注射用右兰索拉唑治疗急性胃和/或十二指肠溃疡引起的上消化道出血的有效性及安全性

目的：以注射用兰索拉唑为对照，评价注射用右兰索拉唑15 mg q12 h治疗急性胃和/或十二指肠溃疡引起的上消化道出血的有效性及安全性。方法：选取全国31家研究中心的急性胃和/或十二指肠溃疡引起的上消化道出血患者共202例，按照1∶1随机分配至试验组（注射用右兰索拉唑组）和对照组（注射用兰索拉唑组）。主要疗效终点为72 h有效止血率。对主要疗效终点采用非劣效评价，非劣效性界值δ是10%。结果：有效性方面，全分析数据集分析结果显示：用药72 h后，注射用右兰索拉唑组有效止血率为96.08%(98/102)；注射用兰索拉唑组有效止血率为98.00%(98/100)，两组率差为-1.92%(95%CI-6.58,2.74)。两组72 h有效止血率差异无统计学意义（P=0.682 9）。两组率差的双侧界值均低于δ(10%)，注射用右兰索拉唑非劣于注射用兰索拉唑。安全性方面，试验组的不良事件及不良反应发生率与对照组差异无统计学意义，无非预期不良反应和严重不良反应。主要的不良反应为白细胞计数降低、中性粒细胞计数降低等。结论：注射用右兰索拉唑15 mg q12 h在治疗急性胃和/或十二指肠溃疡引起的...

Efficacy and Safety of Dexlansoprazole for Injection in the Treatment of Upper Gastrointestinal Bleeding due to Acute Gastric and/or Duodenal Ulcers

Objective: The purpose of this study is to compare the efficacy and safety of dexlansoprazole with lansoprazole in treating upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcers. Method: A total of 202 patients with upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer from 31 research centers in China were randomly assigned to either the experimental group (Dexlansoprazole for Injection) or the positive control group (Lansoprazole for injection) in 1∶1 ratio. The primary efficacy endpoint was the rate of 72 hour effective hemostasis, and was evaluated for non-inferiority using a cut-off value of 10%. Results: For efficacy, the results of the full analysis dataset (FAS) showed that after 72 hours of treatment, the effective hemostasis rate was 96.08% (98/102) in the dexlansoprazole group and 98.00% (98/100) in the lansoprazole group, respectively. The difference between the two groups was -1.92% (95%CI -6.58; 2.74). There was no significant difference in the 72 hour effective hemostasis rates between the two groups (P = 0.682 9). The lower limit of the 95% confidence interval for the rate difference was -6.58%, which was higher than -10%. Thus, the 72 hour effective hemostasis rate of dexlansoprazole for injection was found to be non-inferior to that of lansoprazole for injection. Additionally, there was no significant difference in the incidence of adverse events and adverse reactions between the dexlansoprazole group and lansoprazole group, and no unexpected or serious adverse reactions were reported. The main adverse reactions observed were decreased white blood cell count and neutrophil count. Conclusion: Dexlansoprazole for injection 15 mg q12 h has been shown to be just as effective as lansoprazole for injection 30 mg q12 h in treating upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcers, with a good safety record. This suggests that dexlansoprazole for injection may offer a new clinical alternative for managing acute upper gastrointestinal bleeding.