Abstract：
BACKGROUND: This study aimed to compare the efficacy of partial splenic embolization (PSE) combined with endoscopic therapy and endoscopic therapy alone in cirrhosis patients with acute variceal bleeding (AVB) and hypersplenism.
METHODS: Cirrhosis patients with AVB who visited three hospitals from June 2016 to June 2022 were prospectively enrolled and randomly allocated to either the endoscopic therapy combined with PSE group (EP group) or the endoscopic intervention group (E group) in a 1:1 ratio. The primary endpoint of the study was re-bleeding of varices during follow-up, and the secondary endpoints were the recurrence of varices, death, and adverse events.
RESULTS: One hundred and fourteen patients were prospectively included, of whom 110 completed the trial. The risk of variceal re-bleeding (19.3% vs. 40.4% (23/57), p = 0.013) and variceal recurrence (28.1% vs. 63.2%, p < 0.001) five years after treatment was significantly lower in the EP group than in the E group, and the EP treatment was the only significant independent risk factor affecting variceal re-bleeding and variceal recurrence in patients. The mortality rate was comparable between the EP and E groups. Peripheral blood counts and liver function all improved significantly in the EP group compared to the E group during the follow-up (p < 0.05).
CONCLUSIONS: The rates of variceal re-bleeding and recurrence were significantly lower in cirrhosis patients with AVB and hypersplenism after combined endoscopic and PSE treatment compared to those who were provided endoscopic treatment only. The peripheral blood counts and liver function were also improved significantly in EP group (NCT02778425).
METHODS: Cirrhosis patients with AVB who visited three hospitals from June 2016 to June 2022 were prospectively enrolled and randomly allocated to either the endoscopic therapy combined with PSE group (EP group) or the endoscopic intervention group (E group) in a 1:1 ratio. The primary endpoint of the study was re-bleeding of varices during follow-up, and the secondary endpoints were the recurrence of varices, death, and adverse events.
RESULTS: One hundred and fourteen patients were prospectively included, of whom 110 completed the trial. The risk of variceal re-bleeding (19.3% vs. 40.4% (23/57), p = 0.013) and variceal recurrence (28.1% vs. 63.2%, p < 0.001) five years after treatment was significantly lower in the EP group than in the E group, and the EP treatment was the only significant independent risk factor affecting variceal re-bleeding and variceal recurrence in patients. The mortality rate was comparable between the EP and E groups. Peripheral blood counts and liver function all improved significantly in the EP group compared to the E group during the follow-up (p < 0.05).
CONCLUSIONS: The rates of variceal re-bleeding and recurrence were significantly lower in cirrhosis patients with AVB and hypersplenism after combined endoscopic and PSE treatment compared to those who were provided endoscopic treatment only. The peripheral blood counts and liver function were also improved significantly in EP group (NCT02778425).
摘要：
背景：本研究旨在比较部分脾栓塞术（PSE）联合内镜治疗和单纯内镜治疗对急性静脉曲张破裂出血（AVB）和脾功能亢进的肝硬化患者的疗效。
方法：前瞻性纳入2016年6月至2022年6月在三家医院就诊的AVB肝硬化患者，并按1:1的比例随机分为内镜治疗联合PSE组（EP组）或内镜干预组（E组）。该研究的主要终点是随访期间静脉曲张的再出血，次要终点是静脉曲张的复发，死亡,和不良事件。
结果：前瞻性纳入了114例患者，其中110人完成了审判。静脉曲张再出血的风险（19.3%vs.40.4%（23/57），p=0.013）和静脉曲张复发（28.1%vs.63.2%,p<0.001)治疗后5年EP组明显低于E组,EP治疗是影响患者静脉曲张再出血和静脉曲张复发的唯一显著独立危险因素。EP组和E组的死亡率相当。随访期间EP组外周血计数和肝功能均较E组明显改善(p<0.05)。
结论：肝硬化合并AVB和脾功能亢进患者经内镜和PSE联合治疗后，静脉曲张再出血和复发率明显低于仅接受内镜治疗的患者。EP组（NCT02778425）的外周血计数和肝功能也明显改善。
方法：前瞻性纳入2016年6月至2022年6月在三家医院就诊的AVB肝硬化患者，并按1:1的比例随机分为内镜治疗联合PSE组（EP组）或内镜干预组（E组）。该研究的主要终点是随访期间静脉曲张的再出血，次要终点是静脉曲张的复发，死亡,和不良事件。
结果：前瞻性纳入了114例患者，其中110人完成了审判。静脉曲张再出血的风险（19.3%vs.40.4%（23/57），p=0.013）和静脉曲张复发（28.1%vs.63.2%,p<0.001)治疗后5年EP组明显低于E组,EP治疗是影响患者静脉曲张再出血和静脉曲张复发的唯一显著独立危险因素。EP组和E组的死亡率相当。随访期间EP组外周血计数和肝功能均较E组明显改善(p<0.05)。
结论：肝硬化合并AVB和脾功能亢进患者经内镜和PSE联合治疗后，静脉曲张再出血和复发率明显低于仅接受内镜治疗的患者。EP组（NCT02778425）的外周血计数和肝功能也明显改善。
