➥【重點摘要】:
新冠肺炎全球大流行以來,對可能面臨藥物原料供應短缺,進而導致慢性病患所需服用的常規藥物短缺問題,Dr. Alexander和Dr. Qato提出以下幾個因應措施:
1.建議政府列出普遍使用的常規藥物清單,確保這些藥物取得無虞。
2.對這些常規藥物,應與藥廠協調訂出一套合理公平的分配措施。
3.放寬現行取藥的管道,例如:可採郵購或宅配到府的管道。
此外,私人保險業者應放寬理賠標準,尤其是對經濟弱勢的族群;此外,建議政府應做長遠考量規劃,在下次緊急事件來臨時,確保治療慢性疾病的常規藥物來源,供應和取得不會產生問題。
(「財團法人國家衛生研究院」蔡慧如博士 摘要整理)
📋Ensuring Access to Medications in the US During the COVID-19 Pandemic (2020/04/09)+中文摘要轉譯
➥Author: G. Caleb Alexander,Dima M. Qato, PharmD, et al.
➥Link: JAMA
https://jamanetwork.com/journals/jama/fullarticle/2764562
#2019COVID19Academic
衛生福利部
疾病管制署 - 1922防疫達人
疾病管制署
國家衛生研究院-論壇
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medications中文 在 眼科陳慶隆醫師-視網膜的大小事 Facebook 的最佳解答
術後可調整度數及散光的人工水晶體 RxSight,正式被美國FDA通過,如果未來能在台灣上市,將是眼科醫師與患者的一大福音!
美國食品藥物管理局(FDA)昨(22)日批准了RxSight的光調節水晶體(light adjustable lens)和光傳遞設備(light delivery device, LDD),這是第一個可以在白內障手術後,對人工水晶體(intraocular lens, IOL)進行小幅度調整的醫療器械系統,幫助患者不戴眼鏡也能擁有良好視力。
白內障通常是由於年紀增長,水晶體變硬或混濁,影響患者視力。也有些是由於外傷性、併發性(如青光眼)、代謝性(如糖尿病)等引起的白內障。
解決療法之一便是進行人工水晶體置換手術,然而許多患者會有些微屈光不正,需要使用眼鏡或隱形眼鏡矯正。
為了替患者解決人工水晶體不當聚焦的問題,RxSight 建構獨特材料IOL,在手術後17至21天,對LDD發出的紫外線進行反應。根據所需調整量,患者在1到2周內接受3或4次光照治療,每次約40-150秒。
白內障手術開始到光療結束,患者必須配戴特殊眼鏡防護紫外線,保護新水晶體免受紫外線照射影響。
FDA批准是基於針對此產品所做的試驗成果,該研究隨機性地在17個研究地點挑選600名患有散光的患者,比較了光調節水晶體與現有的單焦點水晶體。
使用光調節水晶體的患者接受輕度LDD治療,術後6個月的裸眼視力(uncorrected visual acuity, UCVA)達到20/20或更高,是接受單焦點水晶體患者的兩倍。與使用傳統IOL相比,患者平均遠距離裸眼視力在視力表上可多看清楚一行。
75%的患者散光也有所減少,91.8%使用光調節水晶體的患者也達到目標驗光球鏡度數(manifest refraction spherical equivalent)0.5D以內的結果,這與近期LASIK研究中所見屈光準確性相似。
FDA醫療器械暨輻射健康中心(Center for Devices and Radiological Health)眼科和耳鼻喉科部門主任Malvina Eydelman表示,到今天為止,白內障手術常見的屈光不正問題,都還得透過眼鏡矯正。不過這個系統為部分患者提供了一個新的選擇,使醫生在初次手術後,可進行多次,可在辦公室內操作的步驟,對植入的水晶體做些調整,提高不戴眼鏡的視力。
RxSight執行長Eric Weinberg指出,我們很高興全球首個手術後可調式IOL成功到達另一個里程碑,這對期待屈光人工水晶體技術再度突破的患者、外科醫生和驗光師來說,是一個相當令人振奮的機會。我們很感謝所有參與這項工作的人員,包括協助研究的臨床工作人員,以及準備審查監管報告的雙方(RxSight和FDA)工作人員。
感謝 David 提供中文翻譯。
資料來源:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586405.htm
The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses. Refractive error, which is caused when the artificial lens does not focus properly, causes blurred vision.
“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”
The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.
A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75 percent also had a reduction in astigmatism.
The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases.
The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.
The FDA approved the Vision Light Adjustable Lens and the Light Delivery Device to RxSight Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
medications中文 在 我的ivf试管婴儿の日记 Facebook 的最讚貼文
从老公的角度看试管婴儿疗程
当一对夫妻要做 #IVF试管疗程时,做丈夫的应该用什么态度来面对?常常有网友告诉我说,我的老公精子不好,可是他还是不能戒烟戒酒,好不配合。要知道,不孕症不只是女人的责任,男人也是有责任。这篇文章,是以男人的角度出发,里面分享身为丈夫应该如何帮助太太一起度过疗程,文章是英文内容,是奥莉爸爸写的,奥莉爸不会中文。分享给大家😊
IVF Journey, A Husband’s Perspective
Hi all, before reading further I would like to say this is NOT an instruction or tips for IVF and hopefully readers will understand my poorly written English. This is my journey as a father of the IVF baby girl. Why am I sharing all this? It is because my wife had a Facebook page of her IVF journey at https://facebook.com/ivfjourney2015/ and she told me that majorities (not all but most) feedback indicate husband not supportive enough to commit into a journey of IVF. I’m not a true supportive husband either, least I made up my mind to make it happen.
Let’s start with “Why IVF?”
We went for a fertilization test and results with;
Husband: Teratospermia (Human language, sperm is weak for fertilization process)
Wife: Unexplained infertility (I think this is easy to understand, there is for the confirming reason for this result and we don’t go for further test after it because it will consumes too much time and money)
We married and planned to have children late 2011, both our ages were 37 in 2015 because of late marriage. My wife introduced IVF because she does not want to give up and feels regretful in future and so do I. Maybe because I did too many regretful things in the past, now I do not want this happened to my wife. At least I do it better then ignoring it.
Preparation for IVF
Financially, I know it will involve amount of 20k – 30k “Ringgit Malaysia” in the whole process depending on the situation and this is only one chance for me. I don’t have the money for a second attempt because I need to allocate funds for delivery if success.
Mentally, I do some studies/research on IVF. The whole journey took 50 days and in one of the process my wife needs to do a self-injection daily. I quickly asked my wife “Daily injection?! Do I need to fetch you to clinic daily to do this?” She answered “No, we need to do this ourselves”. A final question from me going to be “How?!” After we sat down and discuss, we comes into conclusion and I will do the injection for her. This was the most painful and nervous moment I ever experience by poking a needle to my wife’s belly EVERYDAY!
Lifestyle, 6 months earlier. My wife told me the NO’s, NO alcohol NO smoking NO midnight wandering NO stress. I said, I will fly up to the skies like butterfly if I able to do all the NO’s. It’s like a mission impossible. How can a man like me not go out to social with friends without alcohol and smoke? The joke was sleeping early! You want me to social with my friends in breakfast or lunch time? At this time, she softly said “I really wants to have a cute baby in future, it looks more like a family. Furthermore, I don’t want to have regretful moments in future”. All these words came out of my love (wife), her words melted in my heart deeply. I told her “Ok, we will go for it BUT you will need to promise me ONE IMPORTANT thing. No matter the process success or not we only have one attempt we need to accept the truth and live happily without regret in future.” she agreed.
Commitment, this is not some empty promise. I made a huge commitment to change my lifestyle into zero alcohol, tobacco and lesser stress. If comparing the pain and suffers my wife will take in this journey e.g., injection, medication effects, hormone changes and all the effects from pregnancies to delivery, mine looks more alike small potatoes (looks much more simple). Trust me guys, don't compare it, if you do and more likely you're going loose badly. For the sake of making a better future, I had fulfilled this commitment.
IVF Journey Phase 1 “Unskilled Husband Injection”
Day 1, doctor consults us for Buserelin injection. I need to inject this medication into my wife's belly each day sharp at 8AM. The nurse had guided me side by side to do the first injection.
Day 2, I started my first injection to my wife's belly without anyone guiding beside. Feels a bit nervous because this time I'm doing it all by myself. I try to hum some music to distract my wife's from looking at the needle while injecting but still she is looking at it.
Day 3 - Day 15, sometime the injection hurting and causes bleeding/bruise to her. I need to find a new spot to inject every time and sees her bruise makes my pain in the heart too. My injection skills improved dramatically. She even told me that she doesn't feel pain like the beginning stages.
Day 16, follow up 2nd checkup. Doctor said, everything goes smoothly and added another medication to inject called Gonal-F to take home and start injecting on day 23. This message never surprises me because I've been told earlier, but just that the price to pay for this medication is quite costly.
Day 17 - Day 22, nothing much on these days and we just stick on the plan as usual.
IVF Journey Phase 2 “Stressful Night”
Day 23, Gonal F injections start today. This needle doesn't look same as those earlier, it comes with medication in it and look like a pen.
Day 24 - Day 26, side effects of the Gonal F medications started. My wife is feeling irritation at the injection site, fullness, bloating and tenderness in the lower abdomen due to the increasing size of the ovaries. Her mood changes dramatically as I can tell, but she endures it and tell me she can handle it.
Day 27, follow up 3rd checkup. Doctor said wife has eggs total of 12 and is ready for Transvaginal oocyte retrieval "Human language, Egg retrieval" at day 31.
Day 28 - Day 29, final injection of Gonal F. At day 29 night, I inject Ovidrel to wife belly to that causes the growth and release of a mature egg (ovulation) for day 31.
Day 30, resting whole day. Finally, we had a day without injection and worrying about holding any needles. Today we wondering about the egg growth, not knowing will the eggs grow more or still the same amount of 12.
Day 31, egg retrieval. 8 egg success retrieves and I give out my sperm for oocytes selection on the same day. Wife given cyclogest for oval protection after the egg retrieval.
IVF Journey Phase 3 “Hopeful Embryo Culture & Embryo Transfer”
Day 32 - Day 35, rest at home. We had pillow talk every night concerning about the growth of an embryo. We also look at sample growth stages of an embryo from the web to see what the current growth stage is.
Day 36, another hopeful and nervous morning. Doctor tells us the result of embryo culture as below;
Total Embryo Retrieve: 8
Embryo Qualified for ICSI: 6
Embryo Success until Cleavage Stage (Day 2 – Day 4): 3
Embryo Success until Blastocyst Stage (Day 5): 2
Embryo Qualified / Recommended for Transfer: 1
Both our eyes looked at each other, knowing only 1 Blastocyst Embryo available to transfer and doctor tell the same after it. I really do not know how to express both our feelings into words here, as we expected to have at least 2 Blastocyst out of 8 embryos and only left 1. We both agreed to proceed this only 1 Blastocyst transfer as this is the only choice we had. It's more likely walking on a 100ft tall string with no supports mission, a single error will fail the mission.
After the transfer process, wife given a room to rest for few hours. A nurse came and give us adjunctive medications, injections and advice while resting at room.
IVF Journey Phase 4 “The Final Moment of IVF”
Day 37 - Day 49, after the transfer. This period is known as 2WW (2 Weeks Wait) with adjunctive medications, injections and be very careful. I just let her sleep/rest more on the bed, I served her every meal in the room. We're also nervous and curious about pregnancy results on day 44, we tested with cheap pregnancy tester and get got a double line on it and we do have a little hope and joy with this result. On day 47, again we test, but this time with expensive pregnancy tester and the results double line again! We're so hopeful and happy at this moment. We really hope this result is true until the next checkup.
Day 50, final checkup. My wife goes for the hCG test by giving a sample of blood, we waited 2 hours for the results. While waiting, nurse guide us to a room to rest. Wife slept and I sat beside concerned on the hCG test results. 2 hours later, the doctor invited us to look for him. Before doctor speaks, while we are sitting down, my wife's eyes were starring in the hCG results number and she spotted the hCG number is 452. She smiles happily while doctor tells her "You are pregnant and congratulations! Come back after 2 weeks to scan for baby heartbeats. And please go out to the counter and ring the bell!”
Just Sharing My Thoughts
By all means, I’m not bragging about my success. I would like to say if anyone is planning on IVF, teamwork is very important and husband play a very important role to increase the success rate. Sometimes, I do feel like a spectator than a participant myself because I never experience any of the medical exams but this is not true. Every injection I put on her belly, I feel the pain in my heart as bad as she has on the belly. Ok, nothing much to share in this IVF journey and next time I might be sharing another journey as a Father! Here is my little baby girl Facebook page奥莉 Olivia Baby - 梁童心心 https://fb.me/oliviababylove if you wish to see her growth updates.
End.
#ivf #ivfmalaysia #ivfjourney #baby #alphafertility
medications中文 在 コバにゃんチャンネル Youtube 的最佳解答
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medications中文 在 大象中醫 Youtube 的最佳貼文
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