A meta-analysis of the efficacy and safety of paclitaxel-coated balloon and ordinary balloon in the treatment of femoral popliteal arteriosclerosis obliterans
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摘要: 目的 荟萃分析药物涂层球囊治疗股腘段动脉硬化闭塞症的疗效和安全性。 方法 通过计算机检索并收集国内外关于药物涂层球囊治疗股腘动脉硬化闭塞症的随机对照实验文献,检索年限为建库至2018年6月,采用Review Manager 5.1软件对收集整理的数据资料进行Meta分析,对比药物涂层球囊与普通球囊治疗股腘动脉硬化闭塞症术后血管通畅率及并发症等发生情况。 结果 按照检索策略进行系统检索后,依照纳入标准,最终确定12篇文献纳入统计分析,共计2 373例病例。Meta分析结果显示,术后6个月药物涂层球囊在晚期管腔丢失、再狭窄发生率均低于普通球囊,差异均具有统计学意义(均P<0.05);2组术后12个月一期通畅率比较,异质性检验显示有明显的差异性(χ2=13.660,P<0.05,I2=71%),采用随机效应模型分析药物涂层球囊维持通畅率明显优于普通球囊(P<0.05);术后最长随访至12个月截肢率比较,异质性检验无明显的差异性(χ2=0.420,P=0.510,I2=0%),采用固定效应模型分析2组患者截肢率未见明显差异性(P=0.710);术后随访至24个月靶病变血运重建对比,药物涂层球囊明显优于普通球囊(P<0.05)。 结论 药物涂层球囊治疗股腘动脉硬化闭塞症较普通球囊具有更好的临床优势,有助于降低术后再狭窄、再闭塞的发生率,提高远期通畅率。
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关键词:
- 药物涂层球囊 /
- 普通球囊/非药涂球囊 /
- 股腘动脉
Abstract: Objective To analyze the efficacy and safety of drug coated balloon in the treatment of femoral popliteal arteriosclerosis obliterans. Methods The randomized controlled trial literature on the treatment of femoral popliteal arteriosclerosis obliterans by drug coated balloon was retrieved and collected at domestic and abroad. The retrieval years were established to June 2018. Review Manager 5.1 software was used to carry out Meta analysis on the data collected and collated, compared with drug coated balloon and common balloon treatment stock. Postoperative patency and complications of popliteal arteriosclerosis obliterans. Results According to the inclusion criteria, 12 articles were included in the statistical analysis and 2 373 cases were included in the statistical analysis. The results of Meta analysis showed that the late lumen loss and restenosis at 6 months after the operation were all lower than that of the common balloon(all P<0.05). The two groups were compared with the 12-month primary patency rate, and the heterogeneity test showed significant difference(χ2=13.660, P<0.05, I2=71%). The random effect model was used to analyze the patency rate of the drug coated balloon significantly better than that of the common balloon(P<0.05). The longest follow-up to 12 months after the operation was compared with the rate of amputation, and there was no significant difference in the heterogeneity test(χ2=0.420, P=0.510, I2=0%). The amputation rate of two groups was not significantly different(P=0.710). After follow up to 24 months, the drug coated balloon was significantly better than that of the common balloon(P<0.05). Conclusion The drug coated balloon in the treatment of femoral popliteal arteriosclerosis obliterans has better clinical advantages than common balloon, which can help to reduce the incidence of restenosis and restenosis after operation, and improve the long-term patency rate.
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