2026年9月18日 星期五

抗體藥物複合體(ADC)毒性

 

抗體藥物複合體(ADC)毒性:急診臨床重點

來源:Markides DM, Hita AG, Merlin J, Reyes-Gibby C, Yeung SJ. Antibody-Drug Conjugates: The Toxicities and Adverse Effects That Emergency Physicians Must Know. Ann Emerg Med. 2025;85(3):214-229. doi:10.1016/j.annemergmed.2024.10.015

一、為什麼急診醫師需要認識這類藥

ADC 是「單株抗體+連接子+細胞毒藥物」的三段式標靶化療。抗體負責導航,藥物進入癌細胞後才被釋放。這個設計讓副作用比傳統化療輕,但並沒有消失,只是換了分布方式:有些來自抗體本身,有些來自細胞毒藥物外漏,還有一些機轉不明。

對急診真正的問題是,這類藥的核准數量與使用人數都在快速增加,而多數 ADC 的真實世界不良反應發生率仍然未知,原始文獻承認目前沒有研究評估過這些病人到急診的盛行率。我們會愈來愈常遇到,但沒有流行病學基準可用。

骨髓抑制、噁心嘔吐、腹瀉、周邊神經病變、皮疹這些常見副作用依標準處置即可。急診的加值在於辨認會偽裝成常見疾病、以及罕見但延遲辨認就致命的那一群。

實務上最重要的第一步不是檢查,而是病史:用的是哪一支 ADC,最後一劑什麼時候打的。缺了這兩個資訊,後面所有的鑑別診斷都會失焦。

二、六個必須認得的致命併發症

間質性肺病與肺炎

這是 ADC 相關死亡的首要原因。Trastuzumab deruxtecan(T-DxD)的肺炎發生率為 13.58%,grade ≥3 佔 2.19%;mirvetuximab soravtansine 約 10%,grade ≥3 為 1%;brentuximab vedotin 的上市後監測顯示間質性肺病總發生率 3.9%、grade ≥3 為 3.2%。Enfortumab vedotin 在一份南韓參與者的回溯分析中有 28% 出現肺炎,6.3% 為 grade ≥3。T-DM1 與 tisotumab vedotin 低於 2%,但仍有致死案例。

症狀完全非特異:乾咳、活動時喘、疲倦、胸痛、發燒,聽診可能只有喘鳴或囉音,也沒有任何高特異性的實驗室檢查。關鍵在影像:胸部 X 光敏感度不足,只要把間質性肺病放進鑑別診斷,就應該做高解析度電腦斷層,典型表現是廣泛斑塊狀實質化,可能合併小葉間網狀陰影與間隔增厚。

處置分兩軸。感染這一軸,因為與感染性肺炎在急診幾乎無法區分,可先經驗性抗生素,但不要因為在等病原學而延遲類固醇。發炎這一軸依 CTCAE 分級:grade 1 通知腫瘤科即可;grade 2 口服相當於 prednisone 1 至 2 mg/kg/day,可離院;grade 3 給氧、住院、prednisolone 1 mg/kg/day;grade 4 比照呼吸衰竭處理,methylprednisolone 2 mg/kg/day 或脈衝 500 至 1000 mg/day 連續三天。48 至 72 小時無改善可加 infliximab、tocilizumab、mycophenolate mofetil 或免疫球蛋白。及早會診胸腔科,因為多半需要支氣管鏡與肺泡灌洗。

肝竇阻塞症候群

舊稱肝靜脈阻塞疾病,主要見於 gemtuzumab ozogamicin(第三期試驗中 4.6%)與 inotuzumab ozogamicin(約 13%)。機轉是肝竇內皮細胞受損造成腫脹與微血管血栓,阻塞肝竇層面的血流。

最早出現的症狀是快速的體重增加,在急診很容易被當成無關的主訴帶過。之後才是水腫、腹水、黃疸與肝腫大壓痛,嚴重者進展到肋膜積液、低血氧、腦病變與腎衰竭。實驗室看膽紅素與轉胺酶上升,可合併血小板低下;超音波可見腹水、肝腫大、肝靜脈血流減弱或反轉。嚴重度分級可參考歐洲骨髓移植學會標準,以症狀出現時間、膽紅素、轉胺酶、體重增加幅度與腎功能五個面向評估。

急診處置不必等到確診:輸液與電解質調整先做,體液過載以 furosemide 或 spironolactone 輕度利尿,腹水造成呼吸窘迫時可抽取,但一次不超過 1 公升以保護腎臟。體液無法控制則考慮血液透析或過濾。唯一有實證的藥物是 defibrotide,6.25 mg/kg 每六小時一次,嚴重者立即開始,輕中度若支持治療兩天內未改善也可使用,療程 21 天。

高血糖與糖尿病酮酸中毒

Enfortumab vedotin 有 4% 至 6% 的病人出現嚴重高血糖。在核准依據的試驗中有三例糖尿病酮酸中毒,其中一例死亡,而且其中兩例沒有糖尿病病史。Polatuzumab vedotin 與 brentuximab vedotin 也有高血糖與酮酸中毒的報告。這類病人主訴口渴、多尿、倦怠時,驗血糖與酮體的門檻應該放低。處置與其他酮酸中毒沒有差異,重點在於想到。

腫瘤溶解症候群

Gemtuzumab ozogamicin、polatuzumab vedotin 與 brentuximab vedotin 的仿單都帶有警示。Gemtuzumab 的三個第二期試驗中有四例含一例死亡,brentuximab 的一項第二期研究發生率 1.7%。本文特別提到一個理論風險:ADC 的高效率標靶遞送反而可能提高腫瘤溶解的機會,仍待上市後研究釐清。

出血

Tisotumab vedotin 的第二期試驗中 39% 有治療相關出血,第三期試驗鼻出血 26%、陰道出血 10%;T-DM1 的鼻出血率 17% 至 31%,嚴重出血 0.4% 至 4%,已有數例顱內出血或血腫擴大的報告,特別是曾接受腦轉移放射治療者。Gemtuzumab 與 inotuzumab 則透過血小板低下造成出血,前者 7% 至 21% 有 grade ≥3 出血含顱內出血,後者 33% 至 42% 有血小板低下相關出血。

輸注相關反應

多數發生在輸注後 30 至 120 分鐘內,但嚴重或延遲的反應可超過 24 小時才發生,也就是會直接到急診。Brentuximab 合併 bendamustine 的試驗中,43.6% 出現超過 24 小時的延遲反應,表現為發燒、廣泛性斑丘疹、畏寒、噁心與搔癢,12.7% 為 grade 3。臨床上與真正的過敏反應無法區分,治療也完全相同。

三、其他值得放在鑑別診斷裡的

眼部症狀常見卻容易被低估。Mirvetuximab 的視力模糊與乾眼達 41% 至 57%、角膜病變 32% 至 34%;tisotumab 的結膜炎 26% 至 31%、角膜炎 11% 至 15.6%。角膜炎以局部類固醇處理並轉介眼科;懷疑葡萄膜炎需局部甚至全身類固醇與緊急眼科會診。只要懷疑是 ADC 造成的眼部問題就該通知腫瘤科,因為可能需要延遲或減量。

肝功能異常的門檻值得記下來:轉胺酶超過正常上限 20 倍,或任何程度上升合併黃疸,需加速檢查並會診腫瘤科與肝膽科;5 至 15 倍、無症狀且無黃疸者可門診追蹤,但仍應在數日內回診評估是否調整劑量。

進行性多發性白質腦病與 brentuximab 及 polatuzumab 有關,發生率低於 0.1% 但常致命,表現為語言、運動、認知、視覺或步態功能在數週至數月內進行性惡化。磁振造影遠優於電腦斷層,病灶在 T2 與 FLAIR 呈高訊號、T1 低訊號且無明顯水腫,腦脊髓液 JC 病毒 PCR 有助診斷。目前無有效治療。

積液與周邊水腫:loncastuximab tesirine 造成周邊水腫 20%、肋膜積液 10%、心包積液 3%。這支藥的病人喘,要想到找積液而不只是找肺炎。

胃腸道毒性是最常造成急診就醫的原因,多支 ADC 的腹瀉發生率超過 20%,sacituzumab govitecan 有 10% 為 grade ≥3。因為常合併高比例嘔吐,這些病人需要的是積極靜脈輸液與電解質補充,不只是止吐。分級處置為 grade 1 口服補水加 loperamide,grade 2 加靜脈輸液並考慮 octreotide,grade 3 以上住院並矯正電解質。此外 brentuximab 與胰臟炎有明確關聯且已有死亡報告,處置與一般胰臟炎相同,可加驗空腹三酸甘油酯。

皮膚:皮疹超過 10% 但多半輕微。Enfortumab、tisotumab 與 brentuximab 都有史蒂芬強生症候群與毒性表皮壞死溶解的案例報告,真實發生率不明,治療與一般情況無異。

心臟毒性罕見。T-DxD 的統合分析顯示左心室射出分率下降 1.95%、QTc 延長 7.7%,grade 3 以上不到 1%;T-DM1 的 1961 人分析中心臟事件為 3.37%。目前沒有 ADC 專屬的治療建議。

四、帶回臨床的操作原則

第一,問藥名與最後一劑時間,這決定了整個鑑別診斷的形狀。

第二,把「常見主訴」的懷疑指數往上調。呼吸症狀在 T-DxD 或 mirvetuximab 病人身上要想間質性肺病並直接做電腦斷層;喘在 loncastuximab 病人身上要找積液;體重增加或腹水在 gemtuzumab 或 inotuzumab 病人身上要想肝竇阻塞症候群;口渴多尿在 enfortumab 病人身上要驗血糖與酮體。

第三,每一例都通知腫瘤科主治。劑量延遲、減量或停藥的決定都需要原治療團隊介入,而急診的辨認往往是這條決策鏈的起點。

2011年7月1日 星期五

細菌性腸炎

Invasive Bacterial Enteropathies

How do patients with invasive enteropathies present?
Patients with acute invasive enteropathies typically present with fever and frequent bowel movements that contain mucus or blood or both; the mucus or blood often contains leukocytes.

What are the causes of invasive bacterial enteropathies?
Causes of invasive bacterial enteropathies in adults include campylobacteriosis, salmonellosis, shigellosis, enteroinvasive Escherichia coli, and yersiniosis, among others. Vibrio parahaemolyticus, which is most commonly reported in Asia, can cause either bloody or watery diarrhea and is usually associated with the ingestion of seafood.

When is microbiologic evaluation of stool indicated?
Microbiologic evaluation of stool is not usually indicated for most travelers with acute watery diarrhea, such as this patient, since the illness is usually self-resolving or can be treated empirically with hydration, agents that control symptoms, or antimicrobial agents. In contrast, microbiologic evaluation of stool is usually indicated for patients with evidence of an invasive enteropathy, those with persistent diarrhea, and those whose illness is part of an outbreak that has potential public health importance and has an uncertain cause.

What is the recommended treatment for travelers’ diarrhea?
Azithromycin is an agent of choice for the treatment of persons with cholera and those with travelers’ diarrhea. Many strains of campylobacter are now resistant to fluoroquinolones, and the Haitian strain of cholera has reduced susceptibility to ciprofloxacin, a pattern associated with clinical and microbiologic failure in cholera patients.

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NEJM Teaching Topics
June 30, 2011

2011年5月27日 星期五

急診留觀可減少小兒頭部外傷病患做斷層掃描

Emergency Department Observation of Children with Minor Head Injury Reduces Use of Computed Tomography
But does not impair identification of clinically important traumatic brain injuries

In a secondary analysis of data from the Pediatric Emergency Care Applied Research Network, researchers evaluated whether observing children (age, less than 18 years) with minor head injury before deciding whether to obtain a head computed tomography (CT) scan affects use of CT and diagnosis of traumatic brain injury (TBI). Data on duration of observation were not collected.

Of 40,113 patients (median age, 5.6 years), 5433 (14%) were observed. Observed patients were significantly less likely to undergo CT than patients who were not observed (31% vs. 35%). After adjustment for clinical covariates, the likelihood of CT scanning remained lower for patients who were observed (adjusted odds ratio, 0.53). Rates of clinically important TBI (defined as intracranial injury resulting in death, neurosurgical intervention, intubation for more than 24 hours, or hospital admission for 2 or more nights) were similar between groups (0.75% and 0.87%, respectively).

The authors conclude that observing intermediate-risk patients would result in approximately 39 fewer CT scans per 1000 children who present to the emergency department with blunt head trauma; intermediate-risk children were defined as those with normal mental status and no evidence of skull fracture and at least one of the following: loss of consciousness, severe mechanism of injury, vomiting, not acting normally per parents (children less than 2 years), or severe headache (children above 2 years).

Comment: The lack of data on duration of observation makes practical application of these findings difficult. However, neurologically normal children with a history of loss of consciousness, transient vomiting, or headache can be observed before deciding about CT. Children with persistent symptoms or any sign of clinical deterioration should undergo immediate CT.


Katherine Bakes, MD
Published in Journal Watch Emergency Medicine May 27, 2011

Citation(s): Nigrovic LE et al. The effect of observation on cranial computed tomography utilization for children after blunt head trauma. Pediatrics 2011 Jun; 127:1067.

2011年5月20日 星期五

視神經超音波可以評估腦壓

Optic Nerve Ultrasound Predicts Elevated Intracranial Pressure
In a small meta-analysis, ultrasound measurement of optic nerve sheath diameter had a sensitivity of 90% for predicting elevated ICP.

Bedside emergency department ocular ultrasound is increasingly used to detect retinal detachment, but does it also have other uses? Researchers performed a meta-analysis of six prospective studies (231 patients) in which researchers compared intracranial pressure (ICP) monitoring and ultrasound measurement of optic nerve sheath diameter (ONSD) in consecutive adult patients with suspected elevated ICP. ONSD was measured 3 mm behind the globe; ICP and ONSD measurements were performed within 1 hour of each other.

The pooled sensitivity for ONSD detection of elevated ICP was 90% and the pooled specificity was 85%. The pooled diagnostic odds ratio was 51, meaning that patients with elevated ICP were 51 times more likely to have a positive ONSD test than those without elevated ICP.

Comment: With a 90% sensitivity for ruling out elevated intracranial pressure, bedside ultrasound measurement of optic nerve sheath diameter shows promise as a new tool to guide decision making, including prioritizing patients for diagnostic studies and determining whether computed tomography is needed before an unstable polytrauma patient is taken to the operating room.


Kristi L. Koenig, MD, FACEP
Published in Journal Watch Emergency Medicine May 20, 2011

Citation(s): Dubourg J et al. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: A systematic review and meta-analysis. Intensive Care Med 2011 Apr 20; [e-pub ahead of print]. (http://dx.doi.org/10.1007/s00134-011-2224-2)

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【實際做法】
http://emj.bmj.com/content/26/9/630.full.pdf

2011年5月6日 星期五

外傷急救新觀念:術中血壓不必keep太高!

Hypotensive Resuscitation in Trauma Patients Lessens Transfusion Needs
Also reduces incidence of postoperative coagulopathy and associated death.



The authors report an interim analysis of the first prospective randomized trial of intraoperative hypotensive resuscitation in patients. At a single level I trauma center, 90 patients with at least one episode of in-hospital systolic blood pressure ≤90 mm Hg who were undergoing laparotomy or thoracotomy for blunt (6 patients) or penetrating (84) trauma were randomized at entry to the operating room to have their mean arterial pressure (MAP) maintained at a target minimum of 50 mm Hg (low MAP) or 65 mm Hg (high MAP). Methods of achieving target levels were at the discretion of the anesthesiologist. MAPs that rose above the target were not lowered.

The low-MAP group received a significantly smaller amount of blood products (packed red blood cells, fresh frozen plasma, platelets) than the high-MAP group (1594 mL vs. 2898 mL) and had significantly lower mortality within 24 hours of admission to the intensive care unit (2.3% vs. 17.4%) and significantly lower mortality due to coagulopathy-associated postoperative hemorrhage (0 of 6 vs. 7 of 10). Mortality at 30 days did not differ significantly between the two groups (23% and 28%, respectively).

Comment: This interim analysis suggests that maintaining a low MAP during intraoperative resuscitation in seriously ill trauma patients is safe, reduces use of blood products, and decreases the incidence of postoperative coagulopathy and the related consequence of death. If these promising findings hold in the final analysis, similar approaches should be undertaken in the field and the emergency department.


John A. Marx, MD, FAAEM
Published in Journal Watch Emergency Medicine May 6, 2011

Citation(s): Morrison CA et al. Hypotensive resuscitation strategy reduces transfusion requirements and severe postoperative coagulopathy in trauma patients with hemorrhagic shock: Preliminary results of a randomized controlled trial. J Trauma 2011 Mar; 70:652.

2011年4月22日 星期五

治敗血症休克用Levophed比Dopamine好

Norepinephrine Outperforms Dopamine in Adults with Septic Shock
Use of norepinephrine was associated with a 9% reduction in mortality compared with dopamine.

According to the Surviving Sepsis Campaign guidelines, norepinephrine or its precursor, dopamine, are both recommended as first-line treatments to improve organ perfusion in patients with septic shock. To determine which vasopressor is better, researchers conducted a meta-analysis of six randomized trials that compared the two agents in patients with septic shock and that reported in-hospital or 28-day mortality.

The trials included a total of 995 patients randomized to norepinephrine and 1048 randomized to dopamine. Overall, mortality was significantly lower in the norepinephrine group than in the dopamine group (48% vs. 53%). Arrhythmias were significantly less common with norepinephrine than with dopamine (relative risk, 0.43).

Comment: This study suggests that norepinephrine is superior to dopamine for adult patients with refractory septic shock. The finding that dopamine is associated with more arrhythmias might explain the higher mortality, as arrhythmias can impair cardiac function, thereby leading to worse outcomes.


Kristi L. Koenig, MD, FACEP
Published in Journal Watch Emergency Medicine April 22, 2011

Citation(s): Vasu TS et al. Norepinephrine or dopamine for septic shock: A systematic review of randomized clinical trials. J Intensive Care Med 2011 Mar 24; [e-pub ahead of print].
http://dx.doi.org/10.1177/0885066610396312

2011年4月8日 星期五

Midazolam plus Ketamine

Adding Midazolam to Ketamine for Procedural Sedation Reduces Emergence Reactions in Adults
Coadministration significantly reduced incidence of emergence reactions, and route of ketamine administration had no effect on incidence of adverse events.

Ketamine is associated with untoward emergence reactions after procedural sedation, including nightmares and hallucinations. Coadministration of midazolam to mitigate this reaction is ineffective in children. Researchers assessed the effect of midazolam on incidence of ketamine emergence reactions and the effect of route of ketamine administration on incidence of adverse events in adult patients undergoing procedural sedation. In a prospective, double-blind, placebo-controlled study, 182 patients (age range, 18–50) at an academic emergency department in Turkey were randomized to receive ketamine either intravenously (1.5 mg/kg) or intramuscularly (4.0 mg/kg), either with or without intravenous midazolam (0.03 mg/kg).
Recovery agitation occurred significantly less frequently when midazolam was coadministered with ketamine (8% vs. 25%). Incidence of adverse events (recovery agitation, respiratory events, nausea and vomiting) was similar with the two routes of ketamine administration; no patient had respiratory compromise.

Comment: Coadministration of midazolam with ketamine in adults seems to mitigate emergence reactions with no significant downside.

Richard D. Zane, MD, FAAEM
Published in Journal Watch Emergency Medicine April 8, 2011

CITATION(S): Sener S et al. Ketamine with and without midazolam for emergency department sedation in adults: A randomized controlled trial. Ann Emerg Med 2011 Feb; 57:109.e2.