12. ADA 2022 差異: 12. Retinopathy

diabetes retinopathy

Diabetic Retinopathy
Recommendations

2021 vs 2022:
大型前瞻性隨機研究表明,以達到血糖接近正常為目標的強化糖尿病管理可預防和/或延緩糖尿病視網膜病變的發作和進展,減少對未來眼部外科手術的需求,並可能改善患者報告的視覺功能。 2,7-10)。 心血管結局研究數據的薈萃分析顯示GLP-1 RA治療與視網膜病變本身之間沒有關聯,除了視網膜病變與 3 個月和 1 年的平均 A1C 降低之間存在關聯。 這些試驗沒有研究改善血糖控制對視網膜病變的長期影響。 在強化降糖治療(例如使用 GLP-1 RA 的治療)時,應評估視網膜病變狀態 (11)。
Intensive diabetes management with the goal of achieving near-normoglycemia has been shown in large prospective randomized studies to prevent and/or delay the onset and progression of diabetic retinopathy, reduce the need for future ocular surgical procedures, and potentially improve patient reported visual function (2,7–10). A meta-analysis of data from cardiovascular outcomes studies showed no association between glucagon-like peptide 1 receptor agonist (GLP-1 RA) treatment and retinopathy per se, except through the association between retinopathy and average A1C reduction at the 3-month and 1-year follow-up. Long-term impact of improved glycemic control on retinopathy was not studied in these trials. Retinopathy status should be assessed when intensifying glucose-lowering therapies such as those using GLP-1 RAs (11)
 
2021:
一些病例係列和一項對照前瞻性研究表明,1 型糖尿病患者懷孕可能會加重視網膜病變並威脅視力,尤其是在受孕時血糖控制不佳時 (115,116)。 激光光凝手術可以最大限度地降低視力喪失的風險 (116)。 但是,在懷孕期間不宜進行干預。 這個問題通常在懷孕後消失,因此不需要治療。
Several case series and a controlled prospective study suggest that pregnancy in patients with type 1 diabetes may aggravate retinopathy and threaten vision, especially when glycemic control is poor at the time of conception (115,116). Laser photocoagulation surgery can minimize the risk of vision loss (116). However, intervention is not appropriate during pregnancy. This problem often resolves after pregnancy and so does not require treatment.
2022 修正:
幾個病例係列和一項對照前瞻性研究表明,1 型糖尿病患者的妊娠可能會加重視網膜病變並威脅視力,尤其是當受孕時血糖控制不佳或視網膜病變嚴重程度已達到晚期時 (12,13)。 對於患有高危增殖性糖尿病視網膜病變 (PDR) 或中心受累的糖尿病黃斑水腫 (13) 的患者,雷射光凝固手術可以最大限度地降低懷孕期間視力喪失的風險 糖尿病妊娠患者不應使用抗血管內皮生長因子 (anti-VEGF) 藥物,因為理論上對發育中胎兒的脈管系統存在風險。
Several case series and a controlled prospective study suggest that pregnancy in patients with type 1 diabetes may aggravate retinopathy and threaten vision, especially when glycemic control is poor or retinopathy severity is advanced at the time of conception (12,13). Laser photocoagulation surgery can minimize the risk of vision loss during pregnancy for patients with high-risk proliferative diabetic retinopathy (PDR) or center-involved diabetic macular edema (13). Anti–vascular endothelial growth factor (anti-VEGF) medications should not be used in pregnant patients with diabetes because of theoretical risks to the vasculature of the developing fetus.

Screening
Recommendations

2022 新增:
PDR 或黃斑水腫患者可能無症狀這一事實和預防的成效,給予篩查發現糖尿病視網膜病變提供了強有力的支持。
The preventive effects of therapy and the fact that patients with proliferative diabetic retinopathy (PDR) or macular edema may be asymptomatic provide strong support for screening to detect diabetic retinopathy.
 
2021:
如果視網膜病變正在發展,則需要眼科醫生進行更頻繁的檢查。
More frequent examinations by the ophthalmologist will be required if retinopathy is progressing.
2022 修正:
然而,重要的是要根據視網膜病變發作和視網膜病變惡化的特定風險因素的存在來調整篩查間隔。 如果視網膜病變正在進展或存在風險因素,例如不受控制的高血糖或晚期基線視網膜病變或糖尿病性黃斑水腫,則需要眼科醫生進行更頻繁的檢查。
However, it is important to adjust screening intervals based on the presence of specific risk factors for retinopathy onset and worsening retinopathy. More frequent examinations by the ophthalmologist will be required if retinopathy is progressing or risk factors such as uncontrolled hyperglycemia or advanced baseline retinopathy or diabetic macular edema are present.
 
2021 vs 2022:
FDA 授權使用AI 來作除了傳統篩查方法外另一個檢查 ,人工智能係統不僅可以檢測到輕度糖尿病性視網膜病變和糖尿病性黃斑水腫 (122)。 然而,這種篩選的好處和最佳利用尚未完全確定。 人工智能係統不應該用於已知有視網膜病變、接受過視網膜病變治療或有視力障礙症狀的患者。 應記錄眼科檢查結果並將其傳送給轉診的醫療保健專業人員。
Artificial intelligence systems that detect more than mild diabetic retinopathy and diabetic macular edema authorized for use by the FDA represent an alternative to traditional screening approaches (122). However, the benefits and optimal utilization of this type of screening have yet to be fully determined. Artificial intelligence systems should not be used for patients with known retinopathy, prior retinopathy treatment, or symptoms of vision impairment. Results of (Results of all screening) eye examinations should be documented and transmitted to the referring health care professional. (2022 修正)

Treatment
Recommendations

2021 vs 2022:
11.20 立即將患有任何程度的黃斑水腫、中度或更嚴重的非增殖性糖尿病視網膜病變(增殖性糖尿病視網膜病變的前兆)或任何增殖性糖尿病視網膜病變的患者轉診給在糖尿病視網膜病變管理方面知識豐富且經驗豐富的眼科醫生。 A
11.20 Promptly refer patients with any level of macular edema, severe moderate or worse (2022 修正)nonproliferative diabetic retinopathy (a precursor of proliferative diabetic retinopathy), or any proliferative diabetic retinopathy to an ophthalmologist who is knowledgeable and experienced in the management of diabetic retinopathy. A
 
2021 vs 2022:
11.22 對於一些增殖性糖尿病視網膜病變患者,玻璃體內注射抗血管內皮生長因子並不遜色於是傳統的全視網膜雷射光凝的合理替代方案,並且還表明可降低增殖性糖尿病視網膜病變這些患者視力喪失的風險。 A
11.22 Intravitreous injections of anti–vascular endothelial growth factor are not inferior to reasonable alternative to traditional panretinal laser photocoagulation for some patients with proliferative diabetic retinopathy and are also indicated to reduce the risk of vision loss in these patients with proliferative diabetic retinopathy. A
 
2022 新增:
12.13 黃斑局灶/網格光凝術和玻璃體內注射皮質類固醇是治療持續性糖尿病性黃斑水腫眼睛的合理治療方法,儘管之前接受過抗血管內皮生長因子治療或不適合該一線治療的眼睛。 A
12.13 Macular focal/grid photocoagulation and intravitreal injections of corticosteroid are reasonable treatments in eyes with persistent diabetic macular edema despite previous anti–vascular endothelial growth factor therapy or eyes that are not candidates for this first-line approach. A

Photocoagulation Surgery

2022 新增
ETDRS 顯示一種更溫和的黃斑局灶/網格激光光凝技術可有效治療具有臨床意義的糖尿病黃斑水腫的眼睛 (28),但現在這在很大程度上被認為是糖尿病性黃斑水腫的二線治療。
A more gentle, macular focal/grid laser photocoagulation technique was shown in the ETDRS to be effective in treating eyes with clinically significant macular edema from diabetes (28), but this is now largely considered to be second-line treatment for diabetic macular edema.

Anti–Vascular Endothelial Growth Factor Treatment

2021:
糖尿病視網膜病變臨床研究網絡和其他機構的最新數據表明,玻璃體內註射抗血管內皮生長因子 (anti-VEGF) 藥物,特別是ranibizumab,其視力結果並不遜於接受全視網膜激光治療的患者。 在 2 年的隨訪中 (128)。
Recent data from the Diabetic Retinopathy Clinical Research Network and others demonstrate that intravitreal injections of anti–vascular endothelial growth factor (anti-VEGF) agent, specifically ranibizumab, resulted in visual acuity outcomes that were not inferior to those observed in patients treated with panretinal laser at 2 years of follow-up (128).
 
2022 修正:
來自 DRCR Retina Network(前身為糖尿病視網膜病變臨床研究網絡)和其他機構的數據表明,與全視網膜雷射相比,玻璃體內注射抗 VEGF 藥物在 2 年的隨訪中能有效地消退增殖性疾病,並導致非劣或優越的視力結果(29,30)。
Data from the DRCR Retina Network (formerly the Diabetic Retinopathy Clinical Research Network) and others demonstrate that intravitreal injections of anti-VEGF agents are effective at regressing proliferative disease and lead to noninferior or superior visual acuity outcomes compared with panretinal laser over 2 years of follow-up (29,30).
 
2021 vs 2022:
雖然 ETDRS (28) 確定了局灶性激光光凝手術對具有臨床顯著黃斑水腫(定義為位於或威脅黃斑中心或距黃斑中心 500 µm 以內的視網膜水腫)的眼睛的益處,但來自精心設計的臨床試驗的當前數據表明,玻璃體內的抗 VEGF 藥物為中心受累的糖尿病性黃斑水腫提供比單一療法甚至激光單藥聯合治療更有效的治療方案 (32,33)。

目前有 3 種抗 VEGF 藥物常用於治療患有中樞性糖尿病黃斑水腫的眼睛—

bevacizumab, ranibizumab, and aflibercept (107)。
 
2022新增:大多數患者在治療的前 12 個月內需要幾乎每月使用抗 VEGF 藥物進行玻璃體內治療,隨後幾年需要更少的注射來維持中心受影響的糖尿病性黃斑水腫的緩解。目前有 3 種抗 VEGF 藥物常用於治療患有中心受累糖尿病性黃斑水腫的眼睛——bevacizumab, ranibizumab, and aflibercept(1)——一項比較有效性研究表明,當眼睛出現以下情況時,aflibercept提供的視力結果優於bevacizumab。糖尿病性黃斑水腫引起的中度視力障礙(視力為 20/50 或更差)(34)。對於儘管有糖尿病性黃斑水腫但視力良好(20/25 或更好)的眼睛,與立即開始抗 VEGF 治療相比,如果視力惡化,開始密切監測並開始抗 VEGF 治療可提供相似的 2 年視力結果(35)。
While the ETDRS (28) established the benefit of focal laser photocoagulation surgery in eyes with clinically significant macular edema (defined as retinal edema located at or threatening located at or within 500 µm the macular center), current data from well-designed clinical trials demonstrate that intravitreal anti-VEGF agents provide a more effective treatment regimen for center-involved diabetic macular edema than monotherapy or even combination therapy with laser (32,33).
There are currently three anti-VEGF agents commonly used to treat eyes with central-involved diabetic macular edema—bevacizumab, ranibizumab, and aflibercept (107).
2022新增:Most patients require near-monthly administration of intravitreal therapy with anti-VEGF agents during the first 12 months of treatment, with fewer injections needed in subsequent years to maintain remission from central-involved diabetic macular edema. There are currently three anti-VEGF agents commonly used to treat eyes with central-involved diabetic macular edema—bevacizumab, ranibizumab, and aflibercept (1)—and a comparative effectiveness study demonstrated that aflibercept provides vision outcomes superior to those of bevacizumab when eyes have moderate visual impairment (vision of 20/50 or worse) from diabetic macular edema (34). For eyes that have good vision (20/25 or better) despite diabetic macular edema, close monitoring with initiation of anti-VEGF therapy if vision worsens provides similar 2-year vision outcomes compared with immediate initiaion of anti-VEGF therapy (35).
2021:
在 DRS 和 ETDRS 中,雷射光凝手術有利於降低受影響患者進一步視力喪失的風險,但通常對扭轉已經降低的視力無益。 抗 VEGF 治療可改善視力,並已取代絕大多數糖尿病黃斑水腫患者對雷射光凝的需求 (132)。 大多數患者在治療的前 12 個月內需要幾乎每月使用抗 VEGF 藥物進行玻璃體內治療,隨後幾年需要更少的注射來維持中樞性糖尿病性黃斑水腫的緩解。
In both the DRS and the ETDRS, laser photocoagulation surgery was beneficial in reducing the risk of further visual loss in affected patients but generally not beneficial in reversing already diminished acuity. Anti-VEGF therapy improves vision and has replaced the need for laser photocoagulation in the vast majority of patients with diabetic macular edema (132). Most patients require near-monthly administration of intravitreal therapy with anti-VEGF agents during the first 12 months of treatment, with fewer injections needed in subsequent years to maintain remission from central-involved diabetic macular edema.
2022 修正:
儘管進行了抗 VEGF 治療,但仍存在持續性糖尿病性黃斑水腫的眼睛,可能會受益於黃斑雷射光凝術或使用皮質類固醇的玻璃體內治療。 對於因妊娠等全身性考慮而不適合抗 VEGF 治療的患者,這兩種療法也是合理的一線治療方法
Eyes that have persistent diabetic macular edema despite anti-VEGF treatment may benefit from macular laser photocoagulation or intravitreal therapy with corticosteroids. Both of these therapies are also reasonable first-line approaches for patients who are not candidates for anti-VEGF treatment due to systemic considerations such as pregnancy.

Adjunctive Therapy

2021 vs 2022:
降低血壓已被證明可以減少視網膜病變的進展,儘管嚴格的目標(收縮壓 <120 mmHg)不會帶來額外的好處(113)。 ACE 抑製劑和 ARB 都是糖尿病視網膜病變的有效治療方法 (133)。 在血脂異常患者中,加入非諾貝特可能會減緩視網膜病變的進展,尤其是基線時非常輕微的非增殖性糖尿病視網膜病變 (111,134)。
Lowering blood pressure has been shown to decrease retinopathy progression, although tight targets (systolic blood pressure <120 mmHg) do not impart additional benefit (113). ACE inhibitors and ARBs are both effective treatments in diabetic retinopathy (133).  (2022 刪除) In patients with dyslipidemia, retinopathy progression may be slowed by the addition of fenofibrate, particularly with very mild nonproliferative diabetic retinopathy at baseline (111,134).

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