奧洛他定與依美斯汀及氯替潑諾治療兒童季節(jié)性過敏性結膜炎的有效性和安全性及耐受性的隨機對照研究
發(fā)布時間:2018-05-14 12:08
本文選題:季節(jié)性過敏性結膜炎(SAC) + 0.1%奧洛他定��; 參考:《大連醫(yī)科大學》2017年碩士論文
【摘要】:目的:過敏性結膜炎是由多種因素導致的影響患兒身心健康的疾病,然而目前尚未發(fā)現(xiàn)短期、有效和安全的治療藥物,而且由于患兒依從性比較差,因而探究兒童有效、安全和短程的用藥方案很是有必要的。本試驗目的:對比0.1%奧洛他定、0.05%依美斯汀、0.5%氯替潑諾和對照劑(0.5%羧甲基纖維素鈉)治療兒童季節(jié)性過敏性結膜炎(SAC)的有效性、安全性以及患兒的耐受性。方法:本研究采取前瞻性、單盲性與隨機對照研究。在受檢對象監(jiān)護人知情同意和配合下,按統(tǒng)一的診斷標準隨機納入于2015年7月-2015年11月來大連醫(yī)科大學附屬二院眼科門診就診的80例160只眼4-10歲的SAC的患兒,依照數(shù)字表法將患兒隨機分為3個治療組與1個對照組,每組20例,一共80例。第1個治療組共20例40只眼使用質(zhì)量分數(shù)為0.1%奧洛他定滴眼液(帕坦洛)日2次點雙眼,1滴/次,第2個治療組共20例40只眼使用質(zhì)量分數(shù)為0.05%依美斯汀滴眼液(埃美丁)日2次點雙眼,1滴/次,第3治療組20例40只眼使用質(zhì)量分數(shù)為0.5%氯替潑諾滴眼液(露達舒)日4次點雙眼,1滴/次,而關于對照組則使用質(zhì)量分數(shù)為0.5%羧甲基纖維素鈉滴眼液(亮視)日3次點雙眼,1滴/次。于用藥前、用藥后7天及用藥后14天對患兒進行隨訪觀察。觀察患兒用藥前后的癥狀(眼癢、畏光和眨眼)體征(乳頭、濾泡、充血和水腫)和視力、眼底與眼壓的變化以及用藥后的患兒的不適反應。結果:用藥后一周,在畏光和充血方面,0.05%依美斯汀、0.5%氯替潑諾與對照劑之間差異有統(tǒng)計學意義(P0.05);在乳頭方面,治療組3組與對照劑之間差異有統(tǒng)計學意義(P0.05);在濾泡方面,0.5%氯替潑諾與對照劑之間差異有統(tǒng)計學意義(P=0.023)。用藥后兩周,主要癥狀(眨眼除外)與體征的改善方面,治療組3種藥物同對照劑之間差異均有統(tǒng)計學意義(P0.05)。0.1%奧洛他定、0.5%氯替潑諾與0.05%依美斯汀3種滴眼液之間(畏光、眨眼和充血除外)差異均無統(tǒng)計學意義(P0.05);0.1%奧洛他定、0.5%氯替潑諾與0.05%依美斯汀在畏光方面差異有統(tǒng)計學意義(P0.05);0.05%依美斯汀與0.5%氯替潑諾在眨眼、充血方面差異有統(tǒng)計學意義(P0.05)。在本研究中,0.1%奧洛他定和0.05%依美斯汀及0.5%氯替潑諾3種滴眼液之間用藥后一周與用藥后兩周眼壓各組之間差異均無統(tǒng)計學意義(P≥0.05),治療組3組與對照組之間差異同樣均無統(tǒng)計學意義(P≥0.05)。本研究在試驗組3組之間以及試驗組與對照組之間并均未發(fā)現(xiàn)有臨床意義的眼壓升高(≥10mmHg),未發(fā)現(xiàn)明顯的視力改變,未發(fā)現(xiàn)有臨床上眼底的改變,未發(fā)現(xiàn)患兒其他的不適。結論:0.1%奧洛他定和0.05%依美斯汀與0.5%氯替潑諾3種滴眼液之間有效性相似;0.1%奧洛他定與0.05%依美斯汀和0.5%氯替潑諾3種滴眼液與對照劑是同樣安全易耐受的。
[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.
【學位授予單位】:大連醫(yī)科大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R777.31
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本文編號:1887786
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