Treatment of complicated urinary tract infection and acute pyelonephritis by short-course intravenous levofloxacin (750 mg/day) or conventional intravenous/oral levofloxacin (500 mg/day): prospective, open-label, randomized, controlled, multicenter, non-inferiority clinical trial

被引：24

作者：

Ren, Hong ^{[1
]}

Li, Xiao ^{[1
]}

Ni, Zhao-Hui ^{[2
]}

Niu, Jian-Ying ^{[3
]}

Cao, Bin ^{[4
]}

Xu, Jie ^{[5
]}

Cheng, Hong ^{[6
]}

Tu, Xiao-Wen ^{[7
]}

Ren, Ai-Min ^{[8
]}

Hu, Ying ^{[9
]}

Xing, Chang-Ying ^{[10
]}

Liu, Ying-Hong ^{[11
]}

Li, Yan-Feng ^{[12
]}

Cen, Jun ^{[13
]}

Zhou, Rong ^{[14
]}

Xu, Xu-Dong ^{[15
]}

Qiu, Xiao-Hui ^{[16
]}

Chen, Nan ^{[1
]}

机构：

[1] Shanghai Jiao Tong Univ, Dept Nephrol, Rui Jin Hosp, Sch Med, 197 Rui Jin Er Rd, Shanghai 200025, Peoples R China

[2] Shanghai Jiao Tong Univ, Dept Nephrol, Rui Jin Hosp, Sch Med,Pu Dong New Area, 1630 Dong Fang Rd, Shanghai 200127, Peoples R China

[3] Fudan Univ, Peoples Hosp Shanghai 5, Dept Nephrol, 801 He Qing Rd, Shanghai 200240, Peoples R China

[4] Beijing Chao Yang Hosp, Dept Infect Dis, 8 Gong Ti South Rd, Beijing 100020, Peoples R China

[5] Peking Univ, Dept Infect Dis, Hosp 3, 49 Hua Yuan North Rd, Beijing 100191, Peoples R China

[6] Capital Med Univ, Beijing Anzhen Hosp, Dept Nephrol, 2 An Zhen Rd, Beijing 100029, Peoples R China

[7] Rocket Force Gen Hosp, Dept Nephrol, 16 Xin Jie Kou Wai St, Beijing 100088, Peoples R China

[8] Capital Med Univ, Beijing Friendship Hosp, Dept Infect Dis, 95 Yong An Rd, Beijing 100050, Peoples R China

[9] Zhejiang Univ, Dept Nephrol, Affiliated Hosp 2, Sch Med, 88 Jiefang Rd, Hangzhou 310009, Zhejiang, Peoples R China

[10] Jiangsu Prov Hosp, Dept Nephrol, 300 Guangzhou Rd, Nanjing 210029, Zhejiang, Peoples R China

[11] Cent S Univ, Dept Nephrol, Xiangya Hosp 2, 139 Renmin Middle Rd, Changsha 410011, Hunan, Peoples R China

[12] Daping Hosp, Dept Urol Surg, 10 Changjiang Zhi Rd, Chongqing 400042, Peoples R China

[13] Shanghai Construct Grp Hosp, Dept Nephrol, 666 Zhongshan North Rd, Shanghai 200083, Peoples R China

[14] Cent Hosp Yangpu Dist, Dept Nephrol, 450 Tengyue Rd, Shanghai 200090, Peoples R China

[15] Cent Hosp Minhang Dist, Dept Nephrol, 170 Shensong Rd, Shanghai 201199, Peoples R China

[16] Lihuili Hosp, Dept Nephrol, Ningbo Med Treatment Ctr, 57 Xingning Rd, Ningbo 315040, Zhejiang, Peoples R China

来源：

INTERNATIONAL UROLOGY AND NEPHROLOGY | 2017年 / 49卷 / 03期

关键词：

Levofloxacin; Complicated urinary tract infection (cUTI); Acute pyelonephritis (APN); Noninferiority trial; BACTERICIDAL ACTIVITY; RESISTANT STRAINS; DOUBLE-BLIND; CIPROFLOXACIN; MG; PHARMACODYNAMICS; MODEL;

D O I：

10.1007/s11255-017-1507-0

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

To compare the efficacy and safety of short-course intravenous levofloxacin (LVFX) 750 mg with a conventional intravenous/oral regimen of LVFX 500 mg in patients from China with complicated urinary tract infections (cUTIs) and acute pyelonephritis (APN). This was a prospective, open-label, randomized, controlled, multicenter, non-inferiority clinical trial. Patients with cUTI and APN were randomly assigned to a short-course therapy group (intravenous LVFX at750 mg/day for 5 days) or a conventional therapy group (intravenous/oral regimen of LVFX at 500 mg/day for 7-14 days). The clinical, laboratory, and microbiological results were evaluated for efficacy and safety. The median dose of LVFX was 3555.4 mg in the short-course therapy group and 4874.2 mg in the conventional therapy group. Intention-to-treat analysis indicated the clinical effectiveness in the short-course therapy group (89.87%, 142/158) was non-inferior to that in the conventional therapy group (89.31%, 142/159). The microbiological effectiveness rates were also similar (short-course therapy: 89.55%, 60/67; conventional therapy: 86.30%, 63/73; p > 0.05). There were no significant differences in other parameters, including clinical and microbiological recurrence rates. The incidence of adverse effects and drug-related adverse effects were also similar for the short-course therapy group (21.95%, 36/164; 18.90%, 31/164) and the conventional therapy group (23.03%, 38/165; 15.76%, 26/165). Patients with cUTIs and APN who were given short-course LVFX therapy and conventional LVFX therapy had similar outcomes in clinical and microbiological efficacy, tolerance, and safety. The short-course therapy described here is a more convenient alternative to the conventional regimen with potential implication in anti-resistance and cost saving.

引用

页码：499 / 507

页数：9

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