中华核医学与分子影像杂志
中華覈醫學與分子影像雜誌
중화핵의학여분자영상잡지
Chinese Journal of Nuclear Medicine and Molecular Imaging
2014年
1期
34-38
,共5页
杜延荣%李方%王蒨%李殿富%龙明清%刘轶敏%李必禄
杜延榮%李方%王蒨%李殿富%龍明清%劉軼敏%李必祿
두연영%리방%왕천%리전부%룡명청%류질민%리필록
冠状动脉疾病%盐酸去甲乌药碱%腺苷%体层摄影术,发射型计算机,单光子%MIBI
冠狀動脈疾病%鹽痠去甲烏藥堿%腺苷%體層攝影術,髮射型計算機,單光子%MIBI
관상동맥질병%염산거갑오약감%선감%체층섭영술,발사형계산궤,단광자%MIBI
Coronary disease%Higenamine hydrochloride%Adenosine%Tomography,emission-computed,single-photon%MIBI
目的 评价盐酸去甲乌药碱注射液(HG)在负荷MPI诊断冠心病中的有效性和安全性.方法 采用多中心、随机、开放、阳性药自身交叉对照设计研究.怀疑或已经确诊为冠心病的患者120例,每例均根据随机数字表按照不同顺序先后进行HG和腺苷负荷MPI.受试者负荷显像前后90 d内行CAG检查,主要血管狭窄程度＞50％为冠心病.负荷MPI按心肌缺血严重程度与缺血范围分析,以CAG结果为“金标准”,比较HG和腺苷负荷MPI诊断冠心病的诊断效能及结果的一致性.同时进行试验的安全性评价,包括检查生命指征,血、尿常规、血生化指标等,以及记录不良反应.组间比较用两样本t检验、r检验或Fisher确切概率法,一致性分析采用Kappa检验.结果 120例受试者中有11例未完成全部试验,不参加有效性分析,但参加安全性评价；另109例参加有效性分析.HG负荷MPI诊断冠心病的灵敏度为56.1％(32/57),特异性为78.8％ (41/52),准确性为67.0％(73/109),阳性预测值为74.4％(32/43),阴性预测值为62.1％ (41/66)；腺苷负荷MPI的诊断灵敏度为52.6％(30/57),特异性为82.7％(43/52),准确性为67.0％ (73/109),阳性预测值为76.9％ (30/39),阴性预测值为61.4％(43/70).2药各对应诊断效能指标的差异均无统计学意义(x2=0～0.2476,均P＞0.05).HG负荷MPI诊断单支、双支和三支病变的灵敏度分别为29.6％(8/27)、64.7％(11/17)和100％(13/13),腺苷负荷MPI相应结果分别为22.2％(6/27)、64.7％(11/17)和100％(13/13).两药负荷MPI诊断LAD、LCX、RCA缺血的总一致性分别为95.41％ (104/109)、97.25％(106/109)和97.25％(106/109),Kappa值分别为0.8905、0.8420和0.8874.HG对受试者的收缩压几乎没有影响,舒张压有一定程度下降；心率可明显升高；血、尿常规和血生化等结果无异常改变.试验中共发生176例次与试验药物有关的不良反应,主要为胸闷、气短、心悸、头晕、头痛等,但症状轻微,停药后很快自行缓解.HG和腺苷负荷试验不良反应的发生率分别为69.2％ (83/120)和77.5％(93/120),差异无统计学意义(x2=2.1307,P＞0.05).结论 HG用于负荷MPI诊断冠心病的灵敏度和特异性与腺苷类似,安全性良好,具有临床应用价值.
目的 評價鹽痠去甲烏藥堿註射液(HG)在負荷MPI診斷冠心病中的有效性和安全性.方法 採用多中心、隨機、開放、暘性藥自身交扠對照設計研究.懷疑或已經確診為冠心病的患者120例,每例均根據隨機數字錶按照不同順序先後進行HG和腺苷負荷MPI.受試者負荷顯像前後90 d內行CAG檢查,主要血管狹窄程度＞50％為冠心病.負荷MPI按心肌缺血嚴重程度與缺血範圍分析,以CAG結果為“金標準”,比較HG和腺苷負荷MPI診斷冠心病的診斷效能及結果的一緻性.同時進行試驗的安全性評價,包括檢查生命指徵,血、尿常規、血生化指標等,以及記錄不良反應.組間比較用兩樣本t檢驗、r檢驗或Fisher確切概率法,一緻性分析採用Kappa檢驗.結果 120例受試者中有11例未完成全部試驗,不參加有效性分析,但參加安全性評價；另109例參加有效性分析.HG負荷MPI診斷冠心病的靈敏度為56.1％(32/57),特異性為78.8％ (41/52),準確性為67.0％(73/109),暘性預測值為74.4％(32/43),陰性預測值為62.1％ (41/66)；腺苷負荷MPI的診斷靈敏度為52.6％(30/57),特異性為82.7％(43/52),準確性為67.0％ (73/109),暘性預測值為76.9％ (30/39),陰性預測值為61.4％(43/70).2藥各對應診斷效能指標的差異均無統計學意義(x2=0～0.2476,均P＞0.05).HG負荷MPI診斷單支、雙支和三支病變的靈敏度分彆為29.6％(8/27)、64.7％(11/17)和100％(13/13),腺苷負荷MPI相應結果分彆為22.2％(6/27)、64.7％(11/17)和100％(13/13).兩藥負荷MPI診斷LAD、LCX、RCA缺血的總一緻性分彆為95.41％ (104/109)、97.25％(106/109)和97.25％(106/109),Kappa值分彆為0.8905、0.8420和0.8874.HG對受試者的收縮壓幾乎沒有影響,舒張壓有一定程度下降；心率可明顯升高；血、尿常規和血生化等結果無異常改變.試驗中共髮生176例次與試驗藥物有關的不良反應,主要為胸悶、氣短、心悸、頭暈、頭痛等,但癥狀輕微,停藥後很快自行緩解.HG和腺苷負荷試驗不良反應的髮生率分彆為69.2％ (83/120)和77.5％(93/120),差異無統計學意義(x2=2.1307,P＞0.05).結論 HG用于負荷MPI診斷冠心病的靈敏度和特異性與腺苷類似,安全性良好,具有臨床應用價值.
목적 평개염산거갑오약감주사액(HG)재부하MPI진단관심병중적유효성화안전성.방법 채용다중심、수궤、개방、양성약자신교차대조설계연구.부의혹이경학진위관심병적환자120례,매례균근거수궤수자표안조불동순서선후진행HG화선감부하MPI.수시자부하현상전후90 d내행CAG검사,주요혈관협착정도＞50％위관심병.부하MPI안심기결혈엄중정도여결혈범위분석,이CAG결과위“금표준”,비교HG화선감부하MPI진단관심병적진단효능급결과적일치성.동시진행시험적안전성평개,포괄검사생명지정,혈、뇨상규、혈생화지표등,이급기록불량반응.조간비교용량양본t검험、r검험혹Fisher학절개솔법,일치성분석채용Kappa검험.결과 120례수시자중유11례미완성전부시험,불삼가유효성분석,단삼가안전성평개；령109례삼가유효성분석.HG부하MPI진단관심병적령민도위56.1％(32/57),특이성위78.8％ (41/52),준학성위67.0％(73/109),양성예측치위74.4％(32/43),음성예측치위62.1％ (41/66)；선감부하MPI적진단령민도위52.6％(30/57),특이성위82.7％(43/52),준학성위67.0％ (73/109),양성예측치위76.9％ (30/39),음성예측치위61.4％(43/70).2약각대응진단효능지표적차이균무통계학의의(x2=0～0.2476,균P＞0.05).HG부하MPI진단단지、쌍지화삼지병변적령민도분별위29.6％(8/27)、64.7％(11/17)화100％(13/13),선감부하MPI상응결과분별위22.2％(6/27)、64.7％(11/17)화100％(13/13).량약부하MPI진단LAD、LCX、RCA결혈적총일치성분별위95.41％ (104/109)、97.25％(106/109)화97.25％(106/109),Kappa치분별위0.8905、0.8420화0.8874.HG대수시자적수축압궤호몰유영향,서장압유일정정도하강；심솔가명현승고；혈、뇨상규화혈생화등결과무이상개변.시험중공발생176례차여시험약물유관적불량반응,주요위흉민、기단、심계、두훈、두통등,단증상경미,정약후흔쾌자행완해.HG화선감부하시험불량반응적발생솔분별위69.2％ (83/120)화77.5％(93/120),차이무통계학의의(x2=2.1307,P＞0.05).결론 HG용우부하MPI진단관심병적령민도화특이성여선감유사,안전성량호,구유림상응용개치.
Objective To evaluate the effectiveness and safety of higenamine (HG),a pharmaco logical stress agent,for the detection of myocardial ischemia using SPECT.Methods This study was an open,multi-center,randomized and positively controlled trial with crossover references.It consisted of 120patients clinically confirmed or suspected of myocardial ischemia.Each patient underwent a resting MPI and two separate stress MPI in a randomized crossover manner with intravenous administration of HG or adenosine (Ad) on different days.The severity and extent of myocardial ischemia were diagnosed on stress MPI.The degree of vascular stenosis in terms of percentage narrowing was measured by CAG (＞50％ was defined as coronary disease),thus defined as gold standard.The diagnostic efficacy of HG and Ad was compared.Vital signs,routine blood and urine tests,blood biochemical items and side effects were documented for evaluation of procedure safety.Two-sample t test,x2 or Fisher's exact test,and Kappa test were used.Results A total of 109 patients completed the trim and CAG.The diagnostic sensitivity,specificity,accuracy,positive predictive value,negative predictive value of HG MPI were 56.1％ (32/57),78.8％ (41/52),67.0％(73/109),74.4％ (32/43) and 62.1％ (41/66),respectively,which were not significantly different from those ofAd MPI (52.6％ (30/57),82.7％ (43/52),67.0％ (73/109),76.9％ (30/39) and 61.4％(43/70) ;x2 =0-0.2476,all P＞0.05).The sensitivity of HG vs Ad MPI in the diagnosis of single-,double-and triple-vessel ischemia was 29.6％ (8/27) vs 22.2％ (6/27),64.7％ (11/17) vs 64.7％ (11/17)and 100％ (13/13) vs 100％ (13/13),respectively.The concordance between HG and Ad for the detection of LAD,LCX and RCA ischemia was 95.41％ (104/109),97.25％ (106/109) and 97.25％ (106/109) (Kappa=0.8905,0.8420 and 0.8874).HG did not induce significant systolic blood pressure change during or after administration.Both HG and Ad could induce temporary decrease of diastolic blood pressure.Either HG or Ad induced significantly increased HR during administration and 5 min after administration.The clinical laboratory profile (hematology,serum chemistry,and urinalysis) was either normal or with no significant change.A total of 176 side effects (e.g,dyspnea,short breath,palpitation,dizziness,headache) were found related to HG (69.2％,83/120) and Ad (77.5％,93/120) administration (x2=2.1307,P＞0.05),which were mostly mild and transient.Conclusion HG is a safe and effective pharmacological stress test agent as compared to adenosine for the detection of CAD with SPECT perfusion imaging.
