多西他赛注射液与卡培他滨片治疗进展期胃癌的临床研究

Clinical trial of docetaxel injection and capecitabine tablets in the treatment of advanced gastric cancer

目的观察在奥沙利铂注射液基础治疗下,多西他赛注射液与卡培他滨片(DOX方案)治疗进展期胃癌的临床疗效及安全性。方法将65例进展期胃癌患者分为A组30例、B组18例、C组17例。A组予以第1天奥沙利铂130mg·m^(-2),静脉滴注2 h+第1天多西他赛75 mg·m^(-2),静脉滴注2 h+第1~14天口服卡培他滨1000 mg·m^(-2)bid;B组予以第1天奥沙利铂130 mg·m^(-2),静脉滴注2 h+第1~14天口服卡培他滨1000 mg·m^(-2)bid;C组予以第1天奥沙利铂130 mg·m^(-2),静脉滴注2 h+第1天多西他赛75 mg·m-2,静脉滴注2 h+第1~5天氟尿嘧啶500 mg·m^(-2),静脉滴注2 h。3组患者一个疗程均为21 d,共治疗4个疗程。比较3组患者的短期疗效、生活质量(SF-36)评分、复发情况、生存期,以及药物不良反应的发生情况。结果治疗后6个月,A、B、C组的总有效率分别为96.67%(29/30例),77.78%(14/18例),41.18%(7/17例);SF-36评分分别为(70.11±9.21),(62.42±8.43),(55.45±7.86)分,差异均有统计学意义(P<0.05)。A、B、C组的1年内复发率分别为0,11.11%,29.41%;1~2年内复发率分别为3.32%,26.67%,50.00%;2~3年内复发率分别为11.54%,33.33%,66.67%,差异均有统计学意义(P<0.05)。A、B、C组的平均生存期分别为(2.80±0.35),(2.22±0.55),(1.65±0.46)年,差异有统计学意义(P<0.05)。3组患者的主要药物不良反应为血液学毒性、腹泻、恶心和呕吐、手足病变、肝毒性,且A、B、C组的药物不良反应发生率分别为16.67%,22.22%和58.82%,A、B组与C组比较差异均有统计学意义(P<0.05)。结论 DOX方案治疗进展期胃癌的临床疗效确切、药物不良反应轻微、复发率低,可延长患者的生存期,改善患者的生活质量。

Objective To observe the clinical efficacy and safety of docetaxel and capecitabine （DOX） in the treatment of advanced gastric cancer, on the basis treatment with oxaliplatin. Methods Sixty -five patients with advanced gastric cancer were divided into groups A, B, C with 30,18,17 cases, respectively. Group A was given oxaliplatin 130 mg·m^-2 day 1 intravenous infusion for 2 h ± docetaxel 75 mg·m^-2 day 1, intravenous infusion for 2 h ± capecitabine 1000 mg·m^-2, day 1 -14, oral, b/d. Group B was given oxaliplatin 130 mg·m^-2, day 1, in- travenous infusion for 2 h; capecitabine 1000 mg·m^-2, day 1 - 14, oral, bid. Group C was given oxaliplatin 130 mg·m^-2, day 1 , intravenous infusion for 2 h; docetaxel 75 mg·m^-2, day 1 , intravenous infusion for 2 h, fluorouracil 500 mg·m^-2, day 1 - 5 , intravenous injection 2 h. Three groups were treated for four courses with 21 days per course. The short - term efficacy, quality of life （ SF - 36） score, recurrence, survival and adverse drug reactions were compared between three groups. Results Six months after treatment, the total effective rates of A, B and C groups were 96. 67% （29/30 cases）, 77.78% （14/18 cases）, 41.18% （7/17 cases）; the SF - 36 scores were （ 70. 11 ±9.21 ） , （ 62.42 ± 8.43 ）, （ 55.45 ± 7.86 ） points, with significance difference （P 〈 0. 05）. In the groups A, B, C, the recurrence in 1 year were 0, 11.11%, 29.41% ; the recurrence in 1 - 2 years were 3.32%, 26. 67%, 50. 00% ;the recurrence in 2 -3 years were 11.54%, 33.33%, 66. 67%, with signifi- cant difference （ P 〈 0.05 ）. The average survival time of groups A, B and C were （2.80 ± 0. 35 ）, （2. 22±0. 55 ） , （ 1.65 ± 0. 46） years with significant difference （P 〈 0. 05 ）. The main adverse drug reactions in the three groups were based on hematologic toxicity, diarrhea, nausea and vomiting, hand - foot disease and hepatotoxicity. The incidences of adverse drug reaction rates in groups A, B and C were 16. 67% , 22.22% and 58.82%, the differences between groups A, B and C were significant （ P 〈 0. 05 ）. Conclusion DOX has a definitive clinical efficacy in the treatment of advanced gastric cancer, which has a low adverse drug reaction rate and low recurrence rate. DOX can improve the survival time and quality of life for patients with advanced gastric cancer.