安罗替尼胶囊联合卡培他滨片治疗结直肠癌患者的临床研究

Clinical trial of anlotinib capsules combined with capecitabine tablets in the treatment of patients with colorectal cancer

目的观察安罗替尼胶囊联合卡培他滨片治疗结直肠癌患者的临床疗效及安全性.方法将88例结直肠癌患者随机分为对照组44例和试验组44例.对照组给予1250 mg·m^(2)卡培他滨,早晚各口服1次,连续服药2周后停药1周;试验组在对照组治疗的基础上,加用安罗替尼胶囊每次12 mg,qd,口服,连续服药2周后停药1周.2组患者均连续治疗2个疗程,每个疗程3周.比较2组患者的临床疗效、内脂素及磷脂酶Cε1(PLCE1)水平,以及药物不良反应的发生情况.结果试验过程中共脱落3例.治疗后,试验组和对照组的客观缓解率分别为58.14%(25例/43例)和35.71%(15例/42例),疾病控制率分别为86.05%(37例/43例)和66.67%(28例/42例),差异均有统计学意义(均P<0.05).治疗后,试验组和对照组的内脂素分别为(32.87±8.43)和(37.42±10.32)ng·mL^(-1),PLCE1分别为(1.05±0.23)和(1.17±0.24)ng·mL^(-1),差异均有统计学意义(均P<0.05).试验组发生的药物不良反应有胃肠道反应(51.16%)、肝功能异常(18.60%)、口腔黏膜炎(13.95%)、血细胞减少(9.30%)和皮疹(6.98%);对照组发生的药物不良反应有胃肠道反应(45.24%)、肝功能异常(16.67%)、口腔黏膜炎(11.63%)、血细胞减少(4.76%)和皮疹(2.38%).2组患者的上述药物不良反应发生率比较,差异均无统计学意义(均P>0.05).结论安罗替尼胶囊联合卡培他滨片治疗结直肠癌患者的临床疗效较单用卡培他滨片好,前者能更显著地降低患者内脂素及PLCE1水平,且不增加药物不良反应的发生率.

Objective To observe the clinical efficacy and safety of anlotinib capsules combined with capecitabine tablets in the treatment of patients with colorectal cancer.Methods A total of 88 patients with colorectal cancer were randomly divided into control and treatment groups with 44 cases per group.Control group was given 1250 mg·m^(2)capecitabine,once in the morning and evening,then stopped the medication for 1 week after taking the medicine for 2 consecutive weeks.On the basis of control group,treatment group was given anlotinib capsules 12 mg per time,qd,orally,then stopped the medication for 1 week after taking the medicine for 2 consecutive weeks.Two groups were treated for 2 courses with 3 weeks per course.The clinical efficacy,levels of visfatin and phospholipase Cε1(PLCE1),and adverse drug reactions were compared between two groups.Results Three cases dropped out the trial.After treatment,the objective remission rates of treatment and control groups were 58.14%(25 cases/43 cases)and 35.71%(15 cases/42 cases),the disease control rates were 86.05%(37 cases/43 cases)and 66.67%(28 cases/42 cases),the differences were statistically significant(all P<0.05).After treatment,the visfatin levels of treatment and control groups were(32.87±8.43)and(37.42±10.32)ng·m L^(-1),PLCE1 were(1.05±0.23)and(1.17±0.24)ng·m L^(-1),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were gastrointestinal reactions(51.16%),abnormal liver function(18.60%),oral mucositis(13.95%),blood cell reduction(9.30%)and skin rash(6.98%),which in control group were gastrointestinal reactions(45.24%),abnormal liver function(16.67%),oral mucositis(11.63%),blood cell reduction(4.76%)and skin rash(2.38%).There were no statistically significant differences in the incidences of above-mentioned adverse drug reactions between two groups(all P>0.05).Conclusion Anlotinib capsules combined with capecitabine tablets have better clinical efficacy than capecitabine tablets alone in the treatment of patients with colorectal cancer,the former can significantly reduce the levels of visfatin and PLCE1 in patients without increasing the incidence of adverse drug reactions.