健脾养正消癥方加减联合安罗替尼二线治疗晚期食管癌的临床研究

Clinical study on modified Tonifying Spleen and Nourishing qi Recipe combined with anlotinib as second-line chemotherapy in treatment of advanced esophageal cancer

  • 摘要:
    目的 观察健脾养正消癥方加减联合安罗替尼二线治疗晚期食管癌的临床疗效。
    方法 选取经病理组织学检查确诊的60例经一线化疗后进展的晚期食管癌患者为研究对象,将其随机分为对照组(30例)和试验组(30例)。对照组给予安罗替尼12 mg, 1次/d, 连服2周,停药1周, 2个周期后评价疗效。试验组在安罗替尼治疗基础上,以健脾养正法为理论指导采用健脾养正消癥方加减。观察2组疗效、不良反应及临床症状的改善情况。
    结果 试验组卡氏评分(KPS)评定的生活质量好转率为46.67%(14/30), 高于对照组的20.00%(6/30), 差异有统计学意义(P<0.05)。试验组疲乏、高血压及腹泻的发生率分别为46.67%、30.00%和23.33%, 分别低于对照组的56.67%、40.00%和40.00%, 差异有统计学意义(P<0.05)。试验组客观缓解率(ORR)为26.67%, 高于对照组的20.00%;试验组疾病控制率(DCR)为70.00%, 高于对照组的63.33%, 但差异无统计学意义(P>0.05)。试验组恶心、困倦、食欲改善情况优于对照组,差异有统计学意义(P<0.05)。
    结论 健脾养正法联合安罗替尼治疗晚期食管癌能明显提高患者生活质量且不良反应可耐受,可以作为晚期食管癌的有效姑息治疗方法。

     

    Abstract:
    Objective To observe the clinical efficacy of modified Tonifying Spleen and Nourishing qi Recipe combined with anlotinib as second-line chemotherapy in treatment of advanced esophageal cancer.
    Methods A total of 60 patients with advanced esophageal cancer diagnosed by histopathological examination who were progressed after first-line chemotherapy were randomly divided into control group (30 cases) and experimental group (30 cases). The control group was treated with anlotinib for 12 mg once a day, and the drug was continuously administrated for 2 weeks and discontinued for 1 week. The efficacy was evaluated after 2 cycles of treatment. The experimental group administrated modified Tonifying Spleen and Nourishing qi Recipe guided by theory of invigorating the spleen and nourishing healthy qi method based on the treatment of anlotinib. The curative effect, adverse reactions and clinical symptoms of the two groups were observed.
    Results The improvement rate of quality of life assessed by Kanofsky performance score(KPS) in the experimental group was 46.67%(14/30), which was higher than 20.00%(6/30) in the control group, and the difference was statistically significant (P < 0.05). The incidence of fatigue, hypertension and diarrhea in the experimental group were 46.67%, 30.00% and 23.33%, respectively, which were lower than 56.67%, 40.00% and 40.00%, respectively in the control group, and the differences were statistically significant (P < 0.05). The objective response rate(ORR) of the experimental group was 26.67%, which was higher than that of the control group (20.00%); the disease control rate (DCR) of the experimental group was 70.00%, which was higher than 63.33% of the control group, but the differences were not statistically significant (P > 0.05). The improvement of nausea, drowsiness and appetite in the experimental group was better than that in the control group, and the difference was statistically significant (P < 0.05).
    Conclusion Invigorating the spleen and nourishing healthy qi therapy combined with anrotinib can significantly improve the quality of life of patients with advanced esophageal cancer and can be tolerated adverse reactions, therefore, it can be used as an effective palliative treatment for advanced esophageal cancer.

     

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