Background The injection of the bupivacaine hydrochloride compound ithe preferred method fooculatopical anaesthesiabroad.However,in China,an injection of mixture of lidocaine hydrochloride and bupivacaine hydrochloride iused fothe anesthesia.The mixture injection solution needto be prepared jusprioto surgery.The bupivacaine hydrochloride compound used foinjection habeen approved to producdomestically,buitclinical effectivenesand safety needto be studied.Objective Thiclinical trial wato evaluate the application and safety of the injection of the bupivacaine hydrochloride compound aoculatopical anaesthesia.MethodThe Protocol Review Committee and EthiCommittee approved thitrial.Written informed consenwaobtained from each subjecprioto entering the study.randomized and double-masked multi-centeclinical trial wadesigned by personnel irrelevanto the trial.The unilateral eyeof 223 patientwere included and randomized into the bupivacaine hydrochloride compound group (trial group) and the 2％ lidocaine hydrochloride +0.75％ bupivacaine hydrochloride mixture group (control group).The primary end pointincluded the total score of oculamotility and eyelid activity 2,4,6,8 o10 minuteaftethe injection and athe end of the operation to determine the optimal beginning time of operation.The secondary end poinwathe scoring fopain levelduring the operation.Drug safety waassessed by recording the incidence of oculaand systemiadverse event.The variationin the assessed parameteranalyzed by the intention to treaanalysi(ITT) and per-protocol analysi(PP) between the trial group and the control group were compared by the Wilcoxon rank sum test.ResultOne hundred and eighty-eighpatientwere enrolled in the ITseafteone of them wawithdrawn due to drug response;while 120 patientwere enrolled in the control group.Fothe PP set,109 patientwere included in the trial group afte9 patientwere pulled oudue to non-conformity to the trial parameters,and in the control group,114 patientwere included afte6 patientwere removed due to nonconformity to the trial parameters.There were no significandifferencein the scoreof oculamotility and eyelid activity 2,4,6,8 o10 minuteaftedrug administration and athe end of the operation,awell athe optimal beginning time of operation between the two groups,whetheiwathe ITseand PP se(all aP＞0.05).Oculaand systemiadverse eventwere recorded in 5 patients,with 4 in the trial group and 1 in the control group,withousignificandifference between them (P＞0.05).No statistically significandifferencewere found in the incidenceof pulse abnormality,respiratory change,blood pressure alteration,SPO2 change and electrocardiogram abnormality between the trial group and the control group (all aP＞0.05).ConclusionThe clinical efficacy and safety of the injection of the domestically-made bupivacaine hydrochloride compound aoculalocal anaesthesiare identical to the injection of the mixture of lidocaine hydrochloride and bupivacaine hydrochloride.Iifeasible,economiand easy-to-use during eye surgery.%背景 复方盐酸布比卡因注射液是国外眼科手术中局部麻醉的首选药物,而中国眼科临床手术中采用盐酸利多卡因和盐酸布比卡因单方混合注射液作为麻醉药物,虽然麻醉效果可靠,但需临床配制.复方盐酸布比卡因注射液已于2005年获得国家食品药品监督管理局批准生产,但其临床效果及安全性仍需要临床研究证实. 目的 评估国产复方盐酸布比卡因注射液用于眼科手术局部麻醉的临床效果和安全性.方法 采用多中心、随机、双盲临床试验设计.对河南省眼科研究所、青岛眼科医院、青岛市立医院、温州医学院附属眼视光医院、复旦大学附属眼耳鼻喉科医院符合纳入标准的223例眼科手术患者进行多中心、随机、双盲、阳性药物平行对照的临床试验,均纳入患者一侧眼.试验组患者行眼科手术前局部注射复方盐酸布比卡因注射液,对照组患者注射质量分数2％盐酸利多卡因及质量分数0.75％盐酸布比卡因两种单方等体积混合注射液.采取球后阻滞或球周麻醉法,每次用药量为3 ～ 10 ml.研究中主要评价药物的疗效指标和安全性评价指标,其中主要疗效指标为遵照Brahma 1994年建立的标准对注射麻醉药物后2、4、6、8、10 min以及手术结束时术眼和患者眼球和眼睑活动度进行评分,确定适宜的开始手术时间；次要疗效指标为眼科手术期间受试者疼痛评分.安全性评价指标包括药物局部注射后患者的眼部和全身不良事件发生情况以及患者的生命体征、血氧饱和度(SPO2)及心电图变化情况.采用Wilcoxon秩和检验法分别对意向性分析(ITT)和符合方案分析(PP)时试验组与对照组间各评价指标的差异进行比较.结果 ITT分析试验组入组118例,但由于药物注射后无法手术退出1例；对照组纳入120例；PP分析中试验组9例不符合试验设计,共纳入109例,对照组6例不符合试验设计要求,入组114例.无论是ITT分析还是PP分析,局部注射麻醉药物后2、4、6、8、10 min及手术结束时,试验组与对照组术眼眼球活动度评分及总评分的差异均无统计学意义(P＞0.05)；两组间术眼用药后眼睑活动度评分及总评分差异均无统计学意义(P＞0.05).ITT分析和PP分析时两组间药物局部注射后各时间点术眼疼痛评分的差异均无统计学意义(P＞0.05),适宜开始手术时间的差异无统计学意义(P＞0.05).药物应用后共记录局部及全身不良事件5例,其中试验组4例,对照组1例,但两组间差异无统计学意义(P＞0.05).药物注射后患者生命体征各指标变化的例数、SPO2改变例数及心电图变化例数的差异均无统计学意义(P＞0.05).结论 复方盐酸布比卡因注射液用于眼科手术局部麻醉效果与盐酸利多卡因和盐酸布比卡因单方混合注射液相同,药物安全性好,适用人群广,经济性好,使用方法简便.
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