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[前两项GISSI研究中急性心肌梗死所致医院死亡率的演变。GISSI 1和GISSI 2研究的参与者。意大利心肌梗死链激酶研究组]

[The evolution of hospital mortality due to acute myocardial infarct in the first 2 GISSI studies. Participants in the GISSI 1 and GISSI 2 studies. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico].

作者信息

Mauri F, De Vita C, Staszewsky L, Piantadosi F R, Bosi S, Mantini L, Matta F, Negrini M, Valente S, Martini L [corrected to Mantini L ]

出版信息

G Ital Cardiol. 1994 Dec;24(12):1597-604.

PMID:7883133
Abstract

During the short while of 5 years, between 1984 and 1985, two large clinical trials have been performed in Italy concerning fibrinolytic therapy in Acute Myocardial Infarction: GISSI 1 and GISSI 2. They made possible to evaluate the evolution of demographic and clinical features, the in-hospital mortality rate, and the causes of death of a huge number of patients admitted to CCU throughout the whole country. Out of 31,826 patients with acute myocardial infarction admitted to 176 CCU participating to the GISSI 1 16.9% were 75 years old and 24.7% were females; 21.8% and 26.4% were the percentages in the 38,086 patients admitted to the 223 CCU participating in the GISSI 2. Despite the higher prevalence of the two demographic characteristic with the worse prognosis, the in-hospital mortality rates were respectively 12.2% in the GISSI 1 and 10.0% in the GISSI 2 studies, with a statistically significant decrease (RR 0.84; C.L. 0.80-0.88). The significant decrease in the in-hospital mortality concerns also the patients populations selected according to the same criteria of inclusion in the two trials (within 6 hours from the onset of symptoms and with only ST elevation at the ECG of admission) and to the treatment with fibrinolytic drug (SK or rtPA). As a matter of fact 468 patients died of the 4,696 (10.0%) treated with SK in the GISSI 1 against 1,092 patients of 12,381 (8.8%) enrolled in the GISSI 2 and treated with SK or rtPA (RR 0.87; L.C. 0.78-0.98). The reduction of in-hospital mortality may be explained by some differences in the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在1984年至1985年这短短5年时间里,意大利针对急性心肌梗死的纤溶疗法开展了两项大型临床试验:GISSI 1和GISSI 2。这两项试验使得评估全国众多入住冠心病监护病房(CCU)患者的人口统计学和临床特征演变、住院死亡率及死亡原因成为可能。在参与GISSI 1的176个CCU收治的31826例急性心肌梗死患者中,16.9%为75岁及以上,24.7%为女性;在参与GISSI 2的223个CCU收治的38086例患者中,这两个比例分别为21.8%和26.4%。尽管这两个人口统计学特征的患病率较高且预后较差,但GISSI 1研究中的住院死亡率为12.2%,GISSI 2研究中的住院死亡率为10.0%,有统计学显著下降(相对危险度0.84;可信区间0.80 - 0.88)。住院死亡率的显著下降也涉及根据两项试验相同纳入标准(症状发作后6小时内且入院心电图仅表现为ST段抬高)入选并接受纤溶药物(链激酶或重组组织型纤溶酶原激活剂)治疗的患者群体。事实上,GISSI 1中接受链激酶治疗的4696例患者中有468例死亡(10.0%),而GISSI 2中纳入的12381例接受链激酶或重组组织型纤溶酶原激活剂治疗的患者中有1092例死亡(8.8%)(相对危险度0.87;可信区间0.78 - 0.98)。住院死亡率的降低可能由两组间的一些差异来解释。(摘要截选至250词)

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