复方麻杏石甘汤防治Ⅲ期NSCLC同步放化疗所致放射性肺损伤的临床研究
发布时间：2019-06-08 11:41
【摘要】：目的观察复方麻杏石甘汤对Ⅲ期NSCLC患者同步放化疗所致放射性肺损伤的防治效果及其对血浆中TGF-β1水平的影响。方法共收集67例自2014年10月-2015年12月住院的Ⅲ期NSCLC行同步放化疗患者,将入选的患者按完全随机的方法分为2组,分别采用同步放化疗加中药干预组(试验组)、单纯同步放化疗组(对照组)。两组患者的性别、年龄、肿瘤分期及病理分型均具有可比性(p0.05)。若发生放射性肺损伤,均采用激素治疗方案,并给予吸氧、化痰、平喘等对症治疗,必要时给予抗生素治疗。记录放射性肺损伤的发生情况,包括严重程度(参照NCI-CTCAE4.0标准)、肿瘤治疗效果及KPS评分。记录治疗期间及以后出现的药物不良反应的发生时间、持续时间、症状、程度及处理措施(参照《药品不良反应报告和监测管理办法》)。采用ELISA法检测同步放化疗前1周、同步放化疗结束时、同步放化疗结束5周后患者血浆TGF-β1含量。结果1.放射性肺损伤的发生情况：同步放化疗结束后,试验组和对照组放射性肺损伤的发生率分别为10%和34%,其差别具有统计学意义(p0.05)。2.放射性肺损伤等级的比较：同步放化疗结束后,两组均未发生5级放射性肺损伤。试验组1级、2级、3级、4级放射性肺损伤例数为1、1、1、0例；对照组1级、2级、3级、4级放射性肺损伤例数为2、5、3、1例。两组≥2级放射性肺损伤试验组为2例,对照组为9例,其发生率的差别具有统计学意义(p0.05)。3.近期肿瘤疗效的比较：同步放化疗结束5周后,试验组达到CR、PR、SD、PD的例数为2、15、10、2例,对照组为2、18、9、4例。有效率试验组为58%,对照组为62%。两组完全缓解病例数(CR)比较,差异无统计学意义(p0.05),两组有效率(CR+PR)比较,差异无统计学意义(p0.05)。4.功能状态KPS评分：在同步放化疗前1周,两组患者的KPS评分无明显差别,差异无统计学意义(p0.05)；在同步放化疗结束后、同步放化疗结束5周后,试验组的KPS评分均高于对照组,差异有统计学意义(p0.05)。5.不良反应：同步放化疗结束后,对照组出现1例血糖紊乱,两组患者其他不良反应无明显差别。6.血浆TGF-β1水平：在未行放化疗之前,两组患者的血浆TGF-β1水平差异无统计学意义(p0.05)。在同步放化疗结束后,两组患者的血浆TGF-β1水平均升高,且对照组明显高于试验组,差异有统计学意义(p0.05)。在同步放化疗结束5周后,两组患者的血浆TGF-β1水平均有下降,试验组下降的幅度明显大于对照组,差异有统计学意义(p0.05)。结论1.复方麻杏石甘汤可以降低Ⅲ期NSCLC患者同步放化疗所致放射性肺损伤的发生率及严重程度,显著提高患者生活质量,表明复方麻杏石甘汤对放射性肺损伤具有较好的防治作用。2.复方麻杏石甘汤能够降低同步放化疗的Ⅲ期NSCLC患者血浆TGF-β1水平,提示其防治放射性肺损伤的机理可能与抑制血浆TGF-β1的生成有关。
[Abstract]:Objective to observe the preventive and therapeutic effect of compound Maxing Shigan decoction on radiation lung injury induced by concurrent radiotherapy and chemotherapy in patients with stage III NSCLC and its effect on plasma TGF- 尾 1 level. Methods A total of 67 patients with stage III NSCLC hospitalized from October 2014 to December 2015 were enrolled in this study. The patients were randomly divided into two groups. The patients were treated with synchronous radiotherapy and chemotherapy plus traditional Chinese medicine intervention group (experimental group). Simple synchronous radiotherapy and chemotherapy group (control group). The sex, age, tumor stage and pathological classification of the two groups were comparable (p0.05). If radiation lung injury occurs, hormone therapy is used, oxygen inhalation, expectoration, antiasthma and antibiotics are given if necessary. The occurrence of radiation-induced lung injury was recorded, including severity (reference to NCI-CTCAE4.0 standard), tumor therapeutic effect and KPS score. The occurrence time, duration, symptom, degree and treatment measures of adverse drug reactions during and after treatment were recorded (refer to medicines adverse reaction report and Monitoring and Management measures). ELISA method was used to detect the plasma TGF- 尾 1 level one week before concurrent radiotherapy and chemotherapy, at the end of synchronous radiotherapy and chemotherapy, and 5 weeks after synchronous radiotherapy and chemotherapy. Result 1. The occurrence of radiation lung injury: after synchronous radiotherapy and chemotherapy, the incidence of radiation lung injury in the experimental group and the control group was 10% and 34% respectively, the difference was statistically significant (p0.05). Comparison of radiation lung injury grades: after simultaneous radiotherapy and chemotherapy, no grade 5 radiation lung injury occurred in both groups. The cases of grade 1, grade 2, grade 3 and grade 4 radiation lung injury in the test group were 1, 1, 1 and 0, respectively, while in the control group, the number of radiation lung injuries in grade 1, grade 2, grade 3 and grade 4 was 2, 5 and 3, respectively. There were 2 cases of radiation lung injury 鈮，
本文编号：2495257
[Abstract]:Objective to observe the preventive and therapeutic effect of compound Maxing Shigan decoction on radiation lung injury induced by concurrent radiotherapy and chemotherapy in patients with stage III NSCLC and its effect on plasma TGF- 尾 1 level. Methods A total of 67 patients with stage III NSCLC hospitalized from October 2014 to December 2015 were enrolled in this study. The patients were randomly divided into two groups. The patients were treated with synchronous radiotherapy and chemotherapy plus traditional Chinese medicine intervention group (experimental group). Simple synchronous radiotherapy and chemotherapy group (control group). The sex, age, tumor stage and pathological classification of the two groups were comparable (p0.05). If radiation lung injury occurs, hormone therapy is used, oxygen inhalation, expectoration, antiasthma and antibiotics are given if necessary. The occurrence of radiation-induced lung injury was recorded, including severity (reference to NCI-CTCAE4.0 standard), tumor therapeutic effect and KPS score. The occurrence time, duration, symptom, degree and treatment measures of adverse drug reactions during and after treatment were recorded (refer to medicines adverse reaction report and Monitoring and Management measures). ELISA method was used to detect the plasma TGF- 尾 1 level one week before concurrent radiotherapy and chemotherapy, at the end of synchronous radiotherapy and chemotherapy, and 5 weeks after synchronous radiotherapy and chemotherapy. Result 1. The occurrence of radiation lung injury: after synchronous radiotherapy and chemotherapy, the incidence of radiation lung injury in the experimental group and the control group was 10% and 34% respectively, the difference was statistically significant (p0.05). Comparison of radiation lung injury grades: after simultaneous radiotherapy and chemotherapy, no grade 5 radiation lung injury occurred in both groups. The cases of grade 1, grade 2, grade 3 and grade 4 radiation lung injury in the test group were 1, 1, 1 and 0, respectively, while in the control group, the number of radiation lung injuries in grade 1, grade 2, grade 3 and grade 4 was 2, 5 and 3, respectively. There were 2 cases of radiation lung injury 鈮，
本文编号：2495257
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