【摘要】：目的觀察復方麻杏石甘湯對Ⅲ期NSCLC患者同步放化療所致放射性肺損傷的防治效果及其對血漿中TGF-β1水平的影響。方法共收集67例自2014年10月-2015年12月住院的Ⅲ期NSCLC行同步放化療患者,將入選的患者按完全隨機的方法分為2組,分別采用同步放化療加中藥干預組(試驗組)、單純同步放化療組(對照組)。兩組患者的性別、年齡、腫瘤分期及病理分型均具有可比性(p0.05)。若發(fā)生放射性肺損傷,均采用激素治療方案,并給予吸氧、化痰、平喘等對癥治療,必要時給予抗生素治療。記錄放射性肺損傷的發(fā)生情況,包括嚴重程度(參照NCI-CTCAE4.0標準)、腫瘤治療效果及KPS評分。記錄治療期間及以后出現(xiàn)的藥物不良反應的發(fā)生時間、持續(xù)時間、癥狀、程度及處理措施(參照《藥品不良反應報告和監(jiān)測管理辦法》)。采用ELISA法檢測同步放化療前1周、同步放化療結(jié)束時、同步放化療結(jié)束5周后患者血漿TGF-β1含量。結(jié)果1.放射性肺損傷的發(fā)生情況：同步放化療結(jié)束后,試驗組和對照組放射性肺損傷的發(fā)生率分別為10%和34%,其差別具有統(tǒng)計學意義(p0.05)。2.放射性肺損傷等級的比較：同步放化療結(jié)束后,兩組均未發(fā)生5級放射性肺損傷。試驗組1級、2級、3級、4級放射性肺損傷例數(shù)為1、1、1、0例；對照組1級、2級、3級、4級放射性肺損傷例數(shù)為2、5、3、1例。兩組≥2級放射性肺損傷試驗組為2例,對照組為9例,其發(fā)生率的差別具有統(tǒng)計學意義(p0.05)。3.近期腫瘤療效的比較：同步放化療結(jié)束5周后,試驗組達到CR、PR、SD、PD的例數(shù)為2、15、10、2例,對照組為2、18、9、4例。有效率試驗組為58%,對照組為62%。兩組完全緩解病例數(shù)(CR)比較,差異無統(tǒng)計學意義(p0.05),兩組有效率(CR+PR)比較,差異無統(tǒng)計學意義(p0.05)。4.功能狀態(tài)KPS評分：在同步放化療前1周,兩組患者的KPS評分無明顯差別,差異無統(tǒng)計學意義(p0.05)；在同步放化療結(jié)束后、同步放化療結(jié)束5周后,試驗組的KPS評分均高于對照組,差異有統(tǒng)計學意義(p0.05)。5.不良反應：同步放化療結(jié)束后,對照組出現(xiàn)1例血糖紊亂,兩組患者其他不良反應無明顯差別。6.血漿TGF-β1水平：在未行放化療之前,兩組患者的血漿TGF-β1水平差異無統(tǒng)計學意義(p0.05)。在同步放化療結(jié)束后,兩組患者的血漿TGF-β1水平均升高,且對照組明顯高于試驗組,差異有統(tǒng)計學意義(p0.05)。在同步放化療結(jié)束5周后,兩組患者的血漿TGF-β1水平均有下降,試驗組下降的幅度明顯大于對照組,差異有統(tǒng)計學意義(p0.05)。結(jié)論1.復方麻杏石甘湯可以降低Ⅲ期NSCLC患者同步放化療所致放射性肺損傷的發(fā)生率及嚴重程度,顯著提高患者生活質(zhì)量,表明復方麻杏石甘湯對放射性肺損傷具有較好的防治作用。2.復方麻杏石甘湯能夠降低同步放化療的Ⅲ期NSCLC患者血漿TGF-β1水平,提示其防治放射性肺損傷的機理可能與抑制血漿TGF-β1的生成有關。
[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，

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