目前日期文章:201609 (3)

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學名藥

 

「學名藥」是指與原廠藥具有相同有效成分、劑型、劑量及療效的藥品,世界各國基於原廠藥的安全與療效證據已足夠的基礎下,均認可學名藥可以用生體相等性(Bioequivalence, BE)試驗來取代臨床試驗,以證明學名藥與該原廠藥的吸收藥量及吸收率均相同,所以,學名藥的安全及療效與原廠藥相似。

所有的學名藥皆須經過食品藥物管理署(以下簡稱食藥署)審核通過後才可以上市,食藥署是藉由上市前的審查,以及上市後監測二部分,確保學名藥品質。上市前除須確認製造廠符合現行PIC/S GMP製藥標準外,更須經過科學性的文件審查確認學名藥的品質;而上市後則透過定期與不定期的實地查廠、市售藥品的抽驗及比照國際所建立的藥品品質安全監測機制,主動、被動的監測學名藥的品質,除要求醫療機構、藥局及廠商端的通報,並即時偵測全球及國內異常情形,立即調查處理,以確保民眾用藥品質及安全。

此外,針對較有可能有療效相等性疑慮的藥品,或常被通報療效不等之藥品,食藥署每年已加強監測,並將主動發函詢問相關醫學會臨床上較懷疑有療效疑慮的藥品,加強市售品抽驗及製造廠稽查。

值得一提的是,食藥署已製作「國產學名藥報乎你知」懶人包,並置於食藥署的網頁上以供下載參閱

另外,為向民眾宣導學名藥的品質,食藥署還特別製作了民眾版的「認識學名藥」摺頁單張,詳細列出常見的問題,包括:「學名藥與原廠藥一樣的安全有效嗎」、「原廠藥的製造廠是否比學名藥的製造廠好」、「為什麼學名藥比較便宜」、「學名藥是否需要較長時間才能發揮藥效」等的品質等問題,歡迎自行上網下載參閱。

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Night Vision Problems and Driving

 

by Berkeley Wellness | March 16, 2016

 

If you have more diffi­culty seeing when you drive at night than in the day, you’re hardly alone. But it’s not something to be taken in stride, since prob­lems in night vision are a major factor in traffic fatalities. According to Consumer Reports, about 70 percent of accidents involving cars striking pedestrians occur at night.

Improved highway lighting, reflective paints on roads, and shoulder rumble strips, among other infrastructure initiatives, have all made night driving safer. Ironically, however, fog lights, high beams, and auxil­iary lights, all designed to increase safety, can put drivers of oncoming vehicles at risk because of increased glare from them.

Older people are especially susceptible to night vision problems—even if their daylight vision is okay—because of changes that occur in aging eyes, including a gradual reduction in the size of the pupil (so less light hits the retina) and a decrease in the number of rods in the retina (the cells that are important for twilight and night vision). There is also a loss in contrast sensitivity (the ability to distinguish an object from its background), which makes it harder to see pedestrians, animals, and obstacles on the road. Plus, the retina’s ability to quickly adjust between bright light (as with oncoming headlights) and low-light condi­tions decreases with age.

On top of these changes, older people are more likely to have other eye conditions that affect the ability to see in low light, including cataracts, macular degeneration, and glaucoma. Night vision may also worsen in people of all ages who have dia­betes or dry eye syndrome and after LASIK and other refractive eye surgeries.

Routine eye exams typically test vision only under daylight conditions, which does not predict night vision. In fact, many peo­ple test well in standard eye exams but have night vision problems, whether they are aware of them or not.

How low light affects vision

In a small study in the journal Optometry and Vision Science, researchers tested the visual acuity of 43 people (ages 14 to 32)—first at daylight levels and then at different levels of twilight—using light fil­ters and found that vision decreased significantly with each drop in illumination. In fact, the subjects, who had about 20/20 vision at daylight levels, dropped on average one to two lines on the eye chart in twilight conditions and almost three lines in dimmer light.

An older study, published in Human Factors, tested the driving performance of young, middle-aged, and older people under both day and night conditions. Participants in all age groups slowed their vehicles under low light conditions, but not enough to compensate for degraded visibility at night. And the middle-aged and older groups performed worse in spotting pedestrians.

Can food or supplements improve night vision?

Don't count on it. A Chinese study in Nutrition found that lutein supplements improved contrast and glare sensitivity, which suggests that this carotenoid, found in many fruits and vegetables, may improve twilight and night vision. But the findings may not generalize beyond a Chinese population—and it’s unlikely that Americans who are well nourished would benefit from eating bushels of carrots or other lutein-rich pro­duce. The only benefit would be in people who have deficiencies due to, for instance, malabsorption problems or alcoholism. Plus, we don’t recommend carotenoid supple­ments, which can have adverse effects.

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What about blueberries, which are also purported to improve night vision? They did not have a clinically beneficial effect in a study in the Journal of Agricultural and Food Chemistry. Of course, it’s always a good idea to eat lots of colorful fruits and vegetables, which offer an array of vitamins, minerals, and phytochemicals and have other important health benefits.

What you can do

  • If you have trouble seeing in low light, consult an eye care professional, who, in addition to giving you a standard eye exam, may use special charts or other equipment to pinpoint any night vision problems. You may be a candidate for prescription night-driving glasses, even if you don’t wear glasses during the day. These other tips may also help:
  • Ask your eye care professional for glasses with anti-reflective coatings, which cut down on glare. High-definition lenses can give you sharper vision and also reduce glare for nighttime driving. Yellow-tinted lenses can increase contrast sensitivity, though they may also intensify glare, and any tint reduces the amount of light that reaches the eye.
  • If you are having cataract surgery, ask about getting an aspheric intraocular lens, a type of “premium” lens that improves con­trast sensitivity (though these lenses are not covered by Medicare or other insurance).
  • Treat dry eye syndrome if you have it (and get evaluated if you think you have it). The condition can cause you to experience light scatter. For more on dry eyes, see Dry Eyes: Treatment and Prevention.
  • When driving at night, make sure your headlights, windows, and mirrors are clean; use your window defoggers in inclement weather; slow your speed; and turn on the high-beams more often (but not in fog or when there are oncoming vehicles).
  • If you are in the market for a new car—and can afford the über-expensive price tag—check out models that have new night-vision systems, such as infrared cam­eras that detect people and animals and then alert you to their presence through an image on the dashboard or by beeping. Such high-tech features, available only on high-end luxury cars now, should become more common and affordable in the future.
  • Lastly, some tips for home owners, pedestrians, and cyclists: Problems with night vision are responsible for an untold number of falls, so you should keep your walkways well illuminated at night and not skimp on indoor lighting. Wear light-col­ored clothing or reflective markings if you are walking or cycling on dark streets.

Note: If you are over age 50 and want to participate in a research project on night vision being conducted at Queensland Uni­versity of Technology in Australia, take this online survey. It asks detailed questions about how well you see in low light and how this impacts your driving and other daily behav­iors. It takes about 15 minutes and is done anonymously; you get no personal feedback.

 

http://www.berkeleywellness.com/self-care/preventive-care/article/night-vision-problems-and-driving?s=EFA_160908_AA1&st=email&ap=ed

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Aging and Driving

by John Swartzberg, M.D. October 01, 2012

 

Getting a driver’s license is a milestone in many people’s lives. Another milestone that many older people may have to face, far more reluctantly, is hanging up their car keys.

The risk of fatal accidents increases with age, due to various physical and mental factors. No matter how healthy you are, you can develop subtle deficits that impair your driving. Though there’s no age at which anyone should automatically stop driving, I think it’s critical for older people—myself included—to periodically re-evaluate their driving skills, not only for their own safety, but also for the safety of others. It’s also essential to check in on aging parents, spouses or other loved ones whose driving abilities may be on the decline.

You may also want to talk to your doctor, who can help assess the situation. Perhaps an undiagnosed medical condition is interfering with driving and can be remedied, or some medication is at fault and can be changed. Physical therapy may help increase flexibility, and brain games may help you think and react faster. Some simple car adjustments—such as installing wider side mirrors or pedal extenders—can also increase safety.

It’s not inevitable that you (or a loved one) will have to stop driving. That’s good news, considering the consequences this can have— loss of freedom and independence and increased social isolation, which can lead to depression and affect your health in other ways, too (if, for example, it prevents you from getting to doctors’ appointments). In fact, many older people are safer drivers than younger people. They are less likely to speed or drive while intoxicated, and more likely to wear seat belts. They’re also more likely to avoid driving at night, in bad weather and on high-speed roads. And contrary to expectations, crash rates in older drivers actually declined between 1997 and 2008 (more so than in younger people), especially in those 70 and older, according to a study by the Insurance Institute for Highway Safety.

Still, it’s a good idea to plan ahead in case you do have to stop driving eventually by checking out alternative transportation options. Will a friend or family member be able to help out? Does your community offer van or taxi services? What public transportation is available?

Already there are some 33 million drivers in the U.S. who are at least 65 years old. With aging baby boomers, that number is rising fast. It’s estimated that by 2030, one in five drivers will be over 65. Let’s all make sure we keep it safe.

http://www.berkeleywellness.com/healthy-mind/mind-body/article/aging-and-driving

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