血府逐瘀汤防治血瘀型食管癌同步放化疗放射性肺纤维化的临床研究

Clinical Study of Xuefu Zhuyu Decoction in the Prevention and Treatment of Radiation-Induced Lung Fibrosis in Esophageal Cancer Patients with Blood Stasis Type Underwent Concurrent Chemoradiotherapy

  • 摘要:
    目的 观察血府逐瘀汤防治血瘀型食管癌同步放化疗患者放射性肺纤维化(RILF)的临床疗效。
    方法 选取血瘀型食管癌同步放化疗患者130例,采用随机数字表法分为试验组、对照组各65例,研究期间无患者脱落。2组患者均接受标准放化疗方案,治疗期间若发生放射性肺损伤则依据病情给予规范化对症支持治疗。试验组在对照组治疗基础上,从放化疗开始当日加服血府逐瘀汤,连续服用至放化疗结束后30 d。比较服药前后2组患者中医证候积分变化;比较放化疗结束后6个月、12个月急性放射性肺炎(RP)和慢性RILF的发生率以及肺功能指标第1秒用力呼气容积占预计值百分比(FEV1%pred)、用力肺活量绝对值(FVC)、FVC占预计值百分比(FVC%pred)、第1秒用力呼气容积/用力肺活量(FEV1/FVC)及一氧化碳弥散量占预计值百分比(DLCO%pred)、血清细胞因子指标白介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、缺氧诱导因子-1α(HIF-1α)、血管内皮细胞生长因子(VEGF)、转化生长因子β1(TGF-β1)水平变化,同时记录治疗期间2组患者不良反应发生情况。
    结果 治疗后,2组患者中医证候总积分均显著改善,试验组优于对照组(P < 0.01);试验组中医临床疗效总有效率优于对照组(P < 0.01)。放疗结束后6个月,2组患者急性RP发生率差异无统计学意义(P > 0.05),试验组肺功能指标FEV1%pred、FVC%pred及DLCO%pred水平高于对照组(P < 0.05),试验组血清各项细胞因子水平均显著低于对照组(P < 0.05,P < 0.01)。放疗结束后12个月,试验组患者慢性RILF发生率显著低于对照组(P < 0.05),试验组患者DLCO%pred水平高于对照组(P < 0.01),血清HIF-1α、VEGF及TGF-β1水平显著低于对照组(P < 0.05,P < 0.01)。治疗期间2组患者均未观察到严重不良事件的发生。
    结论 血府逐瘀汤可有效降低血瘀型食管癌放疗患者RILF的发生率,减轻放疗对患者肺功能的损伤,其机制可能与下调患者血清HIF-1α、VEGF及TGF-β1等细胞因子水平有关。

     

    Abstract:
    OBJECTIVE To observe the clinical efficacy of Xuefu Zhuyu Decoction (XFZY) in the prevention and treatment of radiation-induced lung fibrosis (RILF) in esophageal cancer patients with blood stasis type underwent concurrent chemoradiotherapy(CRT).
    METHODS A total of 130 esophageal cancer patients with blood stasis type who treated with concurrent CRT were randomly divided into an experimental group and a control group, with 65 cases in each group. No patients dropped out during the study period. Patients in both groups received CRT and standardized symptomatic treatment was given according to the condition if radiation-induced lung injury occurred during treatment. On the basis of the treatment of the control group, the patients in the experimental group received XFZY from the beginning day until 30 days after the completion of CRT. The TCM syndrome score of the two groups were compared before and after treatment. The incidence of acute radiation pneumonia (RP) and chronic RILF and changes in pulmonary function indicators forced expiratory volume in the first second as a percentage of predicted value (FEV1%pred), forced vital capacity (FVC), FVC as a percentage of predicted value (FVC%pred), FEV1/FVC ratio, and carbon monoxide diffusing capacity as a percentage of predicted value (DLCO%pred) and serum cytokine levels interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), hypoxia-inducible factor-1α (HIF-1α), vascular endothelial growth factor (VEGF), and transforming growth factor β1 (TGF-β1) were compared at 6 months and 12 months after the completion of CRT. The occurrence of adverse reaction during treatment was recorded.
    RESULTS The total score of TCM syndrome of the two groups was significantly improved and the experimental group was better than that of the control group (P < 0.01) after treatment. The efficacy of TCM syndrome was better in the experimental group than that of the control group (P < 0.01). There was no statistically significant difference in the incidence rate of acute RP between the two groups (P > 0.05) at 6 months after the completion of CRT. The levels of lung function indicators FEV1%pred, FVC%pred, and DLCO%pred in the experimental group were higher than those in the control group (P < 0.05), and the levels of various cytokines in the experimental group were lower than those in the control group (P < 0.05). The incidence rate of chronic RILF in the experimental group was significantly lower than that of the control group (P < 0.05) at 12 months after the completion of CRT. The DLCO%pred level in the experimental group was higher than that in the control group (P < 0.01), and the levels of cytokines HIF-1α, VEGF, and TGF-β1 were lower than those in the control group (P < 0.05, P < 0.01). There was no serious adverse event observed in either group of patients during the treatment.
    CONCLUSION XFZY can effectively prevent and treat RILF in esophageal cancer patients with blood stasis type underwent CRT, reducing the loss to lung function caused by radiotherapy, and its mechanism may be related to downregulating the levels of cytokines of HIF-1α, VEGF, and TGF-β1.

     

/

返回文章
返回