annana 2010-5-28 11:31
緩釋型眼用插入劑可改善乾眼症的徵兆與症狀
作者：Fran Lowry
出處：WebMD醫學新聞
May 11, 2010 (佛州羅德岱堡) — 根據發表於視力與眼科研究協會2010年會一篇對418名病患進行研究的壁報，使用羥丙基纖維素眼用插入劑(hydroxypropyl cellulose ophthalmic inserts，HCOI)治療一個月可改善乾眼症的徵兆與症狀。
Albert Einstein醫學院與South Shore Eye Care的Jodi Luchs醫師向Medscape Ophthalmology表示，這個插入劑的商品名為Lacriserts (Aton Pharma公司)，在1970年代時，原本由Merck藥廠行銷，許多醫師不認為這個產品可以回到市場，我們試著指出，這是一個治療中度到嚴重病患、實在沒有辦法使用現有選項時的好方法。
在研究開始時與治療後1個月時，病患完成一份問卷，詢問他們在各種環境狀況下，眼睛不適的症狀與程度，根據眼球表面疾病指標(OSDI)和每日活動量表，這些病患有65%屬於中度或嚴重；另外也測量淚液層瓦解時間(TFBUT)。
羥丙基纖維素眼用插入劑每天插入一次。
Luchs醫師報告指出，治療1個月之後，嚴重和中度組的OSDI分數有顯著差異。嚴重組的分數減少程度最多(29.8%；P< .001)，中度組則是減少18.9% (P= .016)。
Luchs醫師表示，研究對象的OSDI分數改善超過他們在研究前接受之乾眼治療的改善程度。
該研究也發現，正常組和輕微組的OSDI分數分別增加83.7% (P=.001)與30.2% (P=.01)。嚴重度分類也有顯著改變，在研究開始時，65%的病患有嚴重乾眼症候群，治療1個月之後，這些嚴重病患中有44%變成正常、輕微、中度組。
Luchs醫師也報告指出，相較於開始時，正常組左眼的TFBUT顯著增加(P<.05)，但是輕微或中度組的任一眼都沒有增加。嚴重組病患中，雙眼的TFBUT都比開始時顯著增加(P< .005)。
Luchs醫師表示，最常見的不良反應是視力模糊。
他解釋，HCOI是羥丙基纖維素製成的一個桿子，置入下眼瞼囊，在該處緩慢溶解並釋放，可被視為緩釋型人工淚液。就像隱形眼鏡一樣放入眼中，大約僅一分鐘左右感覺到它，然後它就在那慢慢溶解，它已經獲得美國食品藥物管理局核准多年。
他指出，這個研究並未排除已經使用cyclosporine的病患，事實上，我們認為使用cyclosporine的病患屬於中度到嚴重的乾眼症，將HCOI加入他們的處方也有較好的效果。
休士頓Baylor醫學院Cullen眼科研究中心的Elizabeth Yeu醫師受Medscape Ophthalmology之邀發表評論時表示，研究發現支持她對乾眼症病患使用HCOI的經驗。
未參與研究的Yeu醫師表示，這篇壁報的研究發現相當有臨床意義，因為，有時候病患的症狀和醫師的檢查之間有斷層，對於幫助醫師瞭解病患的乾眼症嚴重度而言，OSDI是一個很好的工具。
她指出，如前述，中度到嚴重的病患最能從HCOI獲得幫助，這些病患也最常需要潤滑(眼睛)來緩解症狀，每天需要人工淚液潤滑眼睛超過4-6次的病患，使用插入劑獲得持續的潤濕之後，生活品質獲得相當大的改善。
Aton Pharma, Inc公司支持該研究，Luchs醫師與Yeu醫師皆報告與Aton Pharma公司有財務關係。
視力與眼科研究協會2010年會：摘要 6262。發表於2010年5月6日。
Slow-Release Ophthalmic Inserts Improve Signs and Symptoms of Dry Eye
By Fran Lowry
Medscape Medical News
May 11, 2010 (Fort Lauderdale, Florida) — One month of treatment with hydroxypropyl cellulose ophthalmic inserts (HCOI) improved the signs and symptoms of dry eye syndrome, according to a registry study of 418 patients presented in a poster here at the Association for Research in Vision and Ophthalmology 2010 Annual Meeting.
The inserts, called Lacriserts (Aton Pharma, Inc), were originally marketed in the 1970s by Merck, Jodi Luchs, MD, from Albert Einstein College of Medicine and South Shore Eye Care in Wantagh, New York, told Medscape Ophthalmology. "Many clinicians aren't aware that the product is back on the market. We're trying to get the word out that this is a good way of treating patients who are in the moderate-to-severe category who really don't have a lot of good options currently available to them."
The patients filled out a questionnaire that asked them about their symptoms and degree of ocular discomfort in various environmental conditions at baseline and 1 month after treatment. Of these patients, 65% were designated as being moderate or severe, according to the Ocular Surface Disease Index (OSDI) and activities of daily living scale. Tear film break-up time (TFBUT) was also measured.
The hydroxypropyl cellulose ophthalmic inserts were inserted once daily.
After 1 month of treatment, there were significant differences in OSDI scores between severe and moderate groups, Dr. Luchs reported. The largest decrease in scores was seen in the severe group (29.8%; P?< .001). Scores in the moderate group decreased by 18.9% (P?= .016).
Improvement in OSDI scores for patients in the study was over and above any improvement patients gained from dry eye therapies that they received before the study, Dr. Luchs said.
The study also found that there were significant increases in OSDI scores of 83.7% (P?=.001) and 30.2% (P?=.01) for the normal and mild groups, respectively. There was also a significant shift in the severity category. At the beginning of the study, 65% of patients had severe dry eye syndrome. After 1 month, 44% of those patients scored within the severe range, shifting the distribution to normal, mild, and moderate groups.
Dr. Luchs also reported that there was a significant increase in TFBUT for the left eye in the normal group (P?<.05), compared with baseline, but there were no increases in either eye for mild or moderate groups. In the severe group of patients, there was a significant increase in TFBUT for both eyes (P?< .005), compared with baseline.
The most commonly reported adverse effect was blurred vision, Dr. Luchs said.
"[HCOI] is a rod of material made up of hydroxypropyl cellulose that is placed into the interior eyelid sac where it remains throughout the day, slowly dissolving and releasing the material, so it is considered sustained-release artificial tears," he explained. "You put it in, similar to a contact lens, you feel it for about a minute, and then it sits there and slowly dissolves. It has been approved by the [US Food and Drug Administration] for years."
He added that "this study did not exclude patients who were on [cyclosporine] and, in fact, we think that patients who are on [cyclosporine] and who have moderate-to-severe dry eye do better with [HCOI] added to their regimen."
Asked to comment on this study for Medscape Ophthalmology, Elizabeth Yeu, MD, from the Cullen Eye Institute, Baylor College of Medicine, in Houston, Texas, said the findings support her experience with HCOI in her dry eye patients.
"The findings of this poster are very relevant, clinically. Because there sometimes is a disconnect between patients' symptoms and clinicians' exam findings, the OSDI is a wonderful tool to help clinicians translate the severity of patients' dry eye disease," said Dr. Yeu, who was not part of the study.
"As demonstrated, the patients who benefit the most from HCOI are those who have more moderate-to-severe disease processes, where there is a frequent demand for lubrication to alleviate their symptoms," she added. "Patients who need artificial lubrication more than 4 to 6 times daily experience a great improvement in their quality of life from having the consistent moisture provided by the insert."
The study was supported by Aton Pharma, Inc. Dr. Luchs and Dr. Yeu report financial relationships with Aton Pharma Inc.
Association for Research in Vision and Ophthalmology (ARVO) 2010 Annual Meeting: Abstract?6262. Presented May?6, 2010.