Paques M, Chastang C, Mathis A, Sahel J, Massin P, Dosquet C, Korobelnik J F, Le Gargasson J F, Gaudric A
Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, France.
Ophthalmology. 1999 May;106(5):932-8. doi: 10.1016/s0161-6420(99)00512-6.
To evaluate prospectively the efficacy and safety of autologous platelet concentrate (APC) as an adjuvant in surgery for idiopathic macular hole.
Multicenter, double-masked, randomized clinical trial.
Four university-based ophthalmology clinics.
One hundred ten patients with stage 3 or 4 idiopathic full-thickness macular holes of less than 3 years' duration were randomized (53 eyes to the platelet group and 57 eyes to the control group).
Standardized macular hole surgery versus surgery combined with injection of an APC. In all cases, the procedure consisted of three-port pars plana vitrectomy, posterior hyaloid separation, and nonexpansile fluid-gas exchange. After the fluid-gas exchange, patients were randomized to receive either injection of an APC or no adjunctive treatment. After surgery, patients were positioned face down for 12 days. Platelet counts showed that the concentrates contained a mean of 96.106 platelets (range, 82-102).
Anatomic and functional evaluations were performed at 1, 3, and 6 months after surgery in a double-masked fashion by an independent observer. The main outcome was reapposition of the edge of the macular hole 1 month after surgery. Secondary outcomes were anatomic status at 3 and 6 months, changes in Early Treatment Diabetic Retinopathy Study score, and complications.
One month after surgery, the anatomic success rate in the platelet group was 52 of 53 (98%; 95% confidence interval, 0.90-1.00) versus 47 of 57 (82%; 95% confidence interval, 0.70-0.91) in the control group (P = 0.009, Fisher's exact test; relative risk, 0.11; 95% confidence interval, 0.01-0.81). Visual acuity was not significantly different between the two groups at any timepoint. There were no complications specifically attributable to the platelet injection.
Injection of APC improved significantly the anatomic success rate of surgery for idiopathic macular holes of less than 3 years' duration, but postoperative visual acuity of the platelet group was not statistically different from the control group.
前瞻性评估自体血小板浓缩液（APC）作为特发性黄斑裂孔手术辅助治疗的有效性和安全性。
多中心、双盲、随机临床试验。
四家大学附属医院眼科诊所。
110例病程小于3年的3期或4期特发性全层黄斑裂孔患者被随机分组（53眼进入血小板组，57眼进入对照组）。
标准化黄斑裂孔手术与手术联合注射APC。所有病例均采用三通道平坦部玻璃体切除术、玻璃体后脱离及非膨胀性液气交换。液气交换后，患者被随机分为接受APC注射或不接受辅助治疗。术后患者需面朝下体位12天。血小板计数显示浓缩液平均含有9⁶.¹⁰⁶个血小板（范围8²-1⁰²）。
术后1、3和6个月由独立观察者以双盲方式进行解剖和功能评估。主要观察指标为术后1个月黄斑裂孔边缘的重新贴合。次要观察指标为3个月和6个月时的解剖状态、糖尿病视网膜病变早期治疗研究评分的变化以及并发症。
术后1个月，血小板组的解剖成功率为53眼中的52眼（98%；95%置信区间，0.90-1.00），而对照组为57眼中的47眼（82%；95%置信区间，0.70-0.91）（P = 0.009，Fisher精确检验；相对风险，0.11；95%置信区间，0.01-0.81）。两组在任何时间点的视力均无显著差异。没有明确归因于血小板注射的并发症。
注射APC显著提高了病程小于3年的特发性黄斑裂孔手术的解剖成功率，但血小板组术后视力与对照组无统计学差异。
