Generic Intravenous Amisulpride (QLG2069) for the Prevention of Postoperative Nausea and Vomiting in Adults: A Phase III, Multicenter, Randomized, Placebo-Controlled Study.

IF 5.1 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-09-03 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S529526

Hong Zhang, Saiying Wang, Mengchang Yang, Yanjuan Huang, Kai Wang, Ke Jiang, Foquan Luo, Xianwen Hu, Yi Hong, Furong Huang, Shuan Jin, Feng Qi, Shoushi Wang, Xiaoqing Zhang, Huiyu Luo, Langtao Guo, Longzhen Zhang, Jiangang Li, Yongquan Chen, Zhong Qin, Chun Chen, Jianjun Yang, Wanwei Jiang, Nini Fu, Yunfei Ju, Yuanyuan Li, Juan Wang, Wen Ouyang, Yi Feng

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引用次数: 0

Abstract

Background: The dopamine D2/D3 antagonist amisulpride has demonstrated its superiority and efficacy in prophylaxis of postoperative nausea and vomiting (PONV). Given the branded intravenous amisulpride (Barhemsys^®) has not been approved in China, there is unmet clinical need for amisulpride. Our primary objective was to ascertain the efficacy and safety of the generic intravenous amisulpride (QLG2069) in the prophylaxis of PONV.

Methods: In this phase III, multicenter, randomized, double-blind, placebo-controlled study, 551 adult Chinese patients (with ≥2 Apfel risk factors for PONV) undergoing elective laparoscopic gynecological or abdominal surgery were randomly allocated in a 1:1 ratio to receive either generic intravenous amisulpride or placebo. The primary endpoint was the complete response (CR) rate, defined as the proportion of patients demonstrating neither emetic episodes (vomiting/retching) nor requiring rescue antiemetics throughout the 24-hour postoperative window.

Results: Totally, 542 patients (amisulpride group: n=275; placebo group: n=267) were included in the full analysis set. Amisulpride demonstrated significantly higher CR rate compared to placebo (53.82% vs 40.07%; P=0.0011) within 24-h postoperative period. Patients treated with intravenous amisulpride exhibited significantly lower incidence of moderate-to-severe nausea (28.36% vs 37.08%; P=0.0266) and emesis (44.73% vs 57.30%; P=0.0030) compared to the incidence in the placebo group. The proportion of patients without nausea was numerically higher (45.09%) in the amisulpride group compared to that in the placebo group (37.45%), although the difference did not reach statistical significance (P=0.0685). No significant difference in the proportions of patients receiving rescue medication was noticed between the two groups (21.09% vs 28.09%; P=0.0569). The incidence of adverse events were comparable in two groups.

Conclusion: The generic intravenous amisulpride was safe and effective in prophylaxis of PONV in Chinese patients with moderate-to-high risk of PONV to were undergoing laparoscopic gynecological or abdominal surgery.

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非专利静脉注射氨硫pride （QLG2069）预防成人术后恶心和呕吐：一项多中心、随机、安慰剂对照的III期研究

背景：多巴胺D2/D3拮抗剂氨硫pride在预防术后恶心和呕吐（PONV）方面具有优越性和有效性。鉴于品牌静脉注射氨硫pride （Barhemsys®）尚未在中国获得批准，氨硫pride的临床需求尚未得到满足。我们的主要目的是确定非专利静脉注射氨硫pride （QLG2069）预防PONV的有效性和安全性。方法：在这项多中心、随机、双盲、安慰剂对照的III期研究中，551名接受选择性腹腔镜妇科或腹部手术的中国成年患者（PONV的Apfel危险因素≥2）按1:1的比例随机分配，接受普通静脉注射氨硫pride或安慰剂。主要终点是完全缓解（CR）率，定义为在术后24小时内既没有出现呕吐（呕吐/干呕）也不需要紧急止吐药物的患者比例。结果：全分析共纳入542例患者（氨硫pride组：n=275；安慰剂组：n=267）。在术后24小时内，氨硫pride的CR率明显高于安慰剂（53.82% vs 40.07%； P=0.0011）。与安慰剂组相比，静脉注射氨硫傲的患者中至重度恶心（28.36% vs 37.08%， P=0.0266）和呕吐（44.73% vs 57.30%， P=0.0030）的发生率显著降低。氨硫pride组无恶心症状患者比例（45.09%）高于安慰剂组（37.45%），但差异无统计学意义（P=0.0685）。两组患者接受抢救用药的比例差异无统计学意义（21.09% vs 28.09%， P=0.0569）。两组不良事件发生率具有可比性。结论：非专利静脉注射氨硫pride对中国腹腔镜妇科或腹部手术中高危PONV患者预防PONV安全有效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.