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雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期胃癌的临床研究 被引量:8

Clinical trial of raltitrexed injection combined with oxaliplatin injection in the treatment of advanced gastric cancer
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摘要 目的观察雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期胃癌的临床疗效和安全性。方法将44例晚期胃癌患者随机分为对照组22例和试验组22例。对照组予以第1天奥沙利铂130 mg·m^(-2),静脉滴注3 h+第1~5天亚叶酸钙200 mg·m^(-2),静脉滴注+第1~5天氟尿嘧啶375 mg·m^(-2),静脉滴注;试验组予以第1天雷替曲塞3 mg·m^(-2),静脉滴注15 min+第1天奥沙利铂130 mg·m^(-2),静脉滴注3 h。2组患者1个周期均为3周,共治疗2个周期。比较2组患者的临床疗效、中位无疾病进展时间和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为59.09%(13/22例)和31.82%(7/22例),中位无疾病进展时间分别为7.1和5.6个月,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应主要为粒细胞减少和恶心呕吐。试验组和对照组的血液学毒性发生率分别为18.18%和13.64%,消化道反应发生率分别为4.55%和9.09%,差异均无统计学意义(均P>0.05)。结论雷替曲塞注射剂联合奥沙利铂注射剂治疗晚期胃癌的临床疗效确切,且不增加药物不良反应的发生率。 Objective To observe the clinical efficacy and safety of raltitrexed injection combined with oxaliplatin injection in the treatment of advanced gastric cancer. Methods Forty-four patients with advanced gastric cancer were randomly divided into control group and treatment group with 22 cases per group. Control group was given oxaliplatin 130mg·m^(-2),intravenous infusion for 3 h at the first day + calcium folinate200 mg·m^(-2),intravenous infusion for day 1-5 + 5-fluorouracil 375mg·m^(-2),intravenous infusion for day 1-5. Treatment group was given raltitrexed 3 mg·m^(-2),intravenous infusion for 15 min at the first day +oxaliplatin 130 mg·m^(-2),intravenous infusion for 3 h at the first day.Two groups were treated for 2 cycles with 3 weeks per cycle. The clinical efficacy,progression-free survival( PFS) and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates in treatment and control groups were 59. 09%( 13/22 cases) and 31. 82%( 7/22 cases),the PFS in treatment and control groups were 7. 1 and 5. 6 months,the differences were statistically significant( all P〈0. 05). The adverse drug reactions in two groups werebased on granulocytopenia,nausea and vomiting. The incidences of hematological toxicity and gastrointestinal reactions in the treatment group were 18. 18% and 4. 55%,which in control group were 13. 64% and 9. 09%,without significant differences( P〈0. 05). Conclusion Raltitrexed injection combined with oxaliplatin injection has a definitive clinical efficacy in the treatment of advanced gastric cancer,without increasing the incidence of adverse drug reactions.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2017年第15期1437-1439,共3页 The Chinese Journal of Clinical Pharmacology
基金 河南省医学科技攻关基金资助项目(201303021)
关键词 雷替曲塞注射剂 奥沙利铂注射剂 胃癌 安全性 rahitrexed injection oxaliplatin injection gastric cancer safety
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