腹腔鏡手術與開腹手術於治療大腸癌患者之成本效果分析

Abstract

研究背景 由於台灣地區大腸癌直腸發生率逐年攀升，且每年耗費龐大的健保醫療資源，大腸直腸癌已成為目前國人及政府極需重視的健康問題之一。大腸癌的治療模式以手術為大宗，除了傳統的開腹結腸切除術外，近年來，腹腔鏡手術技術趨於成熟，逐漸應用於治療大腸癌患者。然而目前台灣地區少有利用健保資料庫進行回溯性研究，比較腹腔鏡手術與開腹手術於治療大腸癌患者的臨床結果、醫療費用以及成本效果分析。 研究目的 本研究目的為以中央健康保險署的觀點，比較與分析採用腹腔鏡手術與傳統開腹手術治療大腸癌患者之臨床結果與醫療費用是否有差異，以及進行腹腔鏡手術與開腹手術之成本效果分析。 研究方法 本研究利用健保資料庫之2010年承保抽樣歸人檔，探討2007年至2012年接受腹腔鏡手術及開腹手術之新發大腸癌患者，並觀察兩組患者之手術當次住院天數、術後30日內併發症人數、出院後30日內再入院人數、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計算傾向分數進行1:1配對。臨床結果部分以卡方檢定、無母數Wilcoxon rank-sum test、廣義估計方程式(GEE)、Cox比例風險迴歸模型以及Kaplan-Meier存活曲線分析兩組手術之差異。費用的部份亦使用GEE比較兩種手術模式於手術當次醫療費用以及術後一年內醫療費用之差異。成本效果分析計算兩種手術模式間之遞增成本效果比(ICER)，並進行單維敏感度分析以及利用靴環法(bootstrap)探討ICER值之分佈。 研究結果 本研究經過傾向分數配對後，腹腔鏡手術與開腹手術各為125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，腹腔鏡手術較開腹手術短3.6日(p <0.001)，術後30日內併發症，腹腔鏡手術為15人、開腹手術10人；出院後30日內再入院，腹腔鏡手術6人、開腹手術19人；術後一年內死亡，腹腔鏡手術2人、開腹手術3人，皆不具有統計上顯著差異，而三年整體存活(p =0.827)及無復發存活率(p =0.689)則是兩組手術相似。在醫療費用的部分，手術當次醫療費用，腹腔鏡手術相較於開腹手術可節省3,280元，術後一年內醫療費用則可節省11,569元，然而術後一年內大腸癌相關醫療費用則較開腹手術高出9,239元，但未達到統計上顯著差異。在成本效果分析的部分，腹腔鏡手術相較於開腹手術為較具優勢的治療模式。 結論 整體而言，以中央健康保險署的觀點，腹腔鏡手術相較於開腹手術的臨床結果較佳，且其醫療費用較開腹手術低，因此，腹腔鏡手術相較於開腹手術於治療大腸癌患者上為具有優勢之治療模式。

Background: Due to the increasing incidence rate of colorectal cancer in Taiwan, and spend a tremendous amount of medical utilizations under National Health Insurance (NHI) every year, colorectal cancer has become one of the most important health issue that people and government should be concerned. The most commonly used treatment for colorectal cancer is by surgery. In addition to the open surgery, the technology of laparoscopic surgery is now more mature, and has been used more frequently to treat the colorectal patients in recent years. However, there is yet enough retrospective study on the clinical outcomes, medical costs and cost-effectiveness analysis between laparoscopic surgery and open surgery on colon cancer patients using the National Health Insurance Research Database (NHIRD) in Taiwan. Objective: The aim of the study is to compare the difference in clinical outcome and medical costs between laparoscopic and open surgery, and to estimate the cost-effectiveness between laparoscopic and open surgery from the perspective of National Health Insurance in Taiwan. Methods: This study used the 2010 Longitudinal Health Insurance Database (LHID2010) of NHIRD. We selected only newly diagnosed cases who received a laparoscopic or open surgery from 2007 to 2012, and 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 1 year, overall 3-year survival and recurrence-free 3-year survival, and medical costs of hospitalization of surgery. We conducted logistic regression to calculate the propensity score for 1:1 matching (PSM). 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 costs. Incremental cost-effectiveness ratio (ICER) was calculated in cost-effectiveness analysis. This study also conducted one-way sensitivity analysis and non-parametric bootstrap to estimate the distribution of ICER. Results: There were 125 patients in each of the laparoscopic surgery and open surgery group after PSM and there were no differences in the baseline characteristics between these two groups. The length of stay were 3.6 days shorter for laparoscopic (p <0.001). The number of complication cases within 30 days were 15 and 19 cases, the number of readmission within 30 days were 6 and 10 cases, and the number of death within 1 year were 2 and 3 cases for laparoscopic surgery and open surgery, respectively. Overall 3-year survival (p =0.827) and recurrence-free 3-year survival (p =0.689) are similar for the two groups. In medical costs analysis, laparoscopic surgery patients saved NT$3,280 for medical costs of hospitalization of surgery and NT$11,569 for medical costs within 1 year. Colon cancer related medical costs within 1 year of laparoscopic surgery patients were NT$9,239 higher than that of open surgery patients, however the difference was not significant. For cost-effectiveness analysis, compared to open surgery, laparoscopic surgery was the dominant treatment option. Conclusions: In general, laparoscopic surgery had better clinical outcomes and also lower medical costs comparing to open surgery. Therefore, laparoscopic surgery was a dominant treatment option on colon cancer patients from the perspective of NHI administration.