摘要
目的系统评价常规治疗(conventional treatment,CT)联合导管内溶栓(catheter-directed thrombolysis,CDT)治疗与只进行常规治疗对急性下肢深静脉血栓形成(deep vein thrombosis,DVT)的有效性以及安全性。方法计算机检索The Cochrane Library、Pubmed、EMBASE.com、Medline、CNKI、WanFang Data、CBM、CSJD、CJFD等数据库及Google Scholar查找有关CT联合DVT治疗急性下肢深静脉血栓形成的随机对照试验(RCT),时限均为建库至2013年6月30日止。由两位研究者依据纳入与排除标准独立筛选文献、提供资料并评价文献质量。对纳入的研究以RevMan 5.1软件进行Meta分析。结果共入选2个RCT 3篇文献,224例患者。纳入的文献无发表偏倚(Begg检验,Z=1.02,P>0.05;Egger检验,t=0.98,P>0.05)。Meta分析结果显示:术后6个月CDT组髂股静脉通畅率高于CT组(OR=3.62,95%CI:1.51~8.64,P=0.004);术后6个月髂股静脉闭塞和(或)静脉反流率CDT组低于CT组(OR=0.24,95%CI:0.11~0.53,P=0.000);CDT组术后24个月下肢深静脉血栓后遗症(PTS)发生率要低于CT组(OR=0.55,95%CI:0.31~0.96,P=0.040);在其他严重并发症发生率上CDT组与CT组间差异无统计学意义(OR=1.34,95%CI:0.12~15.69,P=0.810);而CT组的其他次要并发症发生率以及手术后总并发症发生率较CDT组低,统计值分别为OR=13.67,95%CI:4.08~45.83,P<0.000 1和OR=11.67,95%CI:4.40~30.99,P<0.000 01。结论 CDT在治疗早期深静脉血栓形成对血管再通,防止血管再次闭塞、反流及PTS发生上具有较为肯定的疗效。受纳入研究质量和数量的限制,以上结论仍需要更多高质量的研究,特别是需要大样本、多中心的随机双盲对照试验来加以验证。腔内治疗的应用应根据患者的具体情况而定。
Objective To evaluate the effectiveness and safety of the additional catheter-directed thrombolysis(CDT) and conventional treatment(CT) for treatment primary deep vein thrombosis. Methods Databases such as CNKI, WanFang Data, Pubmed, EMBASE.com, Medline, CBM, CSJD, CJFD, and the Cochrane Library were electronically searched from the date of their establishment to 30 June, 2013, and the relevant literatures and conference proceedings were also manually searched to include randomized controlled trials(RCTs) on comparison of additional CDT versus CT for primary deep vein thrombosis. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data, and accessed the methodological quality of the included studies. Then the metaanalysis was performed by using RevMan 5.1 software. Publication bias was assessed by STATA software. A metaregression model was used to describe between study variability. Results Two RCTs including 3 literatures contain 224 patients reporting data on safety and effi cacy of CDT versus CT were included. There were no publication bias(Begg'Stest, Z=1.02. P > 0.05;Egger'S test, t=0.98, P > 0.05). The results of meta-analysis showed that: in 6 months after surgery iliofemoral vein patency rate of CDT group was higher than that of CT group(OR=3.62, 95% CI:1.51-8.64, P=0.004), in 6 months after surgery CDT group with a lower rate than CT group of the iliofemoral vein occlusion and(or)venous reflux rate(OR=0.24, 95% CI:0.11-0.53, P=0.000), and the incidence rate of PTS in 24 months after surgery in CTD group was less than that of CT group(OR=0.55, 95% CI:0.31-0.96, P=0.040). There were no statistically signifi cant of the major complications after surgery between CDT group and CT group(OR=1.34, 95% CI:0.12-15.69, P=0.810). But the incidence rates of minor complications and total complications after surgery in CT group were lower than those of CDT group(OR=13.67, 95% CI:4.08-45.83, P<0.00 01 and OR=11.67, 95% CI:4.40-30.99, P<0.000 01). Conclusions CDT is a effective and positive way to treat early deep venous thrombosis especially in terms of the patency of vascular and prevent the occlusion and PTS. Due to the limitation of the included studies, large sample size, multicenter, and high quality studies are needed to verify the above conclusion, such as the ATTRACT Study. The intracavitary therapy could be applied to clinic combining individual conditions of patients.
引文
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