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口服谷氨酰胺预防癌症患者多西他赛或紫杉醇相关味觉改变:一项随机、安慰剂对照、双盲研究。

Prevention of docetaxel- or paclitaxel-associated taste alterations in cancer patients with oral glutamine: a randomized, placebo-controlled, double-blind study.

作者信息

Strasser Florian, Demmer Ruth, Böhme Christel, Schmitz Shu-Fang Hsu, Thuerlimann Beat, Cerny Thomas, Gillessen Silke

机构信息

Oncology and Palliative Medicine, Division of Oncology/Haematology, Department of Internal Medicine and Palliative Care Centre, Cantonal Hospital, Rorschacherstrasse, 9007 St. Gallen, Switzerland.

出版信息

Oncologist. 2008 Mar;13(3):337-46. doi: 10.1634/theoncologist.2007-0217.

Abstract

Taste alteration (dysgeusia), an underrecognized toxicity associated with taxane-based chemotherapy (TaxCh), lacks standard treatment. We investigated prevention of dysgeusia with oral glutamine in patients undergoing first-time TaxCh. Adult patients were randomized to receive either 30 g/day glutamine or placebo (maltodextrin) from day 1 of TaxCh. Dysgeusia was measured daily with a visual analogue scale (VAS). On each chemotherapy cycle, objective (sour, sweet, salty, bitter) and subjective (four-category scale) taste and toxicity (National Cancer Institute Common Toxicity Criteria, v.3) were assessed. Stomatitis and zinc deficiency were treated. For primary outcomes, repeated dysgeusia scores were analyzed with a linear mixed model. Repeated data on each objective or subjective taste item were analyzed with a generalized estimating equation. Of 52 patients randomized, 41 completed treatment (median study duration, 74 days). At baseline, the glutamine (n = 21) and placebo (n = 20) groups were comparable for age (64 years), gender (32% men), tumor types, chemotherapy (docetaxel, 44%; paclitaxel, 56%), schedule (weekly, 78%; 3-weekly, 22%), treatment intention (15% adjuvant), dysgeusia (VAS, 11/100), and taste recognition (88%). Twenty-four patients had peripheral neuropathy grades 1-2; none had grade 3. Glutamine and placebo were not different for maximal dysgeusia and increase from baseline, with an insignificant linear time effect. Separate subgroup analyses for patients with baseline dysgeusia < or =11 or >11 did not alter the results. Objective or subjective taste tests were not different, neither were adverse events. Compared with placebo, oral glutamine did not prevent or decrease subjective taste disturbances or altered taste perception associated with TaxCh. The role of glutamine in supportive care of taxane-associated dysgeusia seems limited.

摘要

味觉改变(味觉障碍)是一种与紫杉烷类化疗(TaxCh)相关但未得到充分认识的毒性反应,目前缺乏标准治疗方法。我们研究了口服谷氨酰胺对首次接受TaxCh治疗的患者味觉障碍的预防作用。成年患者从TaxCh治疗第1天起随机分为两组,分别接受30克/天的谷氨酰胺或安慰剂(麦芽糖糊精)。每天用视觉模拟量表(VAS)测量味觉障碍。在每个化疗周期,评估客观味觉(酸、甜、咸、苦)和主观味觉(四类量表)以及毒性反应(美国国立癌症研究所通用毒性标准,第3版)。对口腔炎和锌缺乏进行治疗。对于主要结局,使用线性混合模型分析重复的味觉障碍评分。对每个客观或主观味觉项目的重复数据使用广义估计方程进行分析。在随机分组的52例患者中,41例完成治疗(中位研究持续时间为74天)。基线时,谷氨酰胺组(n = 21)和安慰剂组(n = 20)在年龄(64岁)、性别(男性占32%)、肿瘤类型、化疗药物(多西他赛,44%;紫杉醇,56%)、治疗方案(每周一次,78%;每三周一次,22%)、治疗意图(辅助治疗占15%)、味觉障碍(VAS评分,11/100)和味觉识别(88%)方面具有可比性。24例患者有1 - 2级周围神经病变;无3级病例。谷氨酰胺和安慰剂在最大味觉障碍程度及与基线相比的增加幅度方面无差异,线性时间效应不显著。对基线味觉障碍评分≤11或>11的患者进行的单独亚组分析未改变结果。客观或主观味觉测试无差异,不良事件也无差异。与安慰剂相比,口服谷氨酰胺不能预防或减少与TaxCh相关的主观味觉障碍或味觉感知改变。谷氨酰胺在紫杉烷类相关味觉障碍的支持性治疗中的作用似乎有限。

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