肺岩宁颗粒治疗精气两亏型中晚期肺腺癌的临床研究

Clinical study of Feiyanning Granule in the treatment of advanced lung adenocarcinoma with syndrome of deficiency of both essence and qi

目的观察肺岩宁颗粒治疗精气两亏型中晚期肺腺癌的临床疗效。方法采用前瞻性随机对照研究,将100例精气两亏型中晚期肺腺癌患者随机分为治疗组(49例)与对照组(51例)。治疗组予肺岩宁颗粒,对照组予肺岩宁颗粒模拟剂。两组疗程均为2个月,观察近期疗效及用药安全性,比较中医证候、卡氏评分、体质量及血清肿瘤标志物的变化情况。结果 (1)最终完成试验者,治疗组44例,对照组43例。(2)治疗组、对照组疾病控制率分别为79.5%、53.5%;组间疾病控制率比较,治疗组明显优于对照组(P<0.05)。(3)治疗组、对照组中医证候改善率分别为81.8%、23.3%;组间中医证候改善率比较,治疗组明显优于对照组(P<0.05)。(4)治疗组、对照组卡氏评分总有效率分别为93.2%、65.1%;组间卡氏评分总有效率比较,治疗组明显优于对照组(P<0.05)。治疗组、对照组体质量总有效率分别为79.5%、69.8%;组间体质量总有效率比较差异无统计学意义(P>0.05)。(5)组间治疗后比较,CA125、CA50水平差异有统计学意义,治疗组明显低于对照组(P<0.05)。(6)两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论肺岩宁颗粒治疗精气两亏型中晚期肺腺癌的临床疗效满意,可明显稳定患者病情,改善其临床症状,提高其生活质量。

Objective To study the clinical efficacy of Feiyanning Granule in the treatment of advanced lung adenocarcinoma with syndrome of deficiency of both essence and qi. Methods A prospective randomized controlled study was performed. 100 patients of advanced lung adenocarcinoma with syndrome of deficiency of both essence and qi were randomly divided into the treatment group（ 49 cases） and the control group（ 51 cases）. The patients in the treatment group were treated with Feiyanning Granule and the patients in the control group were treated with analogue of Feiyanning Granule,with a course of 2 months. The short-term efficacy and the medication safety were observed. The changes on the TCM syndromes,Karnofsky performance status（ KPS） score,body weight and serum tumor markers were compared. Results（1）Finally 44 cases in the treatment group and 43 cases in the control group completed the trial.（2）The disease control rates were 79.5%in the treatment group and 53.5% in the control group. The disease control rate in the treatment group was significantly higher than that in the control group（ P〈0.05）.（3）The improvement rates of TCM syndromes were 81.8% in the treatment group and 23.3% in the control group. The improvement rate of TCM syndromes in the treatment group was significantly higher than that in the control group（ P〈0.05）.（4）The total effective rates of KPS score were 93.2% in the treatment group and 65.1% in the control group. The total effective rate of KPS score in the treatment group was significantly higher than that in the control group（ P〈0.05）. The total effective rate of body weight were 79.5% in the treatment group and 69.8% in the control group. There was no statistically significant difference on the total effective rates of body weight between the two groups（ P〉0.05）.（5）After treatment,there were statistically significant differences on the levels of CA125 and CA50 between the two groups（ P〈0.05）,and the levels in the treatment group were significantly lower than those in the control group（ P〈0.05）.（6） There was no statistically significant difference on the incidence rate of adverse reactions between the two groups（ P〉0.05）. Conclusion Feiyanning Granule shows satisfactory clinical efficacy in the treatment of advanced lung adenocarcinoma with syndrome of deficiency of both essence and qi,which can obviously stabilize the illness condition,improve the clinical symptoms and enhance the quality of life.