Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):95-100. doi: 10.1016/j.jvsv.2020.04.028. Epub 2020 May 23.
The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP.
The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications.
The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other.
RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.
本研究旨在评估射频诱导热疗（RFiTT）联合透光动力静脉切除术（TIPP）与高位结扎剥脱术（HLS）联合 TIPP 治疗下肢静脉曲张（VVs）的疗效和安全性。
将下肢 VVs 患者随机分配至 RFiTT 联合 TIPP 或 HLS 联合 TIPP 组。主要终点为 12 个月时大隐静脉完全闭塞率。次要终点包括 12 个月时静脉临床严重程度评分（Venous Clinical Severity Score）和 14 项慢性静脉功能不全问卷评分（14-item Chronic Venous Insufficiency Questionnaire score）变化以及围手术期并发症。
12 个月时大隐静脉完全闭塞率在 RFiTT 组（90.9%[90/99]）略低于 HLS 组（97.0%[98/101]），但无统计学意义（χ²=0.068，P=0.08）。RFiTT 组的手术时间、术中出血量、住院时间、卧床时间和恢复活动时间均显著优于 HLS 组。两组深静脉血栓形成、静脉炎、血肿、疼痛和感染发生率无显著差异。然而，RFiTT 组皮肤色素沉着和感觉异常发生率显著优于 HLS 组。12 个月时，两组静脉临床严重程度评分（RFiTT 组 1.28±0.57，HLS 组 1.33±0.61）和 14 项慢性静脉功能不全问卷评分（RFiTT 组 67.32±1.29，HLS 组 67.45±1.32）均较基线显著改善，但组间差异无统计学意义。
RFiTT 联合 TIPP 是一种治疗下肢 VVs 的有效方法，与 HLS 相比，在 12 个月随访时手术数据、皮肤色素沉着和感觉异常方面具有更满意的临床疗效。
