部分性脾动脉栓塞联合内镜治疗和非选择性β受体阻滞剂降低肝硬化合并脾功能亢进患者的静脉曲张再出血率：一项多中心随机对照试验。
Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial.
机构信息
Department of Gastroenterology, Qilu Hospital of Shandong University, Wenhua Xi Road, 107, Jinan City, 250012, Shandong Province, People's Republic of China.
Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan City, 250021, Shandong Province, China.
出版信息
Hepatol Int. 2021 Jun;15(3):741-752. doi: 10.1007/s12072-021-10155-0. Epub 2021 Feb 27.
BACKGROUND
Global research on endoscopic therapies in combination with partial splenic embolization (PSE) for variceal hemorrhage (VH) is limited. Therefore, we aimed to evaluate the efficacy and safety of endoscopy plus PSE (EP) treatment in comparison to endoscopic (E) treatment for the secondary prophylaxis of VH in cirrhosis patients with hypersplenism.
METHODS
Cirrhosis patients with hypersplenism (platelet count < 100, 000/µL) and those who had recovered from an episode of VH were enrolled in a multicenter randomized controlled trial. The participants were randomly assigned into EP and E groups in a 1:1 ratio. The primary endpoint was variceal rebleeding, and the secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up. Hematological indices, serum biochemical parameters, and the Child-Pugh score were measured at each time point.
RESULTS
From June 2016 to December 2019, 108 patients were enrolled in the study, among which 102 patients completed the protocol (51 in EP and 51 in E group). The rebleeding rate of the varices was significantly reduced in the EP group compared to that in the E group during the 2 years (16% vs. 31%, p < 0.001). The EP group showed a significantly lower variceal recurrence rate than the E group (22% vs. 67%, p < 0.001). The COX proportional hazard models revealed that grouping was an independent predictor for variceal rebleeding (H = 0.122, 95% CI 0.055-0.270, p < 0.001) and variceal recurrence (hazard ratio, H = 0.160, 95% CI 0.077-0.332, p < 0.001). The peripheral blood cell count, Child-Pugh class/score, albumin concentration, and coagulation function in the EP group improved significantly compared to the values observed in the E group at any time point (p < 0.05).
CONCLUSIONS
The EP treatment was more effective in preventing variceal rebleeding and variceal recurrence than the conventional E treatment during the secondary prophylaxis of VH in cirrhosis patients with hypersplenism. Furthermore, the EP treatment could significantly increase the peripheral blood cell count and albumin concentration and also improved the coagulation function and the Child-Pugh score.
CLINICAL TRIALS REGISTRATION
Trial registration number ClincialTrials.gov: NCT02778425. The URL of the clinical trial: https://clinicaltrials.gov/.
背景
全球范围内内镜治疗联合部分性脾栓塞术（PSE）治疗静脉曲张出血（VH）的研究有限。因此，我们旨在评估内镜联合 PSE（EP）治疗与单纯内镜（E）治疗在肝硬化伴脾功能亢进患者 VH 二级预防中的疗效和安全性。
方法
纳入患有脾功能亢进（血小板计数 < 100,000/μL）和 VH 发作已恢复的肝硬化患者，进行一项多中心随机对照试验。将参与者按照 1:1 的比例随机分配到 EP 和 E 组。主要终点是静脉曲张再出血，次要终点是 2 年随访期间严重静脉曲张复发和死亡率。在每个时间点测量血液学指标、血清生化参数和 Child-Pugh 评分。
结果
2016 年 6 月至 2019 年 12 月，共纳入 108 例患者，其中 102 例患者完成了方案（EP 组 51 例，E 组 51 例）。EP 组在 2 年期间静脉曲张再出血率明显低于 E 组（16% vs. 31%，p < 0.001）。EP 组静脉曲张复发率明显低于 E 组（22% vs. 67%，p < 0.001）。COX 比例风险模型显示，分组是静脉曲张再出血（H = 0.122，95%CI 0.055-0.270，p < 0.001）和静脉曲张复发（危险比，H = 0.160，95%CI 0.077-0.332，p < 0.001）的独立预测因素。与 E 组相比，EP 组在任何时间点的外周血细胞计数、Child-Pugh 分级/评分、白蛋白浓度和凝血功能均显著改善（p < 0.05）。
结论
与常规 E 治疗相比，EP 治疗在肝硬化伴脾功能亢进患者 VH 二级预防中更能有效预防静脉曲张再出血和静脉曲张复发。此外，EP 治疗可显著增加外周血细胞计数和白蛋白浓度，并改善凝血功能和 Child-Pugh 评分。
临床试验注册
临床试验注册编号 ClincialTrials.gov：NCT02778425。临床试验网址：https://clinicaltrials.gov/。
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