Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China.
J Integr Med. 2020 Nov;18(6):478-491. doi: 10.1016/j.joim.2020.08.007. Epub 2020 Aug 26.
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).
This systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE.
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 1st, 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.
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.
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).
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.
The systematic review provided preliminary evidence supporting the use of ZBDH as a co-therapy 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.
知柏地黄丸（ZBDH）是一种中药方剂，已广泛用于辅助治疗系统性红斑狼疮（SLE），以帮助减少患者的皮质类固醇剂量并维持低疾病活动度。
本系统评价评估了知柏地黄丸在减少 SLE 患者皮质类固醇使用方面的治疗效果。
系统检索了七个数据库，包括 PubMed、Embase、Cochrane 对照试验中心注册库、中国生物医学文献数据库、中国知网、中国维普信息和万方数据库，从建库到 2019 年 6 月 1 日。检索词包括“系统性红斑狼疮”、“中药”和“临床试验”及其同义词。还使用了与上述术语匹配的主题词。
本荟萃分析纳入了评估 SLE 患者皮质类固醇剂量减少的随机对照试验。实验组中的中药方剂应基于知柏地黄丸，并作为辅助治疗，对照剂应包含皮质类固醇。
两位作者独立进行数据库搜索、研究选择、数据提取和质量评估。提取的信息包括研究设计、样本量、招募模式、诊断标准、纳入和排除标准、参与者特征、中医模式、中医方剂和治疗结果。主要结局是皮质类固醇剂量的变化。次要结局包括系统性红斑狼疮疾病活动指数（SLEDAI）、疾病活动生物标志物和临床反应率。使用 STATA 15.0 分析报告的汇总效应，以加权均数差（WMD）或比值比表示，置信区间（CI）为 95%。
共纳入 20 项试验，涉及 1470 例 SLE 患者。汇总结果显示，与单独标准治疗相比，知柏地黄丸联合标准治疗可导致皮质类固醇剂量更大幅度减少（WMD：3.79；95%CI：2.58-5.01；P<0.001）。次要结局标准，如 SLEDAI 和补体 3 也有良好的结局。知柏地黄丸治疗组无不良反应增加。
系统评价提供了初步证据支持知柏地黄丸作为辅助治疗，以帮助减少 SLE 患者的皮质类固醇剂量。然而，应该进行更严格的研究来验证这些发现，并探索知柏地黄丸相关生物活性成分的作用机制。
