小牛血清去蛋白注射液对食管癌急性放射性食管炎的预防效果

目的在接受放疗的食管癌患者中评价小牛血清去蛋白注射液预防急性放射性食管炎的疗效和不良反应。方法符合纳入标准的食管癌患者根据随机数字表随机分为治疗组和对照组，两组采用基本一致的放疗方案，放疗期间治疗组患者给予小牛血清去蛋白注射液静脉滴注，放疗前2小时内用药，每天1次至放疗结束。对照组则仅给予生理盐水静脉滴注。采用NCI-CTC3．0评分标准、NRS评分表、KPS评分等比较两组急性放射性食管炎的发生率和出现时间、吞咽疼痛、一般状况、治疗前后体重变化。结果共纳入患者46例，治疗组和对照组各23例，治疗组和对照组2级急性放射性食管炎的发生率分别为82．61％和100％（χ2=4．38，P=0．036），出现时间分别为20．74±5．92天和16．83±5．11天（t=2．399，P=0．021）；3级急性放射性食管炎的发生率分别为43．48％和60．87％（χ2=1．39，P=0．238），出现时间分别为30．09±6．33天和26．70±6．28天（t=1．823，P=0．075）。治疗组和对照组在治疗前后平均体重下降分别为2．94±1．31kg以及3．27±1．15kg（t=0．885，P=0．381），两组患者在吞咽疼痛（χ2=3．50，P=0．174），一般状况KPS评分（χ2=4．661，P=0．198）方面的差异无统计学意义。用药过程中未发现与该药相关的不良反应。结论小牛血清去蛋白注射液预防用于食管癌放疗患者可降低2级急性放射性食管炎的发生率和推迟发生时间，值得临床进一步扩大样本量研究和应用。

Effect of deproteinised calf blood serum injection on acute radiation esophagitis in patients with esophageal cancer

Objective To evaluate the efficacy and safety of deproteinised calf blood serum injection on acute radia- tion esophagitis in patients with esophageal cancer through a randomized controlled trial. Method Esophageal cancer pa- tients who met the inclusion criteria were randomly assigned to the treatment group and the control group by random number table. Radiation technique and dose were similar between the two groups. Once-daily intravenous dripping of deproteinised calf blood serum injection or normal saline was administered in the treatment group and control group within 2 hours before radiation till the end of radiotherapy. Incidence and occurrence time of acute radiation esophagitis, swallowing pain degree, general conditions, and weight loss were compared according to NCI-CTC 3.0, NRS and KPS score respectively. Result A total of 46 patients were eligible, with 23 patients in each group. For treatment group compared with control group, theincidence for radiation esophagitis of grade 2 were 82. 61% vs 100% （χ2 = 4. 38, P= 0. 036）, of which the occurrence time were 20. 74±5.92 days vs 16. 83±5. 11 days （t= 2. 399, P= 0. 021 ） ; And the incidence for radiation esophagitis of grade 3 were 43.48% vs 60. 87% （χ2 = 1.39, P=0. 238）, of which the occurrence time were 30. 09±6. 33 days vs 26. 70±6. 28 days （t= 1. 823, P=0. 075）. The two group showed no significant difference in terms of average weight loss [2. 94±1.31 kg vs 3. 27 ±1.15 kg （t=0.885, P=0.381） ], swallowing pain degree （χ2=3.50, P=0.174） and KPS score （χ2= 4. 661, P = 0. 198 ）. No drug-related adverse event was observed. Conclusion The deproteinised calf blood serum injection could decrease the incidence while postpone the occurrence time of grade 2 radiation esophagitis in patients with e- sophageal cancer, and deserves large sample size studies and clinic application.