威麦宁胶囊联合XELOX方案治疗晚期胃癌的效果观察

Efficacy observation of the combination of Weimaining capsule and XELOX regimen in the treatment of advanced gastric cancer patients

目的评价威麦宁胶囊联合XELOX（卡培他滨＋奥沙利铂）方案治疗晚期胃癌的疗效及安全性。方法62例符合入组条件的晚期胃癌患者按随机数字表法随机分为观察组和对照组。观察组31例患者接受威麦宁胶囊和XELOX方案全身化疗，对照组31例患者仅接受同等剂量强度的XELOX方案化疗，21d为1个周期，每例患者至少接受2个周期治疗，每2个周期治疗后评价疗效。结果观察组的中位疾病进展时间（TTP）为5．5个月，对照组为4．8个月，二组间差异无统计学意义（P=0．238）。观察组疾病控制率（DCR）较对照组提高[67．7％（21／31）比41．9％（13／21），P〈0．05]；两组客观有效率（ORR）差异无统计学意义[32．3％（10／31）比25．8％（8／31），P〉0．051。所有患者均未发生V级不良反应（即因药物导致死亡）。观察组Ⅱ-Ⅳ级中性粒细胞下降发生率及Ⅱ-Ⅳ级恶心、呕吐发生率均较对照组低[16．13％（5／31）比38．71％（12／31），P〈0．05；12．90％（4／31）比35．48％（11／31），P〈0．051，其他不良反应两组间差异无统计学意义（P〉0．05）。结论威麦宁胶囊联合XELOX方案治疗晚期胃癌可显著提高DCR并减轻部分患者化疗不良反应，安全性良好，值得临床推广应用。

Objective To evaluate the efficacy and safety of the combination of Weimaining capsule and XELOX regimen （oxaliplatin plus capecitabine） in the treatment of advanced gastric cancer patients. Methods A total of 62 patients with advanced gastric cancer who fulfilled all predetermined criteria were randomly divided into observation group and control group. The 31 patients in observation group received a combination of Weimaining capsule and XELOX regimen, the 31 patients in control group received only XELOX regimen at the same dose intensity. Each patient received at least two cycles （1 cycle = 21 days） of treatment, the efficacy was assessed after two cycles. Results The median time-to-progression （TFP） of observation and control groups were 5.5 and 4.8 months, respectively. The difference had no statistical significance （P = 0.238）. The disease control rates （DCR） of observation group was significantly improved compared with control group [67.7 % （21/31） vs 41.9 % （13/21）, P 〈 0.05], the difference was statistically significant, while the objective response rate （ORR） of the 2 groups had no statistical difference [（32.3 % （10/31） vs 25.8 % （8/31）, P 〉 0.05]. In drug safety aspects, there was no V grade adverse reactions （deaths caused by drug） among all the patients. Rates of grades Ⅱ-Ⅳ neutrocytopenia and nausea, vomiting in observation group were obviously lower than control group [16.13 % （5/31） vs 38.71% （12/31）, P 〈 0.05; 12.90 % （4/31） vs 35.48 % （11/31）, P 〈 0.05], other adverse reactions between the 2 groups had no statistical difference. Conclusions A combination of Weimaining capsule and XELOX regimen in the treatment of advanced gastric cancer patients can improve DCR significantly and reduce part of adverse reaction induced by chemotherapy with satisfactory safety. This method is worthy of application widely.