INTRODUCTION The efficacy of topical hemostatic agents, recommended for peptic ulcer bleeding, remains poorly characterized in malignant gastrointestinal bleeding (GIB). METHODS We performed an individual patient data meta-analysis assessing the efficacy of topical hemostatic agents in malignant GIB. The literature was searched using OVID MEDLINE, EMBASE, and ISI Web of Science databases (database inception to November 2023). Only randomized controlled trials (RCTs) comparing topical hemostatic agents with conventional endoscopic modalities in malignant GIB were included. Original RCT patient-level data were obtained. Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines were followed. Quality of the evidence was evaluated using the revised Cochrane risk-of-bias tool and certainty of evidence with the Grading of Recommendations Assessment, Development, and Evaluation approach. The primary outcome was immediate hemostasis; secondary outcomes were 30-day rebleeding and the composite measure of further bleeding (persistent bleeding or 30-day rebleeding). Other outcomes were all-cause mortality, adverse events, and need for additional nonendoscopic treatment. Odds ratios (ORs) from endpoint comparisons were pooled using logistic regression models. RESULTS Overall, 985 citations were identified; 3 RCTs (n = 160 patients) were included with all assessing TC-325 (Hemospray). TC-325 achieved immediate hemostasis more often than conventional endoscopic modalities (OR 46.6, 95% confidence interval [CI] 5.89-369.1) (low-level certainty). Thirty-day rebleeding (OR 0.28, 95% CI 0.11-0.70) and further bleeding (OR 0.11, 95% CI 0.05-0.26) were both significantly lower with TC-325 (very-low-level certainty). All-cause mortality and need for additional nonendoscopic treatment did not differ between groups. No adverse events were reported. Subgroup analysis confirmed TC-325 superiority in patients with upper GIB. DISCUSSION TC-325 seems superior to conventional endoscopic therapy in managing patients with malignant GIB. TC-325 results in improvements in immediate hemostasis, 30-day rebleeding, and further bleeding, based on very low-to-low certainties of evidence.

中文翻译：

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TC-325 在恶性消化道出血中的优效性：随机试验的个体患者数据荟萃分析。


引言 推荐用于消化性溃疡出血的局部止血剂在恶性消化道出血 （GIB） 中的疗效仍然很差。方法 我们进行了一项个体患者数据荟萃分析，评估局部止血剂对恶性 GIB 的疗效。使用 OVID MEDLINE、EMBASE 和 ISI Web of Science 数据库（建库至 2023 年 11 月）检索文献。仅纳入比较局部止血剂与常规内窥镜方式治疗恶性 GIB 的随机对照试验 （RCT）。获得原始 RCT 患者水平数据。遵循系统评价和 Meta 分析指南的首选报告项目。使用修订后的 Cochrane 偏倚风险工具评估证据质量，并使用推荐评分评估、开发和评价方法评估证据质量。主要结局是即刻止血;次要结局是 30 天再出血和进一步出血的复合指标 （持续出血或 30 天再出血）。其他结局是全因死亡率、不良事件和需要额外的非内窥镜治疗。使用 logistic 回归模型合并终点比较的比值比 （ORs）。结果 共确定了 985 篇引文;3 项 RCT （n = 160 名患者） 与所有评估的 TC-325 （Hemospray） 一起纳入。TC-325 比常规内窥镜检查更常实现即刻止血 （OR 46.6,95% 置信区间 [CI] 5.89-369.1） （低质量）。TC-325 组的 30 天再出血 （OR 0.28,95% CI 0.11-0.70） 和进一步出血 （OR 0.11,95% CI 0.05-0.26） 均显著降低 （极低质量）。 全因死亡率和对额外非内窥镜治疗的需求在各组之间没有差异。未报告不良事件。亚组分析证实 TC-325 在上 GIB 患者中具有优势。讨论 TC-325 在治疗恶性 GIB 患者方面似乎优于常规内窥镜治疗。TC-325 可改善速发型止血、30 天再出血和进一步出血，基于极低到极低的证据质量。