复方盐酸布比卡因注射液作为眼科手术麻醉用药的随机、双盲、多中心临床研究
복방염산포비잡인주사액작위안과수술마취용약적수궤、쌍맹、다중심림상연구
A randomized, double-masked, multi-center clinical trial of the injection of the bupivacaine hydrochloride compound for ocular local anaesthesia
  • 万方数据
    中华实验眼科杂志 중화실험안과잡지
    CHINESE JOURNAL OF EXPERIMENTAL OPHTHALMOLOGY
    2013年 8期 763-769 ,共7页

    张月琴%王丽娅%祝磊%贺燚%赵东卿%李家臣%赵靖%赵武令%陈蔚

    장월금%왕려아%축뢰%하일%조동경%리가신%조정%조무령%진위

    药物%麻醉镇痛%布比卡因/复方,注射液%利多卡因/注射液%随机双盲多中心临床研究%效果%安全性 藥物%痳醉鎮痛%佈比卡因/複方,註射液%利多卡因/註射液%隨機雙盲多中心臨床研究%效果%安全性
    약물%마취진통%포비잡인/복방,주사액%리다잡인/주사액%수궤쌍맹다중심림상연구%효과%안전성
    Drugs and agents%Anesthesia and analgesia%Bupivacaine hydrochloride/compound,injection%Lidocaine hydrochloride/injection%Randomized double-masked multicenter trail%Efficacy%Safety
    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.
    배경 복방염산포비잡인주사액시국외안과수술중국부마취적수선약물,이중국안과림상수술중채용염산리다잡인화염산포비잡인단방혼합주사액작위마취약물,수연마취효과가고,단수림상배제.복방염산포비잡인주사액이우2005년획득국가식품약품감독관리국비준생산,단기림상효과급안전성잉수요림상연구증실. 목적 평고국산복방염산포비잡인주사액용우안과수술국부마취적림상효과화안전성.방법 채용다중심、수궤、쌍맹림상시험설계.대하남성안과연구소、청도안과의원、청도시립의원、온주의학원부속안시광의원、복단대학부속안이비후과의원부합납입표준적223례안과수술환자진행다중심、수궤、쌍맹、양성약물평행대조적림상시험,균납입환자일측안.시험조환자행안과수술전국부주사복방염산포비잡인주사액,대조조환자주사질량분수2％염산리다잡인급질량분수0.75％염산포비잡인량충단방등체적혼합주사액.채취구후조체혹구주마취법,매차용약량위3 ～ 10 ml.연구중주요평개약물적료효지표화안전성평개지표,기중주요료효지표위준조Brahma 1994년건립적표준대주사마취약물후2、4、6、8、10 min이급수술결속시술안화환자안구화안검활동도진행평분,학정괄의적개시수술시간；차요료효지표위안과수술기간수시자동통평분.안전성평개지표포괄약물국부주사후환자적안부화전신불량사건발생정황이급환자적생명체정、혈양포화도(SPO2)급심전도변화정황.채용Wilcoxon질화검험법분별대의향성분석(ITT)화부합방안분석(PP)시시험조여대조조간각평개지표적차이진행비교.결과 ITT분석시험조입조118례,단유우약물주사후무법수술퇴출1례；대조조납입120례；PP분석중시험조9례불부합시험설계,공납입109례,대조조6례불부합시험설계요구,입조114례.무론시ITT분석환시PP분석,국부주사마취약물후2、4、6、8、10 min급수술결속시,시험조여대조조술안안구활동도평분급총평분적차이균무통계학의의(P＞0.05)；량조간술안용약후안검활동도평분급총평분차이균무통계학의의(P＞0.05).ITT분석화PP분석시량조간약물국부주사후각시간점술안동통평분적차이균무통계학의의(P＞0.05),괄의개시수술시간적차이무통계학의의(P＞0.05).약물응용후공기록국부급전신불량사건5례,기중시험조4례,대조조1례,단량조간차이무통계학의의(P＞0.05).약물주사후환자생명체정각지표변화적례수、SPO2개변례수급심전도변화례수적차이균무통계학의의(P＞0.05).결론 복방염산포비잡인주사액용우안과수술국부마취효과여염산리다잡인화염산포비잡인단방혼합주사액상동,약물안전성호,괄용인군엄,경제성호,사용방법간편.
    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.
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