Shimmura S, Ono M, Shinozaki K, Toda I, Takamura E, Mashima Y, Tsubota K
Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
Br J Ophthalmol. 1995 Nov;79(11):1007-11. doi: 10.1136/bjo.79.11.1007.
Several studies in the past have attempted to demonstrate the efficacy of sodium hyaluronate in the treatment of dry eyes. However, results have been conflicting and a definite conclusion has not yet been reached. This study recruited a larger group of patients and has incorporated for the first time both fluorescein and rose bengal staining in the evaluation of the epithelium.
Eighteen albino rabbit corneas were used in a basic animal study to demonstrate the efficacy of sodium hyaluronate by comparing the effects on the rate of epithelial healing. The optimal concentration to be used in the clinical trial was determined from the results of the basic study. In the clinical study 104 patients with dry eye syndrome were enrolled in a double masked controlled clinical trial. Patients received sodium hyaluronate drops in one eye and control medication in the other eye for 4 weeks. Grading of subjective symptoms and clinical examinations were performed at 2 and 4 weeks.
In the animal study sodium hyaluronate at concentrations of 0.1% and 0.5% significantly accelerated the recovery time of iodine vapour induced corneal erosions (p < 0.01). In the clinical study no statistical significance was observed in the improvement of subjective symptoms or rose bengal staining, while fluorescein scores significantly improved in eyes receiving sodium hyaluronate (p = 0.0001) at 4 weeks.
Sodium hyaluronate drops applied in six daily doses could not be demonstrated to offer advantages over conventional tear supplies in the improvement of subjective symptoms, but may play a role in maintaining a healthy corneal epithelium.
过去有多项研究试图证明透明质酸钠治疗干眼症的疗效。然而,结果相互矛盾,尚未得出明确结论。本研究招募了更大规模的患者群体,并首次将荧光素和孟加拉玫瑰红染色纳入上皮评估。
在一项基础动物研究中使用18只白化兔角膜,通过比较对上皮愈合速度的影响来证明透明质酸钠的疗效。根据基础研究结果确定临床试验中使用的最佳浓度。在临床研究中,104例干眼症综合征患者参加了一项双盲对照临床试验。患者一只眼睛滴入透明质酸钠滴眼液,另一只眼睛滴入对照药物,持续4周。在第2周和第4周进行主观症状分级和临床检查。
在动物研究中,0.1%和0.5%浓度的透明质酸钠显著加快了碘蒸气诱导的角膜糜烂的恢复时间(p < 0.01)。在临床研究中,主观症状改善或孟加拉玫瑰红染色方面未观察到统计学意义,而在接受透明质酸钠的眼睛中,荧光素评分在4周时显著改善(p = 0.0001)。
每日6次滴入透明质酸钠滴眼液在改善主观症状方面未显示出优于传统泪液替代品的优势,但可能在维持健康的角膜上皮方面发挥作用。