Scholarlink

Aim <p>To evaluate the effectiveness and safety of 3% polidocanol foam sclerotherapy (PFS) injection under anoscopy in the treatment of hemorrhoidal disease (HD) compared with rubber band ligation (RBL).</p> Method <p>This was a multicenter, open-label, prospective, observational study that enrolled 222 patients with Goligher grade I, II, or III HD (internal or mixed), who were treated with 3% PFS or RBL, which depended on the physician’s assessment and the patient’s willingness. The primary endpoint was the clinical cure rate under anoscopy and clinical symptoms assessment at 4&#xa0;weeks post-treatment.</p> Results <p>A total of 222 patients from 14 centers participated in the study, with 127 patients receiving PFS and 95 patients receiving RBL. Among the effectiveness analysis set (EAS), the clinical cure rate was 74.19% (69/93) in the PFS group and 83.13% (69/83) in the RBL group (<i>P</i> &gt; 0.05). The PFS group showed quicker and better improvement in hemorrhage score post-treatment than the RBL group, with the mean (SD) changes from baseline in hemorrhage score of the two groups (<i>P</i> &lt; 0.001) at 1, 4, and 12&#xa0;weeks being −3.44 (1.99) vs. −1.70 (2.19), −3.85 (1.80) vs. −2.75 (2.02), and −3.81 (1.84) vs. −2.89 (2.10), respectively. The incidences of adverse events (AEs) were 2.36% (3/127) in the PFS group and 3.16% (3/95) in the RBL group, respectively, and no serious adverse events (SAEs) occurred in both groups.</p> Conclusion <p>Patients treated with PFS showed similar effectiveness and safety as those treated with RBL under anoscopy, and a quick improvement trend in hemorrhage score post-treatment was observed in patients treated with PFS, but it needs further verification.</p> Trial registration <p>This study has been registered on the website of Chinese Clinical Trial Registry (<a href="https://www.chictr.org.cn/">https://www.chictr.org.cn/</a>), registration number: ChiCTR2200060325.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Effectiveness and safety of 3% polidocanol foam sclerotherapy in hemorrhoidal disease: a multicenter, prospective study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月26日

查看全文
  • Zhitong Yu,
  • Tianyu Zhou,
  • Yongduo Yu,
  • Xuegui Tang,
  • Shuxin Zhang,
  • lin Peng,
  • Zhiming Ge,
  • Zhongan Guan,
  • Xiangan Zhang,
  • Yuedong Liu,
  • XiaoJun Sun,
  • Yue Xu,
  • Wei Yang,
  • Rong Wang,
  • Xiangdang Hu,
  • Jihua Gao,
  • Shiyong Xin,
  • Xiaojian Li

摘要

Aim

To evaluate the effectiveness and safety of 3% polidocanol foam sclerotherapy (PFS) injection under anoscopy in the treatment of hemorrhoidal disease (HD) compared with rubber band ligation (RBL).

Method

This was a multicenter, open-label, prospective, observational study that enrolled 222 patients with Goligher grade I, II, or III HD (internal or mixed), who were treated with 3% PFS or RBL, which depended on the physician’s assessment and the patient’s willingness. The primary endpoint was the clinical cure rate under anoscopy and clinical symptoms assessment at 4 weeks post-treatment.

Results

A total of 222 patients from 14 centers participated in the study, with 127 patients receiving PFS and 95 patients receiving RBL. Among the effectiveness analysis set (EAS), the clinical cure rate was 74.19% (69/93) in the PFS group and 83.13% (69/83) in the RBL group (P > 0.05). The PFS group showed quicker and better improvement in hemorrhage score post-treatment than the RBL group, with the mean (SD) changes from baseline in hemorrhage score of the two groups (P < 0.001) at 1, 4, and 12 weeks being −3.44 (1.99) vs. −1.70 (2.19), −3.85 (1.80) vs. −2.75 (2.02), and −3.81 (1.84) vs. −2.89 (2.10), respectively. The incidences of adverse events (AEs) were 2.36% (3/127) in the PFS group and 3.16% (3/95) in the RBL group, respectively, and no serious adverse events (SAEs) occurred in both groups.

Conclusion

Patients treated with PFS showed similar effectiveness and safety as those treated with RBL under anoscopy, and a quick improvement trend in hemorrhage score post-treatment was observed in patients treated with PFS, but it needs further verification.

Trial registration

This study has been registered on the website of Chinese Clinical Trial Registry (https://www.chictr.org.cn/), registration number: ChiCTR2200060325.