目的 评价双冬胶囊在广泛人群中治疗急性单纯性下尿路感染的安全性和有效性。方法 单臂、开放、多中心临床试验纳入符合标准的2 100例患者。口服双冬胶囊，3粒/次，3次/d，用药14 d，第0、7、14天进行随访，定为访视1、访视2、访视3。观察患者主要疗效、次要疗效、安全性评价指标和不良事件发生情况。结果 双冬胶囊能明显降低单纯下尿路感染主要症状的总评分；对尿路感染主要症状（尿频、尿急、尿痛）及对下焦湿热、气阴两虚证局部和全身症状有显著改善作用，且随着用药时间的延长，治疗效果逐渐升高。双冬胶囊可有效降低尿白细胞数量，显著提高患者尿白细胞转阴率。以年龄亚组分析，未婚组总分低于婚育组和更年期组，但疗程结束时各组间总分差异并无统计学意义。从安全性研究来看，双冬胶囊对心电图、肝肾功等无明显影响，未见严重不良反应，不良事件发生率为3.29%。结论 双冬胶囊治疗下焦湿热、气阴两虚型下尿路感染疗效确切，可应用人群广泛，安全性高，值得临床进一步推广应用。

Objective To further evaluate the safety and effectiveness of Shuangdong Capsules in treatment of acute simple lower urinary tract infection in a wide range of people. Methods A single-arm, open, multicenter clinical trial enrolled 2 100 patients who met the criteria. The patients were po administered with Shuangdong Capsules, for 14 d. The patients were followed up on day 0, 7, and 14, which were classified as visit 1, visit 2, and visit 3. Main efficacy, secondary efficacy, safety evaluation indexes and adverse events were observed. Results Shuangdong Capsules could significantly reduce the total score of main symptoms of simple lower urinary tract infection. It can significantly improve the main symptoms of urinary tract infection (frequent urination, urgent urination, urination pain) and the local and systemic symptoms of lower coke dampness-heat and deficiency of qi and Yin, and the therapeutic effect gradually increases with the prolongation of medication time. Shuangdong Capsules can effectively reduce the number of urine white blood cells and significantly improve the rate of urine white blood cells turning negative. By age subgroup analysis, the total score of the unmarried group was lower than that of the matrimonial group and menopause group, but there was no statistically significant difference at the end of the treatment course. By age subgroup analysis, the total score of unmarried group was lower than that of marriage-bearing group and menopausal group, but at the end of the course of treatment, there was no statistically significant difference in the total score among all groups, indicating that Shuangdong Capsules was widely used for treatment and there was no obvious group selection. Safety studies showed that Shuangdong Capsules had no significant effect on electrocardiogram, liver and kidney function, and no serious adverse reactions were observed. The incidence of adverse events was 3.29%. Conclusion Shuangdong Capsule has a definite curative effect in the treatment of lower urinary tract infection with deficiency of dampness-heat of lower coke and Qi and Yin, and can be applied to a wide range of people, which is clinically safe and worthy of further clinical application.

R983