替吉奥联合复方苦参注射液治疗老年晚期胃癌的疗效和安全性分析

Efficacy and safety of S-1 combined with compound kushen injection as first-line treatment in older patients with advanced gastric cancer

目的探讨替吉奥(S-1)联合复方苦参注射液治疗老年晚期胃癌的疗效和安全性。方法选取沈阳军区总医院肿瘤科收治的70岁以上老年胃癌患者63例,剔除中途因疾病进展而中止治疗及脱落的4例患者,共59例入组,按随机数字表法分为对照组(n=28)和联合组(n=31),对照组口服单药S-1(40 mg/m^2,2次/日),联合组在其基础上联合复方苦参注射液(20 ml,d1~d14),两组均28天为1个周期。评价两组的疗效、不良反应并随访生存情况。结果联合组总有效率(RR)和疾病控制率(DCR)分别为54.9%和90.3%,对照组的RR和DCR分别为39.3%和85.7%,差异无统计学意义(P>0.05);两组的不良反应多为1~2级,其中联合组乏力、肝功损伤发生率分别为83.9%、74.2%,低于对照组的100.0%、96.4%,差异有统计学意义(P<0.05);联合组的中位无进展生存期为9.0个月,长于对照组的7.9个月,差异有统计学意义(P<0.05);两组中位总生存期分别为14.6个月和13.1个月,差异无统计学意义(P>0.05)。结论 S-1联合复方苦参注射液可延长老年晚期胃癌患者的无进展生存期,且不良反应轻微,安全性较高,值得临床推广。

Objective To explore the effecacy and safety of S-1 plus compound kushen injection curative treatment for advanced gastric cancer. Methods Sixty-three elderly patients over the age of 70 with gastric cancer from the general hospital of shenyang military region were enrolled,excluding 4 patients of disease progression and fall off. Fifty-nine patients in total according to random number table method were divided into 28 cases as the control group and 31 cases as combined group. The control group was taken S-1 orally（ 40 mg / m^2）,and combined group was taken S-1 plus compound kushen injection. The effecacy,adverse reactions and survival were observed. Results The response rate（ RR） and disease control rate（ DCR） of combined group were 54. 9% and 90. 3%,which were similar with 39. 3% and 85. 7% of the control group（ P〉0. 05）. The main side effects were of grade 1-2 in both groups. The incidence of weakness and hepatic injury in combined group were 83. 9% and 74. 2%,lower than those in control group（ 100. 0% and96. 4%）,respectively（ P〈0. 05）. The median progression-free survival of combined group was 9. 0 months,higher than 7. 9 months in control group（ P 0. 05）. The median overall survival in combined group and control group was 14. 6 months and 13. 1 months（ P 0. 05）. Conclusion S-1 combined with compound kushen injection for the treatment of elderly advanced gastric cancer has a longer progression-free survival with slight adverse reactions,worthy of clinical promotion.