Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China.
Department of Clinical Pharmacy, Shenyang Pharmaceutical University, Shenyang, China.
Hepatol Commun. 2024 Sep 18;8(10). doi: 10.1097/HC9.0000000000000526. eCollection 2024 Oct 1.
Terlipressin has been widely used for various cirrhosis-related complications, but its safety profile remains controversial. Herein, this issue was systematically evaluated.
All studies reporting adverse events (AEs) of terlipressin in cirrhosis were screened. Incidences were pooled using a random-effects model. Subgroup analyses were performed according to the patient's characteristics and treatment regimens. Interaction among subgroups was evaluated.
Seventy-eight studies with 7257 patients with cirrhosis were included. The pooled incidences of any AEs, treatment-related AEs, any serious AEs (SAEs), treatment-related SAEs, treatment withdrawal due to AEs, and treatment withdrawal due to treatment-related AEs were 31%, 22%, 5%, 5%, 4%, and 4% in patients with cirrhosis receiving terlipressin, respectively. Patients with hepatorenal syndrome had higher incidences of any SAEs (29% vs. 0% vs. 0%, pinteraction = 0.01) and treatment-related SAEs (8% vs. 1% vs. 7%, pinteraction = 0.02) than those with variceal bleeding or ascites. Patients who received terlipressin with human albumin had higher incidences of any SAEs (18% vs. 1%, pinteraction = 0.04) and treatment-related SAEs (7% vs. 0%, pinteraction = 0.09) than those without albumin. Patients with total bilirubin level >4.3 mg/dL had higher incidences of any AEs (69% vs. 24%, pinteraction = 0.02), any SAEs (64% vs. 0%, pinteraction < 0.01), and treatment-related SAEs (8% vs. 1%, pinteraction = 0.04) than those ≤4.3 mg/dL.
AEs are common in patients with cirrhosis receiving terlipressin and influenced by clinical scenarios, combination with albumin, and bilirubin levels.
特利加压素已广泛用于各种肝硬化相关并发症，但它的安全性仍存在争议。本研究系统评价了特利加压素的安全性。
筛选了所有报道肝硬化患者特利加压素不良事件（AE）的研究。使用随机效应模型对发生率进行汇总。根据患者的特征和治疗方案进行亚组分析。评估亚组间的相互作用。
纳入了 78 项研究，共 7257 例肝硬化患者。接受特利加压素治疗的肝硬化患者中，任何 AE、与治疗相关的 AE、任何严重 AE（SAE）、与治疗相关的 SAE、因 AE 而停药和因与治疗相关的 AE 而停药的发生率分别为 31%、22%、5%、5%、4%和 4%。肝肾综合征患者的任何 SAE（29%比 0%比 0%，p 交互=0.01）和与治疗相关的 SAE（8%比 1%比 7%，p 交互=0.02）发生率均高于静脉曲张出血或腹水患者。接受特利加压素联合人血白蛋白治疗的患者任何 SAE（18%比 1%，p 交互=0.04）和与治疗相关的 SAE（7%比 0%，p 交互=0.09）发生率均高于未用白蛋白的患者。总胆红素水平＞4.3mg/dL 的患者任何 AE（69%比 24%，p 交互=0.02）、任何 SAE（64%比 0%，p 交互＜0.01）和与治疗相关的 SAE（8%比 1%，p 交互=0.04）发生率均高于≤4.3mg/dL 的患者。
接受特利加压素治疗的肝硬化患者常见 AE，且受临床情况、与白蛋白联合应用和胆红素水平影响。
