術中放射治療與全乳房放射治療在早期乳癌病患之成本效益分析

研究目的對於大部分的第零、ㄧ、二期乳癌病人，合併乳房保留手術(Breast Conserving Surgery, BCS)輔以全乳房放射線(Whole-breast external beam radiotherapy，EBRT)治療是優先的選擇。近年來一種治療早期乳癌的新技術--手術中放射治療 (Intraoperative radiotherapy，IORT)，在國外已經此兩種不同的放射治療方式進行了大型的研究並結果發表，但在台灣南部引進此技術後，尚未對其進行相關性之探討，故興起進行本研究之動機。研究方法本研究採取回溯性病例對照研究設計（Ｒetrospective case-control study）方式，資料分析來源取自台灣南部某區域醫院住院與門診醫療資料庫及批價資料檔，自2013 年1月1日到 2017 年12月31日，於本院早期乳癌患者接受乳房切除手術進行IORT治療者219人，EBRT者362人，追蹤兩組之臨床醫療成效及成本效益分析，使用 SAS9.3 套裝軟體進行研究假設驗證。研究結果資料收集共48個月，EBRT組（25人，6.91%）相較IORT組（3人，1.37%）在癌症惡化 (死亡或復發或轉移)的發生情形上，有較高的發生比例（P = 0.002）； Cox比例風險分析EBRT相較IORT有較低的發生疾病惡化的風險（危險比＝ 0.55，95% CI = 0.09-3047），但未達統計上顯著差異（P = 0.525）。於多變項分析(P<0.2)研究結果顯示，EBRT相較IORT有較低的發生疾病惡化的風險（危險比＝0.34，95% CI = 0.08-1.51），但未達統計上顯著差異（P = 0.157）。病人5年疾病存活曲線比較分析(Kaplan-Meier)顯示，EBRT 與 IORT 並無統計上顯著差異(Log-rank test P =0.7732) 。於當次手術費點數分析，EBRT組平均為15605 元(標準差為6190 元，大小值介於 7240 ~42549 元)、相較IORT組平均為13984元(標準差為6456元，大小值介於 0~29372)，兩組在手術費點數上有顯著之差異（P =0.013）。於麻醉費點數比較，EBRT 組平均為 6601元(標準差為1560元，大小值介於 0~14903 元)、相較 IORT 組平均為9132元(標準差為2262元，大小值介於0~19939)，兩組在平均麻醉費點數上也有顯著之差異（P< .0001）。當次住院醫療總費用點數比較，EBRT 組平均為44318元(標準差為9637元，大小值介於20002~80097元)、相較IORT組平均為49235元(標準差為10139元，大小值介於16480~89767)，有顯著性之差異（P<.0001）。 IORT 組手術當次醫療費用須額外自費 235000元，將此筆自費金額合併於 IORT 組門診總醫療費用再與 EBRT 組門診總醫療費用加以比較討論，EBRT 組平均為432179 元(標準差為 493723元，大小值介於 77069~3701192 元)、相較 IORT 組平均為 588546元(標準差為 246422元，大小值介於342527~1164519)，兩組在門診合計醫療總費用點數比較於統計學上無顯著性之差異（P=0.058）。以上統計分析結果顯示，EBRT 與 IORT 兩組之乳癌病人，不會因為採取不同之放射線治療方法而影響當次手術臨床醫療成效；選擇不同治療方式卻會影響當次手術醫療資源臨床利用是成立的。結論與建議隨著醫療的普及與進步，醫療的目標將由單純的診斷與治療疾病，提升到對病人身心干擾最小的醫療方式以及針對病人個人特殊需求而打造的個人化醫療。透過本論文的研究結果，可以了解早期乳癌病人接受手術中進行放射治療之臨床療效具安全性及可靠性，更可以提供給臨床醫師與病人於醫療決策時一參考依據。

關鍵字

乳房保留手術；手術中放射治療；全乳房放射線；成本效益分析

並列摘要

For most patients with stage 0、1 and 2 stage breast cancer, Breast Conserving Surgery (BCS) combined with Whole-breast external beam radiotherapy (EBRT) is a preferred option. In recent years, a new technology for the treatment of early breast cancer, Intraoperative Radiotherapy (IORT), has carried out large-scale research and published results in two different radiotherapy methods abroad, but introduced this technology in southern Taiwan. After that, the relevance of this study has not yet been explored, so the motivation for conducting this research has arisen. methods The study used a retrospective case-control study. The source of data was obtained from a hospitalized and outpatient medical database and a quota data file for a regional hospital in southern Taiwan, from January 1, 2013 to 2017. On December 31, 219 patients with early breast cancer who underwent mastectomy in our hospital underwent mastectomy for IORT, and 362 patients with EBRT. The clinical efficacy and cost-benefit analysis of the two groups were followed. The SAS9.3 software was used to verify the hypothesis. result Data collection for a total of 48 months, the EBRT group (25, 6.91%) compared with the IORT group (3, 1.37%) in the incidence of cancer deterioration (death or recurrence or metastasis), a higher incidence (P = 0.002); Cox proportional hazard analysis EBRT had a lower risk of disease progression than hazard at IORT (hazard ratio = 0.55, 95% CI = 0.09-3047), but did not reach a statistically significant difference (P = 0.525). In the multivariate analysis (P < 0.2), EBRT showed a lower risk of disease progression than IORT (hazard ratio = 0.34, 95% CI = 0.08-1.51), but did not reach statistically significant differences ( P = 0.157). A 5-year comparison of disease survival curves (Kaplan-Meier) showed no statistically significant difference between EBRT and IORT (Log-rank test P = 0.7732). In the current surgery fee point analysis, the average EBRT group was 15,605 NTD (standard deviation was 6,190 NTD, the size was between 7240~42549 NTD), compared with the average IORT group of 13984 NTD (standard deviation of 6456 NTD, size value between 0 ~ 29372), the two groups have significant differences in surgical fees (P = 0.013). Compared with the anaesthetic fee points, the average EBRT group was 6601 NTD (standard deviation was 1,560 NTD, size ranged from 0 to 14903 NTD), compared with the average IORT group of 9132 NTD (standard deviation was 2262 NTD, the size value was 0). ~19939), there was also a significant difference in the average anesthetic fee points between the two groups (P < .0001). When comparing the total cost of hospitalization expenses, the average EBRT group was 44,318 NTD (standard deviation was 9637 NTD, the size value was between 20002 and 80097 NTD), compared with the average IORT group of 49,235 NTD (standard deviation was 10,139 NTD, size value). Between 16480 and 89767), there is a significant difference (P < .0001). In the IORT group, the current medical expenses must be an additional 235,000 NTD. The self-funded amount is combined with the total medical expenses of the IORT group and compared with the total medical expenses of the EBRT group. The average EBRT group is 432,179 NTD (standard deviation is 493,723 NTD). The size of the value is between 77069 and 3,701,192 NTD), compared with the average IO of the IORT group of 588,546 NTD (standard deviation is 246,422 NTD, the size of the value is between 342,527 and 11,645,519), the total cost of total medical expenses in the outpatient department is statistically compared There was no significant difference (P = 0.058). The above statistical analysis shows that the breast cancer patients in the EBRT and IORT groups will not affect the clinical outcome of the current surgery because of different radiation treatment methods; the choice of different treatment methods will affect the clinical utilization of the surgical medical resources. . conclusion and suggestion With the popularization and advancement of medical care, the goal of medical treatment will be from simple diagnosis and treatment of diseases to medical treatments that minimize the physical and mental interference of patients and personalized medical treatments tailored to the specific needs of patients. Through the research results of this paper, we can understand the safety and reliability of the clinical efficacy of early breast cancer patients undergoing radiotherapy during surgery, and provide a reference for clinicians and patients in medical decision-making.