【作者】 李韧；

【导师】 姚克；

【作者基本信息】 浙江大学 ， 眼科学， 2004， 硕士

【摘要】 白内障摘除术是65岁以上老年人中最常见的手术，超声乳化联合人工晶状体植入术具有组织损伤小、术后散光小、视力恢复好等优点，随着这一技术在国内的广泛应用，其术后抗炎也日益受到大家关注。 白内障手术创伤会诱发一系列的炎症反应，如炎症反应控制不当，则可能引起许多术后并发症，如角膜水肿、眼内压升高、黄斑囊样水肿和后囊膜混浊等。局部滴用糖皮质激素被广泛用于白内障术后的炎症控制，尽管其疗效显著，但存在升高眼内压，易致术后眼感染和影响手术切口愈合等危险性。非甾体类抗炎药无上述副作用，国外已被广泛应用于白内障术后的抗炎治疗。国内也开始将其应用于临床，但当前国内白内障术后抗炎仍以局部滴用糖皮质激素为主。 0.1％普南扑灵滴眼液是由日本千寿制药公司生产的丙酸类非甾体类抗炎药普拉洛芬(pranoprofen)的滴眼剂，具有抑制前列腺素合成和稳定细胞膜的作用。动物实验表明其具有显著的抗炎作用，对前列腺素引起的前房闪辉具有良好的抑制作用。国内外临床应用表明它对眼前段炎症疗效显著，与糖皮质激素合用可增加其抗炎作用。 【目的】 通过比较0.1％普南扑灵滴眼液、0.1％氟米龙滴眼液以及两种滴眼液联合使用在白内障超声乳化联合后房型人工晶状体植入术后抗炎治疗中的疗效，为白内障手 浙江大学硕士研究生学位论文术后的抗炎用药提供临床依据，寻求一种药物控制白内障术后炎症的较佳方案。 【研究对象】 2003年10月一2004年5月，我院收治住院的141例(141只眼)老年性白内障连续病例，男58例，女83例，年龄52~82岁，平均69.59士6.72岁。排除全身炎症或眼部感染;排除青光眼、葡萄膜炎、外伤性白内障、假性晶状体囊膜剥脱综合征、严重的糖尿病并发的进行性眼部改变、角膜内皮细胞失代偿者;排除严重的心、肺、肝、肾功能障碍者。术前一周内局部或全身未使用糖皮质激素、非类固醇类抗炎药、免疫抑制剂或秋水仙素。 【研究方法】1.分组方法: 随机分为三组，甲组47例，术后滴用0.1%普拉洛芬滴眼液;乙组47例，术后滴用0.1%氟米龙滴眼液组;丙组47例，术后联合滴用0.1%氟米龙滴眼液和0.1%普拉洛芬滴眼液。2.手术方法: 全部手术由同一位经验丰富的医师完成。术前复方托品酞胺散瞳，2%利多卡因和0.75%布比卡因睫状神经结及面神经分支阻滞麻醉，采用透明角膜隧道切口，连续环形撕囊，超声乳化吸出晶体，注吸净残存皮质，植入后房型人工晶状体于囊袋中。术中使用的灌注液、粘弹剂相同，三组间人工晶体类型无显著性差异。术毕，球结膜下注射庆大霉素2万单位，地塞米松Zmg。3.给药方法: 本研究中的滴眼液，按随机表编号，由同一位临床医师根据患者的手术顺序给药。甲组滴用0.1%普拉洛芬滴眼液，术后第一周每天6次，随后的三周每天4次;乙组滴用0.1%氟米龙滴眼液，术后第一周每天6次，随后的三周每天4次;丙组联合滴用0.1%普拉洛芬和0.1%氟米龙滴眼液，术后第一周每天各4次，随后的三周每天各3次。均为术后24小时(术后第1天观察检查结束后)开始滴药。4.观察方法 三组患者于术前1天和术后第1、7、30天进行视力、裂隙灯、眼底镜、眼压检查，观察体征，并询问症状，记录药物不良反应，全部患者的症状体征评分由 3 浙江大学硕士研究生学位论文同一位医师完成。评分项目包括:症状(畏光、异物感、流泪、眼痛和眼痒);体征(球结膜充血、球结膜水肿、睫状充血、纤维素样瞳孔膜和虹膜后粘连)，症状评分加体征评分得综合评分。前房闪辉由Kowa FC一2000激光闪辉细胞检测仪测量，眼压由Nidek NT-2000非接触式眼压仪测量。5.数据分析 应用SPSSn.0统计软件进行数据处理，以P<0.05判定差异有显著性。数据以均数士标准差反士s)表示，以Malin一whi垃ey非参数秩合检验法检验各组间用药前和用药后症状和体征评分，Wilcoxon检验比较组内用药前和用药后症状和体征评分。以两独立样本t检验法检验各组内用药前和用药后眼压值和前房闪辉值，及各组间同一时间点的眼压值和前房闪辉值。【结果】1.不同时间前房闪辉变化术前1天及术后1天三组间前房闪辉均无显著性差异 (P>0.OS)。术后1天各组内前房闪辉较术前1天显著升高(尸<0.05)。术后7 天各组前房闪辉与术后1天比无显著性差异(P>0.05)。术后30天时普拉洛芬 组及联合组前房闪辉与术后1天比均极显著降低(尸<0 .01);术后30天氟米龙 组前房闪辉比术后1天无显著性降低(P>0.05)。说明术后30天时，普拉洛芬 组和联合组能显著抑制术后的前房闪辉升高，而氟米龙组不能显著抑制术后的 前房闪辉升高。术后7、30天普拉洛芬组和联合组前房闪辉值都比氟米龙组极 显著性低(P<0.01);术后7、30天普拉洛芬组前房闪辉与联合组无显著性差异 (外0.05)。术后1月时，普拉洛芬组及联合组前房闪辉值与同组内术前1天无更多还原

【Abstract】 Cataract removal is the most commonly performed operation in patients over 65 years of age. Phacoemulsification with intraocular lens implantation has the advantages of small incisions, low astigmatism, and so on. With the extensive application of this technique, the control of intra-ocular inflammation following cataract surgery has been an attention by the ocular surgeons increasingly.Surgical trauma elicits a cascade of ocular inflammatory reactions in eyes undergoing cataract surgery, Bad control of this inflammation is related to the postoperative complications such as corneal edema, intraocular pressure spike, cystoid macular edema, and posterior capsule opacification. Topical corticosteroids are used for the prevention of the postoperative inflammation widely, although, they have superior anti-inflammatory effects, they are also responsible for a greater range of adverse events, such as increasing intra-ocular pressure, more presence of postoperative ocular infection. Recently, many medications with low side effects have been applied in the treatment of postoperative inflammation following cataract extraction, many of them are nonsteroidal anti-inflammatory drugs.Pranopulin 0.1% eyedrops is an ophthalmic formulation of pranoprofen, a topical nonsteroid, which is developed by Yoshitomi Pharmaceutical Industries, Ltd, it has thefunction of preventing the synthesis of prostaglandins and stabilizing the cell’s membrane. The lab researches demonstrate an effective anti-inflammatory action, and good inhibit of prostaglandin-induced aqueous flare elevation. Clinical researches indicate that it is effective on the control of intra-ocular inflammation following cataract surgery, and combining with corticosteroid is more effective in suppressing inflammation.[Purpose]Through comparing the efficacy of pranoprofen 0.1% eyedrops, fluorometholone 0.1% eyedrops and their combination in the control of the inflammation after phacoemulsification followed by intraocular lens implantation, to give clinical evidence and to find a better solution on the clinical pharmacologic strategies of the postoperative inflammatory.[Patients and Methods]One hundred and forty-one consecutive senile cataract subjects (141 eyes) were enrolled in a prospective, investigator-masked, randomized controlled trial, 58 male and 83 female, The mean patient age was 69.59years 6.72 (SD) ,range 52 to 82 years. Excluding subjects with systemic inflammatory or ocular infection; excluding glaucoma, uveitis, traumatic cataract, and other diseases that will cause sever inflammatory after cataract surgery.Patients were randomly assigned to three groups; pranoprofen 1% eyedrops group (47 subjects), fluorometholone 0.1% eyedrops group (47 subjects) and combined group (47 subjects).All operations were performed by the same surgeon under topical anesthesia and posterior chamber IOL was placed in the capsular bag. In all cases, the same balanced salt solution (BSS) and viscoelastics were used during the surgery.Postoperatively, patients used topical pranoprofen or fluorometholone drops six times a day for the first one week, four times a day for the following three weeks; and in the combined group patients used topical pranoprofen and fluorometholone drops bothfour times a day for the first one week, both three times a day for the folio whig three weeks. Patients received postoperative topical antibiotic prophylaxis with ofloxacin 0.3% (Tarivid庐), one drop three tunes daily given 10 min after the topical steroid or nonsteroid for two weeks.Patients were examined at the first postoperative day (day 1), and days 7 and 30. Postoperative evaluations included patient history regarding any ocular discomfort, visual acuity, slit-lamp and fundus examinations, IOP measurement. The major efficacy parameters assessed clinically on each visit were anterior chamber flare and conjunctival hyperemia. All evaluations were performed by one same surgeon. Laser flare cell meter FC-2000(Kowa) was employed for examination of anterior chamber更多还原