Department of Nephrology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang Middle Road, Shanghai, 200071, China.
Trials. 2021 Dec 11;22(1):901. doi: 10.1186/s13063-021-05830-4.
Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project.
METHODS/DESIGN: This is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial.
This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients.
Chinese Clinical Trial Registry ChiCTR2100041914 . Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.
鉴于抗菌药物耐药率（AMR）不断上升，复发性尿路感染（rUTI）越来越难以治疗。抗生素预防包括持续低剂量抗生素疗法（CLAT），是世界范围内治疗 rUTI 的常用方法。然而，单独使用 CLAT 可能引起的不良反应应该引起更多关注。研究表明，中草药（CHM）可能是 rUTI 的一种有效治疗方法。Tailin 配方（TLF）是 21 世纪初在上海市中医院开发的一种用于治疗 rUTI 的草药处方。我们之前的研究表明，TLF 可预防肾盂肾炎（PN）大鼠模型和 PN 患者的尿路感染。此外，我们发表的数据表明，TLF 有助于减少 rUTI 的复发并保护肾小管功能。为了寻找治疗 rUTI 的新方法以提高临床疗效，我们尝试将 TLF 与 CLAT 联合治疗 rUTI，并设计了一项优化的、实用的临床试验来评估该方案的疗效和安全性。
方法/设计：这是一项多中心、双盲、随机、对照临床试验。我们将招募 200 名符合条件的诊断为单纯性 rUTI 的患者，然后将他们随机分为两组，比例为 1:1：TLF+CLAT 组和安慰剂+CLAT 组。该试验分为两个阶段，分别为 12 周的治疗期和 12 周的治疗后随访期。主要结局将是随访期第 12 周的复发率；次要结局将是治疗后肾功能和肝功能的变化；此外，将对中医（TCM）症状、非感染相关体征和主观症状进行评分，并记录每位患者的发作次数；同时，整个试验过程中监测生命体征指标和严重不良事件（SAE）。
本研究将提供有说服力的研究数据来评估 TLF 联合 CLAT 治疗 rUTI 的临床疗效和安全性，并为临床医生提供循证推荐。此外，治疗后非感染相关体征和主观症状的变化包括在疗效评估中，这对于评估 rUTI 患者的临床获益非常重要和有意义。
中国临床试验注册中心 ChiCTR2100041914。注册于 2021 年 1 月 10 日。方案日期和版本：2020 年 9 月 12 日；版本 1。
