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经皮机械血栓切除术治疗下肢深静脉血栓形成的荟萃分析和系统评价。

Meta-analysis and systematic review of percutaneous mechanical thrombectomy for lower extremity deep vein thrombosis.

机构信息

Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.

Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.

出版信息

J Vasc Surg Venous Lymphat Disord. 2018 Nov;6(6):788-800. doi: 10.1016/j.jvsv.2018.08.002.

Abstract

OBJECTIVE

The objective of this review was to evaluate the efficacy and safety of percutaneous mechanical thrombectomy (PMT) with or without catheter-directed thrombolysis (CDT) in the treatment of lower extremity deep venous thrombosis (DVT).

METHODS

We searched PubMed for clinical trials and prospective or retrospective case series (comparative or single-arm studies) that focused on PMT ± CDT in the treatment of DVT, published before March 2, 2017. We meta-analyzed perioperative outcomes and complications and long-term outcomes of this procedure. We also compared the results between PMT ± CDT and CDT alone, using the data from comparative studies.

RESULTS

Overall, 1323 PMT ± CDT patients from 35 studies were included in our study. The rate of patients experiencing successful thrombolysis with a partial or complete lysis rate was 93.4% (95% confidence interval [CI], 90.1%-95.6%) or 67.0% (95% CI, 59.1%-76.4%), respectively. The pooled proportion of 30-day rethrombosis rate was 11.9% (95% CI, 6.7%-20.3%). The 30-day DVT-related mortality was 2.4% (95% CI, 1.6%-3.7%). The perioperative incidence of major bleeding and pulmonary embolism was 4.6% (95% CI, 2.9%-7.3%) and 3.8% (95% CI, 2.5%-6.7%), respectively. During the follow-up, the late rethrombosis rate was 10.7% (95% CI, 8.7%-13.0%; the average follow-up period ranged from 2.8 to 32.1 months). About 15.1% (95% CI, 9.6%-22.9%) of patients developed post-thrombotic syndrome during follow-up (the average follow-up period varied from 3.8 to 29.6 months). In comparing the results of PMT ± CDT with CDT alone, six studies were included (195 patients in the PMT ± CDT group and 193 patients in the CDT group). The partial thrombolysis rate was higher in the PMT ± CDT group (odds ratio [OR], 2.64; 95% CI, 1.34-5.21; P = .005), whereas the complete lysis rate was not (OR, 1.38; 95% CI, 0.87-2.18; P = .17). The difference between the Villalta scores of the two groups during follow-up had no statistical significance (OR, -0.50; 95% CI, -1.34 to 0.34; P = .24). The thrombolytic drug dose in the PMT ± CDT group was much lower than that in the CDT group (standard mean difference, -0.98; 95% CI, -1.59 to -0.38; P = .001), and the procedural time was shorter in the PMT ± CDT group (mean difference, -16.94; 95% CI, -22.38 to -11.50; P < .00,001). There was no significant difference in major bleeding (OR, 1.20; 95% CI, 0.50-2.90; P = .24) or pulmonary embolism (OR, 1.18; 95% CI, 0.16-8.73; P = .87) between the two groups.

CONCLUSIONS

PMT with or without CDT is a relatively effective and safe approach for lower extremity DVT patients because of the acceptable incidence of perioperative complications and satisfying short- or long-term outcomes.

摘要

目的

本次综述的目的在于评估经皮机械血栓切除术(PMT)联合或不联合导管溶栓(CDT)治疗下肢深静脉血栓形成(DVT)的疗效和安全性。

方法

我们检索了 PubMed 中截至 2017 年 3 月 2 日发表的有关 PMT ± CDT 治疗 DVT 的临床试验和前瞻性或回顾性病例系列研究(包括比较性或单臂研究)。我们对该手术的围手术期结局和并发症以及长期结局进行了荟萃分析。我们还比较了比较性研究中 PMT ± CDT 组与 CDT 组的结果。

结果

共有来自 35 项研究的 1323 例 PMT ± CDT 患者纳入本研究。有 93.4%(95%置信区间[CI],90.1%-95.6%)或 67.0%(95% CI,59.1%-76.4%)的患者实现了成功溶栓,部分或完全溶解率分别为 93.4%(95% CI,90.1%-95.6%)或 67.0%(95% CI,59.1%-76.4%)。30 天再血栓形成率的汇总比例为 11.9%(95% CI,6.7%-20.3%)。30 天 DVT 相关死亡率为 2.4%(95% CI,1.6%-3.7%)。围手术期大出血和肺栓塞的发生率分别为 4.6%(95% CI,2.9%-7.3%)和 3.8%(95% CI,2.5%-6.7%)。在随访期间,晚期再血栓形成率为 10.7%(95% CI,8.7%-13.0%;平均随访时间为 2.8-32.1 个月)。约 15.1%(95% CI,9.6%-22.9%)的患者在随访期间出现血栓后综合征。将 PMT ± CDT 组与 CDT 组进行比较,纳入了 6 项研究(PMT ± CDT 组 195 例,CDT 组 193 例)。PMT ± CDT 组的部分溶栓率更高(比值比[OR],2.64;95% CI,1.34-5.21;P =.005),但完全溶解率无显著差异(OR,1.38;95% CI,0.87-2.18;P =.17)。两组患者随访期间的 Villalta 评分差异无统计学意义(OR,-0.50;95% CI,-1.34 至 0.34;P =.24)。PMT ± CDT 组溶栓药物剂量明显低于 CDT 组(标准均数差,-0.98;95% CI,-1.59 至-0.38;P =.001),PMT ± CDT 组的手术时间更短(平均差,-16.94;95% CI,-22.38 至-11.50;P <.001)。两组大出血(OR,1.20;95% CI,0.50-2.90;P =.24)或肺栓塞(OR,1.18;95% CI,0.16-8.73;P =.87)的发生率无显著差异。

结论

PMT 联合或不联合 CDT 治疗下肢 DVT 是一种相对有效的安全方法,因为其围手术期并发症发生率可接受,且短期或长期结局令人满意。

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