摘要
目的观察同步放化疗后紫龙金片维持治疗对局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效及生活质量的影响。方法 66例经同步放化疗后取得缓解或稳定的局部晚期NSCLC患者,按随机数字表法分为治疗组和对照组,每组33例。治疗组给予紫龙金片(0.65 g/片),每次4片,每日3次,服药至疾病进展或无法耐受;对照组给予安慰剂,每次4片,每日3次。统计分析两组患者的无疾病进展生存期,1、2年生存率及生活质量的改变。结果试验过程中有4例脱落,62例可评价疗效,治疗组30例,对照组32例。治疗组和对照组的无进展生存期(progression free survival,PFS)分别为9.20个月、6.23个月,两组比较,差异有统计学意义(P<0.05);1年生存率治疗组为73.0%,优于对照组的51.7%(P<0.05);治疗组和对照组2年生存率分别为52.0%、48.6%,两组比较,差异无统计学意义(P>0.05);与对照组比较,治疗组躯体、角色、社会功能领域及总健康状况得分升高,乏力、呼吸困难及咳嗽得分下降(P<0.05),治疗组神疲乏力、少气懒言、头晕眼花、食欲不振、咳嗽、自汗症状改善(P<0.05);两组患者的不良反应均在可接受范围内。结论紫龙金片维持治疗局部晚期NSCLC安全有效,可延长患者的无进展生存期及1年生存率,改善局部晚期NSCLC的中医症状,提高患者的生活质量。
Objective To observe the clinical efficacy and quality of life （QOL） of Zilongjin Tab- let （ZT） as maintenance therapy for patients with locally advanced non-small-cell lung cancer （NSCLC）. Methods Sixty-six patients with relieved or stable locally advanced NSCLC were randomly assigned to the treatment group and the control group, 33 in each group. Patients in the treatment group took ZT （0.65 g/tablet）, 4 tablets each time, thrice per day. Patients in the control group took placebos, 4 tablets each time, thrice per day. Progression-free survival （PFS） was statistically ana- lyzed, 1-year survival rate and 2-year survival rate were calculated, and changes of QOL were ob- served. Results Four cases dropped out in the process. Efficacy could be assessed in 62 cases, 30 in the treatment group and 32 in the control group. Progression free survival （PFS） was 9.20 months in the treatment group and 6.23 months in the control group, with statistical difference （P 〈0.05）. One year survival rate was 73.0% in the treatment group, better than that of the control group （51.7%）, with statistical difference between two groups （P 〈0.05）. Two years survival rate was 52.0% and 48.6% respectively in the two groups, with no statistical difference （P 〉0.05）. Compared with the con- trol group, scores of physical, role, social, global QOL decreased, and disease-related symptoms such as fatigue, dyspnea, cough were improved in treatment group （P 〈0.05）. In the treatment group symptoms such as fatigue, less of strength, shortage of qi, laziness for talking, dizziness, dim of sight, anorexia, cough, spontaneous sweating were all improved （P 〈0.05）. Adverse reactions could be accepted by all patients in the two groups. Conclusions Maintenance treatment of ZT was safe and feasible for locally advanced NSCLC patients. It could prolong PFS and one-year survival rate, improve symptoms of Chinese medicine, and elevate their QOL.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2017年第5期534-538,共5页
Chinese Journal of Integrated Traditional and Western Medicine
基金
浙江省中医药科技计划资助项目(No.2012ZB160)
关键词
紫龙金片
局部晚期非小细胞肺癌
维持治疗
无进展生存时间
生活质量
Zilongjin Tablet
locally advanced non-small-cell lung cancer
maintenance treatment
progression-free survival
quality of life
