注射用盐酸多西环素治疗急性细菌性感染的临床研究

目的评价国产注射用盐酸多西环素治疗轻、中度急性细菌性感染的临床疗效与安全性。方法采用双盲、随机对照实验设计，以注射用阿奇霉索为对照药。试验组0．2g，对照组0．5g溶解于生理盐水500ml中，（1d，静脉滴注，疗程5～12d。结果本研究共纳入84例，注射用多西环索和注射用阿奇霉素组各42例。其中盐酸多西环素组及阿奇霉索组纳入ITT分析均为42例，PP分析均为41例。疗程结束时注射用盐酸多西环素组和注射用阿奇霉素组的总痊愈率和有效率分别为73．81％与97．62％和71．43％与97．62％；两组细菌清除率分别为85．29％，75．76％；以上结果两组间比较无显著性差异（P〉0．05）。注射用盐酸多西环素组和注射用阿奇霉索组的不良反应发生率分别为7．14％和11．9％，主要表现为轻度的局部刺激症状，经减慢输液速度、湿热敷等处理后缓解。结论国产注射用盐酸多西环素治疗轻、中度急性细菌性感染的临床疗效确切，安全性较好。

A clinical trial of doxycyclinc hydrochloride for injection in the treatment of acute bacterial infections

Objective To evaluate the clinical efficacy and safety of domestic doxycycline hydrochloride for injection in the treatment of slight and moderate acute bacterial infections.Methods A double-blind(randomized) clinical trial was conducted to compare the efficacy and safety of doxycycline hydrochloride for injection with that of azithromycin for injection.Trial group was administered intravenously at a dose of 0.2g once daily and control group at a dose of 0.5g once daily for 5 to 12 days.Results A total of 84 patients were(enrolled) in the study.Each group was 42 patients included.There was 42 patients who enrolled in ITT(intention to treat analysis) and 41 in PP(per protocol) of the both groups.At the end of the treatment,the cure rate and effective rate were 73.81% and 97.62% in doxycycline hydrochloride group;while 71.43% and 97.62% in azithromycin group.The bacterial eradication rates were 85.29% and 75.76% respectively.There was no statistical difference between the two groups(P>0.05).Adverse reactions were observed,7.14% and 11.9% respectively in the two groups.The main adverse reaction was partly irritation that it could be relieved through step down transfuse speed and wet heat compress.Conclusion Domestic doxycycline hydrochloride for injection is effective and safe for the treatment of slight and moderate acute bacterial infections.