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Objective <p>To compare the efficacy and safety of Yinhua Miyanling Tablets (YMT) <i>versus</i> levofloxacin in the treatment of female patients with uncomplicated urinary tract infections (uUTIs).</p> Methods <p>A multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical trial was conducted from August 2022 to August 2023 in 9 tertiary hospitals across China. By using a block randomization method, 480 female patients with uUTI were randomized in a 1:1 ratio to receive either YMT 2 g, 4 times daily for 7 consecutive days (plus levofloxacin-matching placebo) or levofloxacin tablets 0.5 g, once daily for 3 consecutive days (plus YMT-matching placebo). The primary outcome was the proportion of patients requiring additional antimicrobial therapy for uUTIs between day 1 and days 38–42 of treatment, while the secondary outcomes included the Acute Cystitis Symptom Score (ACSS) and urinalysis after 42-d treatment. Safety assessments were conducted based on all adverse events (AEs) and abnormal laboratory test results.</p> Results <p>A total of 458 women with uUTIs were enrolled in the modified intention-to-treat analysis. Between day 1 and days 38–42 of treatment, the proportion of patients requiring additional antimicrobial therapy was 20.8% (47/226) in the YMT group and 9.9% (23/232) in the levofloxacin group (<i>P</i>&lt;0.01). The non-inferiority criterion (margin 8 = 20%) was met. YMT treatment improved ACSS typical symptoms and quality-of-life scores and urinalysis results compared with levofloxacin, although the differences between groups were not statistically significant (<i>P</i>&gt;0.05). The incidence of treatment-emergent AEs was 7.7% (17/226) in the YMT group and 7.0% (16/232) in the levofloxacin group (<i>P</i>=0.775).</p> Conclusions <p>YMT is non-inferior to levofloxacin in the proportion of patients requiring additional antimicrobial therapy during treatment of uUTIs in women. YMT treatment is as effective as levofloxacin in terms of improving uUTI symptoms and quality-of-life scores. YMT may be used as a promising adjunctive therapy for uUTIs in women. (Trial registration No. ChiCTR2200066312)</p>

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Efficacy and Safety of Yinhua Miyanling Tablets for Uncomplicated Urinary Tract Infections: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Non-inferiority Clinical Trial

  • 期刊论文

  • 发表日期：

    2026年4月16日

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  • Zhen Du,
  • Yi-wen Tang,
  • Lu-dong Qiao,
  • Liang Cui,
  • Hui-ling Wu,
  • Jin-qiang Yang,
  • Feng Liu,
  • Zhuo Yin,
  • Jian Zhang,
  • Tie-jun Pan,
  • Shan Chen,
  • Zhan Gao

摘要

Objective

To compare the efficacy and safety of Yinhua Miyanling Tablets (YMT) versus levofloxacin in the treatment of female patients with uncomplicated urinary tract infections (uUTIs).

Methods

A multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical trial was conducted from August 2022 to August 2023 in 9 tertiary hospitals across China. By using a block randomization method, 480 female patients with uUTI were randomized in a 1:1 ratio to receive either YMT 2 g, 4 times daily for 7 consecutive days (plus levofloxacin-matching placebo) or levofloxacin tablets 0.5 g, once daily for 3 consecutive days (plus YMT-matching placebo). The primary outcome was the proportion of patients requiring additional antimicrobial therapy for uUTIs between day 1 and days 38–42 of treatment, while the secondary outcomes included the Acute Cystitis Symptom Score (ACSS) and urinalysis after 42-d treatment. Safety assessments were conducted based on all adverse events (AEs) and abnormal laboratory test results.

Results

A total of 458 women with uUTIs were enrolled in the modified intention-to-treat analysis. Between day 1 and days 38–42 of treatment, the proportion of patients requiring additional antimicrobial therapy was 20.8% (47/226) in the YMT group and 9.9% (23/232) in the levofloxacin group (P<0.01). The non-inferiority criterion (margin 8 = 20%) was met. YMT treatment improved ACSS typical symptoms and quality-of-life scores and urinalysis results compared with levofloxacin, although the differences between groups were not statistically significant (P>0.05). The incidence of treatment-emergent AEs was 7.7% (17/226) in the YMT group and 7.0% (16/232) in the levofloxacin group (P=0.775).

Conclusions

YMT is non-inferior to levofloxacin in the proportion of patients requiring additional antimicrobial therapy during treatment of uUTIs in women. YMT treatment is as effective as levofloxacin in terms of improving uUTI symptoms and quality-of-life scores. YMT may be used as a promising adjunctive therapy for uUTIs in women. (Trial registration No. ChiCTR2200066312)