Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study
Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study
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局部应用 GM-CSF 对干细胞移植后口腔粘膜炎的影响：一项前瞻性安慰剂对照双盲研究
DOI：
10.1007/s002770000264
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发表时间：
2001
影响因子：
3.5
通讯作者：
A. von dem Borne
中科院分区：
文献类型：
--
作者：
H. van der Lelie;B. Thomas;R. V. van Oers;Mineke Ek;Sjam A.S. Sjamsoedin;Marjolein L. van Dijk;J. Timmer;A. von dem Borne
口腔粘膜炎是干细胞移植前清髓性化疗和放疗的常见副作用。它会导致疼痛、食物摄入不足，并且是感染的入口。我们研究了在口腔中局部应用 GM-CSF 是否可以预防或改善这种粘膜炎。我们对 36 名连续接受干细胞移植的患者进行了一项双盲安慰剂对照研究，每天将 300 µg GM-CSF 加入 2% 甲基纤维素凝胶中，与单独使用 2% 甲基纤维素凝胶进行比较。两者均局部应用于口腔。主要终点是粘膜炎，通过世界卫生组织粘膜炎毒性量表、口腔评估量表和主观疼痛量表进行测量，所有这些均每天评分。次要终点是需要给予肠外营养和吗啡、发烧和感染的发生率、中性粒细胞减少症和住院时间。安慰剂组和 GM-CSF 组之间的主观疼痛评分中位数、WHO 评分和口腔评估评分没有差异。在两组中，有九名患者需要吗啡来控制疼痛。安慰剂组的 10 名患者和 GM-CSF 组的 11 名患者接受了肠外营养。安慰剂组和 GM-CSF 组中记录的感染、广谱抗生素的使用以及发烧天数相似。中性粒细胞减少症低于 0.5×109/l 的持续时间（安慰剂组的中位时间为 14.5 天，GM-CSF 组的中位时间为 17 天）和住院时间（28.5 天与 29 天）也没有显着差异。我们发现，将 300 µg GM-CSF 溶解在 2% 甲基纤维素凝胶中，局部应用于接受干细胞移植的患者，对化疗和放疗引起的粘膜炎没有任何有益作用。
Oral mucositis is a frequent side effect of myeloablative chemo- and radiotherapy preceding stem cell transplantation. It causes pain, poor food intake, and is a port of entry for infection. We studied whether GM-CSF applied topically in the oral cavity can prevent or ameliorate this mucositis. In 36 consecutive patients undergoing a stem cell transplantation, we performed a double-blind placebo-controlled study of 300 µg GM-CSF in a 2% methylcellulose gel daily versus a 2% methylcellulose gel alone. Both were locally applied in the oral cavity. The primary end-point was mucositis as measured by the WHO toxicity scale for mucositis, oral assessment scale, and a subjective pain scale, all scored daily. The secondary end-points were need to give parenteral nutrition and morphine, incidence of fever and infections, and duration of neutropenia and hospitalization. No differences were found in the median subjective pain scores, WHO scores, and oral assessment scores between the placebo and the GM-CSF groups. In both groups, nine patients required morphine for pain control. Ten patients in the placebo group and 11 in the GM-CSF group received parenteral nutrition. Documented infections, use of broad-spectrum antibiotics, and number of days with fever were similar in the placebo and the GM-CSF groups. The duration of neutropenia below 0.5×109/l (median 14.5 days in the placebo group versus 17 days in the GM-CSF group) and the duration of hospitalization (28.5 versus 29 days) was also not significantly different. We found no beneficial effect of 300 µg GM-CSF dissolved in a 2% methylcellulose gel applied locally for chemo- and radiotherapy-induced mucositis in patients undergoing a stem cell transplantation.