Establishing and evaluating FRAX® probability thresholds in Taiwan

Background/purpose: The Taiwanese FRAX® calculator was launched in 2010. However, cost-effectiveness thresholds for the prescription of antiosteoporosis medications were not established. This study aims to establish and evaluate FRAX®-based probability thresholds in Taiwan. Methods: Using previous data from Taiwan and literature, we determined cost-effectiveness thresholds for prevention of osteoporotic fractures by alendronate with a Markov model, as well as using two other translational approaches. Sensitivity analysis was applied using different alendronate prices. A clinical sample was used to test these Taiwan-specific thresholds by determining the percentages of high-risk patients who would be qualified for current National Health Insurance reimbursement. Results: With the Markov model, the intervention threshold for hip fracture was 7% for women and 6% for men; for major osteoporotic fracture, it was 15% for women and 12.5% for men. Both translational approach models were cost effective only for certain age groups. However, if branded alendronate was reimbursed at 60% of the current price, they became cost effective in almost all age groups. This clinical screening study showed that the National Health Insurance Administration model identified the highest proportion (44%) of patients qualified for National Health Insurance reimbursements, followed by the Markov model (30%), and the United States model (22%). Conclusion: Three FRAX®-based models of alendronate use were established in Taiwan to help optimize treatment strategies. The government is encouraged to incorporate FRAX®-based approaches into the reimbursement policy for antiosteoporosis medicines

鎝-99m HYNIC-Herceptin 對乳癌HER2狀態評估之價值:動物研究

Trastuzumab是DNA重組的人類化單株抗體(recombinant DNA-derived humanized monoclonal antibody)，主要用於治療因人類表皮生長因子第二接受體(human epidermal growth factor receptor 2，HER2)過度表現的乳癌。因為價格昂貴，所以臨床使用與否，必須根據免疫組織化學染色分析（Immunohistochemistry，IHC）或原位螢光雜交（Fluorescence in situ hybridization，FISH）來分析HER2的狀況。而此兩種方法需要切片取出腫瘤組織，屬於侵犯性檢查。一般認為原位螢光雜交（FISH）要比免疫組織化學染色分析（IHC）來得更為準確，但價格方面，原位螢光雜交（FISH）目前比起免疫組織化學染色分析（IHC）來得昂貴許多。所以若能有一非侵入性、評估全身多處不同病灶、半定量攝取值等資訊的造影方法。在某種程度可以取代免疫組織化學染色分析（IHC）或原位螢光雜交（FISH） 這些檢查方法。相信是非常有價值的。由核研所研發的Tc-99m-HYNIC-Herceptin核醫藥物，或許是解決這一問題的方法。Tc-99m-HYNIC-Herceptin藉由TC-99m 結合Trastuzumab之方式，可以結合至人類表皮生長因子第二接受體（HER2）上。在我們的研究裏，我們成功的將兩株人類表皮生長因子第二接受體不同表現量的人類乳癌細胞，分別是HER2高表現的BT-474人類乳癌細胞和HER2低表現的MCF-7人類乳癌細胞，移植至BALB-C 裸鼠兩側大腿上。待腫瘤長至最大直徑約0.6-0.8 cm後，將0.1m Ci Tc-99m-HYNIC-Herceptin由尾靜脈注入，隨之接受核醫照影，然後取下腫瘤作免疫組織化學染色分析。實驗發現核醫照影和免疫組織化學染色分析結果有相當高的關聯性。在動物模型實驗中可以說得到了初步的結果。Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody. It has been used on the treatment of HER2 (human epidermal growth factor receptor 2) overexpression breast cancer. Clinically it is applied on the patients when the IHC (Immunohistochemistry)and FISH (Fluorescence in situ hybridization)present a positive result. Both methods are invasive and it is necessary tumor tissue via biopsy. Generally FISH is more precisely than IHC,however FISH is more expensive than IHC. If we can find a non-invasive, accessing different tumor sites and semi-quantification image method. And this image method can substitute IHC and FISH, it will be vary valuable. Tc-99m-HYNIC-Herceptin developed by the INER may be able to resolve the problem. Tc-99m-HYNIC-Herceptin is combination of TC-99m and Trastuzumab, it can conjugate at the HER2 receptor. In our study, we use two different HER2 expression level human breast cancer cells. We transplanted them in the bilateral thighs of the BALB-C nude mice simultaneously. When the tumor grows up and reach the greatest diameter about 0.6-0.8 cm, we inject 0.1m Ci Tc-99m-HYNIC-Herceptin to the mice via the tail vein. After nuclear scintigraphy, we analyze the tumor by immunohistochemistry. The experimental results show a high correlation between the scintigraphy and immunohistochemistry. So we have an initial result of the animal model.中文摘要 i 英文摘要 ii 目次 iii 表目次 iv 圖目次 v 一、緒論 1 (一)分子影像藥物Tc-99m-HYNIC-Herceptin 1 (二)人類表皮生長因子第二接受體(human epidermal growth factor receptor 2, HER2) 1 (三)Trastuzumab(Herceptin, anti-HER2 monoclonal antibody)作用機制 1 (四)研究背景 2 (五)研究目的 3 二、材料與方法 4 (一)HYNIC-Herceptin之合成 4 (二)BT-474及MCF-7人類乳癌腫瘤細胞 5 (三)藥物專一性實驗 5 (四)細胞存活率分析 5 (五)實驗動物腫瘤模式建立 6 (六)生物分佈分析 6 (七)動物造影 7 (八)腫瘤免疫組織化學染色分析（IHC） 7 三、結果 9 四、討論與結論 12 五、參考書目 4

Calyceal Diverticulum in FDG-PET Imaging

A 46-year-old female underwent a fluorodeoxyglucose F-18 (FDG) positron emission tomography (PET) whole-body scan for tumor screening after showing no symptoms or signs. The PET images showed a large FDG-avid lesion in the left renal pelvis, with a maximum standard uptake value (SUV) of 10.7 at 1 hour and 3.9 at 3 hours. An abdominal computed tomography (CT) scan showed a 3.7-cm cystic lesion with a slightly irregular wall in the left kidney. The immediate impression was that of a complicated cyst. A histopathologic report after surgery confirmed a calyceal diverticulum. To the best of our knowledge, this is the first report of FDG uptake in a case of calyceal diverticulum