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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 recombinant human endostatin combined with raltitrexed and oxaliplatin in the treatment of advanced colorectal cancer. Methods Eighty-two patients with advanced colorectal cancer were randomly divided into control group (n = 38) and experimental group (n = 44). The control group received raltitrexed 3 mg · m-2 on day 1, intravenous infusion of 15 min + oxaliplatin 130 mg · m -2 on day 1 and intravenous drip for 2 h. In the control group On the basis of treatment, to be recombinant human endostatin 15 mg, intravenous infusion of 3 ~ 4 h, 1 to 14 days. One cycle of two groups of patients were 3 weeks, a total of 4 cycles. The clinical efficacy, progression-free survival (PFS) and overall survival were compared between two groups. The improvement rate of quality of life score and the incidence of adverse drug reactions were compared. Results After treatment, the total effective rate was 28.57% (12/42 cases) and 13.89% (5/36 cases) in the experimental group and the control group, respectively. The difference was statistically significant (P <0.05). After treatment, the PFS of the test group and the control group were (7.91 ± 2.42) and (4.21 ± 1.71) months respectively, and the overall survival was (13.92 ± 1.93) and (10.43 ± 2.14) months respectively. The overall quality of life score The improvement rates were 80.95% and 52.78%, respectively, with significant differences (P <0.05). The incidence of hepatic dysfunction was 15.91% and 15.79% in the experimental and control groups respectively. The incidence of nausea was 63.63% and 65.79% respectively. The incidence of diarrhea was 13.64% and 13.16% respectively. The incidence of thrombocytopenia was 22.73% and 21.05% respectively. The incidences of leukopenia were 45.45% and 42.11% respectively, with no significant difference (P> 0.05). Conclusion The recombinant human endostatin combined with raltitrexed and oxaliplatin in the treatment of advanced colorectal cancer has a significant clinical effect, which can effectively prolong the PFS and overall survival of patients and improve the quality of life of patients without increasing adverse drug reactions The incidence of reaction.