目的 評價雙冬膠囊在廣泛人群中治療急性單純性下尿路感染的安全性和有效性。方法 單臂、開放、多中心臨床試驗納入符合標(biāo)準(zhǔn)的2 100例患者。口服雙冬膠囊，3粒/次，3次/d，用藥14 d，第0、7、14天進行隨訪，定為訪視1、訪視2、訪視3。觀察患者主要療效、次要療效、安全性評價指標(biāo)和不良事件發(fā)生情況。結(jié)果 雙冬膠囊能明顯降低單純下尿路感染主要癥狀的總評分；對尿路感染主要癥狀（尿頻、尿急、尿痛）及對下焦?jié)駸?、氣陰兩虛證局部和全身癥狀有顯著改善作用，且隨著用藥時間的延長，治療效果逐漸升高。雙冬膠囊可有效降低尿白細胞數(shù)量，顯著提高患者尿白細胞轉(zhuǎn)陰率。以年齡亞組分析，未婚組總分低于婚育組和更年期組，但療程結(jié)束時各組間總分差異并無統(tǒng)計學(xué)意義。從安全性研究來看，雙冬膠囊對心電圖、肝腎功等無明顯影響，未見嚴重不良反應(yīng)，不良事件發(fā)生率為3.29%。結(jié)論 雙冬膠囊治療下焦?jié)駸?、氣陰兩虛型下尿路感染療效確切，可應(yīng)用人群廣泛，安全性高，值得臨床進一步推廣應(yīng)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