Isenberg Sherwin J, Apt Leonard, Valenton Mario, Sharma Savitri, Garg Prashant, Thomas Philip A, Parmar Pragya, Kaliamurthy Jayaraman, Reyes Johann M, Ong Daniel, Christenson Peter D, Del Signore Madeline, Holland Gary N
Center To Prevent Childhood Blindness, UCLA Stein Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California; Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California.
Center To Prevent Childhood Blindness, UCLA Stein Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.
Am J Ophthalmol. 2017 Apr;176:244-253. doi: 10.1016/j.ajo.2016.10.004. Epub 2016 Oct 27.
To compare povidone-iodine 1.25% ophthalmic solution with topical antibiotics for treatment of bacterial keratitis in areas of the world where use of effective topical antibiotics may not be an option.
Randomized, controlled, investigator-masked clinical trial.
We randomized 172 individuals with bacterial keratitis to topical treatment with povidone-iodine or antibiotics (neomycin-polymyxin B-gramicidin in the Philippines; ciprofloxacin 0.3% in India). Using survival analysis, we compared intervals from start of treatment to "presumed cure" (primary outcome measure, defined as a closed epithelial defect without associated inflammatory signs) and to "recovering" (residual epithelial defect <1 mm with only minimal inflammation).
Median interval to presumed cure in the Philippines was 7 days for povidone-iodine and 7 days for neomycin-polymyxin B-gramicidin (95% confidence interval [CI] for difference in median interval, -9.5 to 0.7 days) and in India was 12 days for povidone-iodine and 17 days for ciprofloxacin (95% CI, -35.2 to 3.2 days). Hazard ratio (HR) for presumed cure among those treated with povidone-iodine (vs antibiotics) was 1.46 in the Philippines (95% CI, 0.90-2.36; P = .13) and 1.70 in India (95% CI, 0.73-3.94; P = .22). Comparisons of intervals to recovering and HR for recovering also revealed no significant differences between treatment groups in either country.
There is no significant difference between the effect of topical povidone-iodine 1.25% and topical antibiotics commonly available in the developing world for treatment of bacterial keratitis. Povidone-iodine 1.25%, which is widely available and inexpensive, can be considered for treatment of bacterial keratitis when antibiotic treatment is not practical.
在有效局部用抗生素可能无法使用的地区，比较1.25%聚维酮碘眼药水与局部用抗生素治疗细菌性角膜炎的效果。
随机、对照、研究者设盲的临床试验。
我们将172例细菌性角膜炎患者随机分为聚维酮碘或抗生素局部治疗组（在菲律宾为新霉素-多粘菌素B-短杆菌肽；在印度为0.3%环丙沙星）。采用生存分析，我们比较了从治疗开始到“假定治愈”（主要结局指标，定义为上皮缺损闭合且无相关炎症体征）和到“恢复”（残留上皮缺损<1毫米且仅有轻微炎症）的时间间隔。
在菲律宾，聚维酮碘组和新霉素-多粘菌素B-短杆菌肽组到假定治愈的中位时间均为7天（中位时间差异的95%置信区间[CI]为-9.5至0.7天）；在印度，聚维酮碘组为12天，环丙沙星组为17天（95%CI为-35.2至3.2天）。聚维酮碘治疗组（与抗生素组相比）假定治愈的风险比（HR）在菲律宾为1.46（95%CI为0.90-2.36；P=0.13），在印度为1.70（95%CI为0.73-3.94；P=0.22）。到恢复的时间间隔比较以及恢复的HR比较也显示，两个国家的治疗组之间均无显著差异。
1.25%聚维酮碘局部用药与发展中国家常用的局部用抗生素治疗细菌性角膜炎的效果无显著差异。1.25%聚维酮碘广泛可得且价格低廉，在抗生素治疗不可行时可考虑用于治疗细菌性角膜炎。
