Jiang Hong, Yang Xue-Mei, Wang Cheng-Qiong, Xu Jiao, Huang Jun, Feng Ji-Hong, Chen Xiao-Fan, Chen Kai, Zhan Lin, Xiao Xue, Xiao Zheng
Department of General Practice, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
Evidence-Based Medicine Center, MOE Virtual Research Center of Evidence-Based Medicine at Zunyi Medical College, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
Front Med (Lausanne). 2022 Apr 25;9:816973. doi: 10.3389/fmed.2022.816973. eCollection 2022.
The staphylococcal enterotoxin C (SEC), a commercially available bio-product from (), has been widely used to control MPE.
We designed and performed a new systematic review (SR) and meta-analysis to clarify the perfusion protocols with SEC, determine their clinical effectiveness and safety, and reveal the indication and optimum usage for achieving the desired responses.
All randomized controlled trials (RCTs) about SEC for MPE were collected from electronic databases (from inception until July 2021), and clustered into multiple logical topics. grading of recommendation assessment, development, and evaluation (GRADE) approach.
All 114 were clustered into SEC alone or plus chemical agents. The SEC alone showed a better complete response (CR), a lower pleurodesis failure, and adverse drug reactions (ADRs), and a higher fever than cisplatin (DDP) alone. The SEC and chemical agents developed 10 perfusion protocols. . The SEC (100-200 ng per time, one time a week for one to four times) with DDP (30-40 mg, or 50-60 mg each time) significantly improved clinical responses for patients with moderate to large volume, Karnofsky performance status (KPS) scores ≥40, ≥50, or ≥60, and anticipated survival time (AST) ≥2 or 3 months. Most results were moderate to low quality.
Current pieces of evidence indicate that super-antigen SEC is a pleurodesis agent, which provides an attractive alternative to existing palliative modalities for patients with MPE. Among 10 protocols, the SEC and DDP perfusion is a most commonly used, which shows a significant improvement in clinical responses with low ADRs. These findings also a possible indication and optimal usage for SEC and DDP perfusion.
葡萄球菌肠毒素C（SEC）是一种可从（）获得的商业生物制品，已被广泛用于控制恶性胸腔积液（MPE）。
我们设计并进行了一项新的系统评价（SR）和荟萃分析，以阐明SEC的灌注方案，确定其临床有效性和安全性，并揭示实现预期反应的适应症和最佳用法。
从电子数据库（从创建至2021年7月）收集所有关于SEC治疗MPE的随机对照试验（RCT），并将其聚类为多个逻辑主题。采用推荐评估、制定和评价分级（GRADE）方法。
所有114项（研究）被聚类为单独使用SEC或联合化学药物。单独使用SEC显示出更好的完全缓解（CR）、更低的胸膜固定术失败率和药物不良反应（ADR），且发热高于单独使用顺铂（DDP）。SEC与化学药物制定了10种灌注方案。。SEC（每次100 - 200 ng，每周一次，共一至四次）联合DDP（每次30 - 40 mg，或50 - 60 mg）可显著改善中至大量胸腔积液、卡氏功能状态（KPS）评分≥40、≥50或≥60以及预期生存时间（AST）≥2或3个月患者的临床反应。大多数结果质量为中等至低等。
目前的证据表明，超抗原SEC是一种胸膜固定剂，为MPE患者提供了一种有吸引力的现有姑息治疗方式的替代方案。在10种方案中，SEC与DDP灌注是最常用的，其显示出临床反应显著改善且ADR较低。这些发现也表明了SEC与DDP灌注的可能适应症和最佳用法。
