2.58–5.01;P<0.001).Favorable outcomes were also seen in secondary outcome criteria,such as SLEDAI and complement 3.The modified ZBDH treatments were well tolerated without increasing adverse effects.Conclusion:The systematic review provided preliminary evidence supporting the use of ZBDH as a cotherapy to aid steroid dose reduction in patients with SLE.However,more rigorous studies should be conducted to validate these findings,and explore the mechanisms of ZBDH’s relevant bioactive constituents.展开更多
文摘Objective:Observe the clinical characteristics of children with SLE,namely,to observe the symptoms and laboratory examinations,such as blood routine,blood lipid,immunoglobulin,complement,autoantibodies,serum 25(OH)D and other indicators,and to explore the clinical characteristics,the difference and the significance of vitamin D supplements between male and female SLE patients in children respectively.Methods:We enrolled 64 cases of SLE patients in children who were admitted into the department of pediatrics and rheumatology of the third affiliated hospital of sun yat-sen university in guangzhou from May 1,2011 to February 1,2019,They were analyzed retrospectively,adoptingΧ²test for statistical analysis.Results:64 cases of SLE in children,which included 10 cases of male and 54 cases of female.Clinical manifestations:facial skin rash in 48 patients(75%),fever in 38 cases(59.4%),arthritis in 28 cases(43.8%),oral ulcer in 18 cases(28.1%),serositis in13 cases(20.3%),and the sun allergy in 9 cases(14.1%),the damage of central nervous system in 7 cases(10.9%).Laboratory examination:30 cases of leukopenia(46.9%),anemia in 30 cases(46.9%),thrombocytopenia in 12 cases(18.8%),hematuria in 18 cases(28.1%),proteinuria in 33 cases(51.2%),6 patients with renal impairment(9.4%),antinuclear antibody positive in 63 cases(98.4%),anti-double-stranded DNA(dsDNA)antibody positive in 48 cases(75%),anti SSA antibody positive in 44 cases(68.7%),SSB antibody positive in 33 cases(51.6%),Sm antibody positive in 40 cases(62.5%),nucleosome antibody positive in 28 cases(43.8%).Among these children,male SLE patients were higher than female children with SLE in the damage of kidney,Sm antibodies and resisting nucleosome antibody positive rates(Χ²=4.451,8.336,6.803,P<0.05),the female children with SLE was higher than male SLE Children in the anti-SSB antibody positive rate(Χ²=4.945,P<0.05).In 64 cases of SLE children,which included 52 cases were lower than the normal level of serum 25(OH)D measurements,12 cases were in the normal lower limit of serum 25(OH)D measurements,at the same time,the female SLE.Patients was higher than male children with SLE in the reduce rate of serum 25(OH)D(Χ²=8.351,P<0.05).Conclusion:Male SLE patients which appeared damage of kidney easier than female patients,the proteinuria was the most common in the damage of kidney.Resistance to Sm antibodies which was the risk factor of renal injury with higher incidence in male children with SLE;Anti nucleosome antibody which was the risk factor for the disease activity in male children with SLE were higher than female children with SLE.It was estimated that the risk of Sjogren’s syndrome appeared in female with SLE were higher than that in male SLE children.In this retrospective study,the serum 25(OH)D levels were significantly lower in children with SLE,and vitamin D supplementation was required.
文摘Background： SmD1-amino-acid 83-119 peptide （SmD183-119） is the major epitope of Smith （Sm） antigen, which is specific for adult systemic lupus erythematosus （SLE）. The anti-SmD183-119 antibody has exhibited higher sensitivity and specificity than anti-Sm antibody in diagnosing adult SLE. However, the utility of anti-SmD183-119 antibodies remains unclear in children with SLE （cSLE）. This study aimed to assess the characteristics of anti-StuD 183-119 antibody in the diagnosis of cSLE. Methods： Samples from 242 children with different rheumatological and immunological disorders, including autoimmune diseases （SLE [n = 46] and ankylosing spondylitis [AS, n = 11]）, nonautoimmune diseases （Henoch-Schonlein purpura [HSP, n = 60], idiopathic thrombocytopenia purpura [n = 27], hematuria [n = 59], and arthralgia [n = 39]） were collected from Shanghai Children＇s Medical Center from March 6, 2012 to February 27, 2014. Seventy age- and sex-matched patients were enrolled in this study as the negative controls. All the patients＇ sera were analyzed for the anti-SmD 183-119, anti-Sm, anti-U 1-nRNP, anti-double-stranded DNA （dsDNA）, anti-nucleosome, anti-SSA/Ro60, anti-SSA/Ro52, anti-SSB, anti-Scl-70, and anti-histone antibodies using the immunoblotting assay. The differences in sensitivity and specificity between anti-SmD183-119 and anti-Sm antibodies were compared by Chi-square test. The correlations between anti-SmD183-119 and other auto-antibodies were analyzed using the Spearman＇s correlation analysis. A value of P 〈 0.05 was considered statistically significant. Results： Thirty-six out of 46 patients with cSLE were found to be positive for anti-SmD183-119, while 12 patients from the cSLE cohort were found to be positive for anti-Sm. Compared to cSLE, it has been shown that anti-SmD183-119 was only detected in 27.3% of patients with AS and 16.7% of patients with HSP. In comparison with anti-Sm, it has been demonstrated that anti-StuD 183-119 had a higher sensitivity （78.3% vs. 26.1%, 2＇2 = 25.1, P 〈 0.05） and a lower specificity （90.8% vs. 100%, x^2 = 13.6, P 〈 0.05） in the diagnosis of cSLE. Further analysis revealed that anti-StuD 183-119 antibodies were positively correlated with anti-dsDNA, anti-nucleosome, and anti-histone antibodies in cSLE. Moreover, it has been clearly shown that anti-SmD183-119was more sensitive than anti-Sm in discriminating autoimmune diseases from nonautoimmune disorders in patients with arthralgia or hematuria. Conclusions： Measurement of anti-SmD183-119 in patients with cSLE has a higher sensitivity and a marginally lower specificity than anti-Sin. It has been suggested that inclusion of anti-SmD183-119 testing in the integrated laboratory diagnosis ofcSLE may significantly improve the overall sensitivity in child populations.
基金Supported by the Ministry of Science and Higher Education of the Russian Federation,No.075-15-2022-301the Russian Science Foundation,No.22-45-08004.
文摘BACKGROUND Systemic lupus erythematosus(SLE)is the most frequent and serious systemic connective tissue disease.Nowadays there is no clear guidance on its treatment in childhood.There are a lot of negative effects of standard-of-care treatment(SOCT),including steroid toxicity.Rituximab(RTX)is the biological B-lymphocyte-depleting agent suggested as a basic therapy in pediatric SLE.AIM To compare the benefits of RTX above SOCT.METHODS The data from case histories of 79 children from the Saint-Petersburg State Pediatric Medical University from 2012 to 2022 years,were analyzed.The diagnosis of SLE was established with SLICC criteria.We compared the outcomes of treatment of SLE in children treated with and without RTX.Laboratory data,doses of glucocorticosteroids,disease activity measured with SELENA-SLEDAI,RESULTS Patients,treated with RTX initially had a higher degree of disease activity with prevalence of central nervous system and kidney involvement,compared to patients with SOCT.One year later the disease characteristics became similar between groups with a more marked reduction of disease activity(SELENA-SLEDAI activity index)in the children who received RTX[-19 points(17;23)since baseline]compared to children with SOCT[-10(5;15.5)points since baseline,P=0.001],the number of patients with active lupus nephritis,and daily proteinuria.During RTX therapy,infectious diseases had three patients;one patient developed a bi-cytopenia.CONCLUSION RTX can be considered as the option in the treatment of severe forms of SLE,due to its ability to arrest disease activity compared to SOCT.
基金Supported by Ministry of Science and Higher Education of the Russian Federation,No.075-15-2022-301the Russian Science Foundation Grant,No.22-45-08004.
文摘BACKGROUND Juvenile systemic lupus erythematosus(SLE)is a severe,life-threatening disease.However,the role of rituximab in managing juvenile SLE remains undefined,although early biological intervention may improve disease outcomes.AIM To assess the differences in the outcomes of different types of rituximab administration(early and late).METHODS In this retrospective cohort study,the information of 36 children with SLE with administration(LRA)was analyzed.We compared initial disease characteristics at onset,at baseline(start of rituximab),and at the end of the study(EOS)at 12 months,as well as outcomes and treatment characteristics.RESULTS The main differences at baseline were a higher daily median dose of corticosteroids,increased MAS frequency,and a higher Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)in the ERA group.No differences in the main SLE outcomes between groups at the EOS were observed.The part of lupus nephritis patients who achieved remission changed from 44%to 31%in ERA and 32%to 11%in the LRA group.Patients with ERA had a shorter time to achieve low daily corticosteroid dose(≤0.2 mg/kg)at 1.2(0.9;1.4)years compared to 2.8(2.3;4.0)years(P=0.000001)and higher probability to achieve this low dose[hazard ratio(HR)=57.8(95%confidence interval(CI):7.2-463.2),P=0.00001 and remission(SLEDAI=0);HR=37.6(95%CI:4.45-333.3),P=0.00001].No differences in adverse events,including severe adverse events,were observed.CONCLUSION ERA demonstrated a better steroid-sparing effect and a possibility of earlier remission or low disease activity,except for lupus nephritis.Further investigations are required.
文摘Objective:To objectively evaluate the effectiveness of psychological interventions for improving health-related quality of life in patients with systemic lupus erythematosus(SLE).Design and review methods:Databases including Ovid-Medline,PubMed,Web of Science,EBSCOhost,the Cochrane Library and Embase were electronically searched to identify randomized controlled trials published from inception through November 2013 involving psychological intervention in SLE patients.Studies that measured physiological function,life vitality,depression,pain degree,disease activity,severity of fatigue,and physical and mental component summaries as outcomes were included.Trials involving patients with multiple diseases or received simultaneous psychological interventions or combinations of other interventions were excluded.Two independent investigators screened the identified articles,extracted the data,and assessed the methodological quality of the included studies.Qualitative descriptions were conducted and quantitative analysis was performed with RevMan software(version 5.2).Results:A total of six randomized controlled trials comprising 394 participants were included in the study.Meta-analyses showed that psychological interventions significantly reduced the degree of depression(standard mean difference=-0.44,95%confidence interval[CI]:-0.78-0.10;P=0.01]and improved the status of the physical health component summary(mean difference=8.85,95%CI:3.69-14.00;P=0.00]in SLE patients.However,there was no significant effect of psychological intervention on disease activity,degree of pain,fatigue or the mental health component summary.Conclusions:The results show that psychological interventions can effectively improve the health-related quality of life in patients with SLE.The full benefit and clinical performance of psychological care requires further investigation by a series of multicenter,large-sample size randomized controlled trails.
基金supported by the Research Fund of Honours Project 2016–2017 of Bachelor of Chinese Medicine of Hong Kong Baptist University。
文摘Background:Zhibai Dihuang pill(ZBDH),a Chinese herbal formula,has been widely used as an adjunctive therapy to help reduce the patient’s steroid dose and maintain low disease activity in systemic lupus erythematosus(SLE).Objective:This systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE.Search strategy:A systematic literature search was carried out using seven databases,including PubMed,Embase,Cochrane Central Register of Controlled Trials,Chinese Biomedical Literature Database,Chinese National Knowledge Infrastructure,Chinese VIP Information and Wanfang Database,from their inception to June 1 st,2019.The search terms included‘‘systemic lupus erythematosus,"‘‘Chinese medicine"and‘‘clinical trial,"and their synonyms.Subject headings matching the above terms were also used.Inclusion criteria:This meta-analysis included randomized controlled trials that evaluated the reduction of steroid dose in patients with SLE.Traditional Chinese medicine(TCM)formulas in experimental group should be prescribed based on ZBDH and used as adjunctive therapy and the comparator should contain steroids.Data extraction and analysis:Two authors independently conducted database search,study selection,data extraction and quality assessment.The extracted information contained study design,sample size,recruitment mode,diagnostic criteria,inclusion and exclusion criteria,participant characteristics,TCM patterns,TCM formulas and treatment outcomes.The primary outcome was the change of steroid dose.Secondary outcomes included SLE Disease Activity Index(SLEDAI),biomarkers of disease activity and clinical response rate.STATA 15.0 was used to analyze the pooled effects reported as weighted mean difference(WMD)or odds ratio,with a 95%confidence interval(CI).Results:In total,20 trials involving 1470 SLE patients were included.The pooled result showed that modified ZBDH taken in combination with standard care led to a larger reduction in steroid dose,compared to standard care alone(WMD:3.79;95%CI:2.58–5.01;P<0.001).Favorable outcomes were also seen in secondary outcome criteria,such as SLEDAI and complement 3.The modified ZBDH treatments were well tolerated without increasing adverse effects.Conclusion:The systematic review provided preliminary evidence supporting the use of ZBDH as a cotherapy to aid steroid dose reduction in patients with SLE.However,more rigorous studies should be conducted to validate these findings,and explore the mechanisms of ZBDH’s relevant bioactive constituents.
