HTA Austria-Austrian Institute for Health Technology Assessment GmbH (Former: Ludwig Boltzmann Institute for HTA), Vienna, Austria.
Klinik Favoriten, Wiener Gesundheitsverbund, Vienna, Austria.
Crit Care Med. 2021 Aug 1;49(8):1347-1357. doi: 10.1097/CCM.0000000000005023.
Evaluating whether there is a clinical benefit of using extracorporeal cytokine adsorption therapy in two indications.
Systematic review.
Search on four databases, Medline, Embase, The Cochrane Library, and the European Network for Health Technology Assessment planned and ongoing projects database.
Patients with sepsis/septic shock; patients undergoing cardiac surgery.
Cytokine adsorption.
Randomized controlled trials and prospective studies with concurrent control were eligible for the evidence synthesis. The quality of the individual studies and the strength of the available evidence were assessed using the Cochrane risk of bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach, respectively. For the preventive treatment of extracorporeal cytokine adsorption therapy in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (five randomized controlled trials, n = 163), length of stay in the ICU (five randomized controlled trials, n = 163), and length of hospitalization (three randomized controlled trials, n = 101). Very low-quality inconclusive evidence was found for (serious) adverse events (four randomized controlled trials, n = 148). For the therapeutic treatment of extracorporeal cytokine adsorption therapy in patients with sepsis/septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (two randomized controlled trials, n = 117), organ function (two randomized controlled trials, n = 117) and length of stay in the ICU (one randomized controlled trial, n = 20). Very low-quality inconclusive evidence was found for (serious) adverse events (two randomized controlled trials, n = 117).
Given the available evidence, the efficacy and safety of extracorporeal cytokine adsorption therapy in combination with standard care in the investigated indications was not established. We strongly recommend considering well-powered studies with patient-relevant endpoints instead of investing further research funds on studies that may not shed light on the clinical benefit of extracorporeal cytokine adsorption therapy.
评估在两种适应证中使用体外细胞因子吸附疗法是否具有临床获益。
系统评价。
在四个数据库（Medline、Embase、Cochrane 图书馆和欧洲卫生技术评估网络计划和正在进行的项目数据库）上进行检索。
脓毒症/脓毒性休克患者；接受心脏手术的患者。
细胞因子吸附。
有对照的随机对照试验和前瞻性研究符合证据综合的纳入标准。使用 Cochrane 偏倚风险工具和推荐、评估、制定和评估方法（Grading of Recommendations, Assessment, Development, and Evaluation，GRADE）分别评估了单个研究的质量和可用证据的强度。对于接受心脏手术的患者进行预防性细胞外细胞因子吸附治疗，我们发现死亡率（5 项随机对照试验，n = 163）、重症监护病房（5 项随机对照试验，n = 163）和住院时间（3 项随机对照试验，n = 101）的高质量证据不足。（严重）不良事件（4 项随机对照试验，n = 148）的证据质量也很低。对于脓毒症/脓毒性休克患者的体外细胞因子吸附治疗的治疗性治疗，我们发现 60 天随访时死亡率（2 项随机对照试验，n = 117）、器官功能（2 项随机对照试验，n = 117）和重症监护病房住院时间（一项随机对照试验，n = 20）的高质量证据不足。（严重）不良事件（2 项随机对照试验，n = 117）的证据质量也很低。
鉴于现有证据，在研究的适应证中，体外细胞因子吸附疗法联合标准治疗的疗效和安全性尚未确定。我们强烈建议考虑采用具有患者相关终点的大型研究，而不是将进一步的研究资金投入到可能无法阐明体外细胞因子吸附疗法临床获益的研究中。
