Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China.
Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, 06520, USA.
Chin J Integr Med. 2021 Oct;27(10):778-787. doi: 10.1007/s11655-021-3497-0. Epub 2021 Jul 28.
To provide evidence on the efficacy and safety of Chinese herbal medicine (CHM) as interventions for systemic lupus erythematosus (SLE).
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.
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.
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.
提供中药干预系统性红斑狼疮（SLE）疗效和安全性的证据。
全面检索 Cochrane 图书馆、中国知网（CNKI）、中文科技期刊数据库（VIP）、中国生物医学文献服务系统（SinoMed）、万方、Embase 和 PubMed 等 7 个电子数据库，从建库至 2020 年 8 月 16 日，检索所有单独使用中药或与常规药物联合治疗 SLE 的随机对照试验（RCT）。结局指标为 SLE 活动指数（SLEDAI）、中医症状/证候评分（TCMSS）、糖皮质激素剂量、主要血清学检测和不良反应发生率。采用 Review Manager 5.3 软件提取和合并数据。
共纳入 13 项 RCT，纳入 856 名患者。Meta 分析结果显示，与安慰剂相比，中药在降低 SLEDAI 评分（MD=-1.74，95%CI：-2.29 至-1.18）、中医症状/证候评分（SMD=-0.89，95%CI：-1.16 至-0.62）、减少糖皮质激素剂量（MD=-2.41 mg/d，95%CI：-3.34 至-1.48）、降低红细胞沉降率（MD=-4.78 mm/h，95%CI：-8.86 至-0.71）和增加血清补体 C4 水平（MD=0.03 mg/dL，95%CI：0.00 至 0.06）方面具有统计学意义。中药和安慰剂在不良反应方面无显著差异。
中药对控制 SLE 患者的疾病活动度和减少糖皮质激素剂量具有显著的有益作用。目前迫切需要进行更多的多中心、长期随访的 RCT，以评估中药治疗中重度 SLE 的效果。
