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脂质体臭氧油可确保玻璃体内注射前微生物负荷进一步降低:“OPERA”研究。

Liposomal Ozonated Oil Ensures a Further Reduction in the Microbial Load Before Intravitreal Injection: the "OPERA" Study.

作者信息

Grassi Maria Oliva, Boscia Giacomo, Alessio Giovanni, Zerbinati Marta, Petrara Giovanni, Puzo Pasquale, Giancipoli Ermete, Giuseppe Campagna, Boscia Francesco, Viggiano Pasquale

机构信息

Department of Translational Biomedicine Neuroscience, "Aldo Moro" University of Bari, Piazza Giulio Cesare, 11, 70122, Bari, Italy.

Department of Medical-Surgical Sciences and of Translational Medicine, "Sapienza" University of Rome, 00161, Rome, Italy.

出版信息

Ophthalmol Ther. 2024 Oct;13(10):2771-2788. doi: 10.1007/s40123-024-01006-w. Epub 2024 Aug 30.

Abstract

INTRODUCTION

This was a prospective study to investigate the antimicrobial efficacy of a novel ophthalmic solution comprising ozonated sunflower oil in liposomes plus hypromellose in conjunction with liposomal foam (BlefOX), in patients undergoing intravitreal injection, in comparison to povidone iodine 5%.

METHODS

The study employed a paired-eye design with n = 195 patients and a total of n = 390 eyes divided into two groups. Conjunctival swabs were collected from both eyes of each patient at baseline (T0-3 days before the injection). The study group underwent home therapy, which included instilling two drops of an isotonic ophthalmic solution containing 0.5% ozonated sunflower oil in liposomes plus hypromellose (Ozodrop) four times daily and applying liposomal foam twice daily to the eye undergoing intravitreal injections. In contrast, the control group (contralateral eyes) received treatment with povidone iodine 5%. This treatment regimen was maintained for 3 days. At T1 (10 min before injection), all patients instilled one drop of a topical solution of povidone iodine 5% into the conjunctival sac of both eyes. After 30 seconds had elapsed, a conjunctival swab was obtained for each eye in both study groups.

RESULTS

The results, derived from conjunctival swabs, exhibited a significant reduction in the microbial load of the study group on both chocolate agar and blood agar (p ≤ 0.007). The study demonstrated that the combination of povidone iodine 5% + Ozodrop + BlefOX provides a greater reduction in microbial load than povidone iodine 5% alone on both chocolate agar (141 [72.31%] vs. 98 [50.26%], p < 0.0001) and blood agar (130 [66.67%] vs. 97 [49.74%], p = 0.0007). The combination of povidone iodine 5% + Ozodrop + BlefOX resulted in the killing of approximately 41% to 49% of bacteria compared to povidone iodine 5% alone on the chocolate agar and blood agar, respectively.

CONCLUSIONS

Liposomal ozonated oil treatment, coupled with liposomal foam, in patients undergoing intravitreal injection led to a substantial reduction in conjunctival microbial load compared to eyes treated solely with povidone iodine 5%.

摘要

引言

这是一项前瞻性研究,旨在调查一种新型眼科溶液(包含脂质体包裹的臭氧化向日葵油加羟丙甲纤维素,并联合脂质体泡沫剂,即BlefOX)在接受玻璃体内注射的患者中的抗菌效果,与5%聚维酮碘进行比较。

方法

该研究采用双眼配对设计,n = 195例患者,共390只眼,分为两组。在基线时(注射前3天,T0)从每位患者的双眼采集结膜拭子。研究组接受家庭治疗,包括每天4次向眼内滴入两滴含有0.5%脂质体包裹的臭氧化向日葵油加羟丙甲纤维素的等渗眼科溶液(Ozodrop),并每天两次向接受玻璃体内注射的眼睛涂抹脂质体泡沫剂。相比之下,对照组(对侧眼)接受5%聚维酮碘治疗。该治疗方案维持3天。在T1(注射前10分钟),所有患者向双眼结膜囊内滴入一滴5%聚维酮碘局部溶液。30秒后,在两个研究组中为每只眼获取结膜拭子。

结果

来自结膜拭子的结果显示,研究组在巧克力琼脂和血琼脂上的微生物载量均显著降低(p≤0.007)。该研究表明,5%聚维酮碘 + Ozodrop + BlefOX组合在巧克力琼脂(141 [72.31%] 对98 [50.26%],p < 0.0001)和血琼脂(130 [66.67%] 对97 [49.74%],p = 0.0007)上比单独使用5%聚维酮碘能更大程度地降低微生物载量。与单独使用5%聚维酮碘相比,5%聚维酮碘 + Ozodrop + BlefOX组合在巧克力琼脂和血琼脂上分别导致约41%至49%的细菌被杀死。

结论

与仅用5%聚维酮碘治疗的眼睛相比,脂质体包裹的臭氧化油治疗联合脂质体泡沫剂在接受玻璃体内注射的患者中导致结膜微生物载量大幅降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a3ae/11408443/ff69d844d56a/40123_2024_1006_Fig1_HTML.jpg

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