[作者简介]李峻(1975-),女,山西介休人,主治医师,医学硕士,以循证医学与内分泌疾病为研究方向。[通讯作者]田浩明,Tel:028-81812303;E-mail:hmtian999@yahoo.com.cn羟苯磺酸钙治疗非增殖性糖尿病视网膜病变的系统评价李峻a,田浩明b(四川大学华西医院a.老年科;b.内分泌科,成都610041)[摘要]目的评估羟苯磺酸钙治疗非增殖性糖尿病视网膜病变的有效性和安全性。方法检索关于羟苯磺酸钙治疗非增殖性糖尿病视网膜病变的随机或半随机对照试验,包括:Cochrane图书馆临床对照试验数据库、MEDLINE、EMBASE数据库以及中国生物医学文献数据库。两位研究者独立地进行研究的选择、质量评价和资料提取。结果共有16个试验903例非增殖性糖尿病视网膜病变患者符合纳入标准。全部试验的方法学质量评价为B级(简单方法)。Meta分析结果显示:羟苯磺酸钙能改善非增殖性糖尿病视网膜病变的临床症状和眼底病变,能改善视网膜出血情况和视力。根据目前证据不能认为羟苯磺酸钙可以改善和减少非增殖性糖尿病视网膜病变患者的微血管瘤病变、眼底毛细血管闭塞情况和视野情况;不能认为其能降低非增殖性糖尿病视网膜病变合并青光眼患者的眼压。已报道的不良反应包括药物过敏、胃肠道不适、轻度胃痛、轻度恶心和食欲下降。结论羟苯磺酸钙可能是一种相对安全和有效的治疗非增殖性糖尿病视网膜病变的药物。由于纳入试验少,样本含量低,方法学质量不高,证据的强度不足,有待大样本、多中心的高质量临床试验进一步证实。[关键词]非增殖性糖尿病视网膜病变;羟苯磺酸钙;随机对照试验;半随机对照试验;系统评价[中图分类号]R774.1;R587.2[文献标识码]A[文章编号]1671-5144(2008)01-0034-08EffectsofCalciumDobesilateonNon-ProliferativeDiabeticRetinopathy:ASystematicReviewLIJuna,TIANHao-mingb(a.DepartmentofGeriatrics;b.DepartmentofEndocrinology,WestChinaHospital,SichuanUniversity,Chengdu610041,China)Abstract:ObjectiveToevaluatethesafetyandefficacyofCalciumDobesilateinsubjectswithnon-proliferativediabeticretinopathy(NPDR).MethodACochranesystematicreviewofallrelevantrandomizedorquasi-randomizedcontrolledtrialsofCalciumDobesilateforNPDRwasperformed.ClinicaltrialsweresearchedfromCochraneControlledTrialsRegister,MEDLINE,EMBASEandTheChineseBiologicalMedicineDatabase(CBM).Theselectionofstudies,dataextractionandassessmentofmethodologicalqualitywereperformedindependentlybytworeviewers.ResultsTherearesixteenrandomizedclinicaltrialsthatmetwiththeinclusioncriteriaofthissystematicreview,including903patientsofNPDR.ThequalityofincludedtrialsisofBlevel(simpleapproaches).Theresultsofmeta-analysisindicate:ThereareevidencestosupportthatCalciumDobesilatecanrelievetheclinicalsignsandpathologicchangesoffundusocliofNPDR;relieveretinalhemorrhageandimprovevisualacuity.ThereisnoevidencetoindicatethatCalciumDobesilatecanimproveordecreasemicroaneurysm,capillaryocclusionandvisualfieldofNPDR.ThereisnoevidencetoprovethatCalciumDobesilatecandecreaseintraocularpressureinpatientswithNPDRandglaucoma.Accordingtoexistingevidences,reportedadverseeventsincludedrugallergy,complaintofgastrointestinaltract,gastricpain,nauseaanddecreaseofappetite.Theseadverseeffectsareallmildanddon^tresultinwithdrawal.ConclusionCalciumDobesilateappearsto2008年2月第8卷第1期循证医学TheJournalofEvidence-BasedMedicineFeb.2008Vol.8No.1糖尿病视网膜病变(diabeticretinopathy,DR)是最严重的糖尿病微血管病变之一。非增殖性糖尿病视网膜病变(non-proliferativediabeticretinopathy,NPDR)是DR的早期阶段,在这一阶段积极治疗有助于延缓视网膜病变进展,维持视敏度(visualacuity,VA),减少致盲率,提高生活质量。羟苯磺酸钙[CalciumDobesilate,化学名:2,5-二羟基苯磺酸钙,2,5-dihydroxybenzenesulfonate,国外商品名为导升明(Doxium),国内商品名为多贝斯、...