金因肽对急性放射性黏膜炎及皮炎的作用

Effect of Gene Time on acute radiation mucositis and dermatitis

目的 观察金因肽 (重组人表皮生长因子 ,rhEGF)预防和治疗急性放射性黏膜炎和急性放射性皮炎的作用。方法 12 0例头颈部肿瘤患者被随机分为 3个组 :(1)黏膜炎预防性用药与对照组 ;(2 )黏膜炎治疗性用药与对照组 ;(3)皮炎治疗性用药与对照组。用药组患者将金因肽喷于受照射区域的皮肤或黏膜 ,常规处理作为对照。预防性用药及对照组的常规处理与放射治疗同期进行。治疗性用药与对照组的处置待出现Ⅰ级放射性黏膜炎或皮炎后再进行。根据RTOG急性放射性黏膜炎和皮炎的分级标准进行临床评价。结果 黏膜炎预防用药与对照组比较 ,放射治疗剂量≤ 10Gy时放射性黏膜炎的发生率分别为 2 0 % (4/2 0 )和 70 % (14 /2 0 ) (P =0 .0 0 4 )。在放射治疗中无论是预防用药组还是治疗用药组的Ⅲ、Ⅳ级急性放射性黏膜炎及皮炎的发生率均低于相应对照组。金因肽治疗急性放射性黏膜炎及皮炎与对照组比较其有效率分别为 90 % (18/2 0 )对 5 0 % (10 /2 0 ) (P =0 .0 16 )和 95 %(19/2 0 )对 5 0 % (10 /2 0 ) (P =0 .0 0 5 ) ,且Ⅲ级放射性皮炎愈合时间≤ 3d在用药组为 3/7,而对照组为 0 /14。结论 预防性用金因肽可推迟放射性黏膜的发生 ,预防用药组及治疗用药组金因肽均可降低Ⅲ、Ⅳ级黏膜炎和皮炎的发生率 ,并可促进?

Objective To evaluate the effect of recombinant human epidermal growth factor (Gene Time) on acute mucositis and dermatitis induced by radiation. Methods 120 head and neck cancer patients were randomized into 3 groups:1. Mucositis prophylactic application (MPA) group with control, 2. Mucositis therapeutic application (MTA) group with control and 3. Dermatis therapeutic application (DTA) group with control. Prophylactic application of drug consisted of spraying the Gene Time preparation on the irradiated skin or mucous membrane as radiotherapy was being carried out. This was compared with control patients who received routine convertional skin care. Therapeutic application was started as grade Ⅰ radiation mucositis or dermatitis appeared. The evaluation of acute radiation mucositis and dermatitis was done according to the systems proposed by RTOG or EORTC.Results The results showed that in the MPA group,the rate of radiation mucositis at ≤ 10 Gy was 20% (4/20) as compared to the 70% (14/20) of the control (P=0.004). During the course of radiation, the incidences of grade Ⅲ,Ⅳ acute radiation mucositis and dermatitis were always lower than the control. In therapeutic application of Gene Time, the response rate of acute radiation mucositis was also better than the control (90% vs 50%)(P=0.016) and that of acute dermatitis was similar (95% vs 50%)(P=0.005). Moreover, the ≤3 d rate of healing of grade Ⅲ dermatitis in the application group was 3/7 as compared to the 0/14 of the control.Conclusion Prophlactic application of recombinant human epidermal growth factor is able to postpone the development of radiation mucositis. This preparation is also able to lower the incidence of grade Ⅲ,Ⅳmucositis and dermatitis both by therapeutic and prophylative application in addition to the hastened healing of grade Ⅲdermatitis.