| 摘要: | 本品為十字花科植物菘藍的根，是一種常用於涼血止血、清熱解毒、涼血利咽的常用中藥。根據現代藥學研究，板藍根主要成分含靛藍、靛玉紅等成分，具有抗病毒、清熱、解毒和抗發炎功效，並且毒性與副作用都很小。放射線口腔炎是頭頸部癌症病人接受放射治療期間最主要的急性副作用，目前主要的治療藥物其藥效有限，病人常需要暫停放射治療來緩和症狀。我們的目的是應用板藍根以降低放射性口腔炎並且評估其臨床效果，並探討可能的作用機轉，以期可在臨床廣泛的應用。
方法：
分為二部分：(1). 應用板藍根於降低放射線口腔炎的臨床試驗：針對頭頸部癌症病人接受放射治療時，將病人分成兩組，一組為口服板藍根組，另ㄧ組為對照組(口服生理食鹽水)，進行臨床觀察並評估放射性口腔炎的嚴重程度；(2). 小鼠在經放射線照射後投與板藍根，評估其抗發炎的效果：以8週BALB/c公鼠，經連續三天以放射線9 MeV照射全身共5.4 Gy的劑量，投與板藍根ㄧ周後犧牲，評估BALB/c公鼠體內的發炎指標。
結果：
在臨床試驗部分，ㄧ共有20位病人進行板藍根的臨床試驗，其中板藍根組11位，對照組9位。臨床試驗證明，板藍根組相對於對照組可有效降低放射線口腔炎(P=0.01)、厭食(P =0.002)和對於病人因放射線口腔炎而引起的吞嚥困難(P =0.02)能顯著改善。病人接受放射治療所需的休息天數也能下降，但未達到顯著意義(P =0.06)。板藍根組的病人血清中的炎性細胞素IL-6與對照組相比，在放射治療第1、5、7週有顯著下降。在動物實驗方面，投與板藍根能顯著降低放射線對於免疫器官的損傷，增加免疫器官的重量，並且使老鼠體內的血球數量如白血球、淋巴球等顯著上升，並且呈現劑量關係。發炎細胞素IL-1β、IL-6與腫瘤壞死因子TNF-?悗h顯著下降，並且呈現劑量關係。
結論：
臨床試驗及動物實驗結果顯示，板藍根可有效降低因放射線所引起的細胞損傷，降低放射性黏膜炎傷害，對於細胞激素的調節有明顯的作用，本研究發現板藍根可成為放射治療之緩解患者因放射性黏膜炎之不適，其機轉應該是經由發炎細胞激素的調節。
Radiotherapy plays major role in the treatment of malignancy. However, acute side effects such as radiation mucositis often cause oral pain and dysphagia of the patients, resulting in poor nutrition status. These disabilities usually influence the effect of radiotherapy. In this study, we evaluated the effect of Ban-Lan-Gen (BLG, radix of Isatis indigotica FORT) on acute mucositis and dermatitis induced by radiation.
Methods: In clinical trial there were total 20 head and neck cancer patients were randomized into two groups: 1. Control group with only normal saline, 2. BLG group: We prophylactic application of BLG consisted of gargling and then swallowing the BLG preparation on the irradiated oral mucosa as radiotherapy was being carried out. This was compared with control patients who received routine conventional analgesics and skin care. Therapeutic application was started on the first day of radiotherapy. We evaluated of acute radiation mucositis and dermatitis according to the gold standard scale proposed by RTOG. In animal study, total 57 BALB/c mice were divided into six groups: three BLG groups with low (BLG-L, 0.195 g/kg/day), moderate (BLG-M, 0.585 g/kg/day) and high dose (BLG-H, 1.170 g/kg/day), glutamine group (1.950 g/kg/day), control group (RO water 10 ml/kg/day) and naïve group. All mice except naïve group were irradiated with 5.4 Gy in three days and then treated according to each group’s regimen for one week.
Results: The clinical trial showed BLG can reduce the severity of radiation mucositis (P=0.01), anorexia (P=0.002) and swallowing (P=0.002). Although the result of resting days needed between groups without significant (P=0.06), but quiet difference still was noted (mean days 1.64±2.46 versus 5.89±6.7). Serum IL-6 was significant lower in BLG group in 1st, 5th and 7th weeks. In animal study, increased thymus and spleen weight were found in BLG groups and in dose-dependent relationship. Blood contents such as leukocyte, lymphocyte, granulocyte and monocyte showed the same result. Serum TNF-??, IL-1?? and IL-6 were also significantly lower in BLG groups and in dose-dependent relationship. Histopathology assessments of intestine were done and villi number was increased in BLG-H group and glutamine group only.
Conclusion: BLG can improve radiation mucositis clinically. Animal study also showed its effects on immune organs preservations, increased cell subpopulation and down-regulated inflammatory cytokines expression in irradiated mice. We suggested that BLG has anti-inflammatory ability to reduce the mucosal damage caused by radiation. |
