榄香烯注射液联合放疗与TP方案联合放疗治疗食管癌的比较研究

目的 比较榄香烯注射液联合放疗与TP方案（紫杉醇+奈达铂）联合放疗治疗食管癌的临床疗效和不良反应。方法 将2006年12月至2009年12月期间收治的125例初诊食管癌患者随机分成3组：单纯放疗组（RT组，n=45）、榄香烯注射液+放疗组（RT+E组，n=42）和TP方案+放疗组（RT+TP组，n=38）。放疗采用常规四野放疗或三维适形放疗，2Gy／次，5次／周，放射总剂量60～66Gy；榄香烯400mg／d静滴，d₁～d₂₁；紫杉醇150mg／m²静滴，d₁；奈达铂50mg／d静滴，d₁～d₃。RT+TP组患者先行1个周期TP方案化疗后完善相关检查，无放疗禁忌证再行放疗；于放疗过程中前4周每周测定白细胞数量，并分析各组白细胞数量变化；3组患者放疗结束时，评价毒副反应及近期疗效；对患者进行随访，分别计算1、2、3年生存率并绘制生存曲线。结果 RT组、RT+E组及RT+TP组的有效率分别为84.4％、90.5％和92.1％，放射性食管炎的发生率分别为66.7％、61.9％和60.5％，放射性肺炎的发生率分别为24.4％、31.0％和28.9％，骨髓抑制的发生率均为100.0%，上述组间差异均无统计学意义（P＞0.05）。从放疗开始后第1～4周，RT+E组白细胞数量与RT组和RT+TP组比较，差异有统计学意义（P＜0.05）。RT组、RT+E组及RT+TP组的1年生存率为600％、73.8％、78.9％，2年生存率为40.0％、54.8％、60.5％，3年生存率为28.9％、33.3％、44.7％，组间差异无统计学意义（P＞0.05）。结论 榄香烯注射液联合放疗与TP方案联合放疗治疗食管癌的近期疗效相当，且两药均不增加放疗的毒副反应，放疗过程中联合使用榄香烯注射液可维持患者的白细胞数量。

Comparison study of elemene injection, TP regimen combined with radiotherapy in the treatment of esophageal cancer

Objective To evaluate the efficacy and side effects of elemene injection combined with radiotherapy compared to TP regime（paclitaxel+nedaplatin） combined with radiotherapy in the treatment of esophageal cancer. MethodsOne hundred and twenty five patients diagnosed as esophageal cancer from December 2006 to December 2009 were randomly divided into three groups: radiotherapy group（RT group， n=45）， radiotherapy combined with elemene injection group（RT+E group， n=42） and radiotherapy combined with TP regimen group（RT+TP group， n=38）. Conventional radiotherapy and three dimensional conformal radiotherapy were applied for patients， and the protocol was 2.0Gy／f, 5f/week， DT 60-66Gy. Chemotherapy drugs were taken as follow： elemene injection 400mg／d iv d₁-d₂₁， paclitaxel 150mg／m² iv d₁； nedaplatin 50mg／d iv d₁-d₃. The patients of RT+TP group received a course of TP regimen chemotherapy primarily， then started to receive radiotherapy after relevant examinations. The number of white blood cell（WBC） of the patients was detected and the change of WBC was analyzed every week within the first four weeks in the process of radiotherapy. The side effects and short term efficacy of each group were evaluated after radiotherapy. The patients were followed up， then we calculated the survival rate of 1-3 year and drew the Kaplan Meier survival curve. Results The response rate of RT group, RT+E group and RT+TP group were 84.4％， 90.5％ and 92.1％, respectively. The incidence rates of the radiation esophagitis were 66.7％， 61.9％ and 60.5％, respectively. The incidence rates of the radiation pneumonitis were 24.4％， 31.0％ and 28.9％, respectively. The incidence rate of the myelosuppression in three groups was 100.0%. There were no significant differences in short term efficacy and side effects including radiation esophagitis， radiation pneumonitis and myelosuppression， when three groups compared with each other（P＞0.05）. There was significant increase in the change of WBC when RT+E group compared with the other two groups from the first week to the fourth week in the progress of radiotherapy（P＜0.05）. The one year survival rates of the RT group, RT+E group and RT+TP group were 60.0％， 73.8％ and 78.9％； two-year survival rates were 40.0％， 54.8％ and 60.5％； three-year survival rates were 28.9％， 33.3％ and 44.7％, respectively. There were no siginificant differences on the survival rates among 3 groups（P＞0.05）. Conclusion The two combination regimens have similar short term efficacy and don't increase the side effects of radiotherapy. In the process of radiotherapy， elemene injection has prominent role on the maintainence of WBC level of patients.