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題 名 | Randomized, Double-blind, Comparative Study of Levofloxacin and Ofloxacin in the Treatment of Complicated Urinary Tract Infections=比較Levofloxacin及Ofloxacin治療複雜性泌尿道感染之雙盲性試驗 |
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作 者 | 彭銘業; | 書刊名 | 微免與感染雜誌 |
卷 期 | 32:1 1999.03[民88.03] |
頁 次 | 頁33-39 |
分類號 | 415.82 |
關鍵詞 | 泌尿道感染; Levofloxacin; Ofloxacin; Complicated urinary tract infections; |
語 文 | 英文(English) |
中文摘要 | Levofloxacin為ofloxacin純左旋異構物,對於一般革蘭氏陽性菌及陰性菌均有良 好療效,其MIC值與ofloxacin相較,平均降低一半;本試驗是以levofloxacin 300 mg/day及ofloxacin 600 mg/day治療複雜性泌尿道感染之雙盲比較性研究, 治療過程為10天。於治療5天後做療效評估,評估指標包含膿尿現象、尿液細菌 培養,症狀改善及臨床療效四項。總共104人進入此試驗,有46人尿液細菌培養 呈陽性為可評估療效之對象。其中20人接受levofloxacin治療為試驗組,26人接 受ofloxacin治療為對照組。這兩組中,其性別,年齡,有無潛在疾病,是否接受 手術或有泌尿道異常,疾病為腎孟腎炎或膀胱炎,之前是否接受抗生素治療等,均 無有意義之差別。藥物治療後其療效評估分別為,膿尿改善率levofloxacin為90.0 %,ofloxacin為80.7%;菌尿廓清率levofloxacin為90.0%,ofloxacin為88.5 %;症狀改善率levofloxacin為90.0%,ofloxacin為80.7%,綜合臨床療效 levofloxacin為90.0%,ofloxacin為84.6%,四項療效評估指標均無差別。進入試 驗之104人中,有3人發生副作用;levofloxacin組有1人胃痛,ofloxacin 組有2 人頭痛。此3人在給予胃藥或止痛藥後,副作用均緩解,仍繼續接受試驗藥物治 療。血液生化檢查有4人異常,但和試驗藥物無關。levofolxacin及ofloxacin均有 良好療效(於80-90%之間),且病人適應良好;與ofloxacin 相較之下, levofloxacin具有相同之抗菌範圍,而其殺菌能力為ofloxacin一倍。 |
英文摘要 | Levofloxacin, the optical S-(-) isomer of ofloxacin, was compared with ofloxacin in the treatment of complicated urinary tract infections (UTIs). Patients eligible for the trial were randomly assigned to either a daily 300 mg of levofloxacin or 600 mg of ofloxacin for 10 consecutive days. The double blind design was achieved by a double-dummy technique utilizing placebo of both test drugs. Efficacy variables measured were:urine white blood cell counts for the effects on pyuria, urine cultures for effects on bacteriuria, subjective symptoms, and voerall clinical efficacy which combined results from effects on bacteriuria, pyuria and subjective symptoms. Safety endpoints were the incidence of adverse events and laboratory test monitoring after a 10- day treatment. A total of 104 patients were enrolled into this trial and 46 patients were evaluable for efficacy endpoints. Most patients with culture-negative (48 cases), mixed flora (5 cases), and less than 10,000 colony forming units/mL of bacteria (3 cases) were excluded from analyses. None of the demographic and baseline characteristics were significantly different between treatments (p>0.05). Therapeutic effects upon bacteriuria for both treatment groups were similar with a response rate of 90.0% for levofloacin and 88.5% for ofloxacin. Efficacy on the subjective symptoms revealed response rates of 90.0% in the levofloxacin group and 80.7% in the ofloxacin group, with the overall clinical efficacy of 90% in the levofloxacin and 84.6% in the ofloxacin groups. All the efficacy variables measured between treatments were not statistically different which indicated an equivalent efficacy in the treatment of complicated UTIs (p>0.05). Of the 104 patients exposed to the test medications, only three having adverse effects. One developed epigastralgia in the levofloxacin group, and 2 developed a headache in the ofloxacin treatment. All events were moderate in severity and were resolved quickly after medication. Four laboratory data abnormalities were observed (defined by 25% as exceeding the normal range), and were considered to not be related to the test medications. Both antibiotics were efficacious in the treatment of complicated UTIs (response rates ranging from 80 to 90%) and were well tolerated. Levofloxacin demonstrated comparable antibacterial effects and safety profiles with double potency dosage, compared to the ofloxacin. |
本系統中英文摘要資訊取自各篇刊載內容。