A randomized, controlled, multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumonia

被引：23

作者：

Li, Ying ^{[1
,2
]}

Zhu, Demei ^{[1
]}

Peng, Yiqiang ^{[3
]}

Tong, Zhaohui ^{[4
]}

Ma, Zhuang ^{[5
]}

Xu, Jinfu ^{[6
]}

Sung, Shenghua ^{[7
]}

Tang, Huaping ^{[8
]}

Xiu, Qingyu ^{[9
]}

Liang, Yongjie ^{[10
]}

Wang, Xiongbiao ^{[11
]}

Lv, Xiaoju ^{[12
]}

Dai, Yuanrong ^{[13
]}

Zhu, Yingqun ^{[14
]}

Qu, Yuejin ^{[15
]}

Xu, Kaifeng ^{[16
]}

Huang, Yijiang ^{[17
]}

Wu, Shiman ^{[18
]}

Lai, Guoxiang ^{[19
]}

Li, Xi ^{[20
]}

Han, Xiaowen ^{[21
]}

Yang, Zegang ^{[22
]}

Sheng, Jifang ^{[23
]}

Liu, Zhuola ^{[24
]}

Li, Hui ^{[25
]}

Chen, Yiqiang ^{[26
]}

Zhu, Huili ^{[27
]}

Zhang, Yingyuan ^{[1
,2
]}

机构：

[1] Fudan Univ, Huashan Hosp, Inst Antibiot, 12 Middle Wulumuqi Rd, Shanghai 200040, Peoples R China

[2] Natl Hlth & Family Planning Commiss, Key Lab Clin Pharmacol Antibiot, Shanghai, Peoples R China

[3] Changsha Cent Hosp, Changsha, Peoples R China

[4] Capital Med Univ, Beijing Chaoyang Hosp, Beijing, Peoples R China

[5] Gen Hosp Northern Theater Command Peoples Liberat, Shenyang, Peoples R China

[6] Shanghai Pulm Hosp, Shanghai, Peoples R China

[7] Cent South Univ, Xiangya Hosp 3, Changsha, Peoples R China

[8] Qingdao Municipal Hosp, Qingdao, Peoples R China

[9] Shanghai Changzheng Hosp, Shanghai, Peoples R China

[10] Shanghai East Hosp, Shanghai, Peoples R China

[11] Putuo Dist Cent Hosp, Shanghai, Peoples R China

[12] Sichuan Univ, West China Hosp, Chengdu, Peoples R China

[13] Wenzhou Med Univ, Affiliated Hosp 2, Wenzhou, Peoples R China

[14] Third Hosp Changsha, Changsha, Peoples R China

[15] Xiamen Univ, Affiliated Hosp 1, Xiamen, Peoples R China

[16] Peking Union Med Coll Hosp, Beijing, Peoples R China

[17] Hainan Prov Peoples Hosp, Haikou, Hainan, Peoples R China

[18] Shanxi Med Univ, Hosp 1, Taiyuan, Peoples R China

[19] Joint Logist Support Force PLA, 900 Hosp, Fuzhou, Peoples R China

[20] Hainan Med Coll, Affiliated Hosp 1, Haikou, Hainan, Peoples R China

[21] Hebei Prov Peoples Hosp, Shijiazhuang, Hebei, Peoples R China

[22] Changde First Peoples Hosp, Changde, Peoples R China

[23] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Hangzhou, Peoples R China

[24] Shanxi Med Univ, Hosp 2, Taiyuan, Peoples R China

[25] Jilin Prov Peoples Hosp, Changchun, Peoples R China

[26] Guangxi Med Univ, Affiliated Hosp 1, Nanning, Peoples R China

[27] Fudan Univ, Huadong Hosp, Shanghai, Peoples R China

来源：

CURRENT MEDICAL RESEARCH AND OPINION | 2021年 / 37卷 / 04期

关键词：

Sitafloxacin; moxifloxacin; community-acquired pneumonia; randomized controlled trial; efficacy; safety;

D O I：

10.1080/03007995.2021.1885362

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives To evaluate the efficacy and safety of oral sitafloxacin versus oral moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia (CAP). Patients and methods This is a multicenter, randomized, open-label, positive-controlled clinical trial (chinadrugtrials.org.cn identifier: CTR20130046). CAP patients received sitafloxacin tablets 100 mg once daily (qd) or 100 mg twice daily (bid) to compare with moxifloxacin tablets 400 mg qd, for 7-10 days. The primary outcome was non-inferiority of sitafloxacin to moxifloxacin in clinical cure rate at test of cure (TOC) visit in per-protocol set (PPS). Results A total of 343 patients were randomized (sitafloxacin 100 mg qd, n = 117; sitafloxacin 100 mg bid, n = 116; moxifloxacin, n = 110), 291 patients were included in the PPS (sitafloxacin 100 mg qd, n = 96; sitafloxacin 100 mg bid, n = 94; moxifloxacin, n = 101). The clinical cure rate was 94.8% in the sitafloxacin 100 mg qd group, 96.8% in the sitafloxacin 100 mg bid group and 95.0% in the moxifloxacin group. At the TOC visit, the microbiological success rate was 97.0% (32/33) in the sitafloxacin 100 mg qd group, 97.1% (34/35) in the sitafloxacin 100 mg bid group and 94.9% (37/39) in the moxifloxacin group in the microbiological evaluable set (MES). The incidence of study-drug-related adverse events (AEs) was 23.3% (27/116) in the sitafloxacin 100 mg qd group, 29.8% (34/114) in the sitafloxacin 100 mg bid group and 28.2% (31/110) in the moxifloxacin group (p > .05). The common AEs related to study drug were dizziness, nausea, diarrhea, increased platelet count and alanine transaminase (ALT) elevation. All the AEs resolved completely after discontinuation of study drug. Conclusion Sitafloxacin 100 mg qd or 100 mg bid for 7-10 days is not inferior to moxifloxacin 400 mg qd for 7-10 days in clinical efficacy for adult CAP patients. Sitafloxacin provides a safety profile comparable to moxifloxacin.

引用

页码：693 / 701

页数：9

共 28 条

[1]

Amano Ayako, 2013, Jpn J Antibiot, V66, P311

[2]

Amano Ayako, 2010, Jpn J Antibiot, V63, P411

[3]

[Anonymous], 2020, SITAFLOXACIN INSERT

[4] Community-acquired pneumonia [J].

Carbonara, Sergio ;

Monno, Laura ;

Longo, Benedetta ;

Angarano, Gioacchino .

CURRENT OPINION IN PULMONARY MEDICINE, 2009, 15 (03) :261-273

[5] In vivo efficacies and pharmacokinetics of DX-619, a novel des-fluoro(6) quinolone, against Streptococcus pneumoniae in a mouse lung infection model [J].

Fukuda, Y ;

Yanagihara, K ;

Ohno, H ;

Higashiyama, Y ;

Miyazaki, Y ;

Tsukamoto, K ;

Hirakata, Y ;

Tomono, K ;

Mizuta, Y ;

Tashiro, T ;

Kohno, S .

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2006, 50 (01) :121-125

[6]

Hori S., 2008, JPN J CHEMOTHER, V56, P49

[7] Detection of mutations in quinolone resistance-determining regions in levofloxacin- and methicillin-resistant Staphylococcus aureus:: effects of the mutations on fluoroquinolone MICs [J].

Horii, T ;

Suzuki, Y ;

Monji, A ;

Morita, M ;

Muramatsu, H ;

Kondo, Y ;

Doi, M ;

Takeshita, A ;

Kanno, T ;

Maekawa, M .

DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 2003, 46 (02) :139-145

[8]

[胡付品 Hu Fupin], 2018, [中国感染与化疗杂志, Chinese Journal of Infection and Chemotherapy], V18, P241

[9] Community-Acquired Pneumonia Requiring Hospitalization among US Adults [J].

Jain, S. ;

Self, W. H. ;

Wunderink, R. G. ;

Fakhran, S. ;

Balk, R. ;

Bramley, A. M. ;

Reed, C. ;

Grijalva, C. G. ;

Anderson, E. J. ;

Courtney, D. M. ;

Chappell, J. D. ;

Qi, C. ;

Hart, E. M. ;

Carroll, F. ;

Trabue, C. ;

Donnelly, H. K. ;

Williams, D. J. ;

Zhu, Y. ;

Arnold, S. R. ;

Ampofo, K. ;

Waterer, G. W. ;

Levine, M. ;

Lindstrom, S. ;

Winchell, J. M. ;

Katz, J. M. ;

Erdman, D. ;

Schneider, E. ;

Hicks, L. A. ;

McCullers, J. A. ;

Pavia, A. T. ;

Edwards, K. M. ;

Finelli, L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (05) :415-427

[10]

KANDA H, 2008, JPN J CHEMOTHER S1, V56, P1

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