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自我实施冷冻疗法对早期乳腺癌患者紫杉醇诱导的周围神经病变的预防作用:倾向评分分析。

Preventive effects of self-administered cryotherapy on paclitaxel-induced peripheral neuropathy in patients with early-stage breast cancer: a propensity score analysis.

机构信息

Department of Pharmacy, National Center for Global Health and Medicine, Tokyo, Japan.

Department of Pharmacy, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Pharmazie. 2021 Jun 1;76(6):261-265. doi: 10.1691/ph.2021.1398.

Abstract

We hypothesized that suppression of peripheral circulation cryotherapy may be effective in preventing paclitaxel-induced peripheral neuropathy (PIPN). Therefore, this study aimed to clarify whether self-administered cryotherapy could prevent PIPN in patients with early-stage breast cancer, using real-world data. A single-center, retrospective, observational study was conducted. Data from the electronic medical records of consecutive patients aged ≥ 20 years with early-stage breast cancer who received a regimen containing paclitaxel for 12 cycles with or without self-administered cryotherapy at the National Cancer Center Hospital from March 2018 to May 2019 were evaluated. The primary endpoint was the cumulative dose of paclitaxel until the onset of grade ≥ 2 PIPN. To compare the difference between the two groups, multivariable Cox proportional hazards models adjusted for prognostically important variables were used. Ninety Japanese patients were included in this study. The estimated incidence of grade ≥ 2 PIPN was 26.9% and 37.7% in the self-administered cryotherapy group and control group, respectively ( = 0.314). The multivariable Cox proportional hazards model showed that the self-administered cryotherapy group had a decreased risk of onset of grade ≥ 2 PIPN (hazard ratio: 0.63, 95% confidence interval: 0.25 to 1.39; = 0.281). Sensitivity analyses using multivariable Cox proportional hazards models along with two propensity score-adjusted methods demonstrated consistent results. The findings suggest that the methods of self-administered cryotherapy may prevent PIPN and should be reinforced appropriately in clinical practice. A randomized controlled multicenter trial of self-administered cryotherapy is warranted.

摘要

我们假设抑制外周循环冷冻疗法可能有助于预防紫杉醇引起的周围神经病变(PIPN)。因此,本研究旨在使用真实世界的数据阐明自我实施的冷冻疗法是否可以预防早期乳腺癌患者的 PIPN。进行了一项单中心、回顾性、观察性研究。评估了 2018 年 3 月至 2019 年 5 月期间,在国立癌症中心医院接受含紫杉醇 12 个周期治疗的早期乳腺癌患者的电子病历中的连续患者数据,这些患者年龄均≥20 岁,且接受了或未接受自我实施的冷冻疗法。主要终点是发生≥2 级 PIPN 的紫杉醇累积剂量。为了比较两组之间的差异,使用调整了预后重要变量的多变量 Cox 比例风险模型。本研究纳入了 90 名日本患者。自我实施冷冻疗法组和对照组发生≥2 级 PIPN 的估计发生率分别为 26.9%和 37.7%(=0.314)。多变量 Cox 比例风险模型显示,自我实施冷冻疗法组发生≥2 级 PIPN 的风险降低(风险比:0.63,95%置信区间:0.25 至 1.39;=0.281)。使用两种倾向评分调整方法的多变量 Cox 比例风险模型的敏感性分析显示了一致的结果。这些发现表明,自我实施冷冻疗法的方法可能预防 PIPN,并且在临床实践中应适当加强。需要进行自我实施冷冻疗法的随机对照多中心试验。

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