采用针灸纠正屈光参差性弱视患者的屈光状态的附加效应：一项随机交叉试验的1年结果

Objectives:To evaluate the safety and adjunctive effect of acupuncture added to refractive correction for anisometropic amblyopia in younger children. Design: Prospective, randomized, controlled, crossover trial. Participants:We included 83 children aged 3 to <7years with untreated anisometropic amblyopia and baseline best-corrected visual acuity (BCVA) of 20/40 to 20/200 in the amblyopic eye. Methods:Participants were randomized to receive spectacles alone (group 1; n=42) or spectacles+acupuncture (group 2; n=41) for 15weeks, and were then crossed over to receive the other regimen for another 15weeks. The BCVA in both eyes was measured at baseline and every 5 (±1)weeks for the initial 45weeks and at 60 (±1)weeks. Main Outcome Measures:BCVA in the amblyopic eye at 15, 30, and 60weeks. Results:The mean baseline BCVA in the amblyopic eye was 0.50 and 0.49 logarithm of the minimum angle of resolution (logMAR) in groups 1 and 2, respectively. After 15weeks of treatment, the BCVA had improved by a mean of 2.2 lines in group 1 and 2.9 lines in group 2. The mean difference in BCVA between groups was 0.77 lines (95% confidence interval (CI), 0.29–1.3; P=0.0020) with baseline adjustment. BCVA of ≤0.1 logMAR was achieved in 14.6% of the patients in group 1 and 57.5% in group 2 (P<0.00010). After the regimens were crossed over at 30weeks, group 1 had a mean of 1.2 (95% CI, 0.98–1.48; P=2.0×10−12) lines additional improvement from the 15-week BCVA, whereas in group 2 the mean improvement was 0.4 (95% CI, 0.19–0.63; P=0.0010) lines. The proportions of responders, resolution, and participants achieving a BCVA of ≤0.1 logMAR at 30weeks were similar between groups. After completion of acupuncture, only 1 participant had >1 line of VA decrease to 60weeks. Acupuncture was well-tolerated by all children, and no severe adverse effect was encountered. Conclusions:Acupuncture is a potentially useful complementary treatment modality that may provide sustainable adjunctive effect to refractive correction for anisometropic amblyopia in young children. Further large-scale studies seem warranted.