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循证医学/严格评价主题。亚大面积肺栓塞的溶栓治疗?

Evidence-based emergency medicine/critically appraised topic. Thrombolytic therapy for submassive pulmonary embolism?

作者信息

Worster Andrew, Smith Camala, Silver Shawna, Brown Michael D

机构信息

Division of Emergency Medicine, McMaster University, Hamilton, Ontario, Canada.

出版信息

Ann Emerg Med. 2007 Jul;50(1):78-84. doi: 10.1016/j.annemergmed.2007.01.002. Epub 2007 Apr 20.

Abstract

STUDY OBJECTIVE

The purpose of this review was to determine the effectiveness of adding thrombolytics to standard heparin therapy for treatment of submassive pulmonary embolism. Patients with submassive pulmonary embolism were considered to be those with evidence of right ventricular dysfunction but without hemodynamic instability.

METHODS

We searched for trials comparing thrombolytics to heparin in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE. We included only studies assessing the effectiveness of thrombolytic therapy for submassive pulmonary embolism and reported the patient-important outcomes of mortality, recurrent pulmonary embolism, and major hemorrhage.

RESULTS

Two randomized trials met the inclusion criteria; one with a total of 256 patients presenting with submassive pulmonary embolism and the other trial including a subgroup of 46 patients with submassive pulmonary embolism. In the larger study, the relative risk (RR) for mortality, recurrent pulmonary embolism, and major hemorrhage was 1.56 (95% confidence interval [CI] 0.36 to 6.83), 1.17 (95% CI 0.30 to 4.57), and 0.23 (95% CI 0.03 to 1.97), respectively. Our post hoc subgroup analysis of the smaller trial identified 2 deaths and 5 patients with recurrent pulmonary embolism among 23 controls, whereas none of the 23 patients randomized to thrombolytics died or had recurrent pulmonary embolism. None of these findings were statistically significant.

CONCLUSION

Results of randomized trials comparing the addition of thrombolytic therapy to standard heparin therapy for treatment of submassive pulmonary embolism fail to show any significant differences in clinically important outcomes.

摘要

研究目的

本综述旨在确定在标准肝素治疗基础上加用溶栓药物治疗次大面积肺栓塞的有效性。次大面积肺栓塞患者被认为是有右心室功能障碍证据但无血流动力学不稳定的患者。

方法

我们在Cochrane对照试验中央注册库、MEDLINE和EMBASE中检索了比较溶栓药物与肝素的试验。我们仅纳入评估溶栓治疗次大面积肺栓塞有效性并报告死亡率、复发性肺栓塞和大出血等对患者重要结局的研究。

结果

两项随机试验符合纳入标准;一项试验共有256例次大面积肺栓塞患者,另一项试验包括一个46例次大面积肺栓塞患者的亚组。在规模较大的研究中,死亡率、复发性肺栓塞和大出血的相对风险(RR)分别为1.56(95%置信区间[CI]0.36至6.83)、1.17(95%CI0.30至4.57)和0.23(95%CI0.03至1.97)。我们对较小试验的事后亚组分析发现,23例对照组中有2例死亡,5例复发性肺栓塞患者,而随机接受溶栓治疗的23例患者中无一人死亡或发生复发性肺栓塞。这些结果均无统计学意义。

结论

比较在标准肝素治疗基础上加用溶栓治疗次大面积肺栓塞的随机试验结果未能显示在临床重要结局方面有任何显著差异。

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