参一胶囊辅助GP方案治疗进展期食管癌的随机对照试验

背景：从中药人参中提制的参一胶囊已被证实具有抑制肿瘤血管生成的作用，对多种肿瘤具有治疗作用，但关于参一胶囊对食管癌疗效的研究较少见。目的：观察参一胶囊辅助吉西他滨联合顺铂（gemcitabine plus cisplatin, GP）治疗进展期食管癌的疗效。设计、场所、对象和干预措施：将河南省肿瘤医院及河南中医学院第一附属医院收治的60例进展期食管癌住院患者随机分为治疗组和对照组各30例，治疗组采用参一胶囊联合GP方案治疗，对照组则单行GP方案化疗。主要结局指标：治疗后进行疗效评价，检测血管内皮细胞生长因子（vascular endothelial growth factor, VEGF）水平，并评价毒副反应和生活质量，进行生存期随访。结果：治疗组和对照组总有效率比较，差异无统计学意义（P=0.297）；两组治疗后血清VEGF水平均低于治疗前，而治疗组治疗后VEGF水平又低于对照组治疗后（P=0.002）；治疗组白细胞和血小板下降率，以及恶心呕吐发生率均低于对照组，差异有统计学意义（P=0.045、0.036、0.037）；治疗组生活质量改善明显优于对照组，差异有统计学意义（P=0.028）；治疗组1年生存率高于对照组，差异有统计学意义（P=0.047）。结论：参一胶囊辅助GP方案是治疗进展期食管癌的一种新的安全有效的方法，有提高总有效率趋势，可抑制食管癌新生血管形成，减少化疗副反应，改善患者生活质量，提高患者生存率，优于单纯化疗。

Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial

Background： In recent years, Shenyi Capsule has been proven to have certain anti-angiogenic effects, and to be effective to many cancers, but its effects on advanced esophageal cancer are scarcely studied.
Objective： To observe the effects of Shenyi Capsule combined with gemcitabine plus cisplatin （GP） regimen in treatment of advanced esophageal cancer.
Design, setting, participants and interventions： Sixty inpatients with advanced esophageal cancer from Henan Tumor Hospital, and the Fist Affiliated Hospital of Zhengzhou University were included and randomly divided into treatment group and control group. There were 30 cases in each group. Patients in the treatment group were treated with Shenyi Capsule combined with GP regimen, and patients in the control group were treated with GP regimen alone.
Main outcome measures： The total response rate was calculated. The level of vascular endothelial growth factor （VEGF）, the chemotherapy side reaction and quality of life in the two groups were evaluated. The follow-up of survival time was conducted too.
Results： There was no significant difference in total response rate between the two groups （P=0.264）. The levels of VEGF in the two groups were decreased as compared with that before the treatment. After treatment, the VEGF level in the treatment group was lower than that in the control group （P=0.002）. The decline rates of white blood cell and blood platelet, and the incidence rate of nausea and vomiting in the treatment group were lower than those in the control group, and there were significant differences between the two groups （P=0.045, P=0.036, P=0.037）. The quality of life of the patients in the treatment group was better than that in the control group （P=0.028）, and one-year survival rate in the treatment group was higher than that in the control group （P=0.047）.
Conclusion： Shenyi Capsule combined with GP regimen is feasible and safe in treatment of advanced esophageal cancer, and the effects are better than chemotherapy alone. It can improve the total response rate, and is effective in inhibiting new angiogenesis of esophageal cancer, reducing chemotherapy side reaction, and improving the patients’ quality of life and survival rates.