洛杉磯兒童醫院暫停使用Sarepta基因療法Elevidys治療所有肌肉萎縮症患者
根據美國食品藥品監督管理局（FDA）最新行動，洛杉磯兒童醫院於本週一宣布，暫停對所有肌肉萎縮症患者使用Sarepta Therapeutics的基因療法Elevidys。
FDA於上週五要求Sarepta自願停止運送該基因療法，此前一名接受不同實驗性治療的肌肉萎縮症患者死亡。儘管如此，Sarepta公司表示不會遵從此要求，將繼續向仍能行走的患者提供該療法。
今年六月，Sarepta曾暫停對病情已惡化至需使用輪椅患者使用Elevidys，因為有兩名青少年患者接受治療後出現肝功能衰竭而死亡。
Elevidys已獲FDA完全批准用於仍能行走的杜氏肌肉萎縮症（Duchenne Muscular Dystrophy）兒童，但對於無法行走的患者則僅獲得有條件批准。
洛杉磯兒童醫院表示，自7月18日起暫停使用Elevidys，並已通知受影響患者家庭，目前正等待FDA進一步指示。
該醫院是超過70家獲授權使用Elevidys的機構之一。路透社向另外五間主要兒童醫院查詢是否會繼續使用該療法，均未獲即時回應。
Sarepta股價今年以來已下跌約90%，週一收市報13.32美元，跌幅5%。
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編輯評論：基因療法的光明與陰影
這宗事件揭示了基因療法在臨床應用中面對的重大挑戰。Elevidys作為針對杜氏肌肉萎縮症的創新療法，理論上能改變患者命運，尤其是對仍能行走的兒童帶來希望。然而，連串肝功能衰竭甚至死亡病例，提醒我們科技進步與患者安全之間的微妙平衡。
FDA的介入和洛杉磯兒童醫院的迅速反應，顯示監管機制在保護患者安全上的重要作用。Sarepta堅持繼續提供療法，則反映出藥企在商業利益與患者安全間的掙扎與矛盾。
對香港乃至全球的醫療界，這是一個警示，提醒我們基因療法雖然前景光明，但安全性監控不可鬆懈。家長和患者在接受新療法時，應充分了解潛在風險與收益，醫生也需保持高度警覺，及時評估療效與副作用。
未來，若能加強基因療法的臨床數據透明度及跨國監管合作，或許能更有效保障患者權益，同時推動療法的安全發展。這亦是香港醫療界可以借鏡的地方，特別是在推動新興醫療技術落地的過程中，如何平衡創新與風險，是一大考驗。
以上文章由特價GPT API KEY所翻譯及撰寫。
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Gallery
![{
"intro": "Create an ultra realistic 8K UHD DSLR photo based on the attached image as a reference of facial features, maintaining 100% likeness.",
"subject": {
"identity": "A stylish beautiful woman portrayed as Cleopatra during her sacred milk bath beauty ritual, embodying divine femininity, sensual elegance, and timeless power.",
"angle": "Close-up beauty editorial captured at a refined 3/4 angle, focusing on her face, shoulders, and upper chest with extreme clarity and no blur.",
"pose": {
"body_position": "She is partially submerged in a luxurious milk bath, her shoulders and collarbones emerging gracefully from the surface.",
"hands": "One hand gently rests at the edge of the bath with milk droplets on her fingers, while the other lightly touches her neck adorned with subtle gold jewelry.",
"expression": "Soft yet commanding gaze directed toward the camera—calm, confident, intimate, and hypnotic."
}
},
"appearance": {
"outfit": "A barely-there, ritual-style ivory silk drape partially submerged in the milk bath, clinging softly to her skin. The fabric is delicate and translucent, edged with fine gold-thread embroidery for a sensual, sacred aesthetic.",
"accessories": "Minimal ritual jewelry—thin gold collar necklace resting above the milk surface, delicate arm cuff, subtle finger ring—kept refined to maintain focus on beauty and skin.",
"hair": "Her hair is sleek and ritual-polished, partially damp and slicked back at the crown, with soft wet strands framing her face naturally, reflecting candlelight.",
"makeup": "High-fashion Cleopatra beauty makeup with ceremonial artistry—perfectly sculpted brows, elongated black kohl eyeliner, vibrant eyeshadow layered in turquoise, teal, emerald, sapphire blue, and metallic gold. Beneath the eyes, subtle artistic ink-inspired accents echo ancient Egyptian symbolism. Her skin is luminous and dewy, cheeks softly flushed, and lips finished in a nude-rose satin sheen."
},
"ritual_props": {
"bath": "A carved alabaster bathtub filled with warm milk infused with honey, almond oil, and lotus essence.",
"floating_elements": [
"Fresh lotus flowers",
"Soft white rose petals",
"Delicate gold flakes shimmering on the milk surface"
],
"beauty_products": [
"Small golden perfume vial with lotus and myrrh oil",
"Alabaster bowl of honey and milk mixture",
"Clay jar of mineral kohl and pigment powders"
]
},
"background": {
"macro_environment": "An intimate royal bathing chamber within Cleopatra’s palace, designed as a sacred beauty sanctuary.",
"midground_details": "Soft linen curtains, glowing oil lamps, tall candles, and subtle steam rising from the bath, creating a warm and sensual atmosphere.",
"micro_elements": "Milk ripples around her skin, floating petals touching her shoulders, tiny droplets of moisture on her collarbones, reflections of candle flames on gold jewelry, visible stone texture on the tub, and delicate fabric translucency—every detail sharply rendered with zero blur."
},
"lighting": {
"type": "Warm cinematic candlelight combined with soft ambient palace glow.",
"effect": "Golden highlights sculpt her face and skin while gentle shadows enhance depth, intimacy, and divine beauty."
},
"camera": {
"camera_type": "DSLR",
"resolution": "8K UHD",
"lens": "85mm prime lens for beauty editorial compression",
"aperture": "f/8 for maximum facial and detail sharpness",
"iso": 100,
"shutter_speed": "1/160s",
"focus": "Extreme sharp focus on facial features, skin texture, makeup details, and milk surface, no bokeh, no blur"
},
"style": "Luxury beauty editorial, sacred milk bath ritual, ancient Egyptian goddess realism, intimate yet powerful, ultra-detailed, luminous skin focus, cinematic elegance"
}](https://ssfuture.shop/wp-content/uploads/ai_gen_1766006026-300x167.png)
Gallery
![[Subject]: Young Asian female with "Imada Mio-inspired" doll-like aesthetic (精緻洋娃娃臉). She has large round expressive eyes, a small V-line face, and rosy cheeks. Her expression is innocent, energetic, and slightly flirty. [Hair]: Messy morning hair (剛睡醒的凌亂感), long dark brown hair, slightly tousled, natural volume. [Outfit]: Wearing an oversized translucent white button-down shirt (男友風白襯衫), unbuttoned at the top to reveal collarbones, creating a "bottomless" look (下衣失蹤風格). [Style]: Japanese Gravure Photobook style (寫真集風格), Pure & Sexy vibe, bright high-key lighting, soft skin texture, Fujifilm PRO 400H color tone.](https://ssfuture.shop/wp-content/uploads/ai_gen_1764969341-300x167.png)
