参一胶囊联合阿帕替尼治疗晚期胃癌的临床研究

Clinical study on Shenyi Capsules combined with apatinib in treatment of advanced gastric cancer

目的探讨参一胶囊联合阿帕替尼治疗晚期胃癌的临床效果和安全性。方法选取河南省肿瘤医院2016年9月—2017年9月收治的晚期胃癌患者123例,随机分成对照组(61例)和治疗组(62例)。对照组患者口服甲磺酸阿帕替尼片,2片/次,1次/d;治疗组患者在对照组的基础上口服参一胶囊,2粒/次,2次/d。两组患者均连续治疗8周。观察两组患者临床疗效,同时比较治疗前后两组患者血清肿瘤标志物水平、KPS和ECOG评分及不良反应情况。结果治疗后,对照组客观缓解率和疾病控制率分别为44.26%和68.85%,均显著低于治疗组的67.74%和88.71%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血清血管内皮生长因子(VEGF)、糖抗原72-4(CA72-4)和癌胚抗原(CEA)水平均显著降低(P<0.05),且治疗组患者较对照组降低的更明显(P<0.05)。治疗后,两组患者KPS评分显著升高(P<0.05),ECOG评分显著降低(P<0.05),且治疗后治疗组患者KPS和ECOG评分均明显优于对照组(P<0.05)。治疗期间,治疗组患者的药物毒副反应发生率为6.45%,显著低于对照组的21.31%,两组比较差异具有统计学意义(P<0.05)。结论参一胶囊联合阿帕替尼治疗晚期胃癌疗效显著、安全性高,同时能够显著改善患者的肿瘤标志物水平和生活质量。

Objective To investigate the clinical efficacy and safety of Shenyi Capsules combined with apatinib intreatment of advanced gastric cancer Methods Patients(123 cases) with advanced gastric cancer in Henan Cancer Hospital from September 2016 to September 2017 were randomly divided into control(61 cases) and treatment(62 cases) groups. Patients in the control group were po administered with Apatinib Mesylate Tablets, 2 tablets/time, once daily. Patients in the treatment group were po administered with Shenyi Capsules on the basis of the control group, 2 grains/time, twice daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical efficacy was evaluated, and the serum tumor marker levels, KPS and ECOG scores, and adverse reactions in two groups before and after treatment were compared. Results After treatment, the objective reaction rate and disease control rate in the control group were 44.26% and 68.85%, which were significantly lower than 67.74% and 88.71% in the treatment group, respectively, and there were differences between two groups(P < 0.05). After treatment, the VEGF, CA72-4 and CEA levels in two groups were significantly decreased(P < 0.05), and these serum tumor marker levels in the treatment group were significantly lower than those in the control group(P < 0.05). After treatment, KPS scores in two groups were significantly increased(P < 0.05), but ECOG scores were significantly decreased(P < 0.05). After treatment, KPS and ECOG scores in the treatment group were significantly better than those in the control group of the same period(P < 0.05). During the treatment, the adverse reactions rate in the treatment group was 6.45%, which was significantly lower than 21.31% in the control group, with significant difference between two groups(P < 0.05). Conclusion Shenyi Capsules combined with apatinib has significant efficacy and safety in treatment of advanced gastric cancer, which can significantly improve the level of tumor markers and the quality of life.