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Abstract：
OBJECTIVE: To provide evidence on the efficacy and safety of Chinese herbal medicine (CHM) as interventions for systemic lupus erythematosus (SLE).
METHODS: Seven electronic databases, including the Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Chinese Biomedical Literature Service System (SinoMed), Wanfang, Embase, and PubMed, were comprehensively searched, from their inception to August 16, 2020, for all randomized controlled trials (RCTs) that focused on CHM used alone or in combination with conventional medicine for SLE. Outcomes were SLE activity index (SLEDAI), traditional Chinese medicine symptom/syndrome score (TCMSS), dosage of glucocorticoids, main serological testing, and incidence of adverse events. Data were extracted and pooled using Review Manager 5.3 software.
RESULTS: A total of 13 RCTs enrolling 856 participants met our inclusion criteria. Meta-analyses showed that, compared to placebo, CHM had statistically significant effect on reducing SLEDAI score (MD=-1.74, 95% CI: -2.29 to -1.18), diminishing TCMSS (SMD=-0.89, 95% CI: -1.16 to -0.62), decreasing dosage of glucocorticoids (MD=-2.41 mg/d, 95% CI: -3.34 to -1.48), lowering erythrocyte sedimentation rate (MD=-4.78 mm/h, 95% CI: -8.86 to -0.71), and increasing serum complement C4 level (MD=0.03 mg/dL, 95% CI: 0.00 to 0.06). No significant difference was found between CHM and placebo on adverse events.
CONCLUSIONS: CHM provided significant beneficial effect on controlling disease activity and reducing dose of glucocorticoids used among SLE patients. Future advanced designed RCTs for CHM treating moderate to severe SLE with multicenter and longer follow-up are urgently needed.
METHODS: Seven electronic databases, including the Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Chinese Biomedical Literature Service System (SinoMed), Wanfang, Embase, and PubMed, were comprehensively searched, from their inception to August 16, 2020, for all randomized controlled trials (RCTs) that focused on CHM used alone or in combination with conventional medicine for SLE. Outcomes were SLE activity index (SLEDAI), traditional Chinese medicine symptom/syndrome score (TCMSS), dosage of glucocorticoids, main serological testing, and incidence of adverse events. Data were extracted and pooled using Review Manager 5.3 software.
RESULTS: A total of 13 RCTs enrolling 856 participants met our inclusion criteria. Meta-analyses showed that, compared to placebo, CHM had statistically significant effect on reducing SLEDAI score (MD=-1.74, 95% CI: -2.29 to -1.18), diminishing TCMSS (SMD=-0.89, 95% CI: -1.16 to -0.62), decreasing dosage of glucocorticoids (MD=-2.41 mg/d, 95% CI: -3.34 to -1.48), lowering erythrocyte sedimentation rate (MD=-4.78 mm/h, 95% CI: -8.86 to -0.71), and increasing serum complement C4 level (MD=0.03 mg/dL, 95% CI: 0.00 to 0.06). No significant difference was found between CHM and placebo on adverse events.
CONCLUSIONS: CHM provided significant beneficial effect on controlling disease activity and reducing dose of glucocorticoids used among SLE patients. Future advanced designed RCTs for CHM treating moderate to severe SLE with multicenter and longer follow-up are urgently needed.
摘要：
目的：为中药（CHM）作为系统性红斑狼疮（SLE）干预措施的有效性和安全性提供证据。
方法：七个电子数据库，包括Cochrane图书馆,中国国家知识基础设施(CNKI),中国科学期刊数据库(VIP),中国生物医学文献服务系统(SinoMed)，万方,Embase,和PubMed,进行了全面搜索，从开始到2020年8月16日，所有随机对照试验（RCT）都侧重于单独使用CHM或与常规药物联合使用治疗SLE。结果是SLE活动指数（SLEDAI），中医症状/证候积分(TCMSS),糖皮质激素的剂量，主要血清学检测，和不良事件的发生率。使用ReviewManager5.3软件提取并汇集数据。
结果：共有13个RCTs纳入856名参与者符合我们的纳入标准。荟萃分析表明,与安慰剂相比，CHM对降低SLEDAI评分具有统计学意义（MD=-1.74，95％CI：-2.29至-1.18），递减的TCMSS（SMD=-0.89，95%CI：-1.16至-0.62），减少糖皮质激素的剂量（MD=-2.41mg/d，95%CI：-3.34至-1.48），降低红细胞沉降率（MD=-4.78mm/h，95%CI：-8.86至-0.71），并增加血清补体C4水平（MD=0.03mg/dL，95%CI：0.00至0.06）。CHM和安慰剂在不良事件方面没有发现显着差异。
结论：CHM在控制SLE患者的疾病活动和减少糖皮质激素剂量方面具有显著的有益效果。迫切需要未来用于CHM治疗中重度SLE的先进RCT，多中心和更长时间的随访。
方法：七个电子数据库，包括Cochrane图书馆,中国国家知识基础设施(CNKI),中国科学期刊数据库(VIP),中国生物医学文献服务系统(SinoMed)，万方,Embase,和PubMed,进行了全面搜索，从开始到2020年8月16日，所有随机对照试验（RCT）都侧重于单独使用CHM或与常规药物联合使用治疗SLE。结果是SLE活动指数（SLEDAI），中医症状/证候积分(TCMSS),糖皮质激素的剂量，主要血清学检测，和不良事件的发生率。使用ReviewManager5.3软件提取并汇集数据。
结果：共有13个RCTs纳入856名参与者符合我们的纳入标准。荟萃分析表明,与安慰剂相比，CHM对降低SLEDAI评分具有统计学意义（MD=-1.74，95％CI：-2.29至-1.18），递减的TCMSS（SMD=-0.89，95%CI：-1.16至-0.62），减少糖皮质激素的剂量（MD=-2.41mg/d，95%CI：-3.34至-1.48），降低红细胞沉降率（MD=-4.78mm/h，95%CI：-8.86至-0.71），并增加血清补体C4水平（MD=0.03mg/dL，95%CI：0.00至0.06）。CHM和安慰剂在不良事件方面没有发现显着差异。
结论：CHM在控制SLE患者的疾病活动和减少糖皮质激素剂量方面具有显著的有益效果。迫切需要未来用于CHM治疗中重度SLE的先进RCT，多中心和更长时间的随访。
