中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2014年
7期
390-393
,共4页
杨玉辉%郑卫星%黄明方%曹小织%章文莉%刘东林%罗助荣
楊玉輝%鄭衛星%黃明方%曹小織%章文莉%劉東林%囉助榮
양옥휘%정위성%황명방%조소직%장문리%류동림%라조영
替格瑞洛%急性冠脉综合征%心血管事件%早期疗效%安全性
替格瑞洛%急性冠脈綜閤徵%心血管事件%早期療效%安全性
체격서락%급성관맥종합정%심혈관사건%조기료효%안전성
ticagrelor%acute coronary syndrome%adverse cardiovascular events%short-term efficacy%safety
目的:探讨替格瑞洛在中国急性冠脉综合征(ACS)患者中的早期疗效及总结治疗经验。方法2012年9月~2013年7月入我院心内科诊断为ACS的患者199例,其中服用替格瑞洛患者96例,服用氯吡格雷患者103例。替格瑞洛组给予180 mg负荷剂量口服,后90 mg每日2次维持。氯吡格雷组给予300/600 mg口服,后服用氯吡格雷维持剂量75 mg每日1次,所有患者均给予阿司匹林。比较两组的基础临床资料,观察两组服药10天、30天、90天的不良事件,并对两组90天的心血管事件和出血情况进行比较。结果两组间基础临床资料无统计学差异(P>0.05)。替格瑞洛组心血管死亡(1%:1.9%)、心肌梗死(0%:1%)、卒中(0%:1.9%)、支架内血栓(0%:1%)、再发心绞痛(2.1%:4.9%)少于氯吡格雷组,呼吸困难(2.1%:0%)、次要出血(3.1%:1.0%)和轻微出血(5.2%:2.9%)多于氯吡格雷组,但均无统计学意义(P>0.05)。替格瑞洛组主要心血管不良事件总和低于氯吡格雷组(3.1%:10.7%),差异有统计学意义(P=0.037)。两组均无主要出血。替格瑞洛组次要出血和轻微出血总和高于氯吡格雷组(8.3%:3.9%),但差异无统计学意义(P=0.188)。结论替格瑞洛在中国患者中的早期疗效与PLATO(血小板抑制和患者预后研究)研究结果基本一致,临床疗效确切,具有良好的安全性和耐受性。
目的:探討替格瑞洛在中國急性冠脈綜閤徵(ACS)患者中的早期療效及總結治療經驗。方法2012年9月~2013年7月入我院心內科診斷為ACS的患者199例,其中服用替格瑞洛患者96例,服用氯吡格雷患者103例。替格瑞洛組給予180 mg負荷劑量口服,後90 mg每日2次維持。氯吡格雷組給予300/600 mg口服,後服用氯吡格雷維持劑量75 mg每日1次,所有患者均給予阿司匹林。比較兩組的基礎臨床資料,觀察兩組服藥10天、30天、90天的不良事件,併對兩組90天的心血管事件和齣血情況進行比較。結果兩組間基礎臨床資料無統計學差異(P>0.05)。替格瑞洛組心血管死亡(1%:1.9%)、心肌梗死(0%:1%)、卒中(0%:1.9%)、支架內血栓(0%:1%)、再髮心絞痛(2.1%:4.9%)少于氯吡格雷組,呼吸睏難(2.1%:0%)、次要齣血(3.1%:1.0%)和輕微齣血(5.2%:2.9%)多于氯吡格雷組,但均無統計學意義(P>0.05)。替格瑞洛組主要心血管不良事件總和低于氯吡格雷組(3.1%:10.7%),差異有統計學意義(P=0.037)。兩組均無主要齣血。替格瑞洛組次要齣血和輕微齣血總和高于氯吡格雷組(8.3%:3.9%),但差異無統計學意義(P=0.188)。結論替格瑞洛在中國患者中的早期療效與PLATO(血小闆抑製和患者預後研究)研究結果基本一緻,臨床療效確切,具有良好的安全性和耐受性。
목적:탐토체격서락재중국급성관맥종합정(ACS)환자중적조기료효급총결치료경험。방법2012년9월~2013년7월입아원심내과진단위ACS적환자199례,기중복용체격서락환자96례,복용록필격뢰환자103례。체격서락조급여180 mg부하제량구복,후90 mg매일2차유지。록필격뢰조급여300/600 mg구복,후복용록필격뢰유지제량75 mg매일1차,소유환자균급여아사필림。비교량조적기출림상자료,관찰량조복약10천、30천、90천적불량사건,병대량조90천적심혈관사건화출혈정황진행비교。결과량조간기출림상자료무통계학차이(P>0.05)。체격서락조심혈관사망(1%:1.9%)、심기경사(0%:1%)、졸중(0%:1.9%)、지가내혈전(0%:1%)、재발심교통(2.1%:4.9%)소우록필격뢰조,호흡곤난(2.1%:0%)、차요출혈(3.1%:1.0%)화경미출혈(5.2%:2.9%)다우록필격뢰조,단균무통계학의의(P>0.05)。체격서락조주요심혈관불량사건총화저우록필격뢰조(3.1%:10.7%),차이유통계학의의(P=0.037)。량조균무주요출혈。체격서락조차요출혈화경미출혈총화고우록필격뢰조(8.3%:3.9%),단차이무통계학의의(P=0.188)。결론체격서락재중국환자중적조기료효여PLATO(혈소판억제화환자예후연구)연구결과기본일치,림상료효학절,구유량호적안전성화내수성。
Objective To discuss the safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese. Methods A total of 199 acute coronary syndromes patients were enrolled.96 of them were given ticagrelor and the other 103 were given clopidogrel. We observed the adverse events in 10 days, 30 days and 90 days, and compared ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) for the prevention of cardiovascular events and bleeding in 90 days. Results There was no significant difference in basic clinical data and related routine examination results between two groups (P>0.05). Patients receiving ticagrelor had lower ratio in cardiovascular death (1%vs. 1.9%), myocardial infarction (0%vs. 1%), stroke (0%vs. 1.9%), stent thrombosis (0%vs. 1%) and recurrent ischemia (2.1% vs. 4.9%) and higher ratio in dyspnea (2.1%vs. 0%), minor bleeding (3.1%vs. 1.0%) and minimal bleeding (5.2%vs. 2.9%) than those receiving clopidogrel with no significant dif-ference (P>0.05). There was no major bleeding in both groups. The ratio of major adverse cardiovascular events was much lower in patients receiving ticagrelor than those receiving clopidogrel (3.1% vs. 10.7%; P=0.037). The total ratio of minor bleeding and minimal bleeding was higher in those receiving ticagrelor with no significant difference (8.3%, vs. 3.9% with clopidogrel; P=0.188). Conclusion The safety and short-term efficacy of ticagrelor in patients with acute coronary syndromes in Chinese were in accordance with PLATO.