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

作　　者：王桥[1] 宋波[2] 赵晶 陈静[4] 李佐强[1] 

机构地区：[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

出　　处：《中国临床药理学杂志》2017年第18期1761-1763,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察注射用重组人粒细胞巨噬细胞集落刺激因子(rh GM-CSF)治疗5-氟尿嘧啶(5-FU)致口腔黏膜炎的临床疗效及安全性。方法将54例进行含5-FU化疗致口腔黏膜炎的患者随机分为对照组27例和试验组27例。对照组予以甲硝唑氯化钠注射液每次15 m L,每天5次,每次含漱15 min;试验组予以1μg·m L^(-1)rh GM-CSF含漱液每次15 m L,每天5次,每次含漱15 min。2组患者均治疗2周。比较2组患者的临床疗效、口腔黏膜炎愈合时间,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为96.30%(26/27例)和77.78%(21/27例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的Ⅰ~Ⅱ度口腔黏膜炎愈合时间分别为(3.86±0.55)和(6.17±0.74)d,Ⅲ~Ⅳ度口腔黏膜炎愈合时间分别为(9.88±1.41)和(13.64±1.65)d,总愈合时间分别为(5.09±0.71)和(8.78±1.24)d,差异均有统计学意义(均P<0.05)。试验组出现一过性发热1例次,对照组出现口腔刺激症状1例次。2组患者的药物不良反应发生率均为3.71%,差异无统计学意义(P>0.05)。结论 rh GM-CSF治疗5-FU致口腔黏膜炎的临床疗效显著,其能显著缩短患者不同程度病灶的愈合时间,且不增加药物不良反应发生率。Objective To observe the clinical efficacy and safety of recombinant human granulocyte-macrophage colony stimulating factor（ rh GM-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）rh GM-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： theclass 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 rh GM-CSF has a definitive clinical efficacy in the treatment of oral mucositis 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 

分 类 号：R973.4[医药卫生—药品]