葡萄球菌噬菌體裂解物
Staphylococcal Phage Lysate
Staphylococcal Phage Lysate (prepared by lysing cultures of Staphylococcus aureus Cowan serologic types I & III by a staphylococcal bacteriophage)
別名: Staphage Lysate · SPL Immune Stimulant
由 VetSheet 獸醫團隊審訂更新於 2026年4月5日本內容以實證獸醫文獻為本
劑量為持牌獸醫專業人員的臨床參考。請務必對照最新藥品說明書及個別病患確認。
各物種劑量
🌎 NA — North America🌍 EU — Europe
狗
| 適應症 | 劑量 | 途徑 | 頻次 | 療程 | 地區 |
|---|---|---|---|---|---|
| Labeled indications (Highly allergic patients) | Skin test with 0.05-0.1 mL intradermally. Therapy: Initially, 0.2 mL SC, then incremental increases of 0.2 mL once a week to 1 mL (a total of 5 injections). Then continue at 1 mL SC weekly for approximately 10-12 weeks. | SC/ID | Weekly | 10-12 weeks | 🌎 NA |
| Labeled indications (Non-allergic patients) | 0.5 mL SC twice weekly for 10-12 weeks, then 0.5-1 mL every 1-2 weeks. | SC | Twice weekly then every 1-2 weeks | 10-12 weeks initial, then maintenance | 🌎 NA |
| Idiopathic, recurrent pyoderma | 0.5 mL SC twice weekly for 10-12 weeks, then tapered to effect. | SC | Twice weekly | 10-12 weeks then tapered | 🌎 NA |
| Chronic recurrent idiopathic pyoderma | Injections are administered twice weekly (0.5 mL) and slowly reduced to 0.5 mL every 2 weeks. | SC | Twice weekly then reduced | Ongoing | 🌎 NA |
- Labeled indications (Highly allergic patients): Concomitant antibiotic therapy is recommended for an initial 4-6 week period. Maximum dose should be decreased in small dogs and can be increased cautiously, if necessary, in large dogs to 1.5 mL.
- Labeled indications (Non-allergic patients): Concomitant antibiotic therapy is recommended for an initial 4-6 week period.
- Idiopathic, recurrent pyoderma: This agent is rarely needed, because in most cases, an underlying cause can be identified and treated.
- Chronic recurrent idiopathic pyoderma: Pyoderma needs to be under control as this product is not a substitute for antibiotics.
劑量為持牌獸醫專業人員的臨床參考。請務必對照最新藥品說明書及個別病患確認。
概覽
葡萄球菌噬菌體裂解物 (SPL) 是一種主要用於獸醫皮膚科的注射型生物製劑與免疫刺激劑。它特別適用於治療犬隻反覆發作的特發性葡萄球菌膿皮症，通常會與適當的抗生素療法合併使用。
臨床重點： 在抗生素抗藥性（例如 MRSP - 耐甲氧西林假中間葡萄球菌）日益增加的時代，像 SPL 這樣的免疫調節劑提供了一種有價值的輔助治療方式，有助於減少全身性抗生素使用的頻率與療程時間。
本產品是利用葡萄球菌噬菌體裂解金黃色葡萄球菌 (Cowan 血清型 I & III；人類菌株) 培養物製成。製備的溶液含有金黃色葡萄球菌成分（A 蛋白萃取物）、噬菌體以及未過濾的牛心浸液肉湯，並經過超濾以達到細菌學上的無菌狀態。
作用機制
SPL functions as an immunomodulator that specifically enhances cell-mediated immunity (Th1 immune response).
- Cytokine Stimulation: It stimulates the production of key pro-inflammatory and immunoregulatory cytokines, including Tumor Necrosis Factor (TNF-α), Interleukin-6 (IL-6), and Interferon-gamma (IFN-γ).
- Mechanism: By upregulating IFN-γ and TNF-α, SPL enhances the phagocytic and bactericidal activities of macrophages and neutrophils → leading to improved clearance of intracellular and extracellular staphylococcal organisms from the skin.
- Protein A Role: The presence of staphylococcal Protein A acts as a potent B-cell superantigen and immunogen, further stimulating a robust host immune response against staphylococcal antigens.
安全性與警告
禁忌症
- Prior systemic hypersensitivity reactions to SPL
- Documented hypersensitivity reactions to beef products (contains unfiltered beef heart infusion broth)
不良反應
- Post vaccine-type reactions (fever, malaise)
- Injection site reactions (redness, itching, swelling occurring 2-3 hours post-injection and persisting up to 3 days)
- Systemic hypersensitivity reactions (weakness, vomiting, diarrhea, severe itching, rapid breathing, fatigue/lassitude)
注意事項
Hypersensitivity Risk: Use with extreme caution (if at all) in patients with a history of systemic hypersensitivity to SPL or documented allergies to beef products, as the formulation contains unfiltered beef heart infusion broth.
- Administration: Avoid administering subsequent doses at the exact same injection site to minimize local reactions.
- Handling: The product contains no preservatives. It must be handled strictly aseptically. The manufacturer recommends using the entire contents of a vial once opened.
- Allergic Patients: In highly allergic patients, reduced desensitizing doses and prior intradermal skin testing may be indicated.
藥物相互作用
May reduce the efficacy of SPL
監測
- Clinical efficacy (resolution of pyoderma)
- Local injection site reactions (redness, swelling, itching)
- Systemic hypersensitivity reactions (anaphylaxis, vomiting, weakness)
過量
No specific information was located regarding acute toxicity. Other than an increased risk for local or systemic hypersensitivity reactions, significant morbidity appears unlikely. Should an anaphylactic-type reaction occur, treat supportively; the manufacturer recommends epinephrine and atropine as antidotes.
可用產品
劑型
- Injection: 1 mL ampules
- Injection: 10 mL multi-dose vials
獸醫用
- Staphage Lysate (SPL) in 1 mL ampules (box of 10)
- Staphage Lysate (SPL) in 10 mL multi-dose vials
各地核准狀態
暫無法規資料: 🇺🇸 US · 🇪🇺 EU · 🇬🇧 UK · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
儲存與穩定性
Store in the refrigerator (2-7°C); do not freeze. Unopened, properly stored vials and ampules have an average expiration date of one year past the shipment date. The product contains no preservative and must be handled aseptically. It is recommended to use the entire contents of the vial after opening. Do not use if contents are cloudy. Do not mix with other drugs or solutions prior to administration.
飼主須知
了解治療方式：
- 這是一種「免疫刺激劑」，旨在幫助狗狗自身的免疫系統對抗慢性或反覆發作的細菌性皮膚感染（膿皮症）。
- 它不是抗生素，但在治療初期通常會與抗生素合併使用以控制感染。
給藥與安全性：
-
重要提示： 由於存在罕見但嚴重的過敏反應（過敏性休克）風險，理想情況下應在獸醫診所內進行注射，以便在需要時能立即進行急救。
注意事項： 如果在注射後發現以下任何情況，請立即聯繫您的獸醫：
- 局部反應： 注射部位發紅、發癢或腫脹（通常在 2-3 小時內發生，可持續長達 3 天）。
- 全身反應： 虛弱、嘔吐、腹瀉、嚴重的全身搔癢、呼吸急促或困難，或突然極度疲倦/嗜睡。
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