[Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial].
[Efficacy of Shenyi Capsule combined with gemcitabine plus cisplatin in treatment of advanced esophageal cancer: a randomized controlled trial].
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DOI：
10.3736/jcim20091105
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发表时间：
2009-11-01
期刊：
影响因子：
--
通讯作者：
Zhang, Yu-qing
中科院分区：
文献类型：
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作者：
Huang, Jing-yu;Sun, Yan;Zhang, Yu-qing
背景：近年来，参益胶囊已被证实具有一定的抗血管生成作用，对多种癌症均有疗效，但对晚期食管癌的疗效研究甚少。目的：观察参益胶囊联合吉西他滨+顺铂（GP）方案治疗晚期食管癌的疗效。设计、环境、参与者和干预措施：选取河南省肿瘤医院和郑州大学第一附属医院住院的60例晚期食管癌患者，随机分为治疗组和对照组。每组30例。治疗组患者给予参益胶囊联合GP方案治疗，对照组患者单独给予GP方案治疗。主要观察指标：计算总有效率。观察两组患者的血管内皮生长因子（VEGF）水平、化疗副反应及生活质量。并对存活时间进行随访。结果：两组患者总有效率比较差异无统计学意义（P=0.264）。两组患者VEGF水平均较治疗前下降。治疗后，治疗组VEGF水平低于对照组（P=0.002）。治疗组患者白细胞、血小板下降率、恶心呕吐发生率均低于对照组，两组比较差异有统计学意义（P=0.045， P=0.036， P=0.037）。治疗组患者的生活质量优于对照组（P=0.028），治疗组1年生存率高于对照组（P=0.047）。结论：参益胶囊联合GP方案治疗晚期食管癌可行、安全，且效果优于单纯化疗。可提高总有效率，有效抑制食管癌新生血管生成，减少化疗副反应，提高患者生活质量和生存率。
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.