Gao Ying, Yang Xiao-Kun, Ji Zhao-Chen, Peng De-Hui, Xu Xin-Yi, Wu Yi-Fan, Li Kai, Zhang Jun-Hua, Cao Lu-Jia
National Clinical Medicine Research Center of Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300381, China Center for Evidence-based Medicine,Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
National Clinical Medicine Research Center of Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300381, China.
Zhongguo Zhong Yao Za Zhi. 2023 Apr;48(7):1962-1975. doi: 10.19540/j.cnki.cjcmm.20230117.501.
In this study, an overview of systematic reviews/Meta-analysis(SR/MA) of Chinese herbal injections for sepsis was performed to provide references for clinical practice and promote the quality improvement of clinical evidence. Eight Chinese and English databases such as CNKI, Medline, and EMbase were electronically searched for SR/MA of Chinese herbal injections for sepsis from database inception to June 2022. AMSTAR 2, PRISMA 2020, and GRADE system, combined with Recommendations for Clinical Evidence Grading on Traditional Chinese Medicine Based on Evidence Body, were applied to evaluate the methodological quality, reporting quality, and evidence quality of the included articles. Twenty-seven articles of SR/MA were included, containing four Chinese herbal injections(Xuebijing Injection, Shenfu Injection, Shenmai Injection, and Shengmai Injection). AMSTAR 2 checklist showed that the methodological quality of the SR/MA ranged from moderate to very low. Item 2(prior study design) was the critical item with poor scores, and the non-critical items with poor scores were items 3(explain the selection of the study designs), items 10(report on the sources of funding), and items 16(conflicts of interest stated). In terms of PRISMA 2020, items in eight topics with complete reporting of missing>50%, including search strategy, certainty assessment, results of syntheses, certainty of evidence, registration and protocol, support, competing interests, availability of data, code and other materials. The included SR/MA involved 30 outcome indicators. Evidence quality of mortality, APACHE Ⅱ, and safety, the top three outcome indicators, was evaluated, and all of them were graded as the medium level. The lack of random allocation sequence, allocation concealment mechanism, blinding, and trial sample size was the main reason for the reduction of the evidence level. The available evidence shows that Chinese herbal injections can serve as an effective and safe adjunctive treatment for sepsis, which can reduce mortality, inhibit inflammation, improve coagulation function, and regulate immune function, tissue perfusion, and oxygenation in patients with sepsis. However, the quality of SR/MA was suboptimal, and more high-quality SR/MA is needed to provide evidence to support the efficacy and safety of Chinese herbal injections in the treatment of sepsis.
在本研究中，对中药注射剂治疗脓毒症的系统评价/Meta分析（SR/MA）进行了概述，为临床实践提供参考，并促进临床证据质量的提高。通过电子检索中国知网（CNKI）、医学在线（Medline）和荷兰医学文摘数据库（EMbase）等8个中英文数据库，检索从建库至2022年6月关于中药注射剂治疗脓毒症的SR/MA。应用AMSTAR 2、PRISMA 2020和GRADE系统，并结合基于证据体的中医临床证据分级推荐意见，对纳入文献的方法学质量、报告质量和证据质量进行评价。共纳入27篇SR/MA文献，涉及4种中药注射剂（血必净注射液、参附注射液、参麦注射液和生脉注射液）。AMSTAR 2清单显示，SR/MA的方法学质量从中等至极低不等。第2项（前期研究设计）是得分较差的关键项，得分较差的非关键项有第3项（解释研究设计的选择）、第10项（报告资金来源）和第16项（说明利益冲突）。依据PRISMA 2020，8个主题中存在缺失报告>50%的项目，包括检索策略、确定性评估、综合结果、证据确定性、注册和方案、支持、利益冲突、数据可用性、代码及其他材料。纳入的SR/MA涉及30个结局指标。对死亡率、急性生理与慢性健康状况评分系统Ⅱ（APACHEⅡ）和安全性这3个主要结局指标的证据质量进行评价，均评为中等水平。缺乏随机分配序列、分配隐藏机制、盲法和试验样本量是证据水平降低的主要原因。现有证据表明，中药注射剂可作为脓毒症有效且安全的辅助治疗手段，可降低死亡率、抑制炎症、改善凝血功能，并调节脓毒症患者的免疫功能、组织灌注和氧合。然而，SR/MA的质量欠佳，需要更多高质量的SR/MA来为中药注射剂治疗脓毒症的疗效和安全性提供证据支持。
