By Allison Gandey
Medscape Medical News
October 28, 2009 (Baltimore, Maryland) — Investigators are reporting a case of motor neuron disease after immunization with the quadrivalent vaccine Gardasil. The Merck product is designed to prevent infection with several types of human papillomavirus.
Presenting here at the 134th annual meeting of the American Neurological Association, researchers describe a case of rapidly progressive disease leading to the death of a 14-year-old girl.
"Pathological features support the temporal association of the clinical presentation and vaccination and provides supporting evidence that immune-mediated reactions to the nervous system are potential risks after Gardasil vaccination," Catherine Lomen-Hoerth, MD, director of the Amyotrophic Lateral Sclerosis Center at the University of California–San Francisco, told the meeting.
"Our patient received 3 doses of Gardasil with symptom onset 2 months after her last dose," the poster presenters wrote. "Despite treatment with aggressive immunosuppression, her weakness relentlessly progressed and she died of respiratory failure 21 months after the onset of her weakness."
Postmortem evaluations revealed widespread infiltrates of T lymphocytes and macrophages in the grey and white matter at all levels of the spinal cord. Researchers also report extensive demyelination and severe loss of motor neurons.
In September, investigators presenting at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting reported cases of autoimmune disorders after immunization with Gardasil.
Two groups presented at the meeting — one identified a case of multiple sclerosis after vaccination and the second a case of neuromyelitis optica.
Other Reports of Autoimmune Disorders
Presenter Maria Bouktsi from the Interbalkan European Medical Center in Thessaloniki, Greece, told Medscape Neurology that her team is questioning whether the immuno-stimulatory properties of the human papillomavirus–like particles of the vaccine are triggering adverse effects in vulnerable patients.
It is the same question that researchers asked in a recent issue of Multiple Sclerosis (2009;15:116–119). Ian Sutton, MD, from St. Vincent's Hospital in New South Wales, Australia, and his team reported 5 cases of multiple sclerosis after vaccination with the drug. The group reported in January that patients presented with multifocal or atypical demyelinating syndromes within 21 days of immunization.
No definitive conclusions can be made based on this report, Dr. Sutton and his team noted. "It should not be overlooked that several epidemiological studies indicate that viral infection is associated with a threefold increase in the risk of a multiple sclerosis relapse," write the researchers.
7 More Cases
Lead investigator of the second group presenting on this topic said that he agrees that postmarketing pharmacosurveillance is necessary to improve safety. "[Human papillomavirus] vaccines elicit a strong inflammatory systemic immune response," said Til Menge, MD, from Heinrich-Heine University in Dusseldorf, Germany.
His group suggests that it was this inflammatory response that may have triggered a case of fulminant neuromyelitis optica in a previously healthy 17-year-old girl.
Investigators have not established a causal relationship, but they are asking clinicians to closely monitor patients for any emerging side effects.
The researchers have disclosed no relevant financial relationships.
American Neurological Association 134th Annual Meeting: Poster WIP-19. Presented October 13, 2009.
October 28, 2009 (巴爾的摩) — 研究者報告一個使用四價疫苗、Gardasil之後的運動神經元疾病案例。Merck藥廠的此項產品設計用於預防多種人類乳突病毒感染。
美國神經協會第134屆年會中，研究者發表一個快速惡化且導致一名14歲女孩死亡的案例報告。
加州大學舊金山分校、肌萎縮性脊髓側索硬化症中心主任Catherine Lomen-Hoerth醫師向與會聽眾表示，病理特徵支持臨床表現和疫苗之間的暫時性關聯，證據也支持使用Gardasil疫苗之後，對於神經系統的免疫媒介反應有潛在風險。
壁報發表者寫道，我們的病患接受三劑的Gardasil，症狀發生在她接受最後一劑之後的兩個月。儘管積極的進行免疫抑制治療，但她越來越虛弱、在之後21個月死於呼吸衰竭。
驗屍發現，整個脊索的灰質和白質都有T淋巴球和巨噬細胞浸潤。研究者也報告指出，有廣泛性的髓鞘脫失與運動神經元嚴重流失。
9月時，研究者在歐洲多發性硬化症治療與研究委員會年會中，發表使用Gardasil之後的自體免疫異常案例報告。
會議中有兩組報告此議題，一組確認一個使用疫苗之後的多發性硬化症案例，一組是視神經脊髓炎的案例。
【其他自體免疫異常報告】
發表者、希臘Thessaloniki、Interbalkan歐洲醫學中心的Maria Bouktsi向Medscape Neurology表示，她的團隊質疑是否是疫苗中的類人類乳突病毒顆粒之免疫刺激性質引起這些病患的不良反應。
最近在Multiple Sclerosis期刊的一篇報告(2009;15:116–119)也有研究者提出同樣的問題。澳洲新南威爾斯、St. Vincent's醫院的Ian Sutton醫師等人，報告使用該疫苗之後的5個多發性硬化症案例。該研究團隊在1月報告指出，病患在使用疫苗後21天內出現多病灶或非典型脫髓鞘症狀。
Sutton醫師等人指出，無法根據此報告做出明確結論。研究者寫道，不應忽略這許多流行病學研究，病毒感染與多發性硬化症復發風險增加三倍有關。
【還有7個案例】
另一個研究團隊的第一作者在發表時表示，他同意必須進行上市後藥物監控以改善安全性。德國杜塞道夫Heinrich-Heine大學的Til Menge醫師表示，人類乳突病毒疫苗引起強烈的發炎性全身免疫反應。
他的團隊認為，是因為這個發炎反應造成一名原本健康的17歲女孩發生猛暴型視神經脊髓炎。
研究者並未建立因果關係，但是他們要求醫師們密切監控病患以注意有無發生任何的不良反應。
研究者皆宣告沒有相關財務關係。
如果還想多了解一點HPV疫苗，可以參考：
子宮頸癌新疫苗Cervarix問世 45歲前施打都有效
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