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目的 :评价乳糖酸阿奇霉素的安全性及有效性。方法 :以乳糖酸红霉素为对照药 ,采用随机对照临床试验方法 ,治疗轻、中度呼吸道感染 35例。给药方案 ,乳糖酸阿奇霉素 ,5 0 0mg,qd ,iv ;对照药 :乳糖酸红霉素 12 0 0mg ,qd ,iv ,疗程 5～ 7d。结果 :乳糖酸阿齐霉素试验组与乳糖酸红霉素对照组病例数均为 35例。细菌学诊断阳性率分别为 91.4%和 80 %。两组临床治疗有效率分别为 94.3%和 91.4%。治疗各种细菌感染的有效率分别为 90 .6 %和 89.3% ,细菌清除率分别为 90 .6 %和 89.3%。药物不良反应发生率分别为 5 .7%和 2 0 %。以上结果除不良反应发生率外 ,经统计学处理均无显著性差异 (P >0 .0 5 )。结论 :乳糖酸阿奇霉素治疗轻、中度呼吸道感染安全有效 ,不良反应较少。
Objective: To evaluate the safety and efficacy of azithromycin lactobionate. Methods: Erythromycin lactobionate was used as a reference drug in a randomized controlled clinical trial to treat 35 cases of mild and moderate respiratory infections. Dosing regimen, azithromycin lactobionate, 500mg, qd, iv; control drug: erythromycin lactobionate 120mg, qd, iv, treatment of 5 ~ 7d. Results: The cases of azithromycin lactobionate group and erythromycin lactobionate group were all 35 cases. The positive rates of bacteriological diagnosis were 91.4% and 80% respectively. The clinical efficacy of the two groups were 94.3% and 91.4% respectively. The effective rates for the treatment of various bacterial infections were 90.6% and 89.3% respectively, and the bacterial clearance rates were 90.6% and 89.3% respectively. Adverse drug reaction rates were 5.7% and 20%. In addition to the above results except for the incidence of adverse reactions, the statistical analysis showed no significant difference (P> 0.05). Conclusion: Azithromycin lactobionate is safe and effective in the treatment of mild and moderate respiratory infections with less adverse reactions.