Department of Medical and Surgical Science, University of Catanzaro, Catanzaro, Italy.
Minerva Surgical Service, Catanzaro, Italy.
Colorectal Dis. 2023 Mar;25(3):386-395. doi: 10.1111/codi.16380. Epub 2022 Nov 9.
Sclerotherapy with 3% polidocanol foam is becoming increasingly popular for the treatment of symptomatic I-II or III degree haemorrhoidal disease (HD). However, there are no studies that have reported a follow-up of more than 1 year. The purpose of this study was to analyse the long-term outcomes of sclerotherapy with 3% polidocanol foam in the treatment of II-degree HD.
This was an open label, single-arm, phase 2b trial conducted in 10 tertiary referral centres for HD. A total of 183 patients with II-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification and unresponsive to medical treatment, were included in the study and underwent sclerotherapy with 3% polidocanol foam. The efficacy was evaluated in terms of bleeding score, haemorrhoidal disease symptom score (HDSS) and short health scale for HD (SHS-HD) score. Successful treatment was defined as the complete absence of bleeding episodes after 7 days (T1) according to the bleeding score.
The overall success rate ranged from 95.6% (175/183) at 1 year to 90.2% (165/183) after the final 3 year follow-up. The recurrence rate, based on the primary outcome, ranged from 12% (15/125) to 28% (35/125). The greatest increase in recurrence (15) was recorded between 12 and 18 months of follow-up, then another five between 18 and 24 months. Both the HDSS and the SHS score remained statistically significant (p < 0.001) from a median preoperative value of 11 (10-13) and 18 (15-20) to 0 (0-2) and 4 (0-4), respectively. Symptom-free (HDSS = 0) patients, excluding patients converted to surgery, increased from 55.5% (101/182) at 1 year to 65.1% at 3 years (110/169). There were no intraoperative complications in redo-sclerotherapy nor additional adverse events (AEs) compared to the first 12 months.
Sclerotherapy with 3% polidocanol foam is gradually establishing itself in the treatment of bleeding HD due to its repeatability, safety, convenience in terms of direct and indirect costs with the absence of discomfort for the patient as well as AEs rather than an excellent overall success rate.
聚多卡醇 3%泡沫硬化剂治疗症状性 I-II 度或 III 度痔病（HD）越来越受欢迎。然而，目前尚无超过 1 年随访的研究报告。本研究旨在分析聚多卡醇 3%泡沫硬化剂治疗 II 度 HD 的长期疗效。
这是一项在 10 个 HD 三级转诊中心进行的开放标签、单臂、2b 期试验。共纳入 183 例 II 度 HD 患者，年龄 18-75 岁，根据 Goligher 分类有症状 HD，且对药物治疗无反应，接受聚多卡醇 3%泡沫硬化剂治疗。以出血评分、痔病症状评分（HDSS）和痔病健康量表短版（SHS-HD）评分评估疗效。根据出血评分，定义治疗后 7 天（T1）完全无出血发作为治疗成功。
1 年时总体成功率为 95.6%（175/183），末次随访 3 年后为 90.2%（165/183）。基于主要结局，复发率为 12%（15/125）至 28%（35/125）。复发最多（15 例）发生在随访 12-18 个月，其次是 18-24 个月，分别为 5 例。HDSS 和 SHS 评分均从术前中位数 11（10-13）和 18（15-20）显著降低至 0（0-2）和 4（0-4）（p<0.001）。排除转为手术的患者，无出血症状（HDSS=0）患者比例从 1 年时的 55.5%（101/182）增至 3 年时的 65.1%（110/169）。与前 12 个月相比，重复硬化治疗无术中并发症，也无其他不良事件（AE）。
聚多卡醇 3%泡沫硬化剂治疗出血性 HD 的疗效逐渐得到认可，这主要归因于其可重复性、安全性、直接和间接成本方面的便利性、患者舒适度以及 AE 发生率，而非卓越的总体成功率。
