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目的观察不同剂量顺铂(CDDP)联合5-氟脲嘧啶(5-Fu)、表阿霉素(EP I)治疗进展期胃癌的疗效及毒副作用。方法62例病人以数字随机表按1:1分为小剂量顺铂组(A组)和大剂量顺铂组(B组)。A组:CDDP 10m g/m2静脉滴注2h d1~5,EP I 50m g/m2静脉滴注d1,5-Fu750m g/m2持续静脉滴注24h d1~5;B组:CDDP 60 m g/m2静滴d1,EP I、5-Fu用法同A组。每3周重复,至少2周期后判定疗效。结果62例均获得随访。A组中有30例可评价疗效及毒副反应,CR 2例(6.7%),PR 11例(36.7%),SD 12例(40.0%),PD 5例(16.7%),RR(CR+PR)43.4%,临床受益率(CBR:CR+PR+SD)83.3%。B组中有26例病人可评价疗效及毒副反应,CR 1例(3.8%),PR 10例(38.5%),SD 10例(38.5%),PD 5例(19.2%),RR 42.3%,CBR 80.8%。A组缓解期为3~7个月,中位缓解期4.8个月,中位生存时间8.5个月;B组缓解期为2~7个月,中位缓解期4.6个月,中位生存时间8.2个月,两组间差异无统计学意义。毒副反应主要为消化道反应、骨髓抑制、脱发及口腔炎,差异有统计学意义(2χ=8.449,P=0.004);Ⅲ、Ⅳ级白细胞减少发生率分别为10.0、34.6%,差异有统计学意义(2χ=5.013,P=0.025)。两组均无治疗相关性死亡。结论大、小不同剂量顺铂联合方案治疗进展期胃癌的疗效相似,而小剂量顺铂不良反应轻,病人耐受性好。
Objective To observe the curative effect and side effects of different doses of cisplatin (CDDP) combined with 5-fluorouracil and epirubicin (EPI) on advanced gastric cancer. Methods Sixty-two patients were divided into low-dose cisplatin group (group A) and high-dose cisplatin group (group B) by 1: 1 digital random table. Group A: CDDP 10 m g / m2 intravenous infusion 2h d1 ~ 5, EP I 50m g / m2 intravenous infusion d1,5-Fu750m g / m2 continuous intravenous infusion 24h d1 ~ 5; B group: CDDP 60 mg / m2 Intravenous d1, EP I, 5-Fu use the same group A. Repeat every 3 weeks, after at least 2 cycles to determine efficacy. Results 62 cases were followed up. There were 30 patients in group A who could evaluate the curative effect and side effect. CR 2 cases (6.7%), PR 11 cases (36.7%), SD 12 cases (40.0%), PD 5 cases (16.7% PR) 43.4%, clinical benefit rate (CBR: CR + PR + SD) 83.3%. Twenty-six patients in group B were evaluated for efficacy and toxicity, CR 1 (3.8%), PR 10 (38.5%), SD 10 (38.5%), PD 5 (19.2%), RR 42.3% , CBR 80.8%. In group A, the remission period was 3 to 7 months, the median remission period was 4.8 months, and the median survival time was 8.5 months. The remission period in group A was 2 to 7 months, and the median remission period was 4.6 months. The median survival time 8.2 months, no significant difference between the two groups. The main side effects were digestive tract reaction, myelosuppression, alopecia and stomatitis. The difference was statistically significant (2χ = 8.449, P = 0.004). The incidence of grade Ⅲ and Ⅳ leukopenia were 10.0 and 34.6% Significance (2χ = 5.013, P = 0.025). No treatment-related death occurred in either group. Conclusion Large and small doses of cisplatin combination regimen for the treatment of advanced gastric cancer have similar efficacy, while low-dose cisplatin has mild adverse reactions and good patient tolerance.