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目的探讨替吉奥联合顺铂治疗晚期胃癌的有效性和安全性。方法采用非盲法随机对照试验。治疗组27例,替吉奥胶囊根据体表面积给药,<1.25m2,40mg,bid;1.25~1.50m2,50mg,bid;>1.50m2,60mg,bid,早晚餐后口服,d1~d14。顺铂:75mg/m2,d1~d3,21d为一疗程。对照组26例,5-Fu 600mg.m-2.d-1以微量泵进行持续静脉滴注,d1~d5;顺铂20mg.m-2.d-1,静脉滴注,d1~d5。28d为一疗程。每完成2个周期复查评价疗效和生活质量状况,观察并记录不良反应。结果治疗组有效率为59.3%,对照组为19.2%,两组间比较差异有统计学意义(P=0.005)。临床获益率比较,治疗组为88.9%,对照组为53.8%,两组间比较差异有统计学意义(P=0.006)。治疗前后治疗组与对照组患者KPS评分改善情况差异有统计学意义(P=0.035),治疗后对照组KPS评分降低较治疗组有显著性差异(P=0.006)。两组患者主要不良反应为消化道毒性、血液学毒性和肝脏毒性,两组间比较差异无统计学意义(P>0.05)。结论替吉奥联合顺铂治疗晚期胃癌安全、有效。
Objective To investigate the efficacy and safety of ticlopidine combined with cisplatin in the treatment of advanced gastric cancer. Methods Non-blinded randomized controlled trials. In the treatment group, 27 cases were treated with TIGO capsules according to the body surface area. The patients were treated with body weight of 1.25ml, 40mg, bid, 1.25-1.50m2, 50mg, bid; 1.50m2, 60mg bid respectively. Cisplatin: 75mg / m2, d1 ~ d3, 21d for a course of treatment. Control group of 26 patients, 5-Fu 600mg.m-2.d-1 continuous infusion with a small amount of pump, d1 ~ d5; cisplatin 20mg.m-2.d-1, intravenous infusion, d1 ~ d5. 28d for a course of treatment. Review and evaluate the efficacy and quality of life for each completed 2 cycles, observe and record adverse reactions. Results The effective rate was 59.3% in the treatment group and 19.2% in the control group, with significant difference between the two groups (P = 0.005). The clinical benefit rate, the treatment group was 88.9%, 53.8% in the control group, the difference between the two groups was statistically significant (P = 0.006). There were significant differences in improvement of KPS scores between the treatment group and the control group before and after treatment (P = 0.035). The KPS score of the control group decreased significantly after treatment compared with the treatment group (P = 0.006). The main adverse reactions of the two groups were gastrointestinal toxicity, hematological toxicity and liver toxicity, with no significant difference between the two groups (P> 0.05). Conclusion It is safe and effective for the treatment of advanced gastric cancer with TIGO and cisplatin.