重组人血管内皮抑制素注射液联合雷替曲塞注射剂和奥沙利铂注射剂治疗晚期结直肠癌的临床研究

Clinical trial of recombinant human endostatin injection combined with raltitrexed injection and oxaliplatin injection in the treatment of advanced colorectal cancer

目的观察重组人血管内皮抑制素联合雷替曲塞和奥沙利铂治疗晚期结直肠癌的临床疗效及安全性。方法将82例晚期结直肠癌患者随机分为对照组38例和试验组44例。对照组予以第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2 h;试验组在对照组治疗的基础上,予以重组人血管内皮抑制素15 mg,静脉滴注3~4 h,第1~14天。2组患者1个周期均为3周,共治疗4个周期。比较2组患者的临床疗效、无进展生存期(PFS)及总生存期、生存质量评分的改善率,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28.57%(12/42例)和13.89%(5/36例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的PFS分别为(7.91±2.42),(4.21±1.71)个月;总生存期分别为(13.92±1.93),(10.43±2.14)个月;生存质量评分的总改善率分别为80.95%和52.78%,差异均有统计学意义(P<0.05)。试验组和对照组的肝功能损害发生率分别为15.91%和15.79%;恶心发生率分别为63.63%和65.79%;腹泻发生率分别为13.64%和13.16%;血小板减少发生率分别为22.73%和21.05%;白细胞减少发生率分别为45.45%和42.11%,差异均无统计学意义(P>0.05)。结论重组人血管内皮抑制素联合雷替曲塞和奥沙利铂治疗晚期结直肠癌的临床疗效显著,能够有效地延长患者的PFS及总生存期,并提高患者生存质量,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of re- combinant human endostatin combined with raltitrexed and oxaliplatin in the treatment of advanced colorectal cancer. Methods Eighty - two pa- tients were randomly divided into control group （ n = 38 ） and treatment group（n =44）. Control group was given 3 mg .m-2 rahitrexed, intrave- nous drip for 15 rain, the first day ＋ 130 mg . m-2 oxaliplatin, intrave- nous drip for 2 h, the first day. Treatment group was received recombi- nant human endostatin 15 mg, intravenous drip for 3 -4 h, on the basis of control group. The course of two groups was 4 cycles with 3 weeks per cycle. The clinical efficacy, progression - free survival （PFS） , overall survival, the improvement rate of quality of life scores and incidence of adverse drug reactions were compared in two groups. Results After treatment, the total effective rates in treatment and control groups were25.87% （12/42） and 13.89% （5/36）, with significant difference （P 〈0. 05）. After treatment, the main indexes in treatment and control groups were compared： the PFS were （7.91 ±2.42）, （4.21 ± 1.71 ） months; the overall survi- val were （13.92 ± 1.93）, （10. 43 ± 2. 14） months; the improvement rates of quality life scores were 80. 95% and 52.78%, with statistically significant difference （P 〈 0. 05 ）. In the treatment and control groups, the incidences of liver dysfunction were 15.91% and 15.79% ; nausea were 63.63% and 65.79% ; diarrhea were 13.64% and 13.16% respectively; thrombocytopenia were 22. 73% and 21.05% ; leukopenia were 45.45% and 42. 11%, the difference was not statistically significant （P 〉 0. 05 ）. Conclusion Recombinant human endostatin combined with raltitrexed and oxaliplatin has a definitive clinical efficacy for the treatment of advanced colorectal cancer, which may improve PFS, overall survival and the quality of life, without increasing the incidence of adverse drug reactions.