溴芬酸钠滴眼液治疗眼部炎症的卫生技术评估

Health Technology Assessment of Bromfenac Sodium Ophthalmic Solution in the Treatment of Ocular Inflammation

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 PubMed,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 cost analysis 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.