普拉洛芬滴眼液在白内障术后单独和联合应用的抗炎疗效评价
详细信息    本馆镜像全文|  推荐本文 |  |   获取CNKI官网全文
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
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 the
    
    
    function 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 both
    
    
    four 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
引文
1. Jaffe NS, Jaffe MS, Jaffe GF. Cataract surgery and its complications. Mosby, St. Louis, 1997; 2-3.
    2. Allen HF, Grove AS. Early acute aseptic iritis after cataract extraction. Trans Am Acad Ophthalmol Otolaryngol. 1976; 81:145-150.
    3. Sanders DR, Kraft M. Steroidal and nonsteroidal anti-inflammatory agents: effects on postsurgieal inflammation and blood-aqueous humor barrier breakdown. Arch Ophthalmol 1984; 102: 145-1456.
    4. Becker B. Intraocular pressure response to topical eortieosteroids. Invest Ophthalmo Vis Sci 1965; 4: 187-197.
    5. Friedlander MH: Corticosteroid therapy of ocular inflammation. Int Ophthalmol Clin 1983, 23:175-182.
    6. Schalnus R. Topical nonsteroidal anti-inflammatory therapy in ophthalmology. Ophthalmologica. 2003 Mar-Apr; 217(2):89-98.
    7. Ogawa T, Ogasawara A. Effects of Proanoprofen on rabbit uveitis. Journal of the Eye.1988,5:1335
    8. Ogawa T, Ogasawara A, Yamamoto Y. Anti-inflammatory activity of Pranoprofen ophthalmic solution on rat experimental conjunctivitis. Folia Ophthalmol Jpn.1982,33 : 1244
    9. Hayasaka Y, Hayasaka S, Zhang XY, et al. Effects of topical anti-inflammatory and antiallergic eyedrops on prostaglandin E2-induced aqueous flare elevation in pigmented rabbits. Arch Ophthalmol. 2002 Jul; 120(7):950-3.
    10. Kitano S, Ochi T, Uchida Y, et al. Study on the effect of Pranoprofen (Y28004) ophthalmic solution on postoperative inflammation and its optimal concentration. Japanese Review of Clinical Ophthalmology. 1985,79 : 425
    11. Kitano S, Uchida Y, Shimizu H, et al. Clinical study of 0.1% Pranoprofen (Y28004)
    
    ophthalmic solution for the treatment of subacute and chronic conjunctivitis. A double-blind controlled trial with 0.05 % dexamethasone ophthalmic solution. Japanese Review of Clinical Ophthalmology. 1985,79 : 432.
    12.前段炎症的临床评价。眼科研究, 2000, 18:560-564。
    13. Ota, I, Miyake C, Miyake Y, et al. Post-implant surgical inflammation following the latest surgical techniques of intraocular lens and anti-inflammatory treatments. Journal of the eye. 10,1773-1778,1993.
    14. Ogawa T, Ohara K, Shimizu H, et al. Effects of a combined use of steroidal and nonsteroidal anti-inflammatory drugs on E.coli endotoxin-induced uveitis in pigmented rabbits. Jpn J Ophthalmol 1995; 39:353-359.
    15. Soon-Phaik chee, FRCS(g), et al. Postoperative inflammation extracapsular cataract extraction versus phacoemulsification. J Cataract Refract Surg, 1999, 25: 1280-1285.
    16. Jorg Schauers Berger, A ndreas Kruger, et al. Course of postoperative inflammation after implantation of 4 types of foldable intraocular lenses. J Cataract Refract Surg. 1999, 25: 1116-1120.
    17. Daniele Tognetto, Giuseppe Ravalico. Inflammatory ceil adhesion and surface defects on heparin-surface-modifided poly (methylmethacrylate) intraocular lenses in diabetic patients. J Cataract Refract Surg, 2001, 27: 239-244.
    18. Sawa M. Clinical application of laser flare-cell meter. Jpn J Ophthalmol. 1990;34(3):346-63
    19. Yoshitomi T, Wong AS, Daher E, etal. Aqueous flare measurement with laser flare-cell meter. Jpn J Ophthalmol. 1990; 34(1):57-62.
    20. Ellis PP. Pharmacological effects of corticosteroids. Int Ophthalmol Clin 1966; 6: 799-819.
    21. Whalen MJ, Kass MA: Prostaglandins and cataract surgery. In Cataract Surgery. Edited by Steele ADMcC,Drew RC. London: Butterworths; 1984:23-44.
    22. Hayasaka Y, Hayasaka S, Zhang XY, et al. Effects of topical corticosteroids and
    
    nonsteroidal anti-inflammatory drugs on prostaglandin E2-induced aqueous flare elevation in pigmented rabbits. Ophthalmic Res. 2003 Nov-Dec; 35(6):341-344.
    23. Malecaze F, Chollet P, Cavrois E, Vita N, Arne JL, Ferrara P. Role of interleukin 6 in the inflammatory response after cataract surgery. An experimental and clinical study. Arch Ophthalmol 1991; 109: 1681-1683.
    24. Kwok AK, Lam DS, Ng JS, et al. Ocular-hypertensive response to topical steroids in children. Ophthalmology. 1997 Dec; 104(12) :2112-2116.
    25. Shingleton BJ, Wadhwani RA, O'Donoghue MW.Evaluation of intraocular pressure in the immediate period after phacoemulsification. J Cataract Refract Surg. 2001 27:1709-1710.
    26. Patikulsila D, Taweemankongsab S, Ngamtipakorn
    S.Comparison of intraocular pressure measured by non-contact air puff versus Goldmann applanation tonometers in gas-filled vitrectomized eyes. J Med Assoc Thai. 2003 May; 86(5):467-472.
    27. Barba KR, Samy A, Lai C, et al. Effect of topical anti-inflammatory drugs on corneal and limbal wound healing. J Cataract Refract Surg. 2000 Jun; 26(6):893-897.
    28. Ogawa T, Ohara K, Shimizu H. Effects of pretreatment with mydriatics on intraocular penetration of 0.1% pranoprofen. Jpn J Ophthalmol, 1993, 37: 47-55.
    29. Fukushi S, Suzuki T. Clinical application of Y28004 (Praoprofen). Japanese Review of Clinical Ophthalmology, 1984, 734:738.
    30. Miyake K, Masuda K, Shirato S, et al. Comparison of diclofenac and fluorometholone in preventing cystoid macular edema after small incision cataract surgery: a multicentered prospective trial. Jpn J Ophthalmol. 2000 Jan-Feb; 44(1):58-67.
    31. Miyake K, Ibaraki N. Prostaglandins and cystoid macular edema. Surv Ophthalmol. 2002 Aug; 47 Suppl 1 :S203-218.

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700