注射用乳糖酸阿奇霉素治疗社区获得性肺炎及盆腔炎的临床研究

目的：评价哈尔滨制药总厂研制的乳糖酸阿奇霉素对社区获得性肺炎与盆腔炎的有效性及安全性。方法：以注射用乳糖酸红霉素为对照药，采用单盲，多中心随机对照试验，注射用乳糖酸酸阿奇霉素500mg/次，每日1次静点，注射用乳糖酸红霉素500mg/次，每日2次静点，均以7－14天为一疗程。结果：试验药平均用药总量明显少于对照组情况下，注射用乳糖酸阿奇霉素临床有效率为89．55％，细菌清除率为89．47％，而对照组分别为70．15％，74．07％，试验组明显优于对照组，起效亦明显较对照组快（P＝0．001），不良反应发生率两组分别为7．46％和23．19％，试验组不良反应发生率明显低于对照组，且程度较轻。结论：注射用乳糖酸阿奇霉素是治疗社区性获得性肺炎和盆腔炎的安全有效药物。

Clinical study of azithromycinin lactobionate for injection in the treatment of patients with community-acquired pneumonia and pelvic inflammatory disease

Objective Using the azithromycinin lactobionate for injection to treat the patients with community acquired pneumonia and pelvic inflammatory disease in order to study its efficacy and safety. Methods This study was conducted as a multicenter, single blind, randomized, comparative trial of azithromycinin lactobionate for injection versus erythromycin lactobionate for injection.One group received azithromycinin lactobionate for injection (one iv dose of 500mg,qd for 7 to 14 days), the second group received erythromycin lactobionate for injection (one iv dose of 500mg ,bid for 7 to 14 days).Results The quantity of experimental drug was less than that of comparative drug, but its clinical efficacy rate was 89.55%,the eradication rate was 89.47%.The rate of comparative group were 70.15%,70.47% respectively. The experimental group was better than the comparative group, the time of drug's going into operation was shorter than that of comparative group ( P =0.001). The occurrence rate of adverse events were 7.46% and 23.19% respectively. The occurrence rate of experimental group was lower than the comparative group, and the adverse events were mild. Conclusion Azithromycinin lactobionate for injection is the effective drug to treat the patients with community-acquired pneumonia and pelvic inflammatory disease, its quantity of treatment is little, the drug's going into operation is quickly. It is very convenient and safe.