0.15%更昔洛韦凝胶局部应用治疗巨细胞病毒前节段感染的房水内药物水平：一项初步研究。
Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study.
作者信息
Waduthantri Samanthila, Zhou Lei, Chee Soon-Phaik
机构信息
Singapore Eye Research Institute, Singapore, Singapore.
Singapore National Eye Centre, Singapore, Singapore.
出版信息
PLoS One. 2018 Jan 29;13(1):e0191850. doi: 10.1371/journal.pone.0191850. eCollection 2018.
PURPOSE
To investigate the intra-cameral level of ganciclovir following topical application of ganciclovir gel, 0.15% for cytomegalovirus (CMV) anterior segment infection.
DESIGN
Non-randomized, prospective, interventional clinical study.
METHODS
Patients with active CMV anterior segment infection seen at Singapore National Eye Centre, confirmed by positive CMV real time PCR (RT-PCR) of the aqueous humor, that had not been treated with any form of ganciclovir in the preceding 1 month were recruited. They were treated with ganciclovir gel, 0.15% 1cc 5 times a day. Following 6 weeks of treatment, CMV load in the aqueous humor was measured using CMV RT-PCR and the ganciclovir drug levels in tears and aqueous humor were measured using high-performance liquid chromatography-mass spectrometry. The clinical features of the disease activity and the central corneal thickness (CCT) were recorded at the baseline and post-treatment.
RESULTS
There were 29 eyes of 29 patients, of which 23 eyes had CMV anterior uveitis and 6 eyes had CMV endotheliitis. At the end of week 6, 26 eyes had undetectable CMV titre in the aqueous humor and no anterior chamber (AC) activity. Two patients had an increased CMV titre and increased AC inflammation. Both of these patients were non-compliant with the treatment. One patient had a reduced CMV titre in the aqueous humor with minimal AC inflammation. The mean ganciclovir concentration in the aqueous humor and the tears were 17.4 ± 30.6 ng/ml and 20,420.9 ± 33,120.8 ng/ml respectively. Mean CCT was 552.2 ± 42.3 microns. There was a weak correlation between the ganciclovir concentration in the aqueous humor and CCT (Spearmen's r = + 0.42, p = 0.025). There was no significant correlation between the ganiclovir concentration in the tears and CCT (Spearmen's r = + 0.39, p = 0.11).
CONCLUSION
Ganciclovir levels in the aqueous humor was below the 50% inhibitory dose (ID50) for CMV replication, following topical application of the ganciclovir gel, 0.15%.
TRIAL REGISTRATION
SingHealth Centralized Institutional Review Board, Singapore; R733/17/2010, ClinicalTrials.gov; NCT01647529.
目的
研究0.15%更昔洛韦凝胶局部应用后，用于巨细胞病毒（CMV）前段感染时房水中更昔洛韦的水平。
设计
非随机、前瞻性、干预性临床研究。
方法
招募在新加坡国立眼科中心就诊的活动性CMV前段感染患者，房水CMV实时荧光定量聚合酶链反应（RT-PCR）呈阳性确诊，且在过去1个月内未接受过任何形式更昔洛韦治疗。患者接受0.15%更昔洛韦凝胶，1cc，每日5次治疗。治疗6周后，使用CMV RT-PCR测量房水中的CMV载量，并使用高效液相色谱-质谱法测量泪液和房水中的更昔洛韦药物水平。在基线和治疗后记录疾病活动的临床特征和中央角膜厚度（CCT）。
结果
29例患者共29只眼，其中23只眼患有CMV前葡萄膜炎，6只眼患有CMV内皮炎。在第6周结束时，26只眼房水中CMV滴度检测不到，且无前房（AC）活动。2例患者CMV滴度升高且AC炎症加重。这2例患者均未遵医嘱治疗。1例患者房水中CMV滴度降低，AC炎症轻微。房水和泪液中更昔洛韦的平均浓度分别为17.4±30.6 ng/ml和20420.9±33120.8 ng/ml。平均CCT为552.2±42.3微米。房水中更昔洛韦浓度与CCT之间存在弱相关性（Spearman's r=+0.42，p=0.025）。泪液中更昔洛韦浓度与CCT之间无显著相关性（Spearman's r=+0.39，p=0.11）。
结论
局部应用0.15%更昔洛韦凝胶后，房水中更昔洛韦水平低于CMV复制的50%抑制剂量（ID50）。
试验注册
新加坡SingHealth中央机构审查委员会；R733/17/2010，ClinicalTrials.gov；NCT01647529。
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