Ophthalmology Volume 130, Number 10, October 2023

美國兒科葡萄膜炎照護可及性的區域差異

中文摘要

這篇文章探討了美國兒童視網膜炎治療可及性的區域差異。兒童視網膜炎的治療十分複雜而繁重，往往需要一個由兒童眼科專家、眼科炎症專家和風濕病專家組成的多學科團隊。雖然兒童視網膜炎的治療可及性可能存在不平等，但目前尚未得到足夠的研究。患者前往醫療服務提供者所需的時間是衡量醫療公平性的一個可靠指標。研究中將60分鐘的車程定義為每個提供者地址周圍的服務區域。本研究使用美國人口普查局的提供者分佈地圖，計算提供者Specialty Care Areas（SCA, 專科提供者區域）內外的人口特徵，並使用卡方檢定來分析是否存在顯著差異。此外，研究還評估了特定地理區域的專科醫生和其SCA之間的差異，這些地理區域參考了聯邦機構的劃分。為了理解形塑提供者決策的因素，將每個地區的專科醫生人數與該地區年齡在1至19歲之間的人口相對比，以區域的特殊職業比例/年齡人口比例計算為定位指數（location quotient, LQ）。LQ < 1表示該地區的專科醫生數量與年齡在1至19歲之間的人口相比，不成比例地較低。為了總結各地區LQ的整體效果，計算了區域分布的不平均程度的指數，該指數衡量了2個分佈在一組地區中的平均程度。此值表示為了使專科醫生的地區分佈與年齡在1至19歲之間的人口的地區分佈相匹配，需要將多少百分比的專科醫生調動到其他地區。該指數可用來評估提供者的地理分佈是否均勻。本研究計算(D)作為兩者比例之間的絕對差異的一半，分別為專科人員(ai)和0至19歲人口比例(bi)的區域計算。研究對1040位小兒眼科醫師、562位葡萄膜炎專科醫師和1409位風濕病學家進行了分析，並對17種葡萄膜炎進行了地圖繪製。小於19歲的人口中，91.3%居住在任何專科的範圍內，而有8.7%居住在這些範圍之外。居住在範圍之外的兒童更有可能屬於白種人種（χ-square [1，n = 78408275] = 297396.8，P < 0.001），生活在聯邦貧窮線以下（χ-square [1，n = 72860312] = 193168.3，P < 0.001），缺乏醫療保險（χ-square [1，n = 78408275] = 18804.9，P < 0.001）。南部和非大陸美國地區的提供者和兒童比例最高和最低。中大西洋和新英格蘭地區的各專業和所有專業的LQs最高。這兩個地區相對於1至19歲的人口而言，專科醫生的比例較高，這是由於從波士頓到華盛頓特區的城市走廊上有大量診所，儘管這兩個地區分別只有全美國小兒人口的15％和5％。近一半的葡萄膜炎研究生計劃也在中大西洋地區。這份研究主要探討美國不同地區兒童眼科醫生、著眼於著眼於眼睛中的發炎疾病的專科醫生（uveitis specialists）以及風濕病科醫生（rheumatologists）的數量分佈情況。結果顯示，大西洋和新英格蘭地區擁有最高的相對指數locat（LQs），而大平原地區和西南地區的LQs最低。另外，研究還發現一些大城市缺乏相關專科醫生。在沒有提供相關專科服務的前十大城市中，人口總數在9萬至26萬之間。有些城市靠近毗鄰大都市地區，那裡有能提供全部三個專科服務的醫生；但有些城市距離最近的專科醫生足足有兩個小時車程之遠。這篇文章探討了由於受限的兒童葡萄膜炎盛行率資料，導致一些地區成為服務沙漠的風險。該研究發現，在美國的鄉村和小型都會地區，兒童葡萄膜炎的醫療不平等存在地理上的障礙，並呼籲進一步研究以克服這些地理和衛生障礙，改善眼科的綜合照護不平等問題。此外，研究還提到了兒童眼科訓練人數下降以及不是所有兒童眼科醫師都會治療葡萄膜炎的現實，因此需要更加謹慎的對待這些地理性障礙。

English Abstract

This content discusses the regional disparities in the availability of pediatric uveitis care in the United States. Pediatric uveitis care is complex and often requires a team of specialists, including a pediatric ophthalmologist, uveitis specialist, and rheumatologist. However, access to this specialized care is likely unequal but has not been extensively studied. The study aimed to analyze the geographic distribution of these specialties and quantify the disparities between their availability and the pediatric population. Provider office addresses were obtained from various professional societies, and their locations were analyzed using geographic mapping software. The study used data from the American Community Survey to measure travel time to providers as an indicator of healthcare equity.The content discusses a study that aimed to analyze population characteristics and the distribution of specialists in different regions. The study used data from the U.S. Bureau and performed chi-square tests to identify significant differences. They also looked at the number of specialists in each region compared to the population and calculated a location quotient to determine if the number of specialists was proportionate. Additionally, the study analyzed the distribution of specialists across regions using the index of dissimilarity. The study took into account uveitis fellowship training programs and assumed that all providers are capable of evaluating and managing children.The content describes the calculation of a metric called “D” which represents the difference between the percentage of specialists in a region and the percentage of the population aged 0-19 in that region. The study analyzed the distribution of pediatric ophthalmologists, uveitis specialists, and rheumatologists in the US and mapped the prevalence of uveitis. It was found that the intersection of Specialty Care Areas (SCAs) generally corresponds to the overall pediatric population density. Most children in the US live within the SCAs, but a small percentage live outside of them, with characteristics such as being of White race, living below the poverty level, and lacking health insurance. The South and non-Continental US regions have the highest percentages of providers and children, while the Mid-Atlantic and New England regions have the highest concentration of specialists relative to the pediatric population. The region between Boston and Washington DC has a high number of practices and uveitis fellowship programs despite its small percentage of the overall pediatric population.The Atlantic and New England regions had higher LQs overall compared to the Great Plains and Southwest regions. The Great Plains and Southwest regions had the lowest LQs overall and for specific specialties, and were the only regions without a medical institution offering a uveitis fellowship. To achieve regional equity with the pediatric population, around 10.8% of pediatric ophthalmologists, 11.4% of uveitis specialists, and 12.1% of rheumatologists (or 11.1% of all specialists combined) would need to be redistributed to these regions. Some large urban areas had no providers, with populations ranging from 90,000 to 260,000. Some of these cities were near larger regions with providers, while others were at least a 2-hour drive away from the nearest specialists. The study is limited by the use of online society directories for provider addresses, which may not include certain practitioners or updates. The study also does not account for allied eye professionals and could not estimate the population need. The study highlights disparities in pediatric uveitis care in rural and small metropolitan areas of the United States, where service availability near ophthalmology training centers is disproportionately high. The geographic barriers in accessing care exacerbate socioeconomic challenges in timely diagnosis and management. The article suggests future studies focused on overcoming telehealth and geographic barriers, as well as exploring referral patterns through clinician surveys, to mitigate care disparities in ophthalmology.

Ophthalmology Volume 130, Number 9, September 2023

對於葡萄膜炎性水腫的玻璃體內治療 – Ranibizumab 與 Methotrexate 對比 the Dexamethasone Implant

中文摘要

多中心葡萄膜炎類固醇治療試驗（Multicenter Uveitis Steroid Treatment Trial, MUST）研究小組進行了一項研究，評估了三種不同的玻璃體內治療（Dexamethasone、Methotrexate和Ranibizumab）對持續或復發的葡萄膜炎性水腫（ME）的療效。來自33個中心的患者被隨機分配接受其中一種治療。主要結果是12週內的視網膜厚度變化。研究發現，只有Dexamethasone組的最佳矯正視力（BCVA）在統計上有顯著改善，並且在12週內在減少視網膜厚度和解決ME方面優越。然而，Dexamthasone組的眼內壓升高發生率較高。Methotrexate的結果較不理想，其中心亞區厚度（central subfield thickness, CST）的減少在臨床上無意義。該研究得出結論，在12週的5追蹤中，對於具有不活躍(inactive)或輕微活躍(minimally active)葡萄膜炎的患者，Dexamethasone優於Methotrexate和Ranibizumab，用於治療持續或復發的ME。

English Abstract

The Multicenter Uveitis Steroid Treatment Trial (MUST) Research Group conducted a study to evaluate the effectiveness of three different intravitreal treatments—dexamethasone, methotrexate, and ranibizumab—for persistent or recurrent uveitic macular edema (ME). Patients from 33 centers were randomized to receive one of these treatments. The primary outcome was reduction in centrals subfield thickness (CST) expressed as a proportion of baseline (CST per CST at baseline) at 12 weeks. The study found that only the dexamethasone group showed a statistically significant improvement in Best-Corrected Visual Acuity (BCVA) and was superior in reducing retinal thickness and resolving ME at 12 weeks. However, the incidence of elevated IOP (elevations of IOP by 10mmHg,to 24mmHg or more,or both) was higher in the dexamethasone group, but IOP spikes to 30mmHg or more were uncommon overall and were not significantly different among groups. Methotrexate showed less promising results, and its reduction in Central Subfield Thickness (CST) was not clinically meaningful. The study concluded that dexamethasone was superior to methotrexate and ranibizumab for treating persistent or recurrent ME in patients with inactive or minimally active uveitis at the 12-week follow-up.

Ophthalmology Volume 130, Number 9, September 2023

眼科執業合併趨勢：2015年至2022年

中文摘要

該研究使用美國醫療保險與醫療補助服務中心（Centers for Medicare and Medicaid Services）國家可下載文件數據庫的數據，研究了2015年至2022年間眼科領域執業的合併趨勢。研究發現，合併趨勢明顯，眼科診所的數量減少了18％，而眼科醫師的數量相對穩定。具有10名或更多眼科醫師的診所增加了16％。這一趨勢在性別、地區和實踐年限方面保持一致。

研究確定了多個導致合併趨勢的因素，包括COVID-19大流行、私募股權收購以及健康政策變化，如引入基於績效的支付模式。研究指出，合併既有優點也有缺點。在積極方面，較大的診所可以實現規模經濟，談判更好的報酬率，並擁有更多資源來滿足報告要求。然而，不利方面，合併可能導致競爭減少，患者的費用上升，並將焦點放在短期經濟利益上，而忽略了對執業和以實證醫療照顧的長期投資。

研究結論是，儘管合併與美國醫療保健景觀的整體趨勢一致，但它對醫療服務和患者結果的影響尚待確定，需要進一步調查。

English Abstract

The study examines the trend of practice consolidation in the field of ophthalmology from 2015 to 2022 using data from the Centers for Medicare and Medicaid Services (CMS) National Downloadable File database. The study found a significant trend toward consolidation, with the number of ophthalmology practices decreasing by 18% while the number of ophthalmologists remained relatively stable. Practices with 10 or more ophthalmologists saw a 16% increase. The trend was consistent across genders, regions, and years spent in practice.

Several factors contributing to this consolidation trend were identified, including the COVID-19 pandemic, private equity acquisitions, and changes in health policy like the introduction of performance-based payment models. The study suggests that consolidation has both advantages and disadvantages. On the positive side, larger practices can achieve economies of scale, negotiate better reimbursement rates, and have more resources to meet reporting requirements. On the downside, consolidation may lead to reduced competition, higher prices for patients, and a focus on short-term financial gains over long-term investments in practice and evidence-based medical care.

The study concludes that while consolidation is in line with general trends in the U.S. healthcare landscape, its implications for healthcare delivery and patient outcomes remain to be determined and warrant further investigation.

Ophthalmology Volume 130, Number 9, September 2023

全身性藥物使用與青光眼和眼壓的關聯性：歐洲眼科流行病學聯盟研究

中文摘要

這是一篇研究文章的詳細摘要，探討常用全身性藥物與青光眼之間的關聯性，特別關注了鈣通道阻滯劑（calcium channel blockers, CCBs）和systemic β-blockers。這項研究似乎發現了CCBs使用與青光眼盛行率之間的潛在有害關聯，以及systemic β-blockers使用與較低眼內壓（IOP）之間的有益關聯。

以下是整理出的一些關鍵點：

CCBs：研究發現CCBs使用與青光眼盛行率增加之間存在顯著關聯。Odd ratio（OR）為1.96，95％信賴區間（CI）為1.23至3.12。這表明使用CCBs的人與不使用這些藥物的人相比，可能患青光眼的機會幾乎是兩倍。

Systemic β-blockers：研究發現β-blockers與較低的IOP之間存在關聯，這在青光眼的背景下通常被認為是有益的。

其他藥物：研究還考慮了其他藥物，如 angiotensin-converting enzyme inhibitors（ACEIs）、 angiotensin-converting enzyme inhibitors（ARBs）、statins和sulfonylureas ，但在研究中發現結果不一致。

混雜因素 (Cofounding factors)：研究考慮了重要的混雜因素，如收縮壓和糖尿病，但承認殘餘混雜可能無法排除。

臨床相關性：如果進一步的研究確認這些發現，這對於高血壓患者的管理，尤其是那些患有或有患青光眼風險的患者，可能會有重大影響。

進一步研究：作者呼籲進行長期研究以確認這些發現並確定因果關係。

限制：該研究存在一些限制，包括對藥物持續時間或劑量的數據缺乏，並且大多數數據是在10年前收集的。

值得注意的是，雖然這些發現很有趣，但它們並不是這些藥物與青光眼之間因果關係的定論性證據。需要進一步的研究來確認這些關聯性並探索可能的機制。

English Abstract

Its a detailed summary of a research article that investigates the association between commonly used systemic medications and glaucoma, including 4 categories of systemic medications: antihypertensive medications(b-blockers,diuretics, calcium channel blockers [CCBs],a-agonists, angiotensin-converting enzyme inhibitors,and angiotensin II receptor blockers), lipid-lowering medications,antidepressants,and anti-diabetic medications with glaucoma prevalence and IOP. The study seems to have found a potentially harmful association between the use of calcium channel blockers (CCBs) and the prevalence of glaucoma, as well as a beneficial association between systemic beta-blockers and lower IOP.

Here are some key points I gathered from the text:

1. Calcium Channel Blockers (CCBs): The study found a significant association between the use of CCBs and increased glaucoma prevalence. The odds ratio (OR) was 1.96, with a 95% confidence interval (CI) of 1.23 to 3.12. This suggests that people who use CCBs may have almost twice the odds of having glaucoma compared to those who don’t use these medications.

2. Systemic Beta-Blockers: The study found that systemic beta-blockers were associated with lower IOP, which is generally considered beneficial in the context of glaucoma.

3. Other Medications: The study also looked at other medications like angiotensin-converting enzyme inhibitors (ACEIs), angiotensin-converting enzyme inhibitors (ARBs), statins, and sulfonylureas but found inconsistent results across studies.

4. Confounding Factors: The study accounted for important confounders like systolic blood pressure and diabetes mellitus but acknowledges that residual confounding cannot be excluded.

5. Clinical Relevance: If further studies confirm these findings, this could have significant implications for the management of patients with hypertension who also have or are at risk of glaucoma.

6. Further Studies: The authors call for longitudinal studies to confirm these findings and determine causality.

7. Limitations: The study had some limitations, including the lack of data on medication duration or dosage, and the fact that most of the data was collected more than 10 years ago.

It’s important to note that while these findings are intriguing, they are not definitive proof of a causal relationship between these medications and glaucoma. Further studies are needed to confirm these associations and to explore potential mechanisms.

Ophthalmology Volume 130, Number 9, September 2023

生物類似物的矛盾：抗血管內皮生長因子生物類似物如何可能增加患者和整體醫療保健成本。

中文摘要

內容是一篇關於引入抗血管內皮生長因子（Anti-VEGF）生物類似物 (biosimilars)，特別是
bevacizumab，在眼科中可能帶來的潛在財務影響的詳細文章或研究。抗血管內皮生長因子藥物對於治療如新生血管性年齡相關性黃斑變性（nAMD）、糖尿病性黃斑水腫和視網膜靜脈阻塞（RVO）等眼部疾病至關重要。這些藥物成本高昂，並且它們的使用量正在增加，導致巨大的醫療保健支出。

該文章指出，雖然生物類似物通常是為了降低成本而引入的，但引入bevacizumab 的生物類似物可能出現費用的悖論。這主要是因為 bevacizumab 經常被off-label use使用於眼部，並且會被重新包裝(repackage)成較小的劑量，使其更具成本效益。然而，專門為眼科使用批准的生物類似物的引入可能會限制對off label bevacizumab 的重新包裝，從而推高成本。

以下是一些關鍵要點：

1. 對醫療保險和患者的成本影響：文章估計，如果一種眼內用 bevacizumab 生物類似物的價格為每劑500美元，醫療保險第B部分的成本將增加4.57億美元，增幅達到15.2%。

2. 切換至其他生物類似物：即使目前正在使用anibizumab or aflibercept 的患者轉換到相應的生物類似物，節省的費用也只能抵銷 bevacizumab 生物類似物所增加的28.8%的成本。

3. 監管問題：藥品質量和安全法案（Drug Quality and Security Act）可能會禁止在為眼科使用批准生物類似物的情況下repackage of off-label bevacizumab，進一步使成本情境變得更加複雜。

4. 患者取得：增加的成本還可能影響患者獲得這些關鍵治療方法的能力，因為成本更高可能導致保險政策變得更加嚴格，需要更多的先前授權要求。

5. 國際影響：該文章還暗示，bevacizumab 生物類似物的影響可能因當地法規和實踐而有所不同。

該文章對眼科中使用抗血管內皮生長因子藥物和生物類似物所涉及的複雜財務和監管環境提供了全面的探討。它提出了關於如何在醫療體系中平衡成本、取得和安全性的重要問題。

English Abstract

The text appears to be a detailed article or study discussing the potential financial implications of introducing biosimilars for anti-VEGF (Vascular Endothelial Growth Factor) drugs, particularly bevacizumab, in ophthalmic care. Anti-VEGF drugs are critical for treating various eye conditions like neovascular age-related macular degeneration (nAMD), diabetic macular edema, and retinal vein occlusion (RVO). These drugs are costly, and their use has been increasing, leading to significant healthcare expenditures.

The article suggests that while biosimilars are generally introduced to reduce costs, the introduction of a biosimilar for bevacizumab could paradoxically increase healthcare costs. This is primarily because bevacizumab is often used off-label for ophthalmic conditions and is repackaged into smaller doses, making it more cost-effective. However, the introduction of a biosimilar specifically approved for ophthalmic use could limit the repackaging of off-label bevacizumab, thus driving up costs.

Here are some key points:

1. Costs to Medicare and Patients: The article estimates that if an intraocular bevacizumab biosimilar were priced at $500 per dose, Medicare Part B costs would increase by $457 million, an increase of 15.2%.

2. Switching to Other Biosimilars: Even if patients currently on ranibizumab or aflibercept were switched to their respective biosimilars, the savings would only offset 28.8% of the increased cost due to the bevacizumab biosimilar.

3. Regulatory Concerns: The Drug Quality and Security Act (DQSA) may prohibit the repackaging of off-label bevacizumab if a biosimilar is approved for ophthalmic use, further complicating the cost scenario.

4. Patient Access: The increased costs could also affect patient access to these crucial treatments, as higher costs could lead to more restrictive insurance policies and prior authorization requirements.

5. International Implications: The article also hints that the impact of a bevacizumab biosimilar could vary internationally, depending on local regulations and practices.

6. Future Uncertainty: The article calls for a reevaluation of FDA policies, suggesting that an exemption for repackaged intraocular use of bevacizumab might be a prudent way to maintain patient access to this cost-effective treatment.

The article provides a comprehensive look at the complex financial and regulatory landscape surrounding the use of anti-VEGF drugs and biosimilars in ophthalmic care. It raises important questions about how best to balance cost, access, and safety in the healthcare system.