Rose-Nussbaumer Jennifer, Prajna N Venkatesh, Krishnan K Tiruvengada, Mascarenhas Jeena, Rajaraman Revathi, Srinivasan Muthiah, Raghavan Anita, Oldenburg Catherine E, O'Brien Kieran S, Ray Kathryn J, McLeod Stephen D, Porco Travis C, Lietman Thomas M, Acharya Nisha R, Keenan Jeremy D
Francis I. Proctor Foundation, University of California, San Francisco2Department of Ophthalmology, University of California, San Francisco3Department of Optometry, University of California, Berkeley.
Aravind Eye Care System, Madurai, India5Aravind Eye Care System, Pondicherry, India6Aravind Eye Care System, Coimbatore, India.
JAMA Ophthalmol. 2015 Jun;133(6):642-6. doi: 10.1001/jamaophthalmol.2015.0319.
Given the limitations in health care resources, quality-of-life measures for interventions have gained importance.
To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire.
DESIGN, SETTING, AND PARTICIPANTS: Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3).
Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%.
Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months.
A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52).
We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole, and especially among patients with Fusarium species as the causative organism. Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions.
clinicaltrials.gov Identifier:NCT00996736.
鉴于医疗保健资源的限制，干预措施的生活质量衡量标准变得愈发重要。
通过印度视觉功能问卷来确定在真菌性溃疡治疗试验I中，那他霉素治疗组和伏立康唑治疗组之间与视力相关的生活质量结果是否存在差异。
设计、地点和参与者：对印度南部阿拉文眼科护理系统多个地点进行的一项双盲、多中心、随机、活性对照临床试验进行二次分析（于2014年10月11日至25日进行），该试验纳入了培养或涂片阳性的丝状真菌性角膜溃疡患者，其基线视力为20/40至20/400（对数最小分辨角为0.3 - 1.3）。
研究参与者被随机分配至1%的局部用伏立康唑或5%的局部用那他霉素。
3个月时印度视觉功能问卷4个分量表（移动性、活动受限、心理社会影响和视觉功能）各自的分量表得分。
共有323名患者参与该试验，292名（90.4%）在3个月时完成了印度视觉功能问卷。大多数研究参与者的分量表得分表明功能极佳。在对基线视力和病原体进行校正后，我们发现那他霉素治疗组的研究参与者平均得分比伏立康唑治疗组高4.3分（95%置信区间，0.1 - 8.5）（P = 0.046）。在针对由镰刀菌属引起的溃疡进行亚组分析并对基线最佳矫正视力进行校正后，那他霉素治疗组的得分比伏立康唑治疗组高8.4分（95%置信区间，1.9 - 14.9）（P = 0.01）。对于由曲霉菌或其他非镰刀菌属作为病原体的患者，未检测到生活质量差异（1.5分[95%置信区间， - 3.9至6.9]；P = 0.52）。
我们发现，与随机分配至伏立康唑的真菌性溃疡患者相比，随机分配至那他霉素的患者在与视力相关的生活质量方面有改善迹象，尤其是对于由镰刀菌属作为病原体的患者。在临床试验中纳入生活质量衡量标准对于全面评估所研究干预措施的效果很重要。
clinicaltrials.gov标识符：NCT00996736。
