艾迪注射液联合PT方案治疗进展期食管癌的临床观察

Clinical study on efficacy of Aidi injection combined with PT chemotherapy protocol in advanced esophageal cancer patients

目的 观察艾迪注射液联合PT方案（紫杉醇＋顺铂）治疗进展期食管癌患者的疗效及不良反应。方法 试验组（53例）给予艾迪注射液联合PT方案化疗，对照组（53例）给予PT方案化疗。两组患者均以21 d为1个化疗周期，每组患者进行2个周期的治疗。治疗2个周期后评价患者近期疗效、不良反应及生存质量。结果 试验组与对照组总有效率分别为90.57 %（48／53）及81.13 %（43／53），差异无统计学意义（P＝0.164）；试验组中位生存期为48周，对照组为42周，差异有统计学意义（P＝0.027）。试验组Ⅲ～Ⅳ度胃肠道反应发生率与对照组比较差异有统计学意义（Ⅲ度P＝0.026，Ⅳ度P＝0.027）。试验组Ⅲ～Ⅳ度白细胞抑制发生率与对照组比较差异有统计学意义（Ⅲ度P＝0.038，Ⅳ度P＝0.040）。试验组Ⅲ度血小板抑制发生率与对照组比较差异有统计学意义（P＝0.023 ）。试验组Ⅱ～Ⅲ度贫血发生率与对照组比较差异有统计学意义（Ⅱ度P＝0.020，Ⅲ度P＝0.041）。肝、肾损伤及脱发、肌肉酸痛症状试验组与对照组相比差异均无统计学意义（均P 〉 0.05）。试验组Karnofsky评分治疗前后无明显下降（P＝0.067），对照组Karnofsk评分下降（P＝0.006）。结论 艾迪注射液联合PT方案对进展期食管癌患者疗效较好，同时降低了患者不良反应的发生率，改善了生活质量，延长了生存期。

Objective To compare and analyze the effect of single PT （taxol, cisplatin） chemotherapy and the PT chemotherapy combined with Aidi injection in the medium and advanced esophageal patients, in order to maximize the strength chemotherapy＇s effects, reduce the side effects, improve the patients＇ life qualities. Methods 106 cases of esophageal patients were randomly divided into two groups, 53 patients for each group. The control group were treated by the single PT chemotherapy protocol, while the treatment group were combined with Aidi and PT chemotherapy protocol, 21 days time peroid was taken as one circle. After two weeks, the effect, the patients＇ life qualities and the side effects between two groups were compared. Results The effective rates of treatment group and control group were 90.37 % （48/53） and 81.13 % （43/53）, respectively, there was no statistic significance （P 〉 0.05）. The median-survival in two groups were 48 weeks and 42 weeks, which was statistic significance （P = 0.027）. The treatment group＇s side effects incidence rate was lower than that of control group in Ⅲ-Ⅳ degree gastroi ntestinal reaction （Ⅲ degree P = 0.026, Ⅳ degree P = 0.027）, Ⅲ-Ⅳ degree of inhibition of white blood cells （Ⅲ degree P = 0. 038, Ⅳ degree P = 0.040）, Ⅲ degree platelet inhibition （P = 0.023） and Ⅱ-Ⅲ degree hypohemia （Ⅱ degree P = 0.020, Ⅲ degree P = 0.041）. There were no statistically differences between treatment group and control group in liver, muscle, kidney toxicity and baldness （P 〉 0.05）. There were significant differences in Karnofsky score and body mass between pre- and post- treatment in chemotherapy group （P = 0.067）, but those in treatment group were not （P = 0.006）. Conclusion The Aidi injection combined with PT chemotherapy protocol has a better effect in the esophageal cancer patients, longer median survival time, reduced the side effects and improved the patients＇ life qualities, which is deserved to be used in the clinical furtherly.