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題名 | 中西醫療法對肺癌病人預後之長期效益:個案配對研究=Long-term Benefit of Chinese and Western Therapies for the Prognosis of Lung Cancer Patients: Matched Case-Control Study |
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編 次 | (2-1) |
作者 | 唐婉如; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(68)1-(68)35 |
分類號 | 413.2 |
關鍵詞 | 肺癌; 中西醫療法; 個案配對研究; 預後; Lung cancer; Chinese and western therapies; Matched Case-control study; Prognosis; |
語文 | 中文(Chinese) |
中文摘要 | 研究目的:比較西醫治療與合併療法 (合併中西醫治療 )對肺癌病人預後 (存活率、平均存活時間、有無轉移 /何時轉移、症狀困擾、身體活動功能、及生活品質 )之長期效果。 研究方法:本研究為兩年期之個案配對研究,於臺灣北、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。本研究擬招收 15位接受西醫治療及 15位接受中西醫合併療法的肺癌病人。筆者以症狀困擾表(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 (T1)、治療後第 1個月(T2)、3個月(T3)、6個月(T4)、與 12個月時 (T5),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,每位個案在研究過程中都會由同一位研究者負責收集資料。 結果與討論:截至目前為止,共接觸 44位符合收案條件的肺癌初診斷病人,其中 9位因家屬擔心而拒絕參加研究,目前共收案 22位接受西醫治療及 13位接受中西醫合併療法的肺癌病人,反應率為 79.5%。經資料分析顯示,於 T1時間點上,兩組個案在基本人口學與疾病嚴重度的變項上除了教育程度之外並無不同。於 T2時間點上,礙於肺癌病人確診後未必立即接受正規療法,因此目前只完成 26位個案(74.3 %)的資料收集,預計於 12月底將完成兩組所有個案 T2資料之收集。誠如文獻所言,肺癌之死亡率遠高於其他癌症(如乳癌、子宮頸癌、或口腔癌),本研究中已有 4位個案(2位合併組及 2位西醫組個案 )於接受第一次化學治療後隨即往生。根據初步廣義估計方程式 (Generalized Estimating Equation, GEE)分析顯示在控制干擾變項 (教育程度 )之下,兩組個案在 T2 (接受治療後第一個月 )的重要 結果,變項之比較上,除了合併組在財務困難上顯著高於西醫組 (p<.001)之外,兩組在其他症狀困擾、身體活動功能、生活品質、和存活率等重要變項的指標上,皆無顯著差異 (p>.05),可能因為中藥療效非短期所能體現,亦有可能中藥效益並非明顯效益,因此在個案數不足的情況下 (N=26)無法看出兩組之顯著差異。由於 T2兩組資料尚未收集完整,因此不宜依初步分析結果貿然做任何結論,以免誤導讀者。未來將繼續完成兩組個案 T2-T5的資料收集,並在控制教育程度變項後,運用 GEE來檢視兩組在不同收案時間點上之重要結果變項有無不同。 |
英文摘要 | AIM: Compare Western therapy group with combined therapy group for the long-term influence of lung cancer patient prognosis (survival rate, median survival time, occurrence of metastasis, when the metastasis occurred, the symptom distress, performance status, and quality of life). METHOD: This study was a 2-year matched case-control study, and the subjects at Chang Gung Medical Center in northern, central, and southern Taiwan were enrolled simultaneously. For controlling the possible confounding variables, lung cancer patients who meet the inclusion criteria were 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 were used to measure the symptom distress, performance status, and quality of life of patients from two groups before the formal treatment(T1) and at month 1(T2), month 3(T3), month 6(T4), and month 12 after the treatment(T5), respectively. In addition, chart review was 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 was collected by one researcher during the study. RESULTS & DISCUSSION: Until now, 44 patients who meet the inclusion criteria were contacted by the researcher. Nine refused to participate due to concerns from the family caregivers. Twenty-two patients who received western therapy and 13 patients who received combined therapy were recruited for this study. The response rate was 79.5%. After data analysis, there was no difference at T1 on basic information and disease severity level between groups, except for educational level. Subjects who agree to use combined therapy had higher educational level than subjects in the Western therapy group. Because of patients did not receive chemotherapy right after confirmation of diagnosis, the investigator only collected data from 26 patients (74.3%) at T2. We expected to complete data collection for T2 at the end of December, 2011. Same as the literature, the mortality rate for lung cancer patients are much higher than patients with other types of cancer, such as breast cancer, cervical cancer, and oral cancer. Four subjects in this study passed away soon after receiving 1st chemotherapy. From the initial Generalized Estimating Equation (GEE) analysis for T2, after controlling the educational level as the confounding variable, subjects in combined therapy group had more financial difficulty (p<.001) than subjects in the Western therapy group. Other than that, there were no significant difference on symptom distress, physical performance status, quality of life, and survival rate between groups (p> .05). It is possible that the effect of Chinese herbal medicine cannot be experienced within short period of time. It is also possible that the effect size of Chinese herbal medicine is too small to detect under such a small sample size (N= 26). We believe that it is unsuitable to draw any conclusions based on the initial data analysis due to imcomplete data collection at T2. The investigator will continue data collection for T2-T5 and use GEE to examine the difference on important outcome variables between groups. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。