溴芬酸钠滴眼液治疗眼部炎症的卫生技术评估
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摘要
目的:系统评价溴芬酸钠(BRO)滴眼液治疗眼部炎症的有效性、安全性、经济性和依从性,为卫生政策决策和临床实践提供循证依据。方法:计算机检索Pub Med、Embase、Cochrane图书馆、中国知网、万方数据库、中文科技期刊数据库和国内外卫生技术评估(HTA)机构官方网站,纳入BRO滴眼液对比安慰剂、激素类药物、其他非甾体类抗炎药治疗眼部炎症的HTA报告,以及系统评价、随机对照试验(RCT)和药物经济学研究,对RCT文献按照Cochrane系统评价员手册5.1.0进行资料提取和质量评价后,采用Rev Man 5.3软件进行Meta分析;采用描述性分析方法描述已有评估报告和系统评价结果。同时,采用最小成本分析法分析其经济性。结果:共纳入2篇系统评价文献(合计9 528例患者),39篇RCT文献(合计6 848只眼),未检索到HTA报告和药物经济学研究。纳入的系统评价分析结果显示,BRO滴眼液相比安慰剂,可有效缓解眼部炎症、眼部疼痛,并降低相关不良反应发生率。纳入的39篇RCT的Meta分析结果显示,与安慰剂比较,BRO滴眼液抗炎效果[RR=2.10,95%CI(1.78,2.50),P<0.001]、镇痛效果[RR=2.21,95%CI(1.04,4.72),P=0.04]和降低眼压效果[MD=-1.06,95%CI(-2.06,-0.05),P=0.04]方面更优,且总不良事件发生率和严重不良事件发生率方面差异均无统计学意义(P>0.05);与激素类药物比较,BRO滴眼液在抗炎、降低眼压和改善视力方面差异均无统计学意义(P>0.05);与其他非甾体类抗炎药比较,BRO滴眼液在抗炎、镇痛、降低眼压和改善视力方面差异均无统计学意义(P>0.05)。与氯替泼诺滴眼液比较,BRO滴眼液经济性更优;且BRO滴眼液每天2次用药,具有更好的依从性。结论:BRO滴眼液治疗眼部炎症具有良好的有效性、安全性和依从性,且相比氯替泼诺滴眼液更经济。
OBJECTIVE:To provide evidence-based evidence for health policy decision and clinical practice by systematically evaluating efficacy, safety, economical efficiency and applicability of Bromfenac(BRO) sodium ophthalmic solution in the treatment of ocular inflammation. METHODS:Retrieved from Pub Med,Embase,The Cochrane Library,CNKI,Wanfang Data,VIP and health technology assessment(HTA) organization websites,HTA report,systematic reviews(SR),randomized controlled trials(RCT)and pharmacoeconomic studies about inclusion of BRO sodium ophthalmic solution in contrast with placebo,steroids,and the other NSAIDs for ocular inflammation were included. The data extraction and quality evaluation were conducted by using Cochrane systematic evaluator Rev Man 5.1.0. Meta-analysis was conducted in RCT documents,and Rev Man 5.3 was used for Meta analysis,while other studies were analyzed with descriptive analysis qualitatively. Its economy was analyzed by minimum costanalysis method. RESULTS:Totally 2 SR(9 528 patients) and 39 RCTs(6 848 eyes) were included. No HTA report and pharmacoeconomic study was found. Results of systematic reviews showed that BRO ophthalmic solutioncould effectively relieve ocular inflammation,ocular pain and reduce the incidence of relative adverse. Results of Meta-analysis showed that compared with placebo,anti-inflammation [RR=2.10,95% CI(1.78,2.50),P<0.001],analgesia [RR=2.21,95% CI(1.04,4.72),P=0.04] and intra-ocular pressure reduction [MD=-1.06,95%CI(-2.06,-0.05),P=0.04] of BRO sodium ophthalmic solution were better;there was no statistical significance in the incidence of total adverse events or severe adverse events(P>0.05). Compared with steroids,BRO sodium ophthalmic solution showed similar effect on ocular inflammation,decrease of intra-ocular pressure or the improvement of vision(P>0.05). There was no statistical significance in the ocular inflammation,pain decrease of intra-ocular pressure or the improvement of vision between NSAIDs and BRO sodium ophthalmic solution(P>0.05). Compared with loteprednol eye drops, BRO sodium ophthalmic solution showed advantages economically. Twice daily used BRO sodium ophthalmic solution improved compliance of subjects than other eye drops. CONCLUSIONS:BRO sodium ophthalmic solution has favorable efficacy,safety and applicability in the treatment of ocular inflammation. Compared with loteprednol eye drops,it shows advantages economically.
OBJECTIVE:To provide evidence-based evidence for health policy decision and clinical practice by systematically evaluating efficacy, safety, economical efficiency and applicability of Bromfenac(BRO) sodium ophthalmic solution in the treatment of ocular inflammation. METHODS:Retrieved from Pub Med,Embase,The Cochrane Library,CNKI,Wanfang Data,VIP and health technology assessment(HTA) organization websites,HTA report,systematic reviews(SR),randomized controlled trials(RCT)and pharmacoeconomic studies about inclusion of BRO sodium ophthalmic solution in contrast with placebo,steroids,and the other NSAIDs for ocular inflammation were included. The data extraction and quality evaluation were conducted by using Cochrane systematic evaluator Rev Man 5.1.0. Meta-analysis was conducted in RCT documents,and Rev Man 5.3 was used for Meta analysis,while other studies were analyzed with descriptive analysis qualitatively. Its economy was analyzed by minimum costanalysis method. RESULTS:Totally 2 SR(9 528 patients) and 39 RCTs(6 848 eyes) were included. No HTA report and pharmacoeconomic study was found. Results of systematic reviews showed that BRO ophthalmic solutioncould effectively relieve ocular inflammation,ocular pain and reduce the incidence of relative adverse. Results of Meta-analysis showed that compared with placebo,anti-inflammation [RR=2.10,95% CI(1.78,2.50),P<0.001],analgesia [RR=2.21,95% CI(1.04,4.72),P=0.04] and intra-ocular pressure reduction [MD=-1.06,95%CI(-2.06,-0.05),P=0.04] of BRO sodium ophthalmic solution were better;there was no statistical significance in the incidence of total adverse events or severe adverse events(P>0.05). Compared with steroids,BRO sodium ophthalmic solution showed similar effect on ocular inflammation,decrease of intra-ocular pressure or the improvement of vision(P>0.05). There was no statistical significance in the ocular inflammation,pain decrease of intra-ocular pressure or the improvement of vision between NSAIDs and BRO sodium ophthalmic solution(P>0.05). Compared with loteprednol eye drops, BRO sodium ophthalmic solution showed advantages economically. Twice daily used BRO sodium ophthalmic solution improved compliance of subjects than other eye drops. CONCLUSIONS:BRO sodium ophthalmic solution has favorable efficacy,safety and applicability in the treatment of ocular inflammation. Compared with loteprednol eye drops,it shows advantages economically.
引文
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[2]承伟,丁宇华,袁志兰.准分子激光上皮下角膜磨镶术后糖皮质激素诱发一过性高眼压远期视功能观察[J].中国眼耳鼻喉科杂志,2013,13(5):300-303.
[3]姚向超,邓杏灵.非甾体类抗炎药在眼科中的应用研究分析[J].中国医药指南,2011,9(35):303-304.
[4]沈婷,池新昌,郑青青,等.白内障术后非甾体类抗炎药物单独抗炎作用的有效性与安全性研究[J].浙江医学,2015,37(10):840-842.
[5]UCHIO E,ITOH Y,KADONOSONO K.Topical bromfenac sodium for long-term management of vernal keratoconjunctivitis[J].Ophtaalmologica,2007,221(3):153-158.
[6]SCHECHTER BA,TRATTLER W.Efficacy and safety of bromfenac for the treatment of corneal ulcer pain[J].Adv Ther,2010,27(10):756-761.
[7]DONNENFELD ED,HOLLAND EJ,STEWART RH,et al.Bromfenac ophthalmic solution 0.09%(Xibrom)for postoperative ocular pain and inflammation[J].Ophthalmology,2007,114(9):1653-1662.
[8]门鹏,唐惠林,翟所迪.药品卫生技术评估的步骤与方法[J].中国医疗保险,2015(10):57-59.
[9]ZHAI MZ,WU HH,LI JJ,et al.Topical bromfenac for post-cataract extraction:a systematic review and pooled analysis[J].Eur J Inflamm,2015,13(2):130-135.
[10]DUAN P,LIU Y,LI J.The comparative efficacy and safety of topical non-steroidal anti-inflammatory drugs for the treatment of anterior chamber inflammation after cataract surgery:a systematic review and network meta-analysis[J].Graefes Arch Clin Exp Ophthalmol,2017,255(4):639-649.
[11]庞彦英,赵华,梁四妥,等.氯替泼诺、氟米龙、环孢素、溴芬酸钠分别联合玻璃酸钠治疗中重度干眼症的临床观察[J].中国药房,2014,25(32):3000-3003.
[12]陈洁,王桂琴.白内障手术后0.1%溴芬酸钠水合物滴眼液的应用研究[J].国际眼科杂志,2015,15(12):2102-2104.
[13]赵丹丹,张文文,黄蓓,等.1 g/L溴芬酸钠滴眼液在LASEK术后的早期疗效[J].国际眼科杂志,2016,16(8):1522-1524.
[14]郎敏,白继,张国伟,等.溴芬酸钠滴眼液应用于高度近视散光眼SBK术后的临床疗效观察[J].第三军医大学学报,2016,38(16):1872-1876.
[15]冯海江,毛伟.溴芬酸钠水合物眼液应用于准分子激光原位角膜磨镶术后的疗效观察[J].现代实用医学,2012,24(9):1009-1010.
[16]陈实玉.普罗纳克与糖皮质激素在LASIK/LASEK术后的疗效比较[D].北京:北京协和医学院,2012.
[17]陈开建,白继,张国伟,等.非甾体与甾体类抗炎药物在薄瓣LASIK术后的疗效比较[J].中华眼视光学与视觉科学杂志,2015,17(11):654-658.
[18]董媛,张钰,夏英杰,等.0.1%溴芬酸钠水合物滴眼液减轻LASEK术后眼部刺激症状的疗效观察[J].中华眼科杂志,2015,51(1):51-54.
[19]刘曼丽,刘泉,王丹阳,等.0.1%溴芬酸钠滴眼液在SMILE术后的早期疗效[J].中华眼视光学与视觉科学杂志,2014,16(9):551-556.
[20]孙建军.0.1%溴芬酸钠水合物滴眼液与糖皮质激素在LASEK术后的疗效比较[J].医药前沿,2015,5(17):70.
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