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腸胃肝膽健康・醫學週報
整合台灣熱門醫學新聞與頂尖期刊（NEJM・Lancet）肝・膽・胃・腸・減重・代謝領域最新研究，每週自動更新
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台灣醫學新聞 TOP 5
健保放寬B肝抗病毒藥給付：病毒量門檻由2萬降至2000 IU/mL，最多3萬名帶原者受惠
健保共擬會10/15通過放寬慢性B肝抗病毒藥給付，HBV DNA門檻由2萬降至2000 IU/mL，預估1.7萬至3萬人受惠。國內B肝相關肝癌患者中，68.7%確診前從未用過抗病毒藥。
中醫大附醫「仿生呼吸培養平台」訓練幹細胞外泌體治菜瓜布肺，登國際期刊Biomaterials
中醫大附醫團隊模擬肺部規律伸縮環境培養幹細胞，外泌體抗纖維化miR-30含量達傳統培養3.3倍；大鼠經鼻給藥後肺部膠原堆積與發炎指標下降。目前仍屬動物實驗，將續推臨床轉譯。
國內M痘Ib病毒株病例明顯增加：10月已確診18例、16例為Ib型，疾管署籲風險族群完成2劑疫苗
疾管署統計今年累計568例M痘，5月出現首例Ib型迄今30例；10月確診18例中16例為Ib型，年齡20至40多歲。全國327家合作院所提供公費疫苗，2劑保護力約9成、1劑僅4至8成。
沒減肥卻2個月瘦3公斤、常吃不下？腸胃科醫師改排大腸鏡，盲腸揪出3公分早期癌
中年女子未節食卻2個月瘦3公斤、常吃不下，新光醫院張璨璿醫師改排大腸鏡，盲腸揪出3公分早期癌。半年內非刻意減重者4.8%之後確診癌症，約為同齡者3倍；症狀逾2週合併便型改變應就醫。
瘦子有脂肪肝，死亡風險沒比較低：41國1.8萬人研究指關鍵在肝纖維化，醫籲算FIB-4
《JAMA》跨國研究納入41國1萬8326名切片確診脂肪肝患者，瘦型患者病變較輕，但死亡與嚴重併發症風險與肥胖者相近；晚期纖維化者死亡風險2.1倍、肝癌等事件3.41倍。肝指數正常仍應算FIB-4、做肝彈性檢查。
頂尖期刊
NEJM 近期研究
In Vitro Fertilization or Intrauterine Insemination in Unexplained Infertility.
Multicenter noninferiority RCT (FIIX) randomized 737 couples with unexplained infertility to up to four cycles of IUI with ovarian stimulation or one complete IVF cycle. Stage-1 cumulative live-birth rate was 31% with IUI versus 55% with IVF (adjusted risk difference -24 percentage points; 95% CI -31 to -16), so IUI was not noninferior. After stage 2 (IVF for non-pregnant couples), live-birth rates were similar (70% vs 71%). Serious adverse events: 6 vs 14 couples.
多中心非劣性隨機試驗納入737對不明原因不孕夫妻，比較最多4週期排卵刺激加IUI與1個完整IVF週期。第一階段累積活產率IUI為31%、IVF為55%（校正風險差−24個百分點，95% CI −31至−16），IUI未達非劣性；第二階段後兩組活產率相近（70%對71%）。嚴重不良事件分別為6對與14對。
Divarasib as Compared with Sotorasib or Adagrasib in KRAS G12C-Mutated NSCLC.
Phase 3 open-label trial (Krascendo 1) randomized 338 patients with previously treated KRAS G12C-mutated advanced NSCLC to next-generation inhibitor divarasib 400 mg daily or sotorasib/adagrasib. Median PFS was 9.8 vs 5.7 months (HR 0.58; 95% CI 0.44-0.76) and median OS 17.7 vs 12.0 months (HR 0.56; 95% CI 0.41-0.78). Confirmed response 58.4% vs 32.3%; grade 3-4 treatment-related adverse events were fewer with divarasib (24.6% vs 34.5%).
第三期開放性試驗Krascendo 1將338名曾接受治療的KRAS G12C突變晚期非小細胞肺癌病人隨機分配至新一代抑制劑divarasib（400 mg每日一次）或sotorasib／adagrasib。中位PFS為9.8對5.7個月（HR 0.58），中位OS為17.7對12.0個月（HR 0.56）；確認反應率58.4%對32.3%，第3–4級治療相關不良事件反而較少（24.6%對34.5%）。
Tarlatamab-Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer.
International phase 3 open-label trial (DeLLphi-305) randomized 563 patients with extensive-stage small-cell lung cancer without progression after chemoimmunotherapy to maintenance tarlatamab (DLL3xCD3 bispecific T-cell engager) plus durvalumab or durvalumab alone. At interim analysis, median OS was 21.1 vs 12.7 months (HR 0.42; 95% CI 0.32-0.54) and median PFS 7.4 vs 1.9 months (HR 0.34). Grade >=3 adverse events 46.8% vs 40.6%; cytokine release syndrome, mostly grade 1-2, occurred in nearly half of tarlatamab recipients.
國際第三期開放性試驗DeLLphi-305納入563名化學免疫治療後未惡化的廣泛期小細胞肺癌病人，隨機分配至tarlatamab（DLL3×CD3雙特異性T細胞銜接子）合併durvalumab或單用durvalumab維持治療。期中分析中位OS為21.1對12.7個月（HR 0.42），中位PFS為7.4對1.9個月（HR 0.34）；≥3級不良事件46.8%對40.6%，近半數出現多為1–2級的細胞激素釋放症候群。
頂尖期刊
Lancet 近期研究
14-day versus 28-day trifluridine-tipiracil plus bevacizumab for refractory metastatic colorectal cancer (PRABITAS): a pragmatic, multicentre, open-label, randomised, phase 3, non-inferiority trial in Japan.
Pragmatic phase 3 non-inferiority trial at 178 Japanese hospitals randomized 970 patients with refractory metastatic colorectal cancer to FTD-TPI plus bevacizumab on a conventional 28-day schedule or a simplified 14-day schedule (FTD-TPI days 1-5, bevacizumab day 1). Median OS was 10.3 vs 11.3 months (stratified HR 0.93; 95% CI 0.80-1.08), meeting the 1.25 non-inferiority margin. The 14-day schedule reduced grade >=3 neutropenia (13% vs 39%) and grade >=2 anorexia (15% vs 26%).
日本178家醫院的務實性第三期非劣性試驗，將970名難治性轉移性大腸直腸癌病人隨機分配至傳統28天或簡化14天（FTD-TPI第1–5天、bevacizumab第1天）療程。中位OS為10.3對11.3個月（分層HR 0.93，95% CI 0.80–1.08），達到1.25非劣性界值；14天組≥3級嗜中性球低下由39%降至13%，≥2級厭食由26%降至15%。
Sacituzumab tirumotecan versus treatment of physician's choice in previously treated endometrial cancer (TroFuse-005/ENGOT-en23/GOG-3095): a randomised, open-label, phase 3 trial.
Global phase 3 open-label trial randomized 776 patients with advanced or recurrent endometrial cancer previously treated with platinum chemotherapy and anti-PD-1/PD-L1 therapy to the TROP2-directed antibody-drug conjugate sacituzumab tirumotecan (4 mg/kg days 1 and 15 q28d) or physician's choice doxorubicin or paclitaxel. Median PFS was 7.2 vs 3.9 months (HR 0.59; 95% CI 0.50-0.70) and median OS 19.0 vs 12.1 months (HR 0.68; 95% CI 0.55-0.84). Grade >=3 adverse events: 69% vs 57%.
全球第三期開放性試驗納入776名曾接受鉑類化療及抗PD-1/PD-L1治療的晚期或復發子宮內膜癌病人，隨機分配至TROP2標靶抗體藥物複合體sac-TMT（4 mg/kg，每28天第1、15天）或醫師選擇之doxorubicin／paclitaxel。中位PFS為7.2對3.9個月（HR 0.59），中位OS為19.0對12.1個月（HR 0.68）；≥3級不良事件69%對57%。
頂尖期刊
JAMA 近期研究
Left Bundle-Branch Area Pacing vs Right Ventricular Pacing for Atrioventricular Block and Preserved Left Ventricular Function: The LEAP-Block Randomized Clinical Trial
Multicenter RCT in 14 Chinese hospitals randomized 499 patients with atrioventricular block, LVEF ≥50%, and anticipated ventricular pacing >40% to left bundle-branch area pacing (LBBAP) or right ventricular pacing (RVP). At 24 months, the composite of death, heart failure events, or upgrade to biventricular pacing occurred in 2.4% vs 12.5% (absolute difference −10.1%; HR 0.37, 95% CI 0.19–0.73). HF events were fewer with LBBAP (3.4% vs 11.3%); complications did not differ.
中國14家醫院多中心隨機試驗，納入499名房室傳導阻滯、LVEF≥50%且預期心室起搏比例>40%的患者，比較左束支區域起搏與右心室起搏。24個月時，死亡、心衰事件或升級為雙心室起搏的複合終點為2.4% vs 12.5%（絕對差−10.1%；HR 0.37）。LBBAP組心衰事件較少（3.4% vs 11.3%），併發症無差異。
Revascularization of Asymptomatic Carotid Artery Stenosis: Cognitive Results of the CREST-2 Randomized Trials
Prespecified cognitive outcomes of the CREST-2 trials enrolled 2165 patients (mean age 70.1 years) with ≥70% asymptomatic carotid stenosis, randomized to carotid stenting or endarterectomy plus intensive medical management (IMM) vs IMM alone, with five cognitive tests administered annually up to 4 years. Adjusted composite z-score differences at 4 years were 0.03 (95% CI −0.09 to 0.15) for stenting and 0.02 (−0.09 to 0.14) for endarterectomy, with no benefit on any individual test.
CREST-2 試驗預設認知次要終點分析，納入2165名≥70%無症狀頸動脈狹窄患者（平均70.1歲），比較支架或內膜剝脫術合併強化藥物治療與單純藥物治療，每年進行5項認知測驗達4年。4年時校正後複合z分數差異：支架組0.03（95% CI −0.09至0.15）、手術組0.02（−0.09至0.14），各項測驗均無差異，血管重建未改善認知功能。
Sodium-Glucose Cotransporter 2 Inhibitor Use and Levels of Hemoglobin, Markers of Iron Metabolism, and Erythropoiesis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
Systematic review and random-effects meta-analysis of 85 double-masked RCTs (70,543 participants, mean age 62.4 years; median duration 24 weeks) in patients with cardiovascular disease, diabetes, heart failure, or CKD. SGLT2 inhibitors increased hemoglobin by 0.60 g/dL (95% CI 0.55–0.66) and hematocrit by 2.36% versus control, raised erythropoietin (difference 2.11 mIU/mL), and lowered transferrin saturation (−0.84%). Effects were statistically significant but small, with unclear clinical importance.
系統性回顧並以隨機效應模式統合85項雙盲隨機試驗、共70,543名心血管疾病、糖尿病、心衰或慢性腎病患者（平均62.4歲，中位追蹤24週）。相較對照組，SGLT2抑制劑使血紅素增加0.60 g/dL（95% CI 0.55–0.66）、血比容增加2.36%，紅血球生成素上升2.11 mIU/mL，運鐵蛋白飽和度下降0.84%。效應雖顯著但幅度小，臨床意義尚不明確。
Trastuzumab Rezetecan in ERBB2-Low Advanced Breast Cancer: The HORIZON-Breast06 Randomized Clinical Trial
Open-label phase 3 RCT at 73 Chinese hospitals randomized 551 women with ERBB2 (HER2)-low unresectable or metastatic breast cancer (≤1 prior chemotherapy line) to the antibody-drug conjugate trastuzumab rezetecan 6.4 mg/kg every 3 weeks or physician's-choice chemotherapy. Median progression-free survival by blinded central review was 16.4 vs 6.8 months (HR 0.27, 95% CI 0.21–0.34), consistent across hormone-receptor subgroups. Grade ≥3 treatment-related adverse events were 84.1% vs 67.9%, mostly neutropenia.
中國73家醫院開放標籤第三期隨機試驗，納入551名HER2低表現、不可切除或轉移性乳癌女性（先前化療≤1線），比較抗體藥物複合體 trastuzumab rezetecan（6.4 mg/kg，每3週）與醫師選擇化療。盲性中央審查之中位無惡化存活期為16.4 vs 6.8個月（HR 0.27，95% CI 0.21–0.34），各荷爾蒙受體亞組一致。≥3級治療相關不良事件84.1% vs 67.9%，以嗜中性球減少為主。
頂尖期刊
Gastroenterology 近期研究
Tasty and Healthy Diet Reduces Fecal Calprotectin in High-Risk First-Degree Relatives of Patients with Crohn's Disease: PIONIR Randomized Crossover Trial
PIONIR, a randomized crossover trial, enrolled 29 first-degree relatives of Crohn's disease patients with persistently elevated fecal calprotectin (>70 ug/g) but no diagnostic endoscopic lesions, comparing 8 weeks of the Tasty&Healthy diet versus habitual diet. At week 8 median calprotectin was 64 vs 112 ug/g (P=.022); a 50% or greater reduction occurred in 71% vs 27% (RR 2.68). Across both periods calprotectin fell 37% more with the diet, with 83% good adherence, supporting dietary prevention trials.
PIONIR 隨機交叉試驗納入 29 名糞便鈣衛蛋白持續 >70 μg/g 的克隆氏症一等親，比較 Tasty&Healthy 飲食與日常飲食各 8 週。第 8 週鈣衛蛋白中位數 64 vs 112 μg/g，下降 ≥50% 者 71% vs 27%（RR 2.68）；整體額外降低 37%，依從性 83%，支持以飲食預防克隆氏症。
Randomized Sham-Controlled Trial of Translumbosacral Neuromodulation Therapy for Fecal Incontinence
In a multicenter double-blind trial, 109 patients with weekly fecal incontinence were randomized to translumbosacral neuromodulation therapy (TNT, 1 Hz magnetic stimulation at 2400 or 3600 pulses) or sham, weekly for 6 weeks. Responders (50% or greater fewer episodes) were 65.8%, 81.1% and 32.4% respectively (OR 3.91 and 8.53 vs sham). Severity index, nerve conduction latencies and anal squeeze pressures improved with TNT; no serious treatment-related adverse events occurred.
多中心雙盲試驗將 109 名每週大便失禁患者隨機分至 2400 或 3600 脈衝的經腰薦磁刺激神經調節（TNT）或假刺激，每週一次共 6 週。失禁次數減少 ≥50% 的反應率分別為 65.8%、81.1% 與 32.4%（OR 3.91、8.53）；嚴重度指數、神經傳導與肛門收縮壓皆改善，無嚴重不良事件。
Mevalonate Biosynthesis is a Metabolic Vulnerability of Gemcitabine-resistant Pancreatic Cancer
Using acquired gemcitabine-resistant pancreatic ductal adenocarcinoma models and immunocompetent mice, investigators found resistant cells suppress pyrimidine salvage and become selectively dependent on the mevalonate pathway, rendering them highly statin-sensitive. Statins selectively inhibited resistant tumor growth in vivo; geranylgeranyl pyrophosphate depletion, not cholesterol, mediated the effect. HMGCR expression declined with resistance, and low HMGCR predicted poor gemcitabine response in patients, suggesting statins and HMGCR as actionable options.
研究以後天 gemcitabine 抗藥性胰臟癌模型與免疫健全小鼠發現，抗藥細胞抑制嘧啶補救路徑，轉而依賴甲羥戊酸路徑，對 statin 高度敏感；statin 可選擇性抑制抗藥腫瘤生長，機轉為 GGPP 耗竭而非膽固醇。HMGCR 表現隨抗藥性下降，低 HMGCR 預測患者對 gemcitabine 反應不佳。
Chronic Pancreatitis: Mechanisms of Inflammation, Pathways of Progression and Emerging Therapeutic Strategies
This review summarizes chronic pancreatitis as a progressive fibroinflammatory disease following the acinar injury-inflammation-fibrosis model. Diagnosis currently rests on duct dilatation or calcification, reflecting advanced disease, while early-stage detection lacks validated biomarkers and histology access. Current treatment focuses on relieving ductal obstruction endoscopically or surgically. The authors detail inflammatory mechanisms, early-to-late progression pathways, and emerging disease-modifying therapies, advocating patient-tailored approaches that limit inflammation and preserve pancreatic function.
本綜述整理慢性胰臟炎由腺泡損傷、發炎至纖維化的進展模式。目前診斷多依賴胰管擴張或鈣化，代表已屬晚期；早期診斷缺乏有效生物標記。現行治療以內視鏡或手術解除胰管阻塞為主。文中詳述發炎機轉、早晚期進展路徑及新興疾病修飾療法，倡議個別化、抑制發炎並保留胰臟功能的治療。
頂尖期刊
Hepatology 近期研究
A phase 2b/3 trial of saroglitazar in primary biliary cholangitis.
EPICS-III, an adaptive double-blind RCT, tested the dual PPAR alpha/gamma agonist saroglitazar in PBC patients with inadequate UDCA response or intolerance. In phase 3, 148 patients were randomized to saroglitazar 0.97 mg (n=97) or placebo (n=51) for 52 weeks. Biochemical response was 56.7% vs 9.8% (difference 48.0%, p<0.001); ALP normalization 8.2% vs 0%. Serious adverse events were 6.3% vs 11.1%, indicating good tolerability.
EPICS-III 適應性雙盲隨機試驗納入對 UDCA 反應不佳或不耐受的 PBC 病人，第 3 期共 148 人以 2:1 分配 saroglitazar 0.97 mg 或安慰劑 52 週。生化反應率 56.7% 對 9.8%（差異 48.0%，p<0.001），ALP 正常化 8.2% 對 0%，嚴重不良事件 6.3% 對 11.1%，耐受性良好。
Baveno VI criteria validation and development of a new non-invasive strategy for varices rule-out in patients with HCC (SAPHE-R: Stiffness, ALBI, Platelets, HEpatocellular carcinoma Rule).
Using the Italian ITA.LI.CA database, 598 patients with BCLC 0-C HCC and compensated advanced chronic liver disease were analyzed; Baveno VI criteria missed 8.5% of varices and 6.0% of high-risk varices while sparing 31.1% of endoscopies. The new SAPHE-R rule (LSM ≤16 kPa, platelets ≥160x10^9/L, ALBI grade 1) missed only 4.0% of varices (HRV 3.0%), with consistent results in a Vienna validation cohort (n=149, 4.8% missed).
分析義大利 ITA.LI.CA 資料庫 598 位 BCLC 0-C 肝癌合併代償性進展期慢性肝病病人，Baveno VI 準則漏掉 8.5% 靜脈曲張與 6.0% 高風險靜脈曲張，省去 31.1% 內視鏡。新準則 SAPHE-R（肝硬度 ≤16 kPa、血小板 ≥160x10^9/L、ALBI 第 1 級）僅漏 4.0%（高風險 3.0%），維也納驗證組（149 人）漏 4.8%，結果一致。
Trends in the etiologies and outcomes of idiosyncratic drug-induced liver injury in the united states: The DILIN prospective registry, 2004 to 2024.
This 20-year analysis of the US DILIN prospective registry included 1983 high-causality idiosyncratic DILI cases (median age 52, 59% female, 54% hepatocellular injury). Antibiotics remained the leading class (41%), but their share and that of CNS agents declined, while herbal/dietary supplement and antineoplastic (including checkpoint inhibitor) cases rose significantly. Peak bilirubin, INR and severity decreased over time. Oncology patients had 30% 6-month mortality; those with chronic liver disease or age >65 had higher mortality.
美國 DILIN 前瞻性登錄 20 年資料共 1983 例高因果性藥物性肝損傷（中位年齡 52 歲，女性 59%，肝細胞型 54%）。抗生素仍為首位（41%）但比例下降，草藥／膳食補充品與抗腫瘤藥（含免疫檢查點抑制劑）比例顯著上升；膽紅素、INR 與嚴重度隨時間下降。腫瘤病人 6 個月死亡率達 30%，慢性肝病或 >65 歲者死亡率較高。
Phase 1b study of miricorilant in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH).
In this phase 1b study, 70 patients with presumed MASH received the selective glucocorticoid receptor modulator miricorilant daily (30-150 mg) or intermittently (100-200 mg, 1-3 times weekly) for 12-24 weeks. Relative liver fat reductions ranged from 10.1% to 76.6%; adverse events leading to interruption or discontinuation occurred in 12.9% each, mostly aminotransferase rises with rapid fat loss on daily dosing. Intermittent 100 mg twice weekly gave the best benefit-risk (28.2% liver fat reduction at week 12) and advances to phase 2b MONARCH.
第 1b 期研究納入 70 位疑似 MASH 病人，接受選擇性糖皮質素受體調節劑 miricorilant 每日（30–150 mg）或間歇（每週 1–3 次 100–200 mg）給藥 12–24 週。肝臟脂肪相對下降 10.1%–76.6%；因不良事件中斷或停藥各佔 12.9%，多為每日給藥時脂肪急降伴轉胺酶上升。每週兩次 100 mg 效益風險最佳，第 12 週肝脂肪降 28.2%，已進入第 2b 期 MONARCH 試驗。
主題專區
糖尿病・代謝 近期研究
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Acmopatide (CT-868), a Fully Biased GLP-1/GIP Receptor Agonist, in Adults With Type 1 Diabetes and Overweight or Obesity.
In this 16-week phase 2 RCT, 111 adults with type 1 diabetes and BMI ≥27 (mean HbA1c 7.5%, BMI 34.3) were randomized to once-daily acmopatide 1.8, 4.1 or 6.6 mg or placebo. HbA1c fell 0.4-0.6% vs 0.3% (4.1 mg: placebo-adjusted -0.3%, P=0.020); body weight fell 3.3-6.7% vs +0.3%; insulin dose and systolic BP also decreased. Adverse events were mainly gastrointestinal, with no DKA or severe hypoglycemia.
16 週第 2 期試驗納入 111 位 BMI ≥27 之第 1 型糖尿病成人，隨機接受每日 acmopatide 1.8、4.1、6.6 mg 或安慰劑。HbA1c 下降 0.4–0.6%（安慰劑 0.3%），體重減少 3.3–6.7%（安慰劑 +0.3%），胰島素劑量與收縮壓同步下降；主要副作用為腸胃道症狀，無 DKA 或嚴重低血糖。
Target Trial of Semaglutide Versus Dulaglutide or Liraglutide in Patients Receiving Hemodialysis.
Using 2011-2022 USRDS/Medicare data, this target-trial emulation compared 1,312 semaglutide with 2,601 dulaglutide/liraglutide users with diabetes on maintenance hemodialysis (overlap-weighted n=3,200; median follow-up 1.1 years). Semaglutide was associated with lower mortality on dialysis (sHR 0.82, 95% CI 0.70-0.97; 1-year 11% vs 13%), fewer hospitalizations (sHR 0.91) and greater 1-year weight loss (-4.8% vs -3.4%). Benefit was significant versus dulaglutide but not liraglutide.
以 2011–2022 年美國 USRDS/Medicare 資料模擬目標試驗，比較 1,312 位 semaglutide 與 2,601 位 dulaglutide/liraglutide 血液透析糖尿病患者。Semaglutide 透析中死亡風險較低（sHR 0.82，1 年 11% vs 13%），住院 sHR 0.91，1 年減重 4.8% vs 3.4%；相對 dulaglutide 優勢顯著，對 liraglutide 則無差異。
Prediabetes and diabetes as drivers of fibrosis in MASLD: roles of obesity, adipose tissue dysfunction and insulin resistance.
In this prospective real-world study of 1,446 adults from primary care and endocrinology clinics, transient elastography (CAP ≥274 dB/m; LSM ≥8.2 kPa) with MRI or biopsy confirmation showed MASLD prevalence rising from 39% (normoglycemia) to 55% (prediabetes) and 68% (type 2 diabetes), and significant fibrosis from 1% to 6% and 12%. Fibrosis was rare without obesity; obesity plus type 2 diabetes with marked insulin resistance (Adipo-IR, HOMA-IR) carried the highest prevalence (16%).
前瞻性真實世界研究納入 1,446 位基層與內分泌門診成人，以瞬時彈性影像（CAP ≥274、LSM ≥8.2 kPa）評估。MASLD 盛行率由正常血糖 39% 升至糖尿病前期 55%、第 2 型糖尿病 68%；顯著纖維化分別為 1%、6%、12%。無肥胖者纖維化罕見，肥胖合併糖尿病且胰島素阻抗嚴重者最高（16%），建議以 HOMA-IR 強化風險分層。
主題專區
慢性腎臟病（CKD） 近期研究
Long-term efficacy and safety for the complement factor B inhibitor iptacopan in IgA nephropathy.
Open-label rollover extension of the phase 3 APPLAUSE-IgAN trial: 194 iptacopan-arm and 174 placebo-arm patients continued oral iptacopan 200 mg twice daily. Over up to 48 months, total annualized eGFR slope was -3.49 mL/min/1.73 m2/yr with sustained UPCR reduction (geometric mean ratio 0.61). Placebo patients switching to iptacopan improved eGFR slope from -5.29 to -2.11 mL/min/1.73 m2/yr. Safety up to 5 years showed no new signals.
APPLAUSE-IgAN 第三期試驗之開放標籤延伸研究，納入 194 位 iptacopan 組與 174 位安慰劑組患者。持續服用 iptacopan 200 mg 每日兩次達 48 個月，eGFR 年下降率為 -3.49 mL/min/1.73 m²，蛋白尿持續降低（UPCR 比值 0.61）；安慰劑組轉用後 eGFR 斜率由 -5.29 改善至 -2.11。五年安全性無新訊號。
Empagliflozin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Randomized Controlled Trial.
Pilot RCT randomizing 50 adults (age 18-55, mean eGFR 70) with rapidly progressive ADPKD, not on tolvaptan, to empagliflozin 25 mg daily or placebo for 12 months. Adverse events were similar and 96% tolerated full dose. However, height-adjusted total kidney volume grew faster with empagliflozin (10.5%/yr vs 5.1%/yr, P=0.001). An expected acute eGFR dip (-6.2 vs 0.1) was followed by stable eGFR; chronic slope did not differ.
先導型隨機對照試驗，將 50 位高進展風險、未用 tolvaptan 之 ADPKD 成人（平均 eGFR 70）隨機分配至 empagliflozin 25 mg 或安慰劑 12 個月。不良事件相近、96% 耐受全劑量；但 empagliflozin 組總腎體積增長較快（每年 10.5% vs 5.1%，P=0.001）。eGFR 初期下降 -6.2 後趨於穩定，慢性斜率無差異。
Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: Two Randomized Clinical Trials.
PATH-1 and PATH-2, identical phase 3 double-blind RCTs, randomized 768 hemodialysis patients with secondary hyperparathyroidism (iPTH 400-1500 pg/mL) to intravenous upacicalcet (n=510) or placebo (n=258) for 27 weeks. A >=30% iPTH reduction was achieved in 42.1% vs 16.8% (PATH-1) and 43.5% vs 17.4% (PATH-2), both P<0.001. Serious adverse events and gastrointestinal symptoms were similar; asymptomatic hypocalcemia (<7.5 mg/dL) was more frequent (31-45% vs 12-19%).
PATH-1 與 PATH-2 兩項第三期雙盲試驗，將 768 位續發性副甲狀腺機能亢進（iPTH 400–1500 pg/mL）之血液透析患者隨機分配至靜脈注射 upacicalcet（510 人）或安慰劑（258 人）27 週。iPTH 下降 ≥30% 達成率分別為 42.1% vs 16.8% 與 43.5% vs 17.4%（均 P<0.001）。嚴重不良事件與腸胃症狀相近，無症狀低血鈣較常見（31–45% vs 12–19%）。
歷史紀錄