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国产与进口阿奇霉素治疗小儿支原体肺炎随机对照试验 |
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叶巍岭 尹同进 雍其军 吴震
摘 要 目的： 评价国产与进口阿奇霉素治疗小儿支原体肺炎的有效性和安全性。方法： 对确诊的小儿支原体肺炎70例进行临床随机双盲对照试验， 国产组38例， 进口组32例， 两组均以10 mg/kg， 1次/d， 连服3 d后停4 d， 再服3 d， 疗程10 d。结果： 国产组痊愈率97.4%， 总有效率100%； 进口组痊愈率97.0%， 总有效率100%； 两组药物不良反应发生率分别为10.5%， 12.5%。结果经统计学处理差异无显著性。结论： 国产阿奇霉素治疗小儿支原体肺炎临床疗效肯定， 使用安全方便、费用低。
关键词 阿奇霉素 肺炎 支原体 临床研究
A Random Control Study on the Effect of Azithromycin
on the Juvenile Mycoplasmal Pneumonia
Ye Weiling, Yin Tongjin, Yong Qijun, Wu Zheng
(The Third People s Hospital of Yancheng City, Jiangsu 224001, P.R.China)
ABSTRACT To evaluate the efficacy and safety of domestic and imported Azithromycin in the treatment of juvenile mycoplasmal pneumonia, a random control double-blind study were conducted in 70 cases of children with established mycoplasmal pneumonia. The group of domestic drug had 38 patients and group of imported drug included 32 cases. A dosage of 10 mg/kg per day was given to both groups for three days in a row. After 4 day suspension of the treatment, the same treatment was given for 3 days with total treatment course being 10 days. Our results showed that the cure rate in domestic product group was 97.4% with a total effective rate of 100% and the cure rate in imported product group was 97.0 with a total rate of 100%. The rates of adverse drug reaction were 10.5% and 12.5% respectively. Statistical analysis showed that the difference was not significant. It is concluded that domestic Azithromycin is effective, safe and cost-effective.
KEY WORDS Azithromycin; Pneumonia; Mycoplasma; Clinical study▲
阿奇霉素为大环内酯类抗生素， 属15元环类， 以口服吸收迅速、组织内药物浓度高于血液浓度、半衰期长、给药次数少为特点， 国外广泛应用于呼吸道、皮肤及软组织、泌尿生殖系感染， 取得良好疗效， 但对治疗支原体肺炎未见报道。本组采用国产与进口阿奇霉素治疗小儿支原体肺炎70例， 观察其临床疗效及安全性。
1 研究对象与方法
1.1 病例选择
1997年1月～1998年1月被确诊住院的小儿支原体肺炎70例， 男43例， 女27例。年龄6±4.5岁。持续发热70例， 体温39℃±0.9℃； 咳嗽62例， 气喘、呼吸困难41例， 肺部可闻及干湿性噌 罗音68例。检查： WBC＜10×109/L 56例， 10×109[1] [2] 下一页
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