Tacrolimus軟膏治療異位性皮膚炎比Pimecrolimus有效


  July 30, 2004 - 7月29號於紐約舉行之2004美國皮膚學會大會中,所發表的一項大型比較性試驗結果顯示,tacrolimus軟膏在治療輕微、中度、嚴重的成人與兒童異位性皮膚炎(AD)症狀上比pimecrolimus乳膏有效。
  
  北卡羅萊納州溫斯頓-沙倫Wake Forest大學Baptist醫學中心主任與試驗研究者Alan Fleischer醫師在新聞中表示,這項試驗是第一個大型、設計良好的比較性試驗,檢驗tacrolimus軟膏與pimecrolimus乳膏於同樣病患族群,包括年紀、疾病嚴重度、治療時間長短、效果試驗終點、與不良反應。這項試驗中,tacrolimus軟膏看起來對不同嚴重度AD比pimecrolimus乳膏有效,受試者包括輕微的患者與特別嚴重的患者。
  
  總共1056位輕微到嚴重的AD患者收納至3組中,在為期6週、研究者不知情的試驗設計下,隨機分派到2種局部免疫調節藥物中的1種。在第1組,從輕微到非常嚴重的AD成人患者以0.1% tacrolimus軟膏(210位)或是1% pimecrolimus乳膏(203位)治療;第2組包括2到15歲中度到非常嚴重的兒童病患,以0.1% tacrolimus軟膏(112位)或是1% pimecrolimus乳膏(106位)治療;在第3組,患有輕微AD的兒童病患使用0.03% tacrolimus軟膏(208位)或是1% pimecrolimus乳膏(217位)。
  
  每位病患AD的範圍在第1、3與6週透過醫師評估體表面積(BSA)方式、溼疹區域與嚴重度指標(EASI)、病患自我評估的「搔癢指數」與研究者全面性異位性皮膚炎評估(IGADA)加以評估;藥物效果定義為「消除」、IGADA指數顯示AD「消除」或「幾乎消除」的病患百分比。
  
  第6週時,相較於pimecrolimus組,於治療輕微到非常嚴重AD成人病患上,在tacrolimus組的消除率顯著較好(46%相較於27%),治療2到15歲中度到非常嚴重的AD兒童病患方面,也是tacrolimus比較有效(32%相較於18%);患有輕微AD的兒童病患的消除率,tacrolimus的治療效果比較好(47%相較於41%)。
  
  Fleischer醫師向Medscape表示,tacrolimus在其他評估方式上同樣比較有效;EASI指數顯示,在全部3組中,連同總合分析,tacrolimus軟膏比pimecrolimus乳膏更有效;以另外一項搔癢指數評估,搔癢是異位性疾病的主要症狀,這3組的結果都顯示,相較於pimecrolimus乳膏,tacrolimus軟膏在減少搔癢程度方面不但更有效,且速度更快,而這是改善病患生活品質的關鍵所在。
  
  Fleischer醫師指出,雖然IGADA指數在患有輕微AD的兒童病患沒有達到統計上的差異,但在改善患病體表面積、EASI指數、與第1週時降低搔癢指數皆達到統計上的差異。
  
  Fleischer醫師進一步指出,這兩組病患族群在副作用上,包括灼熱感、刺痛感、紅腫、搔癢與皮膚感染病並沒有差異;副作用與皮膚發炎的病患數量有關,輕微疾病與輕微發炎患者比較少發生副作用。隨著症狀惡化,將使病患的皮膚更容易受到刺激,且就算是很好的保溼乳液或自來水,也會造成皮膚表面嚴重的灼熱感或搔癢,因此某些嚴重病患,對藥物較可能產生灼熱感、搔癢及刺痛感。
  
  Fleischer醫師表示,世界各地已有超過2百萬病患使用過tacrolimus軟膏,已有超過1萬6千位AD病患在試驗中接受tacrolimus治療,其中50%是兒童,顯示這個藥物是安全且有效的,因此對這個高危險群有大量的數據;此外,我們發現,嚴重搔癢的病患能有一種安全且有效的治療選擇是件值得欣喜的事,而搔癢對其他人來說是很平常的。
  
  這項試驗由tacrolimus軟膏的製造廠商Fujisawa Healthcare公司贊助。

Tacrolimus Ointment More Effec

By Yael Waknine
Medscape Medical News

July 30, 2004 — Tacrolimus ointment is more effective than pimecrolimus cream in the treatment of mild, moderate, and severe atopic dermatitis (AD) symptoms in adult and pediatric patients, according to preliminary results of a large comparative trial presented on July 29 at the Academy 2004 meeting of the American Academy of Dermatology in New York.

"This study is the first large, well-designed comparative trial to examine tacrolimus ointment and pimecrolimus cream in the same patient populations, including age, disease severity, length of treatment, efficacy end points, and adverse events," said Alan Fleischer, MD, study investigator and director of the Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, in a news release. "In this study, tacrolimus ointment seemed to work better for all severities of [AD] than pimecrolimus, including mild sufferers and particularly in severe patients."

A total of 1,056 patients with mild to severe AD were enrolled in a three-group, six-week, investigator-blinded study and randomly assigned to treatment with one of the two topical immunomodulators. In the first group, adults with mild to very severe AD were treated with tacrolimus ointment 0.1% (n = 210) or pimecrolimus cream 1% (n = 203). The second group consisted of pediatric patients aged two to 15 years with moderate to very severe AD, treated with tacrolimus ointment 0.1% (n = 112) or pimecrolimus cream 1% (n = 106). In the third group, pediatric patients with mild AD were treated with tacrolimus ointment 0.03% (n = 208) or pimecrolimus cream 1% (n = 217).

The scope of AD was evaluated in each patient at baseline and weeks 1, 3, and 6 using the physician-rated Body Surface Area (BSA) assessment, the Eczema Area and Severity Index (EASI), a patient self-assessed "itch score," and the Investigator's Global Atopic Dermatitis Assessment (IGADA). Drug efficacy was defined by "clearance," the percentage of patients with IGADA ratings showing them to be "clear" or "almost clear" of AD.

At six weeks, clearance rate was significantly higher in the tacrolimus group compared with the pimecrolimus group among adults with mild to very severe AD (46% vs. 27%) and children aged two to 15 years with moderate to very severe AD (32% vs. 18%). The clearance rate also showed a trend toward greater efficacy of tacrolimus in the pediatric group with mild AD (47% vs. 41%).

Tacrolimus was similarly more effective in other outcome measures. "The EASI score showed that in all three arms, as well as in pooled overall analysis, tacrolimus ointment was more effective than pimecrolimus cream," Dr. Fleischer told Medscape. "In terms of another outcome measure, itch scores — the main symptom of atopic disease is itching — all three studies show that not only is tacrolimus more effective than pimecrolimus in reducing itch, but tacrolimus is more rapid in reducing itch symptoms, which is really key to improving the quality of life in patients."

Although the IGADA scores in the pediatric mild AD group did not achieve statistical significance, "there were highly statistical differences in terms of improvements in body surface area, the EASI score, and reduction in itch scores even at week 1," Dr. Fleischer pointed out.

According to Dr. Fleischer, the two drugs showed no differences in rates of adverse effects such as burning, stinging, erythema, itching, and skin infections in comparable patient populations. "The side effects are related to the amount of skin inflammation patients have. Patients with mild disease and low inflammation have relatively few side effects. As symptoms become more severe, patients' skin becomes more irritable and even good moisturizing lotions or tap water can cause tremendous burning on the surface of the skin, or itching. So more severely affected patients are more likely to have burning, itching, and stinging with use of any drug."

"More than 2 million patients have been treated worldwide with tacrolimus ointment. There have been studies involving more than 16,000 patients with AD who have been safely and effectively treated with tacrolimus, and 50% of these were children," Dr. Fleischer said. "So we have a large amount of data on this most at-risk group — and we find that it's nice to have treatment options that are safe and effective for our patients with severe itching diseases...itching is only trivial when it comes to the other person."

The study was funded by Fujisawa Healthcare Inc., the makers of tacrolimus ointment.

AAD Academy 2004 Meeting: Evening Session. Presented July 29, 2004.

Reviewed by Gary D. Vogin, MD

    
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