Thalidomide對HIV引起的結節性癢疹具療效


  July 19, 2004-根據皮膚醫學檔案(Archives of Dermatology)七月刊載的研究成果指出,Thalidomide可減輕病毒(HIV)免疫不全患者的PN症狀,但是有三分之一的患者會發展成末梢神經病變。
  
  美國加州舊金山市聯合大學Toby Maurer醫師及其同僚指出,PN是一種特徵未知的慢性皮膚病,它是種首先損害伸肌末端表面的一種症狀,為極度搔癢、對稱性、結狀丘疹,可能發生在HIV疾病患者身上;Thalidomide已經被習慣於治療頑固型非感染性HIV之PN患者,以及兩個有感染性HIV患者。
  
  10位由皮膚科和神經科診所挑選出符合納入條件之感染性HIV之PN 患者進入此試驗,其中兩位無法持續治療;在為期一個月的試驗中,受試者每天接受100mg的thalidomide治療後,然後隨機分別接受每天100 或200 mg,在基線和一個月之後,監測受試者身體上搔癢的程度和受PN影響的範圍,並做連續性神經學評估,如果有不良作用產生,則降低藥品到可接受的劑量,或者停止服藥。
  
  Thalidomide一天劑量由33到200 mg,其中有8位受試者完成試驗,平均經過3.4個月以上治療後,發癢症狀降低50%以上;其中的7位受試者經過5個月治療後,影響皮膚症狀減少超過50%,另有3位受試者發展成thalidomide末梢精神病變。
  
  TPN和治療期間或與thalidomide的蓄積劑量無關聯,好的TPN標誌為10 點神經損傷的變化,或是小腿肌感覺神經電位振幅減少50%以上。
  
  這項研究限制的因素,包含那些內在不受控制的連續病症、非盲性設計、受試者搔癢程度和缺少患者僅接受蛋白脢抑制劑或合併thalidomide治療的後續長期追蹤報告。
  
  研究人員指出,Thalidomide減少了感染性HIV 患者的PN症狀,有三分之一的受試者發展成為TPN;此外,研究人員認為,強調仔細的神經學評估的重要性,聯合的症狀、仔細的神經學檢查和神經傳導研究,將有助於正確的監測受試者的TPN反應。
  
  Andrulis藥物股份有限公司,在此試驗中提供thalidomide,研究人員指出此論文沒有相關財物利益支持。

Thalidomide Effective for Prur

By Laurie Barclay, MD
Medscape Medical News

July 19, 2004 — Thalidomide reduces the signs and symptoms of prurigo nodularis (PN) of human immunodeficiency virus (HIV), but one third of patients develop peripheral neuropathy, according to the results of a prospective study published in the July issue of the Archives of Dermatology.

"PN is a chronic dermatosis of unknown etiology characterized by discrete, intensely pruritic, symmetric, papulo-nodular lesions primarily on the extensor surfaces of the extremities. It may occur in HIV disease," write Toby Maurer, MD, from the University of California, San Francisco, and colleagues. "Thalidomide has been used to treat refractory PN in non–HIV-infected subjects and two HIV-infected subjects."

Of 10 HIV-infected patients at outpatient dermatology and neurology clinics who met inclusion criteria for refractory PN, two could not be followed up. After one month of treatment with thalidomide, 100mg per day, subjects were randomized to receive 100 or 200 mg per day. At baseline and monthly thereafter, subjects were monitored for degree of pruritus and total area of body involvement of PN and had sequential neurologic assessments. If there were adverse events, the drug was reduced to a tolerable dose or discontinued.

At a thalidomide dose ranging from 33 to 200 mg per day, the eight subjects not lost to follow-up had, on average, a greater than 50% response in reduction of itch over 3.4 months. Seven subjects had a greater than 50% reduction of skin involvement over five months, and three subjects developed thalidomide peripheral neuropathy (TPN).

TPN was not correlated with duration of treatment or with daily or cumulative dose of thalidomide. Good markers of TPN were a change in the Neuropathy Impairment Score of 10 points, or a greater than 50% decrease in the sural sensory nerve action potential amplitude.

Study limitations include those inherent in an uncontrolled case series, unblinded design, subjective grading of pruritus, and lack of long-term follow-up for patients receiving protease inhibitors alone or in combination with thalidomide.

"Thalidomide reduced the signs and symptoms of prurigo nodularis in HIV-infected subjects. One third of subjects developed TPN, underscoring the importance of careful neurologic assessment," the authors write. "A combination of symptoms, careful neurologic examination, and nerve conduction studies was helpful to accurately monitor for TPN in this subject population."

Andrulis Pharmaceuticals Corp. provided thalidomide used in this study. The authors report no relevant financial interest in this article.

Arch Dermatol. 2004;140:845-849

Reviewed by Gary D. Vogin, MD

    
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