奥洛他定与依美斯汀及氯替泼诺治疗儿童季节性过敏性结膜炎的有效性和安全性及耐受性的随机对照研究

发布时间：2018-05-14 12:08

  本文选题：季节性过敏性结膜炎(SAC) + 0.1%奥洛他定　； 参考：《大连医科大学》2017年硕士论文

【摘要】：目的:过敏性结膜炎是由多种因素导致的影响患儿身心健康的疾病,然而目前尚未发现短期、有效和安全的治疗药物,而且由于患儿依从性比较差,因而探究儿童有效、安全和短程的用药方案很是有必要的。本试验目的:对比0.1%奥洛他定、0.05%依美斯汀、0.5%氯替泼诺和对照剂(0.5%羧甲基纤维素钠)治疗儿童季节性过敏性结膜炎(SAC)的有效性、安全性以及患儿的耐受性。方法:本研究采取前瞻性、单盲性与随机对照研究。在受检对象监护人知情同意和配合下,按统一的诊断标准随机纳入于2015年7月-2015年11月来大连医科大学附属二院眼科门诊就诊的80例160只眼4-10岁的SAC的患儿,依照数字表法将患儿随机分为3个治疗组与1个对照组,每组20例,一共80例。第1个治疗组共20例40只眼使用质量分数为0.1%奥洛他定滴眼液(帕坦洛)日2次点双眼,1滴/次,第2个治疗组共20例40只眼使用质量分数为0.05%依美斯汀滴眼液(埃美丁)日2次点双眼,1滴/次,第3治疗组20例40只眼使用质量分数为0.5%氯替泼诺滴眼液(露达舒)日4次点双眼,1滴/次,而关于对照组则使用质量分数为0.5%羧甲基纤维素钠滴眼液(亮视)日3次点双眼,1滴/次。于用药前、用药后7天及用药后14天对患儿进行随访观察。观察患儿用药前后的症状(眼痒、畏光和眨眼)体征(乳头、滤泡、充血和水肿)和视力、眼底与眼压的变化以及用药后的患儿的不适反应。结果:用药后一周,在畏光和充血方面,0.05%依美斯汀、0.5%氯替泼诺与对照剂之间差异有统计学意义(P0.05);在乳头方面,治疗组3组与对照剂之间差异有统计学意义(P0.05);在滤泡方面,0.5%氯替泼诺与对照剂之间差异有统计学意义(P=0.023)。用药后两周,主要症状(眨眼除外)与体征的改善方面,治疗组3种药物同对照剂之间差异均有统计学意义(P0.05)。0.1%奥洛他定、0.5%氯替泼诺与0.05%依美斯汀3种滴眼液之间(畏光、眨眼和充血除外)差异均无统计学意义(P0.05);0.1%奥洛他定、0.5%氯替泼诺与0.05%依美斯汀在畏光方面差异有统计学意义(P0.05);0.05%依美斯汀与0.5%氯替泼诺在眨眼、充血方面差异有统计学意义(P0.05)。在本研究中,0.1%奥洛他定和0.05%依美斯汀及0.5%氯替泼诺3种滴眼液之间用药后一周与用药后两周眼压各组之间差异均无统计学意义(P≥0.05),治疗组3组与对照组之间差异同样均无统计学意义(P≥0.05)。本研究在试验组3组之间以及试验组与对照组之间并均未发现有临床意义的眼压升高(≥10mmHg),未发现明显的视力改变,未发现有临床上眼底的改变,未发现患儿其他的不适。结论:0.1%奥洛他定和0.05%依美斯汀与0.5%氯替泼诺3种滴眼液之间有效性相似;0.1%奥洛他定与0.05%依美斯汀和0.5%氯替泼诺3种滴眼液与对照剂是同样安全易耐受的。
[Abstract]:Objective: allergic conjunctivitis is a disease which is caused by a variety of factors that affect the physical and mental health of the children. However, there are no short-term, effective and safe treatment drugs, and because the compliance of the children is poor, it is necessary to explore the effective, safe and short-range regimen of the children. The purpose of this test is to compare 0.1% otodosin, 0 .05%, 0.5% chloroprepreo and a control agent (0.5% carboxymethyl cellulose sodium) for the treatment of children's seasonal allergic conjunctivitis (SAC), safety and tolerance. Methods: a prospective, single blind and randomized controlled study was taken in this study. Under the informed consent and coordination of the inspected monitor, a unified diagnostic standard 80 children with 160 eyes of 4-10 year old SAC were randomly included in the ophthalmology outpatient department of the Second Affiliated Hospital of Dalian Medical University, July 2015 -2015. According to the digital table method, the children were randomly divided into 3 treatment groups and 1 control groups, 20 cases in each group and 80 cases. 40 eyes in 40 eyes were used in 40 eyes of 0.1% ollow eye drops in 40 eyes. Liquid (Patalo) daily 2 points, 1 drops / times, second treatment groups, 20 cases in 40 eyes, 20 cases with the mass fraction of 0.05% in the eye drops (Ai Meiding) day 2 eyes, 1 drops / times, third treatment group 20 cases 40 eye use mass fraction of 0.5% chloro tadio (Lu Da Shu) day 4 eyes, 1 drop / times, and the control group use quality The scores were 0.5% Carboxymethylcellulose Sodium Eye Drops (eyesight) day at 3 points and 1 drops / times. The children were followed up and observed before medication, 7 days after medication and 14 days after medication. The symptoms (papilla, follicular, congestion and edema) and visual acuity, changes in fundus and intraocular pressure, and after medication were observed before and after medication of the children before and after medication. Results: one week after medication, there was significant difference in the difference between 0.05% and 0.5% chloro tipno and control agents (P0.05) in photophobia and hyperemia (P0.05); in the nipple, the difference between the 3 groups and the control agents was statistically significant (P0.05); in the follicle, there was a statistical difference between the 0.5% chlorobo and the control agent. Significance (P=0.023). Two weeks after medication, the main symptoms (except blink) and the improvement of physical signs, the difference between the 3 drugs and the control agent in the treatment group was statistically significant (P0.05).0.1% ordovid, 0.5% chloro tippn and 0.05% of the 3 kinds of eyedrops (except for blink and congestion) were not statistically significant (P0.05); 0.1% Austria The difference in photophobia between 0.5% chlorotipno and 0.05% Edin was statistically significant (P0.05); 0.05% in the blink and 0.5% of the 0.5% chlorotipno in the blink of the eye (P0.05). In this study, 0.1% ootid and 0.05% Edin and 0.5% chlorotipno were used for one week after medication and drug use. There was no significant difference between the groups of intraocular pressure (P > 0.05) in the last two weeks (P > 0.05). There was no significant difference between the 3 groups in the treatment group and the control group (P > 0.05). There was no significant increase in intraocular pressure (> 10mmHg) between the 3 groups of the experimental group and between the experimental group and the control group. The existing clinical fundus changes were not found in other children's discomfort. Conclusion: the effectiveness of 0.1% ololadin and 0.05% estin and 0.5% chlortipre - 3 eye drops is similar, and 0.1% ololadin and 0.05% Edin and 0.5% chlortipre's 3 eye drops are equally tolerable.

【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R777.31
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本文编号：1887786