Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
JAMA Ophthalmol. 2023 May 1;141(5):423-429. doi: 10.1001/jamaophthalmol.2023.0302.
The treatment of moderate to severe meibomian gland dysfunction (MGD) with oral doxycycline requires a 6-week course of treatment and has frequent adverse effects (AEs), which may be associated with poor compliance.
To determine if the AEs of a 3-week course of oral azithromycin were equivalent to the AEs of a 6-week course of oral doxycycline.
DESIGN, SETTING, AND PARTICIPANTS: This double-masked randomized clinical trial was conducted at a referral center in Thailand from September 2018 to May 2022. Participants with moderate to severe MGD judged unresponsive to conservative management were included.
Patients were randomized 1:1 to receive oral azithromycin (1 g once per week for 3 weeks) or oral doxycycline (200 mg daily for 6 weeks).
After initiating therapy, the study team assessed the total MGD score and Ocular Surface Disease Index (OSDI) score at the initial visit, at 6 weeks, and at 8 weeks, and assessed AEs at 6 weeks and 8 weeks. The prespecified equivalence margins for MGD score and OSDI score were set at ±2 and ±9, respectively.
A total of 137 eyes from 137 patients were randomized into groups, 68 eyes in the azithromycin group and 69 eyes in the doxycycline group (female, 66.4%; mean age, 62.0 [SD, 15.1] years). The adjusted mean difference of total MGD scores between groups at week 6 and week 8 were -0.33 (95% CI, -1.70 to 1.03; P for equivalence = .01) and 0.13 (95% CI, -1.59 to 1.84; P for equivalence = .02), respectively. The adjusted mean difference of OSDI between groups score at week 6 and week 8 was -1.20 (95% CI, -5.31 to 2.91; P for equivalence < .001) and -1.59 (95% CI, -5.73 to 2.55; P for equivalence < .001), respectively. In addition, patients treated with azithromycin had fewer gastrointestinal AEs (4.4% vs 15.9%; risk difference, 11.5%; 95% CI 1.6%-21.4%; P = .03).
These data support an equivalency of effects of azithromycin as compared with doxycycline for MGD score and OSDI score at both follow-up times. The study did not show more gastrointestinal AEs in the azithromycin group. The reduced dosing and potentially fewer gastrointestinal AEs associated with azithromycin support its use as an alternative to doxycycline for at least 6 weeks.
ThaiClinicalTrials.org Identifier: TCTR20180810001.
中重度睑板腺功能障碍 (MGD) 的治疗需要口服多西环素 6 周疗程，且有频繁的不良反应 (AE)，这可能与患者顺应性差有关。
确定 3 周疗程的口服阿奇霉素的 AE 是否与 6 周疗程的口服多西环素的 AE 相当。
设计、设置和参与者：这是一项在泰国的转诊中心进行的双盲随机临床试验，于 2018 年 9 月至 2022 年 5 月进行。纳入对保守治疗反应不佳的中重度 MGD 患者。
患者被随机 1:1 分配接受口服阿奇霉素（1 g/周，共 3 周）或口服多西环素（200 mg/天，共 6 周）。
在开始治疗后，研究小组在初始就诊时、第 6 周和第 8 周评估总 MGD 评分和眼表疾病指数 (OSDI) 评分，并在第 6 周和第 8 周评估 AE。MGD 评分和 OSDI 评分的预设等效边界分别设定为±2 和±9。
共有 137 名患者的 137 只眼被随机分为两组，阿奇霉素组 68 只眼，多西环素组 69 只眼（女性，66.4%；平均年龄 62.0[标准差 15.1]岁）。第 6 周和第 8 周时两组间总 MGD 评分的调整平均差异分别为-0.33（95% CI，-1.70 至 1.03；等效性 P=0.01）和 0.13（95% CI，-1.59 至 1.84；等效性 P=0.02）。第 6 周和第 8 周时两组间 OSDI 评分的调整平均差异分别为-1.20（95% CI，-5.31 至 2.91；等效性 P<0.001）和-1.59（95% CI，-5.73 至 2.55；等效性 P<0.001）。此外，阿奇霉素治疗组胃肠道 AE 较少（4.4% vs 15.9%；风险差异，11.5%；95% CI 1.6%-21.4%；P=0.03）。
这些数据支持阿奇霉素与多西环素在 MGD 评分和 OSDI 评分方面的疗效相当，在两个随访时间点均如此。研究并未显示阿奇霉素组有更多的胃肠道 AE。阿奇霉素减少剂量和潜在较少的胃肠道 AE 支持其作为多西环素的替代药物，至少使用 6 周。
泰国临床试验注册中心标识符：TCTR20180810001。
