热淋清颗粒治疗尿路感染的多中心、开放性、Ⅳ期临床研究  

A multicenter,open-label and phaseⅣclinical study on the treatment of urinary tract infections with Relinqing granules

作　　者：王树声[1] 张俊华[2] 于雷[3] 唐汇龙[4] 宋旭[5] 叶纯华[6] WANG Shusheng;ZHANG Junhua;YU Lei;TANG Huilong;SONG Xu;YE Chunhua(Department of Urology,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120,China;Institute of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Department of Urology,Heilongjiang Provincial Hospital,Harbin 150036,China;Department of Urology,The First Hospital of Hunan University of Chinese Medicine,Changsha 410021,China;Department of Urology,Shanghai Seventh People's Hospital,Shanghai 200137,China;Department of Urology,The Affiliated Hospital of Hangzhou Normal University,Hangzhou 310015,China)

机构地区：[1]广东省中医院泌尿外科,广州510120 [2]天津中医药大学中医药研究院,天津301617 [3]黑龙江省医院泌尿外科,哈尔滨150036 [4]湖南中医药大学第一附属医院泌尿外科,长沙410021 [5]上海市第七人民医院泌尿外科,上海200137 [6]杭州师范大学附属医院泌尿外科,杭州310015

出　　处：《医学新知》2024年第7期786-795,共10页New Medicine

摘　　要：目的评价热淋清颗粒在临床使用中的安全性与有效性,以指导优化临床给药方案和提高合理用药水平。方法在51家医院进行开放性、Ⅳ期临床试验,受试者为下焦湿热型单纯性或复杂性尿路感染,单纯性尿路感染患者给予热淋清颗粒每次8 g、每天3次,疗程5 d。复杂性尿路感染患者给予热淋清颗粒每次8 g、每天3次,同时联合喹诺酮类抗生素,疗程7~14 d。结局指标为临床疗效、中医证候疗效、细菌清除率以及安全性。结果共纳入2009例受试者,其中11患者失访脱落。全分析集纳入1998例,其中单纯性尿路感染患者1532例,复杂性尿路感染患者466例。临床治愈率为68.57%,单纯性和复杂性尿路感染患者分别为74.41%和49.36%。中医证候痊显率为72.22%,单纯性和复杂性尿路感染患者分别为75.13%和62.66%。单纯性尿路感染中细菌培养阳性者的细菌转阴率为57.75%,细菌清除率为58.02%;复杂性尿路感染中细菌培养阳性者的细菌转阴率为45.59%,细菌清除率为43.92%。药物相关的不良反应发生24例次,其中单纯性尿路感染17例次,复杂性尿路感染7例次。结论热淋清颗粒治疗单纯性尿路感染的有效性和安全性较好,也可改善下焦湿热证中医证候。Objective To evaluate the safety and efficacy of Relinqing granules in real-world clinical settings and to provide data-based guidance for optimizing clinical dosing regimens and improving rational drug use.Methods Open and phase IV clinical trials were conducted in 51 hospitals,with participants suffering from simple or complex urinary tract infections(UTI)caused by dampness and heat in the lower energizer.Patients with simple UTI were given 8 g of Relinqing granules three times a day for 5 days.Patients with complex UTI were given 8 g of Relinqing granules three times a day,in combination with quinolone antibiotics,for a course of 7~14 days.The outcome indicators were clinical efficacy,traditional Chinese medicine syndrome efficacy,bacterial clearance rate,and safety.Results A total of 2009 subjects were included,of which 11 patients were lost to follow-up and dropped out.A total of 1998 cases were included in the full analysis set,including 1532 patients with simple UTI and 466 patients with complex UTI.The clinical cure rate was 68.57%,with 74.41%and 49.36%for patients with simple and complex UTI,respectively.The cure rate of traditional Chinese medicine syndrome was 72.22%,with 75.13%and 62.66%for patients with simple and complex UTI,respectively.The bacterial conversion rate of patients with positive bacterial culture and bacterial clearance rate in simple UTI were 57.75%and 58.02%,respectively;The bacterial conversion rate of patients with positive bacterial culture in complex UTI was 45.59%,and the bacterial clearance rate was 43.92%.There were 24 cases of drug-related adverse reactions,including 17 cases of simple UTI and 7 cases of complex UTI.Conclusion Relinqing granules have good effectiveness and safety in treating simple UTI,and can also improve the traditional Chinese medicine syndrome of damp heat syndrome in the lower energizer.

关 键 词：热淋清颗粒 尿路感染 Ⅳ期临床试验 临床疗效 安全性 

分 类 号：R277.5[医药卫生—中医学]