血必净注射液预防胸部恶性肿瘤放疗中急性放射性肺损伤的临床研究

目的评价中药血必净注射液能否预防胸部恶性肿瘤放疗中的急性放射性肺损伤的发生。方法选择河南省肿瘤医院放疗科2011-05-10-2012-10-10符合入组条件的38例胸部恶性肿瘤患者,依据＂不平衡指数最小的分配原则＂随机分为放射治疗联合血必净注射液组（实验组A,20例）和单纯放射治疗组（对照组B,18例）,两组均用取调强适型放疗,血必净注射液100mL与生理盐水150mL配伍于放疗开始前3d及放疗期间于每次放疗前1h,静脉滴入,1次/d。于放疗前、放疗40Gy、放疗结束、放疗结束后1个月和放疗结束后3个月不同节点用ELISA方法技术测定患者急性放射性肺损伤相关的细胞炎性因子的表达,包括血小板衍化生长因子（platelet-derived growth factor,PDGF）、高迁移率族蛋白B1（high mobility group protein B1,HMGB1）、转化生长因子-β1（transforming growth factor-β1,TGF-β1）、白介素-6（interleukin-6,IL-6）和肿瘤坏死因子-α（tumor necrosis factor-α,TNF-α）,并观察放射性肺损伤的发生率。结果放疗后A组炎性因子水平低于B组,P值均〈0.05;B组炎性因子水平HMGB1（F=46.764,P〈0.001）、TGF-β1（F=54.752,P〈0.001）、IL-6（F=48.467,P〈0.001）、TNF-α（F=42.645,P〈0.001）和PDGF（F=38.756,P〈0.001）放疗前后不同时间之间差异均有统计学意义,呈上升趋势。A组PDGF（F=52.435,P〈0.001）和TGF-β1（F=77.854,P〈0.001）放疗前后不同时间差异有统计学意义,呈下降趋势。A组HMGB1（F=62.432,P〈0.001）、IL-6（F=74.235,P〈0.001）和TNF-α（F=70.154,P〈0.001）放疗前后不同时间差异有统计学意义,上升趋势不明显。A组急性放射性肺损伤（≥2级）发生率为5%（1/20）,明显低于B组的33.3%（6/18）,χ^2=5.06,P=0.038。结论血必净注射液可以降低急性放射性肺损伤发生率和其相关的细胞性因子的水平,从而预防急性放射性肺损伤的发生。

Prevention effect of Xuebijing injection on acute radiation-induced lung injury during radiation therapy of thoracic malignancies

OBJECTIVE To evaluate whether the traditional chinese medicine Xuebijing injection can prevent the occurrence of acute radiation-induced lung injury during radiation therapy of thoracic malignancies. METHODS Thirty- eight eligible patients with chest malignancies were enrolled between May 10,2011 and October 10, 2012 in H enan Tumor Hospital Department of Radiation, and randomly devided into radiotherapy combined with Xuebijing injection group （experimental group A, 20 cases） and radiotherapy alone group （control group B, 18 cases） according to ＂ the imbalance in- dex minimum distribution rule ＂. Group A and B were taken in intensity modulated radiotherapy. Xuebijing injection 100 mL with physiological saline 150 mL were used in three days before the start of radiotherapy （Ⅳ gtt qd）, and one hour before radiotherapy during radiotherapy period （Ⅳ gtt qd）. At different time points （before radiotherapy, radiotherapy 40 Gy, the end of radiotherapy,1 month after the end of radiotherapy and 3 months after the end of radiotherapy）, cell inflammatory factor associated with acute radiation-induced lung injury, such as platelet-derived growth factor （PDGF）, high mobility group protein B1 （ HMGB1）, transforming growth factor-β1 （TGF-β1）, interleukin-6 （IL-6）,tumor necrosis factor-α（TNF-α） were detected by ELISA and incidence of radiation-induced lung injury were observed. All the data were analyzed statistically by SPSS software 16.0. RESULTS The levels of inflammatory factor in group A were lower than that in group B after radiotherapy （all P;0. 05）. In group B, levels of inflammatory factor level HMGB1 （F=46. 764,P〈0. 001）,TGF-β1（F= 54. 752,P〈0. 001） , IL-6 （F= 48. 467,P〈0. 001）,TNF-α（F= 42. 645,P%0. 001） and PDGF（F= 38. 756,P〈0. 001） had statistical differences between different time before and after radiotherapy. In group A, PDGF（F= 52. 435,P〈0. 001）and TGF-β1（F= 77. 854,P〈0. 001） had statistical differences between differ