研究背景 肺癌為全世界盛行率高的癌症,各地發生率有逐漸攀升趨勢,該疾病對各國而言,造成的醫療財政負擔日漸龐大。外科手術是治療初期非小細胞肺癌最主要的治療模式,自從胸腔鏡手術興起後,迅速成為治療初期非小細胞肺癌常見的方法。 傳統開胸手術和胸腔鏡手術在回顧性研究中顯示對健康結果的影響相似,在於肺癌病人的存活率相當類似,胸腔鏡手術可以降低一年內併發症發生率以及縮短住院天數,由此可知,胸腔鏡手術可提升治療肺癌病人之安全性,以及可降低因手術而導致的其他疾病發生。然而較長期間的治療結果以及兩者相較的成本效果分析為何,則有待進一步分析。 研究目的 本研究目的以中央健康保險署的觀點,分析採用胸腔鏡手術與傳統開胸手術治療非小細胞肺癌第Ⅰ期至第Ⅱ期病人之臨床結果與醫療費用是否有差異,以及進行胸腔鏡肺葉切除手術與開胸肺葉切除手術之成本效果分析。 研究方法 本研究使用健保資料庫之兩百萬人世代追蹤抽樣檔,探討2012年至2014年接受胸腔鏡肺葉切除手術與開胸肺葉切除手術之新發非小細胞肺癌第Ⅰ期至第Ⅱ期病人,比較兩組病人手術當次住院天數、術後30日併發症人數、出院後30日內在入院人數、術後一年內死亡人數、三年整體存活率、三年無復發存活率、手術當次住院醫療費用以及術後一年內醫療費用之差異。本研究以Logistic regression計算傾向分數對胸腔鏡肺葉切除手術及開胸肺葉切除手術病人進行1:1配對。臨床結果使用卡方檢定、無母數Wilcoxon rank-sum test、廣義估計方程式(GEE)、Cox比例風險迴歸模型、Kaplan-Meier存活曲線分析兩組手術之差異。費用部分亦採用廣義估計方程式(GEE)比較兩種手術模式於手術當次醫療費用以及術後三年內醫療費用之差異。最後將臨床結果與費用進行成本效果分析,計算兩種手術模式之遞增成本效果比,並進行單維敏感度分析以及使用無母數靴環法(Bootstrap)探討ICER值之分布。 研究結果 本研究經過傾向分數配對後,胸腔鏡手術與開胸手術各為100人,配對後兩組樣本之基本特質無顯著差異。手術當次住院天數,胸腔鏡肺葉切除手術較開胸肺葉切除手術減少2.55日(p<0.001),在術後30日內併發症中,胸腔鏡肺葉切除手術共為8人,開胸肺葉切除手術共為13人;而出院後30日內再入院人數,胸腔鏡肺葉切除手術有5人,開胸手術肺葉切除手術有7人;術後一年內死亡的人數,胸腔鏡肺葉切除手術有2人,開胸肺葉切除手術僅有1人,而術後三年內死亡人數,胸腔鏡肺葉切除手術有7人,開胸肺葉切除手術有8人,皆不具有統計上顯著差異,在三年整體存活時間(p=0.768)及三年無復發存活時間(p=0.872)方面則是兩組手術相似。在醫療費用的部分,手術當次醫療費用,胸腔鏡手術相較於開胸手術可節省29,028元,術後三年內醫療費用則可節省16,664元。在成本效果分析的部分,胸腔鏡手術相較於開胸手術為較具優勢(dominant)的治療模式。 結論 整體而言,以衛福部中央健康保險署的觀點,病人接受胸腔鏡肺葉切除手術相較於開胸肺葉切除手術的臨床結果較佳,且總醫療費用較開胸肺葉切除手術低,因此,胸腔鏡肺葉切除手術較開胸肺葉切除手術於治療非小細胞肺癌第Ⅰ期至第Ⅱ期病人為具有優勢之治療模式。
Background: In Taiwan, lung cancer has been the major cause of cancer-related mortality for both men and women, and imposed a greatest disease burden in recent years. The preferred treatment of choice for patients with early-stage non-small cell lung cancer (NSCLC) is surgical resection. Compared with the open lobectomy surgery, video-assisted thoracoscopic surgery (VATS) has been accepted as a minimally invasive, safe and effective surgical approach for patients with early-stage non-small cell lung cancer. However, studies on the clinical outcomes, medical costs and cost-effectiveness analysis between video-assisted thoracoscopic surgery and open lobectomy surgery in early-stage non-small cell lung cancer patients using the National Health Database are very limited. Objective: The aim of the study is to compare the difference in clinical outcome and medical costs for patients with clinical stage I and stage Ⅱ NSCLC patients who underwent video-assisted thoracoscopic lobectomy surgery or open lobectomy surgery, and to estimate the cost-effectiveness between two types of surgery from the perspective of the National Health Insurance Administration in Taiwan. Methods: The source of data came from the Longitudinal Health Database of NHIRD. Patients who underwent lobectomy surgery by means of thoracotomy or VATS for primary non-small cell lung cancer (NSCLC) and with clinical stage I and stage Ⅱ disease from the Taiwan National Health Insurance Research Database (NHIRD) between 2012 and 2014 were identified. We compared the difference of the length of stay, number of complications cases within 30 days, number of readmission within 30 days, number of death within 3 years, 3-year overall survival, 3-year recurrence free survival, and medical cost of hospitalization of surgery. Propensity score matching for 1:1 (PSM) was performed. The chi-square test, Wilcoxon rank-sum test, generalized estimating equation (GEE), Cox proportional hazards regression and Kaplan-Meier survival curve were used to compare the difference in clinical outcomes and medical expenditures(cost). Incremental cost-effectiveness ratio (ICER) was calculated in cost-effectiveness analysis. The study used one-way sensitivity analysis and non-parametric bootstrap to discuss the distribution of ICER. Results: There were 100 patients in each of the VAT surgery and open surgery group after matching and no differences were found in baseline characteristics of patients between two groups. In terms of clinical outcomes, the lengths of stay were 2.55 days significantly shorter for VAT surgery than open lobectomy surgery (p<.0001). The number of complications during the 30-day postoperative were 8 cases in VAT and 13 cases in open lobectomy surgery; and the number of readmission cases during the 30-day postoperative after discharge in VAT were 5 and 7 cases in open lobectomy surgery; the number of the postoperative recurrence of cases within three years were 8 cases in VAT and 13 cases in open lobectomy surgery. In addition, there were no significant difference between the two groups in terms of 3-year overall survival rate and the 3-year progression free survival. For medical cost, VAT surgery saved NT$ 29,028 for the surgical cost and saved NT$16,664 total medical expenditure in three years after the surgery. Based on the result of the cost-effectiveness analysis, VAT was the dominant surgical approach. Conclusions: VAT surgery was the dominant surgical approach for patients with early-stage non-small cell lung cancer.