点击显示 收起
作者：Pippa Wysong
出处：WebMD医学新闻
May 7, 2007(罗德岱堡) — 每天使用两次免疫抑制剂环孢灵(Cyclosporine) 类药物—丽眼达眼用乳剂（Restasis）治疗干眼症，每天仅需使用乙次，即可获得相同的效果。
根据一项于视觉与眼科研究协会（Association for Research in Vision and Ophthalmology，简称ARVO）年会所发表的研究指出，干眼症患者中有将近85%的人，在降低局部用药的频率后，其所获得的药效与保持每日两次的患者一样。
纽约州纽约市Weil康乃尔医学院眼科学教授Henry Perry医师于访谈中向Medscape表示，就提高患者使用药物的配合度来看，降低用药频率有其社经上的好处，而且药费支出会变少；他在ARVO的一场演讲中发表研究报告。
为了判定到底减少局部环孢灵药物的使用量是否有效，研究针对100名干眼症患者进行实验，患者必须每天使用两次局部环孢灵药物（0.05%眼用乳剂）持续至少一年，方能成为研究对象。
这100名患者被随机分为两组，第一组维持每天两次的用药疗程，而第二组则减少至每天一次的用药疗程；两组依病况再细分成轻度、中度和重度干眼症；在每天一次用药疗程的第二组中，有25名患者是轻度，15名患者是中度，及7名患者是重度干眼症。
患者接受眼科检查，并用希默氏泪水测试（Schirmer tear test）、眼球表面疾患指标（Ocular Surfacec Disease Index），和萤光染色泪液膜分解时间（fluorescein tear film break-up time）等其他检测法对干眼症进行评估；在开始参与研究后，这100名患者分别在第3个月和第6个月接受相同的检验。
Perry医师表示，于研究期间，有7名患者退出每天一次用药疗程组，回复到每天两次的用药疗程；这7人中轻度、中度和重度干眼症的患者都有；每天两次用药疗程组则无人退出。
Perry医师表示，降低药量的作法并不适用于所有的患者，但似乎对大多数的人是有效的；整体而言，以研究发现为基础，他总结指出，干眼症患者约有85%的人能转而采行低药量的疗程。
研究人员于演讲中表示，在接受最初的治疗后12个月，对大多数的患者而言，每天一次环孢灵药物疗程，和每天两次环孢灵药物疗程，都是同样有效的。
有趣的是，干眼症的严重度和用药减少的适当反应之间，并无关联性，而其间无关联性所带来的缺点是，无法预测或筛选那些患者会在每天一次疗程或每天两次疗程中，获得较佳的疗效。
北卡罗来纳州达拉谟市杜克大学眼科医学中心的Alan Carlson博士表示，他对于如此高比例的患者能保持低药量疗程，感到讶异。
Carlson博士指出，大多数医生认为，病患若能以该药量成功控制病情，那就该一直保持该药量继续下去，但研究显示实际上并非如此，而且使用的药量和频率都能向下调整。
Carlson博士于访谈中表示，尽管这些患者仍需接受药物治疗，但可以降低药量，这是很好的消息；他未参与该研究。
眼保健产品开发商Allergan Inc.(AGN)赞助该研究的所有经费。
ARVO 2007年会：会议摘要374-B576。2007年5月6日发表。
原文：
Topical Cyclosporine Use Can be Cut in Half
By Pippa Wysong
Medscape Medical News
May 7, 2007 (Fort Lauderdale) — Patients who use cyclosporine (Restasis) twice a day for the treatment of dry eye might get the same benefit from treatment if they use the drug only once daily.
According to a study presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), close to 85% of dry-eye patients can reduce the frequency of use of the topical drug with the same benefit as patients who remain on a twice-daily treatment plan.
Reducing the frequency of treatment “has socioeconomic advantages in terms of increased compliance, plus it costs less,” Henry Perry, MD, professor of ophthalmology at Weil Cornell School of Medicine in New York, New York, told Medscape in an interview. He presented the study in a poster at ARVO.
To determine whether topical cyclosporine reduction would be effective, a study was done of 100 dry-eye patients. To qualify for the study, patients had to have been using topical cyclosporine (0.05% ophthalmic emulsion) twice daily for at least 1 year.
The patients were randomized into 2 groups: 1 group continued with the twice-daily regime, and the second group was reduced to a once-daily regime. The 2 groups were subcategorized by severity: mild, moderate, and severe dry eye. The once-daily group consisted of 25 patients with mild disease, 15 with moderate, and 10 with severe dry eye. The twice-daily group consisted of 20 patients with mild, 23 with moderate, and 7 with severe dry eye.
At baseline, patients underwent ophthalmic exams and had their dry eye assessed using, among other tests, the Schirmer tear test, the Ocular Surfacec Disease Index, and fluorescein tear film break-up time. They underwent the same examinations at 3 and 6 months after study entry.
During the study period, 7 patients dropped out of the once-daily group and switched back to twice-daily use. The 7 were a mix of mild, moderate, and severe dry eye patients, Dr. Perry said. Nobody from the twice-daily group dropped out.
A dose reduction doesn’t work for all patients, but seems to be effective in most of them, Dr. Perry said. Overall, based on the study findings, he concluded that about 85% of dry-eye patients can be switched to a reduced dose.
“Once-daily cyclosporine was just as effective as twice-daily cyclosporine in most patients after 12 months of initial therapy,” the researchers said in the poster.
Interestingly, there was no correlation between the severity of dry eye and an adequate response to the decreased medication. The downside of this lack of correlation is that there is no way to predict or select which patients will do well on once- vs twice-daily dosing.
Dr. Alan Carlson, professor of ophthalmology at the Duke University Eye Center in Durham, North Carolina, stated that he was surprised at the large percentage of patients who were able to stay on the lower dose.
“Most people think that if you have success with a dose, patients are destined to remain on that dose,” he said. This study shows that this is not necessarily the case, and that dosages or frequency of use can be altered downward.
“It’s good to know that, while these patients still need to remain on the medication, they can reduce the dosage,” he said in an interview. He was not part of the study group.
The study was funded by an unrestricted grant from Allergan.
ARVO 2007 Annual Meeting: Abstract 374-B576. Presented May 6, 2007.