摘要
目的:观察清热活血散结复方预防放射性肺炎及肺纤维化的临床疗效和对血清细胞因子白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、转化生长因子-β1(TGF-β1)的影响。方法:采用前瞻性随机对照设计,将符合入选标准的患者随机分为治疗组和对照组,每组各62例。对照组单纯行放疗,治疗组在进行放疗的同时口服清热活血散结中药。观察放疗前后、治疗后6个月两组患者的一般情况、临床症状、胸部CT、肺损伤(RTOG标准),并采用身体机能状态量表(karnofsky performance status scale,KPS)进行评估,比较放射性肺炎发生率及放疗前后两组患者血清细胞因子IL-6,TNF-α,TGF-β1水平。结果:两组均无脱落及剔除病例,基线资料无明显差异。与对照组比较,放疗后中药治疗组能够明显提高患者的KPS评分,治疗组肺损伤等级评价的改善情况明显优于对照组(P<0.05),治疗组放射性肺炎及肺纤维化发生率低于对照组(38.71%vs72.58%,P<0.05);两组放疗前血清IL-6,TNF-α,TGF-β1水平比较无统计学差异;放疗结束、放疗后6月,治疗组血清IL-6,TNF-α,TGF-β1水平均明显低于对照组(P<0.01),血清IL-6,TNF-α,TGF-β1水平均在放疗结束时达到高峰。结论:清热活血散结复方安全有效,能够降低放射性肺炎及肺纤维化的发生率,并可减轻患者症状,改善患者生存质量;其作用机制可能与降低放射性肺炎及肺纤维化患者的血清IL-6,TGF-β1水平有关。
Objective:To observe of clinical efficacy of Qingre Huoxue Sanjie Chinese medicine compound against radiation pneumonitis,pulmonary fibrosis and its effect on serum cytokines interleukin-6 (IL-6),tumor necrosis factor-α (TNF-α),transforming growth factor-β1 (TGF-β1) level.Method:Using propective randomized controlled design,patients eligible were randomly divided into a treatment group and a control group,each of 62 cases.The controlled group was only treated with radiotherapy,the treatment group was treated radiotherapy plus oral Chinese medicine.Before and after treatment,the patients's general condition,clinical manifestations,chest CT,lung injury (RTOG criteria) were evaluated as indicators for clinical efficacy observation,and using karnofsky performance status scale (KPS) for performance evaluation,serum cytokines IL-6,TNF-α,TGF-β1 levels were tested respectively.Result:The two groups were no loss and excluding cases,no significant differences in baseline data (P > 0.05); after treatment,compared with the control group,the treatment group was able to significantly improve patients karnofsky ratings,RTOG rating evaluation of improvement in the treatment of lung injury is significantly better than the control group (P < 0.05),the treatment group of radiation pneumonitis and pulmonary fibrosis prevalence was lower than controlled group (38.71% vs 72.58%,P < 0.05); two groups of serum IL-6,TNF-α,TGF-β1level had no significant diference before treatment; at the end of radiotherapy and six months after radiotherapy,the serum IL-6,TNF-α,TGF-β1were both significantly lower than before treatment respectively (P < 0.01),and the serum IL-6,TNF-α,TGF-β1level all reached the peak at the end of radiotherapy.Conclusion:Qingre Huoxue Sanje Chinese medicine compound was safe and effective,which can lower prevalence of radiation pneumonitis and pulmonary fibrosis,and can alleviate the symptoms of patients,improve the quality of life,its mechanism maybe related with reducing serum IL-6,TNF-α,TGF-β1 levels of radiation pneumonitis and pulmonary fibrosis patients.
出处
《中国实验方剂学杂志》
CAS
北大核心
2014年第5期127-130,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
河南省基础与前沿项目(092300410022)
河南省医学科技攻关项目(102102310320)