中西醫療法對肺癌病人預後之長期效益: 個案配對研究
唐婉如
長庚大學護理系
肺癌是預後較差的癌症，五年存活率僅有15%。當國人面對肺癌之威脅時常會併用其它補充性/替代性醫療(Complementary Alternative Medicine, CAM)，其中最常見的就是傳統中醫療法 (Traditional Chinese Medicine, TCM) 的使用。雖然CAM的使用很普遍，相關文獻也日益增多，但是真正客觀評值TCM臨床效果的研究型文獻卻付之闕如。截至目前為止，沒有任何研究者曾經合併客觀和主觀指標來比較西醫、或合併療法對肺癌病人預後的長期效果，因此引發筆者從事本研究之動機。本研究為兩年期之個案配對研究，擬在台灣北、中、南三所醫學中心中同步收案。為控制可能的干擾變項，符合收案條件的肺癌病人將以配對方式(依性別、與肺癌期別進行配對)分別選取到西醫治療組、及合併治療組。筆者擬以症狀困擾表（Symptom Distress Scale, SDS）、身體活動功能量表(Eastern Cooperative Oncology Group Performance Status Rating, ECOG-PSR) 與生活品質量表( European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QOQ C-30 & EORTC QLQ-LC13)等測量工具在正式治療前、治療後第1個月、3個月、6個月、與12個月時，分別測量兩組個案的症狀困擾、身體活動功能、及生活品質。此外，筆者亦會透過病歷回顧方式，收集各個時間點上兩組個案的存活率、平均存活時間、有無轉移或何時轉移等重要預後指標之變化。為增加研究之反應率，每位個案在過程中都會由同一位研究者負責收集資料。本研究個案數的估計將以前驅研究中所得的效應大小(effect size)加上考量30%左右的流失率來決定。廣義估計方程式及Cox’s proportional hazards model將被用來分析中西醫治療對肺癌病人預後之長期影響，研究所得將對驗證臨床中西合併療法有具體貢獻。
關鍵字：肺癌、中西醫療法、個案配對研究、預後
Long-term Benefit of Chinese and Western Therapies for the Prognosis of Lung Cancer Patients: Matched Case-Control Study
Tang, W. R
Lung Cancer has a poorer prognosis and its five-year survival rate is merely 15%. When facing the menace of lung cancer, people in Taiwan tend to use combined therapies of Complementary/Alternative Medicine (CAM). Among them, the most common one is the use of Traditional Chinese Medicine (TCM). Although the use of CAM is quite common and relevant literature has gradually increased as well, the clinical benefit of TCM is seldom objectively evaluated in research literature. Until present, researchers have not combined objective indicators with subjective ones to compare the long-term benefit of Western medicine, or combined therapy for the prognosis of lung cancer patients; hence the motivation to probe into this study is aroused. This study is a 2-year matched case-control study, and the subjects at Chang Gung Medical Center in northern, central, and southern Taiwan are enrolled simultaneously. For controlling the possible confounding variables, lung cancer patients who meet the inclusion criteria are matched (on gender, and cancer stage) and selected to Western therapy group, and combined therapy group. Measurement scales such as Symptom Distress Scale, Eastern Cooperative Oncology Group Performance Status Rating , and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire are used to measure the symptom distress, performance status, and quality of life of patients from two groups before the formal treatment and at month 1, month 3, month 6, and month 12 after the treatment, respectively. In addition, chart review is performed to collect the information of important prognostic indicators such as survival rate, median survival time, occurrence of metastasis, and when the metastasis occurred at each time point for analysis. To increase the response rate of the study, the information of each subject is collected by one researcher during the study. The sample size is calculated based on the effect size obtained from the pilot study and an approximately 30% attrition rate. Generalized Estimating Equation (GEE) and Cox’s proportional hazards model are used to analyze the long-term influence of Chinese and Western therapies on the prognosis of lung caner patients. The findings of this study will provide a valuable reference for combined therapy in clinical care.
關鍵字：Lung cancer, Chinese and western therapies, Matched Case-control study, Prognosis
