注射用阿奇霉素治疗非淋菌性尿道炎和宫颈炎随机对照多中心临床研究

为了评价注射用阿奇霉素治疗衣原体和地原体引起的非淋菌性尿道炎和宫颈炎的疗效和安全性，采用多中心、随机、对照试验，并与口服阿奇霉素胶囊进行比较。共纳入临床试验病例243例，可供疗效评价的病例241例，可进行安全性评价病例242例。其中试验组172例，静脉滴注阿齐霉素500mg，每天一次，连续2d。肌注阿齐霉素500mg，每天一次，连续2d，对照组69例，阿奇霉素胶囊1000mg，单剂量口服一次。总治愈率为74．42％（对照组60．87％）,总有效率为87．21％（对照组73．0％）；病原学清除率为88．44％（对照组81．01％）；不良反应发生率为6．94％（对照组为4．35％）。注射用阿奇霉素与对照药口服奇霉素胶囊相比较，在统计学上总治愈率与总有效率有显著性差异（P＜0．05），病原学疗效无显著性差异（P＞0．05），不良反应发生率无显著性差异（P＞0．05）。结果表明注射用阿奇霉素治疗由衣原体和支原体引起的非淋菌笥尿道炎和宫颈炎疗效确切、安全性好。

Randomized controlled multicenter clinical studies on azithromycin for infection treatment of non-gonococcal urethritis and cervicitis infected with Chlamydia trachomatis or mycoplasma

ABSTRACT:Objective: To study the efficacy and safety of azithromycin for injection in the treatment of non-gonococcal urethritis and cervicitis infected with Chlamydia or Mycoplsma. Method: A randomized, open, and parallelcontrolled clinical trial were carried out. Test group was treated with azithromycin for injection 500mg, iv drip qd for 2days or 500mg im qd for 2 days; Controlled group was treated with azithromycin capsule 1000mg, a single dose. Result:172 patients were involved in test group and 69 patients were involved in controlled group. The total cure rate was74. 42% in test group, and 60. 87% in controlled group. The total efficacy rate was 87. 21 % in test group, and 73. 91 %in controlled group. The total eradication rate was 88. 44% in test group, and 81. 01% in controlled group. The side-effect rate was 6. 94% in test group , and 4. 35% in controlled group. There were signifficant differences in the total curerate and total efficacy rate between the test group and controlled group. There were no signifficant differences in totalpathogen eliminated rate and side-effect rate between the test group and controlled group. Conclusion: Azithromycin forinjection can be used in treatment of non-gonococcal urethritis and cervicitis infected with Chlamydia or Mycoplsmaeffectively and safely.