替吉奥联合顺铂治疗晚期胃癌的近期疗效观察

Short-term clinal investigation of combination chemotherapy with TS-1 and cisplatin on advanced gastric cancer

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 evaluate the effectiveness and safety of combination chemotherapy with TS-1 and eisplatin on advanced gastric cancer. Methods We conducted a non-blinded, randomized, con- trolled trial, 53 patients with advanced gastric cancer were randomly assigned to two groups. The treatment group（n =27） administered with TS-1 capsule（ doses based on patients＇body surface area： 〈 1. 25m2, 40mg,bid; 1. 25 - 1. 50m2,50mg, bid; 〉 1. 50m2,60mg, bid, from day 1 to 14） plus eisplatin （75mg/m2from day 1 through day 3 ） every 21 days. The control group （n = 26 ） administered with 5-Fu 600mg/（ m2 · d） intravenous drip from day 1 to day 5 by micro-pump infusion continuously and cisplatin 20rag/（ m2 · d） intravenous drip on day 1 to day 5 every 28 days. The response rate,life quality and adverse reaction were evaluated after every 2 cycles. Results In the treatment group the effective rate（59. 3% ） , clinical beneficial rate （ 88. 9% ） and improvement of life quality （44.4%） were significantly higher than those of the control group respectly （ P 〈 0. 05 ）. The decrease of life quality were found in 46. 2% of the control group and 11.1% of the treatment group（ P 〈 0. 05 ）. The main adverse events were alimentary canal toxicity,hematologic system and hepatotoxieity. There was no significant difference between the two groups （P 〉 0. 05）. Conclusions TS-1 capsule combined with cisplatin is safe and effective in the treatment of advanced gastric cancer.