Objective: To evaluate the effectiveness of lymphaticovenular anastomosis (LVA) combined with perioperative targeted multi-layer circular lymphatic drainage in the treatment of secondary lower limb lymphedema using a prospective randomized controlled trial.
Methods: In a prospective randomized controlled trial, 80 patients with secondary lower limb lymphedema admitted between January 2023 and September 2025 were initially enrolled and allocated to either the trial group (LVA+targeted lymphatic drainage) or the control group (LVA+conventional lymphatic drainage), 40 in each group. After 2 dropouts in the control group, 78 patients (40 in the trial group, 38 in the control group) were included for analysis. There was no significant difference in the baseline data ( P>0.05), such as age, gender, disease duration, and preoperative lower limb circumference difference, functional scores, and levels of vascular endothelial growth factor C (VEGF-C), transforming growth factor β 1 (TGF-β 1), and interleukin 6 (IL-6). Both groups underwent LVA. The trial group received perioperative targeted multi-layer circular lymphatic drainage, while the control group received conventional manual lymphatic drainage. Changes in lower limb circumference difference, functional scores, and levels of VEGF-C, TGF-β 1, and IL-6 were compared between the two groups at various time points before and after operation. Overall effectiveness and safety were also assessed.
Results: All patients were followed up 3-12 months (mean, 6.5 months). Postoperatively, the trial group demonstrated significantly better functional recovery and a superior trend in lower limb circumference reduction at all time points compared to the control group ( P<0.05). Serological analysis indicated a more pronounced increase in VEGF-C level in the trial group ( P<0.05), and a downward trend in TGF-β 1 and IL-6 levels in both groups ( P<0.05); no significant difference was observed in TGF-β 1 and IL-6 levels between groups ( P>0.05). At 3 months after operation, indocyanine green fluorescence (ICG) lymphography showed an anastomosis patency rate of 95.0% (38/40) in the trial group, significantly higher than the 68.4% (26/38) in the control group ( P<0.05). The overall effectiveness was rated as significantly effective in 30 cases and effective in 15 cases in the trial group, while as significantly effective in 15 cases, effective in 15 cases, and ineffective in 8 cases in the control group. The difference between groups was significant ( P<0.05). The incidence of complications showed no significant difference between trial group and control group (2.5% vs 7.9%， P>0.05).
Conclusion: The application of targeted multi-layer circular lymphatic drainage during the perioperative period of LVA is safe and effective. It significantly promotes lower limb circumference reduction and functional recovery without increasing the risk of complications.
目的: 采用前瞻性随机对照研究，探讨淋巴管-静脉吻合术（lymphaticovenular anastomosis，LVA）联合围术期吻合口靶向多层循环淋巴引流术治疗继发性下肢淋巴水肿的临床疗效。.
方法: 以2023年1月—2025年9月收治的继发性下肢淋巴水肿患者为研究对象，将符合选择标准的80例患者采用随机数字表法分为试验组（LVA+靶向引流）与对照组（LVA+传统引流），每组40例。期间对照组2例患者失访，最终纳入78例（试验组40例，对照组38例）进行分析。 两组患者性别、年龄、病程、术前下肢周径差、肢体功能评分以及血清VEGF-C、TGF-β 1、IL-6水平等基线资料比较，差异均无统计学意义（ P>0.05）。两组均接受LVA，试验组于围术期行吻合口靶向多层循环淋巴引流术，对照组接受传统徒手淋巴引流。比较两组患者术前及术后不同时间点下肢周径差、肢体功能评分及血清VEGF-C、TGF-β 1、IL-6水平，并评估总体疗效与安全性。.
结果: 两组患者均获随访，随访时间为3～12个月，平均6.5个月。术后随时间延长，两组下肢周径差均逐渐缩小，肢体功能评分逐渐改善，组内不同时间点比较差异均有统计学意义（ P<0.05），且试验组术后各时间点肢体功能评分及下肢周径差均优于对照组（ P<0.05）。术后两组血清VEGF-C水平呈上升趋势，且各时间点试验组均高于对照组，差异有统计学意义（ P<0.05）；而TGF-β 1与IL-6呈下降趋势（ P<0.05），但组间差异无统计学意义（ P>0.05）。术后3个月，吲哚菁绿荧光造影检查示，试验组38例（95.0%）、对照组26例（68.4%）吻合口通畅，通畅率差异有统计学意义（ P<0.05）；综合疗效评估试验组获显效30例、有效15例，对照组显效15例、有效15例、无效8例，组间差异有统计学意义（ P<0.05）。治疗期间试验组及对照组并发症发生率（2.5% vs 7.9%）差异无统计学意义（ P>0.05）。.
结论: LVA围术期应用吻合口靶向多层循环淋巴引流术，能安全、有效地促进患肢形态与功能恢复，且未增加并发症风险。.
Keywords: Secondary lymphedema; effectiveness analysis; lymphaticovenular anastomosis; randomized controlled trial; targeted drainage.