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題 名 | Once Daily Isepamicin Treatment in Complicated Urinary Tract Infections=以一天投予一次Isepamicin治療複雜性泌尿系統感染 |
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作 者 | 李欣蓉; 劉永慶; 萬樹人; 林蔚如; 蔡宗宏; 林錫勳; 陳垚生; 顏慕庸; | 書刊名 | 微免與感染雜誌 |
卷 期 | 32:2 1999.06[民88.06] |
頁 次 | 頁105-110 |
分類號 | 418.22 |
關鍵詞 | 泌尿系統感染; 抗微生物製劑; Isepamicin; Aminoglycosides; Urinary tract infection; |
語 文 | 英文(English) |
中文摘要 | Isepamicin 是一種衍生自 gentamicin B 的氨基糖酐抗微生物製劑。在同類藥物 中, 它的腎毒性較低, 且較不易被細菌的酵素所分解。 本研究的目的在藉由比較本藥和 amikacin 治療複雜性的泌尿系統感染,來評估此藥一天投予一次的療效及安全性。在 1997 年 5 月至 1998 年 1 月,高雄榮民總醫院的病患中,總計有 52 名病患被納入此研究。此 研究屬於隨機取樣的前瞻性臨床試驗。 11 名病患因故被排除在試驗之外,故僅有 41 名病 患被納入分析研究,包括 16 名男性及 25 名女性病患,平均年齡為 57.9 歲(範圍 18 至 95 歲)。研究結果顯示 isepamicin 組及 amikacin 組在臨床上判定為進步者均為 100%; 不論在緩解發燒、排尿疼痛、頻尿、菌尿及膿尿等癥候上,均無統計上差異。細菌學上的治 癒率在兩組則分別為 89.4%,100%,無統計上差異。 不良反應發生率頗高,isepamicin 組 為 15/25 人次,而 amikacin 組為 16/27 人次,但大多數僅為輕度不良反應。唯一一例列 為中度不良反應者為嘔吐, 發生於 amikacin 組。 其中僅有 7 例可能和研究藥物有關( isepamicin 組為 3 例, amikacin 組 4 例),包括嗜伊紅性白血球過多症( isepamicin 組 2 例); 肝功能異常( isepamicin 組 1 例, amikacin 組 2 例); 腎功能異常( amikacin 組 1 例)及面部潮紅( amikacin 組 1 例)。 在研究過程中並無嚴重或致命不 良反應而導致的試驗中止。 這些結果顯示在治療複雜性泌尿系統感染上, isepamicin 及 amikacin 具有相等的療效及安全性。 |
英文摘要 | Isepamicin is a new amiolycoside, derived from gentamicin B, which is more stable than other aminoglycosides against inactivating enzymes, and less nephrotoxic. We evaluated the efficacy and safety of a once daily isepamicin in the treatment of complicated urinary tract infections (UTIs), as compared with amikacin. During the period May, 1997, to Junary, 1998, a total of 52 patients with similar demographic and baseline characteristics were enrolled into a prospective, randomized, open-label, single-center trial at the Veterans General Hospital-Kaohsiung. Eleven patients were excluded for protocol violation. The remaining 41 patients were included in the efficacy analysis. Study subjects included 16 men and 25 women, with a mean age of 57.9 (range 18-95) years. Clinical improvement was noted in 100% of pateitns in both the isepamicin and amikacin group. No statistically significant difference was observed between the 2 groups in regard to the rapidity of defervescence, relief of dysuria and urinary frequency, and clearance of bacteriuria and pyuria. Bacteriological cure rates were 89.4% for the isepamicin group and 100% for the amikacin group. Fifteen of 25 subjects who received isepamicin and 16 of 27 subjects who received amikacin had an adverse effect, all of which were considered to be mild except for one in the amikacin group, who had an adverse event of moderate severity (vomiting). Seven (3 isepamicin and 4 amikacin) adverse events were considered probably or possibly related to the study drug, which included eosinophilia (2 isepamicin), liver function impairment (1 isepamicin, 2 amikacin), renal function impairment (1 amikacin) and flushed face (1 amikacin). However, none of the patients had a life-threatening or severe adverse event that required discontinuation of the drug. These results show that once daily administration of isepamicin is as effective and safe as amikacin in treatment of complicated UTIs. |
本系統中英文摘要資訊取自各篇刊載內容。