克唑替尼治疗间变淋巴瘤激酶基因阳性晚期肺腺癌的临床观察

目的 :观察克唑替尼治疗间变淋巴瘤激酶(ALK)基因阳性晚期肺腺癌的疗效与安全性。方法:选取2015年8月-2017年5月我院收治的72例ALK基因阳性晚期肺腺癌患者,按简单随机抽样法分为对照组和观察组,每组36例。对照组患者给予注射用培美曲塞二钠500 mg/m^2,d_1,静脉滴注+注射用顺铂75 mg/m^2,d_1～3,静脉滴注;用药前1 d口服醋酸地塞米松片0.75 mg,早晚各1次;用药前7 d口服叶酸片0.4 mg,至最后1次顺铂给药后21 d+肌内注射维生素B₁₂注射液1 mg,顺铂用药后每3周肌内注射1次;用药前1 d静脉滴注等渗葡萄糖注射液100 g,化疗当日静脉滴注等渗氯化钠注射液或葡萄糖注射液3 000～3 500 mL,同时给予氯化钾注射液0.5 g+甘露醇注射液50 g+呋塞米注射液20 mg,以保证每日尿量2 000～3 000 mL;每21 d为1个疗程,共治疗2个疗程。观察组患者在对照组治疗的基础上给予克唑替尼胶囊250 mg,口服,早晚7点各1次,整粒吞服,不可嚼碎或溶解服用,连用42 d。观察两组患者的临床疗效、生存质量及毒性反应发生情况。结果:观察组患者总有效率(61.11%)、生存质量稳定率(83.33%)均显著高于对照组(27.78%、44.44%)(P<0.05),观察组患者Ⅰ～Ⅳ级骨髓抑制、胃肠道反应、肝功能异常、周围神经炎、脱发的发生率均显著低于对照组,Ⅰ～Ⅳ级视觉效应的发生率显著高于对照组(P<0.05);两组患者Ⅰ～Ⅳ级浮肿的发生率比较,差异无统计学意义(P>0.05)。结论:在常规化疗的基础上加用克唑替尼,可显著提高ALK基因阳性晚期肺腺癌患者的疗效,有效改善患者的生存质量;该药虽然未增加其他组织或器官的毒性反应发生风险,但视觉效应毒性反应的发生率较高。

Clinical Observation of Crizotinib in the Treatment of ALK Positive Advanced Lung Adenocarcinoma

OBJECTIVE:To observe the efficacy and safety of crizotinib in the treatment of anaplastic lymphoma kinase(ALK)positive advanced lung adenocarcinoma.METHODS:From Aug.2015 to May 2017,72 patients with ALK positive advanced lung adenocarcinoma were selected from our hospital.According to the simple random method,the patients were divided into control group and observation group,with 36 patients in each group.The control group was given Pemetrexed disodium for injection 500 mg/m2,d1,ivgtt+Cisplatin for injection 75 mg/m^2,d1-3,ivgtt;Dexamethasone acetate tablets 0.75 mg were given orally one day before administration,once in the morning and again in the evening;7 days before administration,Folic acid tablets 0.4 mg were given orally till 21 days after the last administration of cisplatin;Vitamin B12 1 mg injection was injected intramuscularly every 3 weeks after intramuscular injection of cisplatin.Isotonic Glucose injection 100 g was intravenously dripped 1 day before medication;on the day of chemotherapy,isotonic Sodium chloride injection or Glucose injection was infused intravenously for 3 000-3 500 mL;at the same time,Potassium chloride injection 0.5 g,Mannitol injection 50 g,Furosemide injection 20 mg were given to ensure daily urine volume of 2 000-3 000 mL;a treatment course lasted for 21 d,and there were 2 courses in total.Observation group was additionally given Crizotinib capsules 250 mg orally,once at 7:00 in the morning and evening,swallowing whole capsule,not chewed or dissolved,for 42 days.The clinical efficacies,survival quality and the occurrence of toxic reaction were observed in 2 groups.RESULTS:Total response rate(61.11%)and stable rate of survival quality(83.33%)in observation group were significantly higher than those(27.78%,44.44%)of control group(P<0.05);incidence of gradeⅠ-Ⅳmyelosuppression,gastrointestinal reaction,abnormal liver function,peripheral neuritis and alopecia in observation group were significantly lower than those of control group;incidence of gradeⅠ-Ⅳvisual effect in observation group was significantly higher than control group(P<0.05).There was no statistical significance in the incidence of edema between 2 groups(P >0.05).CONCLUSIONS:Based on routine chemotherapy,additional application of crizotinib can significantly improve therapeutic efficacy of patients with advanced ALK positive lung adenocarcinoma,and effectively improve survival quality of patients without increasing the occurrence of toxic reaction of other tissues or organs,but the incidence of toxic reaction is in high level relatively.