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罗哌丁胺(一种用于预防化疗引起的恶心和呕吐的NK-1受体拮抗剂)安全性和有效性的荟萃分析。

Meta-analysis of safety and efficacy of rolapitant, NK-1 receptor antagonist for prevention of chemotherapy-induced nausea and vomiting.

作者信息

Ahmed Hussien, Hammad Ali Mohamed, Abushouk Abdelrahman Ibrahim, Zidan Mohamed, Salem Mohamed, Negida Ahmed, Abdel-Daim Mohamed M

机构信息

Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt; Medical Research Group of Egypt, Cairo, Egypt; Student Research Unit, Zagazig University, Zagazig, El-Sharkia, Egypt.

Medical Research Group of Egypt, Cairo, Egypt; Faculty of Medicine, Cairo University, Cairo, Egypt.

出版信息

Curr Probl Cancer. 2018 Mar-Apr;42(2):241-255. doi: 10.1016/j.currproblcancer.2017.11.003. Epub 2017 Dec 6.

DOI:10.1016/j.currproblcancer.2017.11.003
PMID:29310827
Abstract

Although chemotherapeutic agents represent a cornerstone of cancer treatment, chemotherapy-induced nausea and vomiting (CINV) affect the patients' quality of life and basic daily activities. Rolapitant is a novel selective neurokinin-1 receptor antagonist (NK-1 RA), which was clinically approved for prevention of CINV. The aim of the present study is to synthesize evidence about the safety and efficacy of rolapitant in combination with other antiemetic agents for prophylaxis against CINV. We performed a web-based literature search of six authentic databases to identify eligible studies. Safety and efficacy endpoints were extracted and pooled as odds ratios (ORs) in a fixed-effect meta-analysis model, using Comprehensive Meta-Analysis software for windows. Five randomized controlled trials (n = 2984) were pooled in the final analysis. Rolapitant (180mg) in combination with a serotonin-3 (5-HT3) receptor antagonist and dexamethasone was superior to placebo plus 5-HT3 receptor antagonist and dexamethasone in term of complete response rate in the acute (OR = 1.4, 95% CI [1.16, 1.7]) and the delayed phases (OR = 1.68, 95% CI [1.44, 1.96]). Moreover, rates of complete protection were significantly higher with rolapitant 180mg than with placebo in the overall, acute, and delayed phases (OR = 1.52, 95% CI [1.3, 1.76]), OR = 1.24, 95% CI [1.04, 1.49], and OR = 1.5, 95% CI [1.29, 1.75]), respectively. In conclusion, rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and more effective than 5-HT3 receptor antagonist plus dexamethasone for the prevention of CINV.

摘要

尽管化疗药物是癌症治疗的基石,但化疗引起的恶心和呕吐(CINV)会影响患者的生活质量和基本日常活动。罗拉匹坦是一种新型的选择性神经激肽-1受体拮抗剂(NK-1 RA),已在临床上被批准用于预防CINV。本研究的目的是综合关于罗拉匹坦与其他止吐药物联合用于预防CINV的安全性和有效性的证据。我们对六个权威数据库进行了基于网络的文献检索,以确定符合条件的研究。使用适用于Windows的综合Meta分析软件,提取安全性和有效性终点数据,并在固定效应Meta分析模型中汇总为比值比(OR)。最终分析纳入了五项随机对照试验(n = 2984)。在急性(OR = 1.4,95%CI [1.16, 1.7])和延迟期(OR = 1.68,95%CI [1.44, 1.96])的完全缓解率方面,罗拉匹坦(180mg)联合5-羟色胺-3(5-HT3)受体拮抗剂和地塞米松优于安慰剂联合5-HT3受体拮抗剂和地塞米松。此外,在总体、急性和延迟期,180mg罗拉匹坦的完全保护率显著高于安慰剂(OR = 1.52,95%CI [1.3, 1.76])、OR = 1.24,95%CI [1.04, 1.49])和OR = 1.5,95%CI [1.29, 1.75])。总之,罗拉匹坦联合5-HT3受体拮抗剂和地塞米松耐受性良好,在预防CINV方面比5-HT3受体拮抗剂加地塞米松更有效。

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