Pan Y, Zhao J, Mei J, Shao M, Zhang J
Department of Vascular Surgery, Shanghai Sixth People's Hospital, Shanghai Jiaotong University, Shanghai 200233, China.
Phlebology. 2014 Mar;29(2):109-19. doi: 10.1177/0268355512473911. Epub 2013 May 6.
To evaluate the efficiency and safety of endovenous laser ablation (EVLA) for primary lower extremity varicosities compared with high ligation and stripping (HLS).
Prospective non-randomized studies and randomized control trials on comparison of EVLA and HLS in treating varicose vein were included in this study. A meta-analysis on the data of suitable 13 clinical trials was performed using the Mantel-Haenszel method and the risk ratio was calculated. Thirteen studies including a total of 2245 limbs were eligible for inclusion. Among them, 1128 limbs were treated with endovenous laser ablation, whereas 1117 were treated with high ligation and stripping. Primary outcome measures were technical success rates and recurrence rates at different follow-up duration and complication rates.
No significant difference in initial technical success rates, Procedural failures were more common following EVLA compared with conventional surgery at one- and two-year follow-up. However, the duplex-detected and clinical recurrence rate was similar between conventional surgery and EVLA after one and two years. No statistical significance was found in postoperative phlebitis and bruise in EVLA and HLS (17.9% versus 21.5%). However, fewer complications were observed in EVLA compared with HLS, including bleeding and haematoma (1.28% versus 4.83%), wound infection (0.33% versus 1.91%) and paraesthesia (6.73% versus 11.27%).
EVLA for varicose veins is safe and effective compared with HLS in a two-year range. More randomized controlled studies follow-up results are needed to clarify long-term recurrence (5 years).
比较腔内激光治疗术(EVLA)与高位结扎剥脱术(HLS)治疗原发性下肢静脉曲张的有效性和安全性。
本研究纳入了关于EVLA与HLS治疗静脉曲张对比的前瞻性非随机研究和随机对照试验。采用Mantel-Haenszel方法对13项合适的临床试验数据进行荟萃分析,并计算风险比。13项研究共纳入2245条肢体,其中1128条肢体接受腔内激光治疗术,1117条肢体接受高位结扎剥脱术。主要观察指标为不同随访期的技术成功率、复发率及并发症发生率。
初始技术成功率无显著差异,在1年和2年随访时,与传统手术相比,腔内激光治疗术后的手术失败更为常见。然而,1年和2年后传统手术与腔内激光治疗术的双功超声检测及临床复发率相似。腔内激光治疗术和高位结扎剥脱术术后静脉炎和瘀斑发生率无统计学意义(分别为17.9%和21.5%)。然而,与高位结扎剥脱术相比,腔内激光治疗术观察到的并发症较少,包括出血和血肿(分别为1.28%和4.83%)、伤口感染(分别为0.33%和1.91%)及感觉异常(分别为6.73%和11.27%)。
在两年范围内,与高位结扎剥脱术相比,腔内激光治疗术治疗静脉曲张安全有效。需要更多随机对照研究的随访结果来阐明长期复发情况(5年)。