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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 curative effect and quality of life of patients with locally advanced non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy. Methods Sixty-six patients with locally advanced NSCLC who achieved remission or stabilization after concurrent chemoradiotherapy were divided into treatment group and control group according to random number table method, with 33 cases in each group. The treatment group was given gold dragon gold tablets (0.65 g / tablet), 4 tablets each time, three times a day, medication to disease progression or intolerance; control group was given placebo, each 4 tablets 3 times a day. Statistical analysis of two groups of patients with disease-free survival, 1, 2-year survival rate and quality of life changes. Results In the experiment, 4 cases were exfoliated, 62 cases could evaluate the curative effect, 30 cases in the treatment group and 32 cases in the control group. The progression free survival (PFS) of the treatment group and the control group were 9.20 months and 6.23 months, respectively, and the difference was statistically significant (P <0.05). The 1-year survival rate was 73.0 %, Which was superior to 51.7% of the control group (P <0.05). The 2-year survival rates of the treatment group and the control group were 52.0% and 48.6% respectively, with no significant difference between the two groups (P> 0.05) Compared with the control group, scores of somatic body, role, social function and general health status increased, fatigue, dyspnea and cough score decreased (P <0.05), the treatment group had less fatigue, less gas laziness, dizziness, loss of appetite, Cough, spontaneous symptoms improved (P <0.05); adverse reactions in both groups were within acceptable range. Conclusions Zilongjin Tablet is safe and effective in the treatment of locally advanced NSCLC. It can prolong the progression-free survival and 1-year survival rate of patients with advanced NSCLC, improve the TCM symptoms and improve the quality of life of patients with locally advanced NSCLC.