복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제3상 전향적 무작위 비교임상시험

Abstract

Purpose: This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron (Zofran )8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods: Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including on dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results: Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment or neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics wee similar except mean age was 52.9±11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron (Zofran ) 8 mg bid dose and metoclopramide 5 mg tid dose were well tolerated without significant side effects. There were no clinically important changes in vital signs or clinical laboratory parameters with either drug. Conclusion: Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to severity of nausea, vomiting and loss of appetite. we concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.