Deliwala Smit S, Chandan Saurabh, Mohan Babu P, Khan Shahab, Reddy Nitin, Ramai Daryl, Bapaye Jay A, Dahiya Dushyant Singh, Kassab Lena L, Facciorusso Antonio, Chawla Saurabh, Adler Douglas
Division of Digestive Diseases, Emory University, Atlanta, Georgia, United States.
Gastroenterology & Hepatology, Creighton University School of Medicine, Omaha, Nebraska, United States.
Endosc Int Open. 2023 Mar 24;11(3):E288-E295. doi: 10.1055/a-2032-4199. eCollection 2023 Mar.
Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I %. Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I 43), 0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I 35), 0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I 0), 0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I 0), 0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I 26), 0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I 62), 0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I 0), 0.02. Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.
血凝素（TC-325）是一种具有吸附特性的矿物粉末，设计用于各种胃肠道出血（GIB）情况。我们对随机对照试验（RCT）进行了系统评价和荟萃分析，比较了TC-325与标准内镜治疗（SET）用于非静脉曲张性GIB（NVGIB）的效果。检索了多个数据库至2022年10月。使用随机效应模型进行荟萃分析，以确定主要止血、止血失败、30天再出血、住院时间（LOS）和抢救干预需求方面的合并相对风险（RR）及比例，并给出95%置信区间（CI）。使用I²%评估异质性。五项RCT共纳入362例患者（TC-325组178例，SET组184例）——123例女性和239例男性，平均年龄65±16岁。最常见的病因是消化性溃疡病（48%）、恶性肿瘤（35%）和其他（17%）。出血特征为Forrest IA（7%）、IB（73%）、IIA（3%）和IIB（1%）。SET包括肾上腺素注射、电灼、止血夹或联合使用。与SET相比，TC-325在主要止血方面无统计学差异，RR为1.09（CI 0.95 - 1.25；I² 43），P = 0.2，包括渗血/喷射性出血患者，RR为1.13（CI 0.98 - 1.3；I² 35），P = 0.08。与TC-325相比，SET的止血失败率更高，RR为0.30（CI 0.12 - 0.77，I² 0），P = 0.01，包括渗血/喷射性出血患者，RR为0.24（CI 0.09 - 0.63，I² 0），P = 0.004。我们发现两种干预措施在再出血方面无差异，RR为1.13（CI 0.62 - 2.07，I² 26），P = 0.8，在住院时间方面，标准化均数差（SMD）为0.27（CI，-0.20 - 0.74；I² 62），P = 0.3。最后，与TC-325相比，SET的抢救干预（血管造影）合并率在统计学上更高，RR为0.68（CI 0.5 - 0.94；I² 0），P = 0.02。我们的分析表明，对于急性NVGIB，包括渗血/喷射性出血，与SET相比，TC-325在主要止血率方面并未更高。然而，TC-325的失败率低于SET。此外，在比较再出血率和住院时间时，两种方式无差异。
