【摘要】 目的 评价热淋清颗粒治疗女性急性单纯性尿路感染（下焦湿热证）的有效性和安全性。方法 采用多中心、随机、双盲双模拟、阳性药平行对照与非劣效临床试验方法，选择2017年6月30日—2018年8月6日9个中心收治的急性单纯性尿路感染（下焦湿热证）的女性患者，随机分为试验组（热淋清颗粒+盐酸环丙沙星片模拟剂）与对照组（热淋清颗粒模拟剂+盐酸环丙沙星片），进行5 d用药及4周随访。以治愈率为主要疗效结局指标，其他疗效结局指标包括细菌清除率、综合痊愈率和复发率，同时观察不良反应发生情况，评价用药安全性。结果 共纳入191例患者，其中试验组97例，对照组94例。试验组与对照组的治愈率分别为71.88%(69/96)和76.34%(71/93)，差异无统计学意义（P=0.377）；非劣效检验显示，2组临床治愈率差值的95%置信区间（CI）下限为-16.94%，未达到给定的非劣效界值-10%。在病情中度患者中，试验组与对照组的治愈率分别为70.45%(31/44)和51.52%(17/33)，差异无统计学意义（P=0.090）；非劣效检验支持试验组非劣效（95%CI下限-2.80%>-10%）。2组的细菌清除率、综合痊愈率、临床结果复发率比较，差异均无统计学意义（P > 0.05）。2组药品不良反应发生率分别为3.13%(3/96)和5.38%(5/93)，差异无统计学意义（P=0.684），试验组未见严重不良反应发生。结论 基于更贴近临床实际的全分析集分析，热淋清颗粒治疗女性急性单纯性尿路感染（下焦湿热证）临床治愈率与盐酸环丙沙星片相近，但未达到预设的非劣效标准。病情中度患者中，热淋清颗粒临床治愈率高于盐酸环丙沙星片，并显示出非劣效趋势。热淋清颗粒安全性良好，不良反应发生率低，且无严重不良反应发生，风险可控。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of Relinqing granules in the treatment of acute uncomplicated urinary tract infection(damp heat in the lower jiao pattern) in females. Methods A multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, non-inferiority clinical trial was conducted. Female patients with acute uncomplicated urinary tract infection(damp heat in the lower jiao pattern) admitted to nine centers between June 30, 2017, and August 6, 2018, were enrolled and randomly assigned to the experimental group(Relinqing granules + ciprofloxacin hydrochloride tablets simulant) or the control group(Relinqing granules simulant + ciprofloxacin hydrochloride tablets). Treatment lasted for 5 days, followed by a 4-week follow-up period. The cure rate served as the primary efficacy outcome. Other efficacy outcomes included bacterial clearance rate, comprehensive recovery rate, and recurrence rate. Safety was assessed by monitoring the occurrence of adverse reactions. Results A total of 191 patients were enrolled, with 97 patients in the experimental group and 94 patients in the control group. The cure rates were 71.88%(69/96) in the experimental group and 76.34%(71/93) in the control group, with no statistically significant differences(P=0.377). The non-inferiority test showed that the lower limit of the 95% confidence interval(CI) for the difference in clinical cure rates between the experimental and control groups was-16.94%, which did not meet the pre-specified non-inferiority margin of-10%. Among patients with moderate severity, the cure rates were 70.45%(31/44) in the experimental group and 51.52%(17/33) in the control group, showing no statistically significant difference(P=0.090); however, the non-inferiority test supported the non-inferiority of the experimental group(lower limit of 95% CI:-2.80%>-10%). No statistically significant differences were observed between the two groups in bacterial clearance rate, comprehensive recovery rate, or recurrence rate of clinical outcomes(P>0.05). The incidences of adverse drug reactions were 3.13%(3/96) in the experimental group and 5.38%(5/93) in the control group, with no statistically significant difference(P=0.684). No serious adverse reactions occurred in the experimental group. Conclusion Based on the full analysis set analysis which is closer to clinical practice, the clinical cure rate of Relinqing granules in the treatment of female acute uncomplicated urinary tract infection(damp heat in the lower jiao pattern) was similar to that of ciprofloxacin hydrochloride tablets, but did not reach the preset non-inferiority standard. In patients with moderate disease, the clinical cure rate of Relinqing granules was higher than that of ciprofloxacin hydrochloride tablets, and showed a non-inferior trend. Relinqing Granules have good safety, low incidence of adverse reactions, and no serious adverse reactions occur, and the risk is controllable.更多还原