Long-term follow up of acute uncomplicated cystitis in females

Therapeutic effects of levofloxacin (LVFX) on acute uncomplicated cystitis in females werecomparatively examined on the basis of the Japanese evaluation criteria for the effect of drugs on urinary tract infection (UTI) and general guidelines for the evaluation of new anti-infective drugs for the tre...

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Published inJapanese Journal of Chemotherapy Vol. 44; no. 12; pp. 896 - 902
Main Authors Kojima, Hironori, Ishida, Yoshio, Yoshida, Masahiko, Fukushima, Syuji, Saito, Isao, Kawamura, Takeshi, Hirose, Tomonobu, Kawada, Yukimichi, Moriyama, Masatoshi, Kawasaki, Chitose
Format Journal Article
LanguageJapanese
Published Japanese Society of Chemotherapy 1996
公益社団法人 日本化学療法学会
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ISSN1340-7007
1884-5886
DOI10.11250/chemotherapy1995.44.896

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Abstract Therapeutic effects of levofloxacin (LVFX) on acute uncomplicated cystitis in females werecomparatively examined on the basis of the Japanese evaluation criteria for the effect of drugs on urinary tract infection (UTI) and general guidelines for the evaluation of new anti-infective drugs for the treatment of UTI established by the Infectious Diseases Society of America. A 100 or 200 mg/day dose of LVFX was administered for 3-5 days to a total of 158 cases in which a diagnosis of acute uncomplicated cystitis, accompanying pyuria with 5 cells/hpf or more and bacteriuria with 103CFU/ml or more, had been made in the facilities participating in this study from September 1994 to March 1995. Clinical effects of LVFX were evaluated immediately, one week and four weeks after completion of drug administration. The results of overall clinical efficacy immediately after completion of administration were as follows: “excellent” in 71.6% of all cases (106/148 cases); “moderate” in 27.7%(41/148); and “failure” in 0.7%(1/148). The effects revealed no significant differences between either daily doses or the numbers of dosing days. The results of microbiological eradication rate/clinical cure rate, one and four weeks after the completion of administration were 93.9%(77/82)/88.1%(74/84) and 92.9%(52/56)/88.5%(54/61), respectively, indicating a high clinical effect. These rates were analyzed according to the number of dosing days, and the following results were obtained, respectively: 89.1%(41/46)/80.4%(37/46) and 90.0%(27/30)/81.3%(26/32) in the 3-day group; 100%(13/13)/100%(13/13) and 88.9%(8/9)/90%(9/10) in the 4-day group; and 100%(23/23)/96.0%(24/25) and 100%(17/17)/100%(19/19) in the 5-day group. Thus, the cure rates tended to be higher in the 5-day administration group, though there were no statistically significant differences. In addition, when the cases were classified into an “excellent” group and “moderate” group immediately after completion of administration to compare the cure rates in the subsequent weeks between the group, the results still showed no significant differences. In some studies, new quinolones even with single dose therapy have shown remarkably high cure rates against acute uncomplicated cystitis. Five-day administration of the drug may, however, be appropriate considering the long-term results (until the 4th week after treatment) obtained in this study. Further acquisition of data from cases and future discussion from the viewpoint of cost-effectiveness are thus considered to be necessary.
AbstractList Therapeutic effects of levofloxacin (LVFX) on acute uncomplicated cystitis in females werecomparatively examined on the basis of the Japanese evaluation criteria for the effect of drugs on urinary tract infection (UTI) and general guidelines for the evaluation of new anti-infective drugs for the treatment of UTI established by the Infectious Diseases Society of America. A 100 or 200 mg/day dose of LVFX was administered for 3-5 days to a total of 158 cases in which a diagnosis of acute uncomplicated cystitis, accompanying pyuria with 5 cells/hpf or more and bacteriuria with 103CFU/ml or more, had been made in the facilities participating in this study from September 1994 to March 1995. Clinical effects of LVFX were evaluated immediately, one week and four weeks after completion of drug administration. The results of overall clinical efficacy immediately after completion of administration were as follows: “excellent” in 71.6% of all cases (106/148 cases); “moderate” in 27.7%(41/148); and “failure” in 0.7%(1/148). The effects revealed no significant differences between either daily doses or the numbers of dosing days. The results of microbiological eradication rate/clinical cure rate, one and four weeks after the completion of administration were 93.9%(77/82)/88.1%(74/84) and 92.9%(52/56)/88.5%(54/61), respectively, indicating a high clinical effect. These rates were analyzed according to the number of dosing days, and the following results were obtained, respectively: 89.1%(41/46)/80.4%(37/46) and 90.0%(27/30)/81.3%(26/32) in the 3-day group; 100%(13/13)/100%(13/13) and 88.9%(8/9)/90%(9/10) in the 4-day group; and 100%(23/23)/96.0%(24/25) and 100%(17/17)/100%(19/19) in the 5-day group. Thus, the cure rates tended to be higher in the 5-day administration group, though there were no statistically significant differences. In addition, when the cases were classified into an “excellent” group and “moderate” group immediately after completion of administration to compare the cure rates in the subsequent weeks between the group, the results still showed no significant differences. In some studies, new quinolones even with single dose therapy have shown remarkably high cure rates against acute uncomplicated cystitis. Five-day administration of the drug may, however, be appropriate considering the long-term results (until the 4th week after treatment) obtained in this study. Further acquisition of data from cases and future discussion from the viewpoint of cost-effectiveness are thus considered to be necessary.
Therapeutic effects of levofloxacin (LVFX) on acute uncomplicated cystitis in females werecomparatively examined on the basis of the Japanese evaluation criteria for the effect of drugs on urinary tract infection (UTI) and general guidelines for the evaluation of new anti-infective drugs for the treatment of UTI established by the Infectious Diseases Society of America. A 100 or 200 mg/day dose of LVFX was administered for 3-5 days to a total of 158 cases in which a diagnosis of acute uncomplicated cystitis, accompanying pyuria with 5 cells/hpf or more and bacteriuria with 103CFU/ml or more, had been made in the facilities participating in this study from September 1994 to March 1995. Clinical effects of LVFX were evaluated immediately, one week and four weeks after completion of drug administration. The results of overall clinical efficacy immediately after completion of administration were as follows: “excellent” in 71.6% of all cases (106/148 cases); “moderate” in 27.7%(41/148); and “failure” in 0.7%(1/148). The effects revealed no significant differences between either daily doses or the numbers of dosing days. The results of microbiological eradication rate/clinical cure rate, one and four weeks after the completion of administration were 93.9%(77/82)/88.1%(74/84) and 92.9%(52/56)/88.5%(54/61), respectively, indicating a high clinical effect. These rates were analyzed according to the number of dosing days, and the following results were obtained, respectively: 89.1%(41/46)/80.4%(37/46) and 90.0%(27/30)/81.3%(26/32) in the 3-day group; 100%(13/13)/100%(13/13) and 88.9%(8/9)/90%(9/10) in the 4-day group; and 100%(23/23)/96.0%(24/25) and 100%(17/17)/100%(19/19) in the 5-day group. Thus, the cure rates tended to be higher in the 5-day administration group, though there were no statistically significant differences. In addition, when the cases were classified into an “excellent” group and “moderate” group immediately after completion of administration to compare the cure rates in the subsequent weeks between the group, the results still showed no significant differences. In some studies, new quinolones even with single dose therapy have shown remarkably high cure rates against acute uncomplicated cystitis. Five-day administration of the drug may, however, be appropriate considering the long-term results (until the 4th week after treatment) obtained in this study. Further acquisition of data from cases and future discussion from the viewpoint of cost-effectiveness are thus considered to be necessary. 女子急性単純性膀胱炎に対するlevofloxacin (LVFX) の治療効果を, UTI薬効評価基準および TheInfectious Diseases Society of Americaの general guidelines for the evaluation of new anti-infective drugs for the treatment of UTI にもとづき比較検討した。1994年9月より95年3月までに各施設で, 膿尿5コ/hpf以上, 細菌尿103CFU/ml以上の急性単純性膀胱炎と診断された症例157例に, LVFXの100または200mgを3~5日間投与し, 投薬終了直後・投薬終了1週後および4週後の臨床効果を判定した。投薬終了直後の総合臨床効果は, 著効71.6%(106例/148例, 以下同様), 有効27.7%(411148), 無効0.7%(1/148) で, 1日投与量または投与日数による有意差は認められなかった。投薬終了1週後および4週後のmicrobiological eradication rate/clinical cure rate II 93.9 %(77/82)/88.1%(74/84) および, 92.9%(52/56)/88.5%(54/61) で, 高い臨床効果が認められた。これらを投与日数別に検討すると, 3日間投与群の投薬終了1週後は89.1%(41/46)/80.4%(37/46) 4週後は90.0%(27/30)/81.3%(26132), 4日間投与群では1週後は100%(13/13)/100%(13/13) 4週後は88.9%(8/9)/90%(9/10), 5日間投与群では1週後100%(23/23)/96.0%(24/25) 4週後は100%(17/17)/100%(19/19) と, 5日間投与群で治癒率がより高い傾向が認められたが, 統計学的な有意差は認められなかった。また, 投薬終了直後の著効群と有効群に分けて比較しても, その後の治癒率には有意差は認められなかった。ニューキノロン剤では急性単純性膀胱炎に対しては単回療法でも十分高い治癒率が報告されるようになってきたが, 治療4週後までの長期治療成績の点では5日間投与が適当である可能性もあり, 今後さらなる症例の蓄積, cost- effectivenessの観点などからの議論が必要であると考えられた。
Author Saito, Isao
Ishida, Yoshio
Hirose, Tomonobu
Moriyama, Masatoshi
Kawasaki, Chitose
Kojima, Hironori
Kawada, Yukimichi
Kawamura, Takeshi
Fukushima, Syuji
Yoshida, Masahiko
Author_FL 森山 正敏
福島 修司
斎藤 功
廣瀬 友信
石田 仁男
吉田 雅彦
河田 幸道
小島 弘敬
川崎 千尋
河村 毅
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DocumentTitleAlternate 女子急性単純性ぼうこう炎の治療後長期観察 UTI薬効評価基準とIDSA基準との比較
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References 11) Non-by S R: Short-term treatment of Uncomplicated lower urinary tract infections in women. Reviews of Infectious Diseases 12: 458-467, 1990
12) Andriole V T: Use of quinolones in treatment of prostatitis and lower urinary tract infections. Eur J Clin Microbiol Infect Dis 10: 342-350, 1991
6) Raz R, Rottensterich E, Leshem Y, Tabenkin H: Double-blind study comparing 3-day regimens of Cefixime and Ofloxacin in treatment of uncomplicated urinary tract infections in women. Antimicrob Agents Chemotherapy 38: 1176-1177. 1994
7) 広瀬嵩興, 他 (15施設): 単回療法による女子急性単純性膀胱炎の治療成績-Levofloxacinによる検討-. 感染症誌66: 177-188, 1992
10) Hooton T M, Johnson C, Winter C, Kuwamura L, Rogers M E, Roberts P L, Stamm W E: Single-dose and tree-day regimens of Ofloxacin versus Trimethoprim-sulfamethoxazole for acute cystitis in women. Antimicrob Agents Chemotherapy 35: 1479-1483, 1991
3) 上間健造, 他 (21施設): 急性単純性膀胱炎における治癒と再発. 西日泌尿54: 7897-798, 1992
1) 大越正秋, 他 (UTI研究会): UTI薬効評価基準 (第3版). Chemotherapy 34: 408-441, 1986
5) Naber K G, Koch E M W: Cefuroxime axetil versus Ofloxacin for short-term therapy of acute uncomplicated lower urinary tract infections in women. Infection 21: 34-39, 1993
9) Naber K G, Thyroff-Friesinger: Fosfomycin Trometamol versus Ofloxacin/Co-trimoxazole as single dose therapy of acute uncomplicated urinary tract infection in females: A multicentre study. Infection 18 (Suppl 2): S70-S76, 1990
2) Rubin R H, Shapiro E D, Andriole V T, Davis R J, Stamm W E: General guidelines for the evaluation of new anti-infective drugs for the treatment of urinary tract infection. Clin Infect Dis 15 (Suppl 1): S216-227, 1992
4) 清田浩, 他 (7施設): 急性単純性膀胱炎に対するtosufloxacin単回投与療法の検討. 感染症誌66: 529-535, 1992
8) Raz R, Genesin E, Gonen E, Shmilovitz M, Hefter H, Potasman I: Single low-dose Ofloxacin for the treatment of uncomplicated urinary tract infection in young women. J Antimicrob Chemotherapy 22: 945-949, 1988
References_xml – reference: 5) Naber K G, Koch E M W: Cefuroxime axetil versus Ofloxacin for short-term therapy of acute uncomplicated lower urinary tract infections in women. Infection 21: 34-39, 1993
– reference: 11) Non-by S R: Short-term treatment of Uncomplicated lower urinary tract infections in women. Reviews of Infectious Diseases 12: 458-467, 1990
– reference: 12) Andriole V T: Use of quinolones in treatment of prostatitis and lower urinary tract infections. Eur J Clin Microbiol Infect Dis 10: 342-350, 1991
– reference: 9) Naber K G, Thyroff-Friesinger: Fosfomycin Trometamol versus Ofloxacin/Co-trimoxazole as single dose therapy of acute uncomplicated urinary tract infection in females: A multicentre study. Infection 18 (Suppl 2): S70-S76, 1990
– reference: 10) Hooton T M, Johnson C, Winter C, Kuwamura L, Rogers M E, Roberts P L, Stamm W E: Single-dose and tree-day regimens of Ofloxacin versus Trimethoprim-sulfamethoxazole for acute cystitis in women. Antimicrob Agents Chemotherapy 35: 1479-1483, 1991
– reference: 2) Rubin R H, Shapiro E D, Andriole V T, Davis R J, Stamm W E: General guidelines for the evaluation of new anti-infective drugs for the treatment of urinary tract infection. Clin Infect Dis 15 (Suppl 1): S216-227, 1992
– reference: 8) Raz R, Genesin E, Gonen E, Shmilovitz M, Hefter H, Potasman I: Single low-dose Ofloxacin for the treatment of uncomplicated urinary tract infection in young women. J Antimicrob Chemotherapy 22: 945-949, 1988
– reference: 3) 上間健造, 他 (21施設): 急性単純性膀胱炎における治癒と再発. 西日泌尿54: 7897-798, 1992
– reference: 7) 広瀬嵩興, 他 (15施設): 単回療法による女子急性単純性膀胱炎の治療成績-Levofloxacinによる検討-. 感染症誌66: 177-188, 1992
– reference: 6) Raz R, Rottensterich E, Leshem Y, Tabenkin H: Double-blind study comparing 3-day regimens of Cefixime and Ofloxacin in treatment of uncomplicated urinary tract infections in women. Antimicrob Agents Chemotherapy 38: 1176-1177. 1994
– reference: 1) 大越正秋, 他 (UTI研究会): UTI薬効評価基準 (第3版). Chemotherapy 34: 408-441, 1986
– reference: 4) 清田浩, 他 (7施設): 急性単純性膀胱炎に対するtosufloxacin単回投与療法の検討. 感染症誌66: 529-535, 1992
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UTI薬効評価基準
急性単純性膀胱炎
Title Long-term follow up of acute uncomplicated cystitis in females
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