糖尿病黄斑浮腫に対する抗VEGF薬硝子体注射導入時1回投与と連続3回投与の経過比較

Comparison of clinical outcomes between one and three monthly initial anti-VEGF therapy for diabetic macular edema

要約　目的：糖尿病黄斑浮腫（DME）の抗VEGF薬治療において，実臨床では導入期の投与回数が統一されていないため，導入期の投与回数による治療成績を比較検討する。

対象と方法：奈良県立医科大学附属病院眼科でDMEと診断され，2013年3月〜2018年1月の間に抗VEGF薬を初回投与し，2年以上経過観察が可能であった46眼を対象とした。初回投与時に1回のみ投与し，その後pro re nata（PRN）レジメンで投与を行った症例を1＋PRN群（20眼），導入期に連続3回，その後PRNレジメンで投与を行った症例を3＋PRN群（26眼）とした。各群において，最高矯正視力（logMar換算）および中心窩網膜厚（CMT）の変化を初回投与前と初回投与12か月後，24か月後で統計学的に比較検討した。

結果：平均年齢は両群間で有意差はなく，初回投与前の最高矯正視力（logMar）は1＋PRN群0.46±0.32，3＋PRN群0.44±0.27であった（p＝0.81）。初回投与12か月後，24か月後の最高矯正視力は，それぞれ1＋PRN群が0.48±0.29，0.47±0.27，3＋PRN群が0.35±0.34，0.31±0.26と両群間に有意差はなかったが，初回投与24か月後の3＋PRN群で良好な傾向であった（p＝0.06）。また，初回投与前のCMTは1＋PRN群411.03±140.39μm，3＋PRN群491.50±113.34μmであり，3＋PRN群が有意に大きかった（p＝0.023）。初回投与12か月後，24か月後のCMTは，1＋PRN群が421.23±185.56μm，403.58±149.79μm，3＋PRN群が441.58±142.89μm，371.20±89.37μmと，3＋PRN群で有意に減少した（p＝0.001）。

結論：DMEに対する抗VEGF薬治療は導入期に連続3回投与するほうが効果的であると考えられた。

Abstract　Purpose：The frequency of initial anti-VEGF therapy for diabetic macular edema（DME）is not consistent. This study aimed to compare the clinical outcomes by the frequency of initial therapy.

Cases and Methods：Forty-six eyes of 46 patients diagnosed with DME at Nara Medical University Hospital were included. They underwent initial therapy from March 2013 to January 2018 and were followed up for two years or longer. Twenty eyes received a 1＋PRN regimen（1＋PRN group）, and 26 eyes a 3＋PRN regimen（3＋PRN group）. The best-corrected visual acuity（BCVA）and central macular thickness（CMT）were measured at baseline and at 12, 24 months after the first therapy.

Results：There was no significant difference in the mean age between the groups. At baseline, the BCVA of the 1＋PRN and 3＋PRN groups were 0.46±0.32 and 0.44±0.27, respectively（p＝0.81）. CMT of the 1＋PRN and 3＋PRN groups at baseline were 411.03±140.39 μm and 491.50±113.34 μm, respectively（p＝0.023）. The BCVA of 1＋PRN group at 12 months and 24 months after the first therapy was 0.48±0.29 and 0.47±0.27, respectively and that of the 3＋PRN group was 0.35±0.34 and 0.31±0.26, respectively. Although we found no significant difference in the BCVA, that of the 3＋PRN group at 24 months after the first therapy was relatively better than the 1＋PRN group（p＝0.06）. The CMT of the 1＋PRN group at 12 months and 24 months after the first therapy was 421.23±185.56 μm and 403.58±149.79 μm, respectively, and that of the 3＋PRN group was 441.58±142.89 μm and 371.20±89.37 μm, respectively. Although there was no significant difference between the two groups, that of the 3＋PRN group significantly decreased in twenty-four months（p＝0.001）.

Conclusion：3＋PRN was a more effective regimen for the treatment of DME.