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臭氧油和妥布霉素/地塞米松滴眼液联合治疗病毒性结膜炎的作用:一项随机临床试验。

The role of ozonized oil and a combination of tobramycin/dexamethasone eye drops in the treatment of viral conjunctivitis: a randomized clinical trial.

机构信息

Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy.

Microbiology Unit, Department of Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy.

出版信息

Int Ophthalmol. 2020 Dec;40(12):3209-3215. doi: 10.1007/s10792-020-01503-4. Epub 2020 Jul 22.

Abstract

PURPOSE

To determine whether topical tobramycin 0.3%/dexamethasone 0.1% plus ozonized oil eye drops reduces clinical signs and infectious viral titers of presumed viral conjunctivitis more than tobramycin/dexamethasone eye drops alone.

METHODS

Prospective, single-blind, randomized, parallel-groups trial. Eighty patients with a clinical diagnosis of presumed viral conjunctivitis were randomizedly divided into two treatment groups: a study group and a control group, 40 for each group. Patients in the study group received topical tobramycin 0.3%/dexamethasone 0.1% eye drops, plus ozonized oil eye drops, both four times daily; patients in the control group received only topical tobramycin 0.3%/dexamethasone eye drops four times daily. The treatment was for seven days in both groups. Swabs were taken from the conjunctival fornix for adenovirus PCR analysis on the day of recruitment and at seven days follow-up. Clinical signs were also recorded on the day of recruitment and at follow-up examination: the main outcomes were conjunctival injection and conjunctival chemosis, graded on a 4-point clinical scale, presence or absence of superficial punctate keratitis and subepithelial corneal infiltrates.

RESULTS

No statistically significant difference was reached in adenoviral infection negativization between the two groups, although the study group showed a higher number of PCR negative results at seven days follow-up. PCR real time detected adenoviral infection in 17 of 24 patients on the day of recruitment and it was positive in 4 patients on the seventh day (viral positivity reduction of 76%). In the control group PCR was positive for adenovirus in 18 of 24 patients on the day of recruitment and in 7 patients at seven days follow-up (reduction of 61%). There was statistically significant difference on conjunctival clinical signs between the study and control groups. Significant difference was also found on superficial punctate keratitis resolution between the study and the control group. In the former superficial punctate keratitis was detected in 14 eyes on the first day and in 5 eyes after seven days while in the latter superficial punctate keratitis was found in 124 eyes on the first day and in 6 eyes on the seventh day. No difference was found in subepithelial corneal infiltrates appearance between the two groups.

CONCLUSIONS

The use of ozonized-oil containing eye drops in combination with topical tobramycin 0.3%/dexamethasone 0.1% eye drops four times daily seems to reduce the signs of conjunctivitis, and the duration of viral infection, although it does not affect the subepithelial corneal infiltrates appearance.

摘要

目的

确定妥布霉素 0.3%/地塞米松 0.1%加臭氧油滴眼液是否比妥布霉素/地塞米松滴眼液单独使用更能减轻疑似病毒性结膜炎的临床症状和感染性病毒滴度。

方法

前瞻性、单盲、随机、平行组试验。80 例临床诊断为疑似病毒性结膜炎的患者被随机分为两组:研究组和对照组,每组 40 例。研究组患者接受妥布霉素 0.3%/地塞米松 0.1%滴眼液,加臭氧油滴眼液,均每日 4 次;对照组患者仅接受妥布霉素 0.3%/地塞米松滴眼液每日 4 次。两组治疗均为 7 天。在招募当天和随访第 7 天,从结膜穹窿处采集拭子进行腺病毒 PCR 分析。在招募当天和随访检查时还记录了临床症状:主要结局是结膜充血和结膜水肿,按 4 分临床量表分级,是否存在浅层点状角膜炎和上皮下角膜浸润。

结果

两组腺病毒感染转阴率无统计学差异,但研究组在随访第 7 天 PCR 阴性结果较多。PCR 实时检测显示,24 例患者中有 17 例在招募当天感染腺病毒,7 例在第 7 天感染(病毒阳性率降低 76%)。对照组 24 例患者中有 18 例在招募当天和 7 例在第 7 天检测到腺病毒阳性(病毒阳性率降低 61%)。研究组和对照组之间的结膜临床体征有统计学差异。研究组和对照组之间的浅层点状角膜炎消退也有统计学差异。前者第 1 天有 14 只眼和第 7 天有 5 只眼检测到浅层点状角膜炎,后者第 1 天有 24 只眼和第 7 天有 6 只眼检测到浅层点状角膜炎。两组间上皮下角膜浸润的出现无差异。

结论

妥布霉素 0.3%/地塞米松 0.1%滴眼液每日 4 次联合臭氧油滴眼液似乎可以减轻结膜炎的体征和病毒感染持续时间,尽管它不会影响上皮下角膜浸润的出现。

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