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帕洛诺司琼是否为化疗所致恶心呕吐的首选 5-HT 受体拮抗剂?一项更新的系统评价和荟萃分析。

Should palonosetron be a preferred 5-HT receptor antagonist for chemotherapy-induced nausea and vomiting? An updated systematic review and meta-analysis.

机构信息

Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada.

Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.

出版信息

Support Care Cancer. 2018 Aug;26(8):2519-2549. doi: 10.1007/s00520-018-4237-7. Epub 2018 May 23.

Abstract

PURPOSE

Chemotherapy-induced nausea and vomiting (CINV) continues to be a common side effect of systemic anticancer therapy, decreasing quality of life and increasing resource utilization. The aim of this meta-analysis was to investigate the comparative efficacy and safety of palonosetron relative to other 5-HTRAs.

METHODS

A literature search was carried out in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Full-text references were then screened and included in this meta-analysis if they were an RCT and had adequate data regarding one of the five primary endpoints-complete response (CR), complete control (CC), no emesis, no nausea, or no rescue medications.

RESULTS

A total of 24 RCTs were included in this review. Palonosetron was statistically superior to other 5-HTRAs for 10 of the 19 assessed endpoints. Only one endpoint-emesis in the overall phase-had noticeable more favorable data for palonosetron to the point that it approached the 10% risk difference (RD) threshold as specified by the MASCC/ESMO antiemetic panel; another two endpoints (CR in the overall phase and nausea in the delayed phase) approached the 10% threshold.

CONCLUSIONS

Palonosetron seems to be more efficacious and safe than other 5-HTRAs-statistically superior in 10 of 19 endpoints. It is, however, only clinically significant in one endpoint and approached clinically significant difference in another two endpoints. Within the limits of this meta-analysis, our results indicate that palonosetron may not be as superior in efficacy and safety as reported in a previous meta-analysis, and supports the recent MASCC/ESMO, ASCO, and NCCN guidelines in not generally indicating palonosetron as the 5-HTRA of choice.

摘要

目的

化疗引起的恶心和呕吐(CINV)仍然是癌症系统治疗的常见副作用,降低了生活质量并增加了资源的利用。本荟萃分析的目的是研究与其他 5-HT3RA 相比,帕洛诺司琼的相对疗效和安全性。

方法

在 Ovid MEDLINE、Embase 和 Cochrane 对照试验中心注册库中进行文献检索。如果是 RCT,并且有关于五个主要终点之一的充分数据 - 完全缓解(CR)、完全控制(CC)、无呕吐、无恶心或无解救药物,则将全文参考文献筛选并纳入本荟萃分析。

结果

本综述共纳入 24 项 RCT。帕洛诺司琼在 19 项评估终点中的 10 项上明显优于其他 5-HT3RA。只有一个终点 - 整个阶段的呕吐 - 帕洛诺司琼的数据更有利,以至于接近 MASCC/ESMO 止吐小组规定的 10%风险差异(RD)阈值;另外两个终点(整个阶段的 CR 和延迟阶段的恶心)接近 10%的阈值。

结论

帕洛诺司琼似乎比其他 5-HT3RA 更有效且安全 - 在 19 个终点中的 10 个具有统计学优势。然而,只有在一个终点具有临床意义,在另外两个终点接近临床显著差异。在本荟萃分析的限制范围内,我们的结果表明,帕洛诺司琼的疗效和安全性可能不如之前的荟萃分析报告的那样优越,并支持最近的 MASCC/ESMO、ASCO 和 NCCN 指南,即一般不将帕洛诺司琼作为首选 5-HT3RA。

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