Prulifloxacin in the Treatment of Urinary Tract Infection: A Double-Blind, Randomized Controlled Trial_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Hongyu ¹ ,  CAI Yongning ² , FU Ping ¹ , ZHENG Li ² , WU Xiaohou ³ , LENG Jing ⁴ , ZHANG Guifa ⁵ , ZHONG Hui ¹ , SHA Zhaohui ¹ , LI Zi ¹ , MI Xuhua ¹ , DAI Qiang ⁶ , LU Ding ⁶

Corresponding author：

CAI Yongning, Email: fuping9@hotmail.com

Keywords：

Urinary tract infection; Prulifloxacin; Levofloxacin; Double-blind randomized controlled trial

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Objective 　To assess the effectiveness and safety of prulifloxacin in the treatment of urinary tract infection.
Methods　 The double-blind, double dummy and randomized controlled method was adopted. One hundred and forty-four patients were randomized to the treatment group (prulifloxacin , 4 tablets, bid) and the control group (levofloxacin, 4 tablets, bid). The randomization code was produced by computer. The treatment duration for both groups was from 7 to 10 days.
Results 　Data were analyzed on the basis of full analysis sets (FAS) and per-protocol (PP) analysis. The total improvement rates of the trial and control groups were 85.07% and 88.52% respectively by FAS analysis, and 90.48% and 91.53% respectively by PP analysis. There was no significant difference between the two groups in improvement rates (P gt;0.05). Bacterial negative rates in the trial and control groups were 93.75% and 93.88% respectively by FAS analysis and 97.83% and 97.87% respectively by PP analysis. The results showed no statistical significance difference between the two groups in bacterial negative rates (P gt;0.05). The adverse events in the prulifloxacin and levofloxacin groups were 2.80% and 5.60% respectively.
Conclusion 　Prulifloxacin has the same clinical effectiveness as levofloxacin with a few toxic adverse effects in the treatment of urinary tract infection.

Citation： QIU Hongyu,CAI Yongning,FU Ping,ZHENG Li,WU Xiaohou,LENG Jing,ZHANG Guifa,ZHONG Hui,SHA Zhaohui,LI Zi,MI Xuhua,DAI Qiang,LU Ding. Prulifloxacin in the Treatment of Urinary Tract Infection: A Double-Blind, Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2006, 06(6): 399-403. doi: Copy

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1. 方利明, 金艳, 魏敏吉. 氟喹诺酮抗菌剂 — 普卢利沙星. 中国医药导刊, 2004; 3(6): 225～227.
2. 叶任高.主编. 内科学. 第6版. 北京: 人民卫生出版社; 2004. 522~528.
3. 张文珍. 氟喹诺酮类抗菌药物的研究进展. 安徽医药, 2002; 6(2): 30.
4. Fang LM, Jin Y, Wei MJ. New quinolone — prulifloxacin. Chinese Medical and Phamaceutical Journal, 2004; 3(6): 225-227.
5. Ye RG Chief editor. Internal Medicine. The 6th Edition. Beijing: People’s Medical Publishing House; 2004. 522-528.
6. Zhang WZ. Reserch of Quinolone. Anhui Medical and Phamaceutical Journal, 2002; 6(2): 30.
7. Yoshida T, Mitsuhashi S. Antibacterial activity of NM394, the active form of prodrug NM441, A new Quinolone. Antimicrob Agents Chemother, 1993; 37(4): 795-800.
8. Picollo R, Brion N, Gualane V, et al. Phamacokinetics and tolerability of Prulifloxacin after single oral administration. Arzneim. –Forsch./ Drug Res., 2003; 53(3): 201-205.

Chinese Journal of Evidence-Based Medicine

Prulifloxacin in the Treatment of Urinary Tract Infection: A Double-Blind, Randomized Controlled Trial

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