中国临床药理学杂志2017，Vol.33Issue(18)：1761-1763,3.DOI:10.13699/j.cnki.1001-6821.2017.18.008
注射用重组人粒细胞巨噬细胞集落刺激因子治疗5-氟尿嘧啶致口腔黏膜炎的临床研究
Clinical trial of recombinant human granulocyte macrophage colony stimulating factor for injection in the treatment of oral mucositis caused by 5-fluorouracil
王桥 1宋波 2赵晶 3陈静 4李佐强1
作者信息
- 1. 齐齐哈尔医学院附属第二医院,口腔科,黑龙江 齐齐哈尔 161006
- 2. 齐齐哈尔医学院医学技术学院临床病原教研室,黑龙江齐齐哈尔161006
- 3. 齐齐哈尔一厂医院功能科,黑龙江齐齐哈尔161006
- 4. 齐齐哈尔医学院附属第二医院,儿科,黑龙江 齐齐哈尔 161006
- 折叠
摘要
Abstract
Objective To observe the clinical efficacy and safety of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) for injection in the treatment of oral mucositis caused by 5-fluorouracil (5-FU).Methods Fifty-four patients with oral mucositis caused by 5-FU were randomly divided into control group and treatment group with 27 cases per group.Control group was given metmronidazole and sodium chloride injection 15 mL,5 times a day with 15 min per time for gargling.Treatment group received 1 μg · mL-1 rhGM-CSF gargarisma 15 mL,5 times a day with 15 min per time for gargling.Two groups were treated for 2 weeks.The clinical efficacy,healing time of oral mucositis and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 96.30％ (26/27 cases) and 77.78％ (21/27 cases) with significant difference (P ＜0.05).After treatment,the main indexes in treatment and control groups were compared:the class Ⅰ-Ⅱ healing time of oral mucositis were (3.86 ±0.55),(6.17 ±0.74)d;Ⅲ-Ⅳ healing time of oral mucositis were (9.88 ± 1.41),(13.64 ± 1.65) d;total healing time of oral mucositis were (5.09 ± 0.71),(8.78 ± 1.24) d,the differences were statistically significant (all P ＜ 0.05).There were 1 cases of transient fever in treatment group and 1 case of oral irritation symptoms in control group.The incidences of two groups were all 3.71％ without significant difference (P ＞ 0.05).Conclusion rhGM-CSF has a definitive clinical efficacy in the treatment of oral rnucositis caused by 5-FU,which can reduce the healing time of oral mucositis with difference class,without increasing the incidence of adverse drug reactions.关键词
注射用重组人粒细胞巨噬细胞集落刺激因子/5-氟尿嘧啶/口腔黏膜炎/安全性Key words
recombinant human granulocyte-macrophage colony stimulating factor for injection/5-fluorouracil/oral mucosal inflammation/safety分类
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王桥,宋波,赵晶,陈静,李佐强..注射用重组人粒细胞巨噬细胞集落刺激因子治疗5-氟尿嘧啶致口腔黏膜炎的临床研究[J].中国临床药理学杂志,2017,33(18):1761-1763,3.
