银花泌炎灵片治疗非复杂性尿路感染的疗效与安全性：一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验

DU Zhen; TANG Yi-wen; QIAO Lu-dong; CUI Liang; WU Hui-ling; YANG Jin-qiang; LIU Feng; YIN Zhuo; ZHANG Jian; PAN Tie-jun; CHEN Shan; GAO Zhan

doi:10.1007/s11655-026-4154-4

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银花泌炎灵片治疗非复杂性尿路感染的疗效与安全性：一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验

Original Article | Updated：2026-08-04

- 银花泌炎灵片治疗非复杂性尿路感染的疗效与安全性：一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验
- 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
- 中国结合医学杂志（英文版） 2026年32卷第7期页码：588-595
- Affiliations：
  
  1.Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing (100730), China
  2.Graduate School of Beijing University of Chinese Medicine, Beijing (100029), China
  3.Department of Urology, Civil Aviation General Hospital, Beijing (100123), China
  4.Department of Urology, Jinhua People's Hospital, Jinhua , Zhejiang Province (321001), China
  5.Department of Urology, Beijing Shunyi District Hospital, Beijing (101300), China
  6.Department of Urology, China-Japan Union Hospital of Jilin University, Changchun (130033), China
  7.Department of Urology, the Second Xiangya Hospital of Central South University, Changsha (410000), China
  8.Department of Urology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi , Jiangsu Province (214023), China
  9.Department of Urology, Chinese People's Liberation Army Central Theater Command General Hospital, Wuhan (430070), China
  10.Department of Urology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing (100091), China
- Author bio：
  
  Prof. CHEN Shan, E-mail: shanchentr002@126.com;
  Prof. GAO Zhan, E-mail: gaozhanmd@vip.163.com
- Funds：
  
  the Major Science and Technology Project of Jilin Provincial Science and Technology Development Plan(20240208009JH);Hospital Capability Enhancement Project of Xiyuan Hospital, China Academy of Chinese Medical Sciences(XYZX0201-05;XYZX0202-02)
- DOI：10.1007/s11655-026-4154-4
  中图分类号：
- 录用：2025-12-24，
  
  网络首发：2026-04-16，
  
  纸质出版：2026-07
- Accepted：
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DU Zhen, TANG Yi-wen, QIAO Lu-dong, 等. 银花泌炎灵片治疗非复杂性尿路感染的疗效与安全性：一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验[J]. 中国结合医学杂志（英文版）, 2026,32(7):588-595.

DU Zhen, TANG Yi-wen, QIAO Lu-dong, et al. 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[J]. Chinese Journal of Integrative Medicine, 2026, 32(7): 588-595.
DU Zhen, TANG Yi-wen, QIAO Lu-dong, 等. 银花泌炎灵片治疗非复杂性尿路感染的疗效与安全性：一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验[J]. 中国结合医学杂志（英文版）, 2026,32(7):588-595. DOI： 10.1007/s11655-026-4154-4.

DU Zhen, TANG Yi-wen, QIAO Lu-dong, et al. 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[J]. Chinese Journal of Integrative Medicine, 2026, 32(7): 588-595. DOI： 10.1007/s11655-026-4154-4.

摘要

目的：

比较银花泌炎灵片（YMT）与左氧氟沙星治疗女性非复杂性尿路感染（uUTI）的疗效与安全性。

方法：

本研究为一项多中心、随机、双盲、双模拟、阳性对照、非劣效性临床试验，于2022年8月至2023年8月在中国9家三级医院进行。采用区组随机化方法，将480例女性uUTI患者按1:1比例随机分配至YMT组（YMT 2 g，每日4次，连续服用7天，并加用左氧氟沙星模拟剂）或左氧氟沙星组（左氧氟沙星片0.5 g，每日1次，连续服用3天，并加用YMT模拟剂）。主要结局指标为治疗第1天至第38–42天期间因uUTI需要额外抗菌治疗的患者比例；次要结局指标包括治疗后第42天的急性膀胱炎症状评分（ACSS）及尿液分析结果。安全性评估基于所有不良事件（AE）及异常实验室检查结果。

结果：

共458例女性uUTI患者纳入改良意向治疗分析。在治疗第1天至第38–42天期间，YMT组需要额外抗菌治疗的患者比例为20.8%（47/226），左氧氟沙星组为9.9%（23/232）（

0.01）。非劣效性标准（界值δ=20%）达到。与左氧氟沙星相比，YMT治疗在改善ACSS典型症状、生活质量评分及尿液分析结果方面效果相当，组间差异无统计学意义（

0.05）。YMT组治疗期间出现的不良事件发生率为7.7%（17/226），左氧氟沙星组为7.0%（16/232

）（

=0.775）。

结论：

在女性uUTI治疗期间，YMT在需要额外抗菌治疗的患者比例方面非劣效于左氧氟沙星。YMT在改善uUTI症状及生活质量评分方面与左氧氟沙星同样有效。YMT可作为女性uUTI有前景的辅助治疗药物。（试验注册号：ChiCTR2200066312）

Abstract

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 (

0.01). The non-inferiority criterion (margin δ = 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 (

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 (

=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)

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