Scholarlink

Introduction <p><i>Sophora flavescens</i> film (SFF), a topical traditional Chinese medicine that primarily contains matrine, has been approved in China since 2009 for chronic gynecological inflammation. However, evidence regarding its clinical value in the management of postpartum vaginal dysbiosis (PVD) remains limited.</p> Aim <p>This study aimed to evaluate the effectiveness, safety, and pharmacoeconomic profile of SFF as an adjunct to conventional therapy in women with PVD.</p> Method <p>This single-center, open-label, non-randomized controlled trial was conducted among postpartum women (6–8 weeks after delivery) diagnosed with PVD. Participants were self-selected into either the SFF group (SFF plus conventional therapy) or the control group (conventional therapy alone). The primary outcome was the overall therapeutic effectiveness based on composite vaginal ecosystem indicators. Secondary outcomes included Vaginal Health Index Score (VHIS), Vaginal Inflammation Score (VIS), EQ-5D-5L health utility, EQ-VAS, and adverse events (AEs). Pharmacoeconomic evaluation was performed using a decision tree model to estimate the incremental cost-effectiveness ratio (ICER). Statistical analyses incorporated logistic regression and analysis of covariance (ANCOVA) with directed acyclic graph (DAG)-based confounder adjustments.</p> Results <p>In total, 126 participants (63 per group) completed the study. The SFF group demonstrated a significantly higher overall effectiveness than the control group (adjusted odds ratio = 3.68, 95% confidence interval [CI]: 1.49–9.09, <i>P</i> = 0.005). Significant post-treatment improvements were observed in VHIS (mean difference [MD] = 2.420, 95% CI: 1.808–3.032, <i>P</i> &lt; 0.001, η<sup>2</sup> = 0.332), VIS (MD = – 0.425, 95% CI: – 0.642 to – 0.208, <i>P</i> &lt; 0.001, η<sup>2</sup> = 0.109), EQ-5D-5L (MD = 0.029, 95% CI: 0.016–0.041, <i>P</i> &lt; 0.001, η<sup>2</sup> = 0.150), and EQ-VAS (MD = 6.329, 95% CI: 2.978–9.680, <i>P</i> &lt; 0.001, η<sup>2</sup> = 0.102). No serious AEs occurred, and the mild local irritation resolved spontaneously. Pharmacoeconomic analysis showed that SFF achieved a 1% increase in treatment effectiveness at an incremental cost of ¥244.23 compared with conventional therapy.</p> Conclusion <p>When combined with conventional care, SFF significantly improved clinical, symptomatic, and quality-of-life outcomes in women with PVD, with favorable tolerability and short-term cost-effectiveness. These results support its potential clinical utility. However, confirmation through multicenter, double-blind, randomized controlled trials is warranted.</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, safety, and pharmacoeconomic profile of Sophora flavescens film in the treatment of postpartum vaginal dysbiosis: a non-randomized controlled trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月18日

查看全文
  • Jiaojiao Zhao,
  • Xiaorang Li,
  • Songsong Tan,
  • Ye Pan,
  • Zhihao Yang,
  • Shuimei Sun,
  • Junjie Lan,
  • Rui Zhang,
  • Huaye Zhao,
  • Linfang Hu,
  • Jiaxue Wang,
  • Wenyi Zheng,
  • Rui He,
  • Chang Xu,
  • Xiaoling Zeng,
  • Jiaxing Zhang

摘要

Introduction

Sophora flavescens film (SFF), a topical traditional Chinese medicine that primarily contains matrine, has been approved in China since 2009 for chronic gynecological inflammation. However, evidence regarding its clinical value in the management of postpartum vaginal dysbiosis (PVD) remains limited.

Aim

This study aimed to evaluate the effectiveness, safety, and pharmacoeconomic profile of SFF as an adjunct to conventional therapy in women with PVD.

Method

This single-center, open-label, non-randomized controlled trial was conducted among postpartum women (6–8 weeks after delivery) diagnosed with PVD. Participants were self-selected into either the SFF group (SFF plus conventional therapy) or the control group (conventional therapy alone). The primary outcome was the overall therapeutic effectiveness based on composite vaginal ecosystem indicators. Secondary outcomes included Vaginal Health Index Score (VHIS), Vaginal Inflammation Score (VIS), EQ-5D-5L health utility, EQ-VAS, and adverse events (AEs). Pharmacoeconomic evaluation was performed using a decision tree model to estimate the incremental cost-effectiveness ratio (ICER). Statistical analyses incorporated logistic regression and analysis of covariance (ANCOVA) with directed acyclic graph (DAG)-based confounder adjustments.

Results

In total, 126 participants (63 per group) completed the study. The SFF group demonstrated a significantly higher overall effectiveness than the control group (adjusted odds ratio = 3.68, 95% confidence interval [CI]: 1.49–9.09, P = 0.005). Significant post-treatment improvements were observed in VHIS (mean difference [MD] = 2.420, 95% CI: 1.808–3.032, P < 0.001, η2 = 0.332), VIS (MD = – 0.425, 95% CI: – 0.642 to – 0.208, P < 0.001, η2 = 0.109), EQ-5D-5L (MD = 0.029, 95% CI: 0.016–0.041, P < 0.001, η2 = 0.150), and EQ-VAS (MD = 6.329, 95% CI: 2.978–9.680, P < 0.001, η2 = 0.102). No serious AEs occurred, and the mild local irritation resolved spontaneously. Pharmacoeconomic analysis showed that SFF achieved a 1% increase in treatment effectiveness at an incremental cost of ¥244.23 compared with conventional therapy.

Conclusion

When combined with conventional care, SFF significantly improved clinical, symptomatic, and quality-of-life outcomes in women with PVD, with favorable tolerability and short-term cost-effectiveness. These results support its potential clinical utility. However, confirmation through multicenter, double-blind, randomized controlled trials is warranted.