冷冻疗法对紫杉醇诱导的周围神经病的客观和主观症状的影响：前瞻性自身对照试验。
Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial.
机构信息
Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Japan Society for the Promotion of Science, Tokyo, Japan.
出版信息
J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178.
BACKGROUND
Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting and disabling side effect of taxane anticancer agents. We prospectively evaluated the efficacy of cryotherapy for CIPN prevention.
METHODS
Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for one hour) wore frozen gloves and socks on the dominant side for 90 minutes, including the entire duration of drug infusion. Symptoms on the treated sides were compared with those on the untreated (nondominant) sides. The primary end point was CIPN incidence assessed by changes in tactile sensitivity from pretreatment baseline in a monofilament test at a cumulative dose of 960 mg/m2. We also assessed thermosensory deficits, subjective symptoms (Patient Neuropathy Questionnaire [PNQ]), manipulative dexterity, and the time to events and hazard ratio by PNQ. All statistical tests were two-sided.
RESULTS
Among the 40 patients, four did not reach the cumulative dose (due to the occurrence of pneumonia, severe fatigue, severe liver dysfunction, and macular edema), leaving 36 patients for analysis. None dropped out due to cold intolerance. The incidence of objective and subjective CIPN signs was clinically and statistically significantly lower on the intervention side than on the control (hand: tactile sensitivity = 27.8% vs 80.6%, odds ratio [OR] = 20.00, 95% confidence interval [CI] = 3.20 to 828.96, P < .001; foot: tacile sensitivity = 25.0% vs 63.9%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; hand: warm sense = 8.8% vs 32.4%, OR = 9.00, 95% CI = 1.25 to 394.48, P = .02; foot: warm sense: 33.4% vs 57.6%, OR = 5.00, 95% CI = 1.07 to 46.93, P = .04; hand: PNQ = 2.8% vs 41.7%, OR = infinite, 95% CI = 3.32 to infinite, P < .001; foot: PNQ = 2.8% vs 36.1%, OR = infinite, 95% CI = 2.78 to infinite, P < .001; hand: hazard ratio [HR] = 0.13, 95% CI = 0.05 to 0.34; foot: HR = 0.13, 95% CI = 0.04 to 0.38, dexterity mean delay = -2.5 seconds, SD = 12.0 seconds, vs + 8.6 seconds, SD = 25.8 seconds, P = .005).
CONCLUSIONS
Cryotherapy is useful for preventing both the objective and subjective symptoms of CIPN and resultant dysfunction.
背景
化疗引起的周围神经病（CIPN）是紫杉烷类抗癌药物的剂量限制和致残性副作用。我们前瞻性地评估了冷冻疗法预防 CIPN 的疗效。
方法
接受每周紫杉醇（80mg/m2 持续 1 小时）治疗的乳腺癌患者在优势侧佩戴冷冻手套和袜子 90 分钟，包括药物输注的整个过程。治疗侧的症状与未治疗（非优势）侧进行比较。主要终点是在累积剂量为 960mg/m2 时，通过单丝试验评估触觉敏感性的变化来评估 CIPN 的发生率。我们还评估了热感觉缺陷、主观症状（患者神经病变问卷[PNQ]）、操作灵巧性以及 PNQ 的时间和风险比。所有统计检验均为双侧。
结果
在 40 名患者中，有 4 名未达到累积剂量（由于肺炎、严重疲劳、严重肝功能障碍和黄斑水肿的发生），留下 36 名患者进行分析。由于不耐寒，没有患者因不耐受而退出。与对照组相比，干预侧的客观和主观 CIPN 体征的发生率在临床上和统计学上均显著降低（手：触觉敏感性 = 27.8% vs 80.6%，优势比[OR] = 20.00，95%置信区间[CI] = 3.20 至 828.96，P <.001；脚：触觉敏感性 = 25.0% vs 63.9%，OR = 无限，95%CI = 3.32 至无限，P <.001；手：温暖感觉 = 8.8% vs 32.4%，OR = 9.00，95%CI = 1.25 至 394.48，P =.02；脚：温暖感觉：33.4% vs 57.6%，OR = 5.00，95%CI = 1.07 至 46.93，P =.04；手：PNQ = 2.8% vs 41.7%，OR = 无限，95%CI = 3.32 至无限，P <.001；脚：PNQ = 2.8% vs 36.1%，OR = 无限，95%CI = 2.78 至无限，P <.001；手：风险比[HR] = 0.13，95%CI = 0.05 至 0.34；脚：HR = 0.13，95%CI = 0.04 至 0.38，灵巧性平均延迟 = -2.5 秒，SD = 12.0 秒，vs +8.6 秒，SD = 25.8 秒，P =.005）。
结论
冷冻疗法可有效预防 CIPN 的客观和主观症状以及由此导致的功能障碍。
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