高考申論題
105年
[藥事] 調劑學與臨床藥學
第 一 題
📖 題組：
下面加框內文為美國 FDA 於 2016 年 4 月 8 日發布有關 metformin 安全訊息的片段。 FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function ● FDA is requiring manufacturers to revise the labeling of metformin-containing drugs to indicate that these products may be safely used in patients with mild to moderate renal impairment. ● We are also requiring manufacturers to revise the labeling to recommend that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (i.e., glomerular filtration rate estimating equation (eGFR)). This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight. ● The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information: Before starting metformin, obtain the patient’s eGFR. Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2. Starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended. Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently. In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment. Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2. Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.
下面加框內文為美國 FDA 於 2016 年 4 月 8 日發布有關 metformin 安全訊息的片段。 FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function ● FDA is requiring manufacturers to revise the labeling of metformin-containing drugs to indicate that these products may be safely used in patients with mild to moderate renal impairment. ● We are also requiring manufacturers to revise the labeling to recommend that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (i.e., glomerular filtration rate estimating equation (eGFR)). This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight. ● The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information: Before starting metformin, obtain the patient’s eGFR. Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2. Starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended. Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently. In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment. Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2. Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.
📝 此題為申論題，共 3 小題
小題 (一)
依據現今醫學指引，metformin 在糖尿病治療的地位為何？有何優點與缺點？一般劑量為何？（12 分）
思路引導 VIP
作答時應先聯想最新 ADA (American Diabetes Association) 指引中 metformin 作為 T2DM 治療基石的地位，並指出針對 ASCVD/CKD 患者治療順序的當代演變。接著，系統性條列其優缺點（包含藥理機轉與副作用），最後列出明確的數值（起始、維持、最大劑量），並務必呼應題幹提及的 eGFR 數值進行劑量調整說明，以展現實務專業。
小題 (二)
請問以前 metformin 在腎功能不佳的病人不能使用，是參考何種參數？該參數於多少時不能使用？（5 分）
思路引導 VIP
考生應從題幹 FDA 警訊內文提及的「changed from... (blood creatinine concentration)」定位舊版評估參數。接著需調用臨床藥學記憶，回想 2016 年以前 Metformin 仿單中，針對男女性別分別訂定的血清肌酸酐 (SCr) 禁用門檻絕對數值。
小題 (三)
根據此訊息，使用 metformin 之病人在何種狀況應停藥？（5 分）
思路引導 VIP
解答此題應直接掃描英文文本中代表停藥的關鍵字「Discontinue」。將找到的段落分為兩大情境：一是單純腎功能下降的閾值（eGFR < 30）；二是與含碘顯影劑檢查相關的特定條件（如特定的 eGFR 區間、共病史、給藥途徑），並精確寫出數值與病史條件即可完整拿分。