目的:本研究評估利用麩胺酸以預防子宮頸癌患者接受化療合併放射治療引發急性腹瀉的效用。 方法:從2005年1月到2006年1月,共有49名接受化療合併放射治療子宮頸癌患者,將其隨機分派為二組,實驗組共21名,每次分別給予口服麩胺酸10公克,一日三次,控制組28名予以安慰劑。全部病患均接受每週五次每天1.8Gy的全骨盆放射治療共50.4Gy與每週一次cisplatin 40mg/平方公尺的化學治療。由治療開始的前三天到最後一天,每天由病患記錄急性毒性反應,並利用NCI-CTC VER2將毒性反應加以分級。 結果:在使用麩胺酸之患者,第三級急性腹瀉的發生率明顯降低(1/21 vs. 9/28, p=0.043),雖然其第一、二級腹瀉發生的比率並未因服用麩胺酸而降低(其p值分別為0.96與0.68);但使用麩胺酸之患者,服用loperamide以改善腹瀉的比率明顯較少(2/21 vs. 10/28, p=0.047),若仍使用loperamide其劑量也比未服用麩胺酸者為低(0.38+-1.2 mg vs. 8.64+-14.06 mg, p=0.01);另外服用麩胺酸可明顯降低第三級腹瀉持續的時間(0.14 week vs. 1.3 week, =0.027)。 結論:補充麩胺酸並無法降低子宮頸癌患者接受化療合併放射治療時輕中度腹瀉的發生率,但對於嚴重急性腹瀉的發生率及持續時間均可減少。進一步大規模的隨機試驗將用以證明此研究結論。
Purpose: This study was designed to determine whether oral glutamine can prevent acute diarrhea induced by concurrent chemotherapy and radiotherapy (CCRT) with cisplatin 40 mg/m^2/week in cervical cancer patients. Methods: From January 2005 to January 2006, 49 cervical cancer patients receiving definitive or adjuvant CCRT were given either oral glutamine (10 g in 100 ml normal saline three times per-day, n=20) or placebo (mixed isonitrogenous glutamine-free proteins, n=28). All patients received whole pelvis irradiation with 5x1.8 Gy weekly to 50.4 Gy and at least 4 cycles of weekly cisplatin (40 mg/m^2) concurrently. Evaluation of acute toxicities and medications was performed on each treatment day until the last day of radiotherapy. NCI-CTC ver. 2 was used to grade toxicities. Results: With glutamine supplementation, the overall incidence of grade 3 acute diarrhea was significantly reduced (1/21 vs. 9/28, p=0.043), but the incidence of grade 1 and grade 2 acute diarrhea did not change significantly (p=0.96 and p=0.68). At the same time, the antidiarrheal agent loperamide was prescribed less frequently in the glutamine group than in the control group (2/21 vs. 10/28, p=0.047), and the total dosage of loperamide per patient was significantly lower in the glutamine group than in the control group (0.38+-1.2 mg vs. 8.64+-14.06 mg, p=0.01). Furthermore, glutamine significantly shortened the duration of grade 3 acute diarrhea (0.14 week vs. 1.3 week, p=0.027). Conclusions: Glutamine supplementation was not effective in preventing the development of mild to moderate diarrhea during CCRT, but effectively decreased the severity of acute diarrhea and shortened the period of severe acute diarrhea. Further phase-Ⅲ randomized trials are needed to validate these results.