A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation

A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation
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DOI:
10.1038/sj.bmt.1705384
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发表时间:
2006-06-01
影响因子:
4.8
通讯作者:
Bensinger, W.
Bensinger, W.
中科院分区:
医学3区
文献类型:
--
作者:
Lilleby, K.;Garcia, P.;Bensinger, W.

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将40例多发性骨髓瘤患者随机分为治疗前30min和治疗后6h口服马法兰200 mg/m(2)自体干细胞移植组。使用国家癌症研究所分级系统对患者进行粘膜炎评估,并评估辅助措施,如完全静脉营养(TPN)天数、麻醉药物使用、住院时间、体重减轻和移植后28天恢复口服卡路里摄入。患者在28天内对疼痛、吞咽、饮水、饮食、睡眠和口味变化进行自我评分。这项试验的主要终点是3-4级粘膜炎的发生率。与生理盐水组相比,接受冷冻治疗的患者发生3-4级粘膜炎的比例较低,分别为14%和74%,P=0.0005。接受冷冻治疗的患者在统计上也较少使用麻醉剂和TPN,尽管在住院时间或体重减轻方面没有差异。冷冻组患者报告的疼痛显著降低,活动明显改善。
Forty patients with multiple myeloma scheduled to receive melphalan 200 mg/m(2) followed by autologous stem cell transplantation were randomly assigned to receive oral cryotherapy or room temperature normal saline rinses 30 min before and for 6 h after high-dose therapy. Patients were evaluated for the development of mucositis using the National Cancer Institute grading system as well as evaluation of secondary measures such as days of total parenteral nutrition (TPN), narcotic use, hospitalization, weight loss and resumption of oral caloric intake for 28 days after transplant. Patients self-scored their pain, swallowing, drinking, eating, sleeping and taste alterations for 28 days. The primary end point of this trial was the incidence of grades 3-4 mucositis. Compared to the normal saline group, patients using cryotherapy experienced less grade 3-4 mucositis, 14 vs 74%, P = 0.0005. Patients receiving cryotherapy also had statistically lower uses of narcotics and TPN, although there were no differences in length of hospitalization or weight loss. Patient-reported pain was significantly lower and activities were significantly better in the cryotherapy group.