洁泽Ⅰ号抗解脲支原体药效实验及其对解脲支原体宫颈炎的治疗作用

Clinical Research of Jieze No.1 on Cervicitis Caused by Ureaplasma Urealyticum and Effect on Ureaplasma Urealyticum in vitro

目的研究洁泽Ⅰ号体外抗解脲支原体（Uu）的作用及其治疗解脲支原体宫颈炎的临床疗效。方法测定洁泽Ⅰ号对解脲支原体临床分离株的最低抑菌浓度（MIC）、最低杀菌浓度（MBC）。310例完成临床观察符合诊断标准无合并症的解脲支原体宫颈炎患者，随机分为三组，A组：阿奇霉素联合洁泽Ⅰ号阴道灌洗治疗组102例；B组：洁泽Ⅰ号阴道灌洗治疗组87例；C组：口服阿奇霉素治疗组121例。三组治疗期间安全套避孕，均治疗满一疗程，停药21d后复查解脲支原体并行妇科检查，观察三组临床疗效。结果洁泽Ⅰ号对解脲支原体耐药株MIC范围为：15．62～250．00（mg／ml，以下均同此单位），MBC的范围为：15．62-250．00；非耐药株MIC范围为：15．62～125．00；MBC范围为：15．62～250．00；耐药株MIC50≤31．25、MBC50≤62．50、MIC90≤125．00，MBC90≤250．00，非耐药株MIC50≤31．25、MBC50≤62．50，MIC90≤62．50，MBC90≤125．00。临床疗效观察：总有效率A组85．3％；B组：67．8％，C组：60．3％，A组与B组、C组相比差异有极显著性意义（均P〈0．01），B组与C组相比差异无显著性意义（P〉0．05）。宫颈分泌物Uu转阴率A组78．4％，B组60．9％，C组47．9％；A组与B组、C组相比差异有极显著性意义（均P〈0．01），B组与C组相比差异无显著性意义（P〉0．05），对耐药菌株Uu转阴率，A组48．1％，B组42．1％，C组16．1％，A组与B组相比差异无显著性意义（P〉0．05），A组与C组相比差异有极显著性意义（P〈0．01），B组与C组相比差异有显著性意义（P〈0．05）。结论体外实验表明洁泽Ⅰ号能有效抑制解脲支原体的生长，联合阿奇霉素对解脲支原体宫颈炎有较好的治疗效果，特别是对耐药菌株疗效有显著优势，值得进一步研究。

Objective To observe the inhibitory effect of Jieze No. 1 on ureaplasma urealyticum in vitro and the clinical therapeutic effect on cervicitis caused by ureaplasma urealyticum （Uu） in vivo. Methods The effect of Jieze No. 1 on the ureaplasma urealyticum strain separated from the secretion of the uropoiesis genital tract was studied. The minimum inhibitory concentration （MIC） and minimum bactericidal concentration （MBC） of Uu were investigated. The therapeutic effect for cervicitis was observed. 310 patients with cervicitis caused by Uu were randomly divided into 3 groups： group A, Jieze No. 1 30 min in vagina once a day for 10 days and Azithromycin orally 1.0 g once 72 h for 3 times; group B, Jieze No. 1 30 min in vagina once a day for 10 days; group C, Azithromycin orally 1.0 g once 72 h for 3 times. Results The scope of MIC of Jieze No. 1 to the drug-resistant strain of Uu was 15.62-250. 00 mg/ml and that of MBC was 15.62-250.00 mg/ml. The scope of MIC of Jieze No. 1 to the no-drug-resistant strain was 15.62--125.00 mg/ml and that of MBC was 15.62-250.00 mg/ml. MIC50of drug-resistant strain was ≤ 31.25 mg/ml, MBC90≤ 62.50 mg/ml, MIC90≤25.00 mg/ml and MBC90≤ 250 mg/ml. MIC50 of the non-drug-resistant strain was ≤ 31.25 mg/ml, MBC50≤ 62.50 mg/ml, MIC90≤ 62.50 mg/ml and MBC90≤ 125.00 mg/ ml. The clinical observation showed that the overall clinical effective rate in groups A, B and C was 85. 3%, 67. 8% and 60. 3 % respectively with the difference being very significant between groups A and B （both P〈0.01）. The clearing rate of Uu in groups A, B and C was 78.4%, 60. 9% and 47.9% respectively, with the difference being very significant between group A and B, C （both P〈0.01）. Especially to drug-resistant strain, the clearing rate of Uu in groups A, B and C was 48. 1%, 42.1% and 16.1% respectively, with the difference being significant between group A and group C （P〈0. 01） and between group B and group C （P〈0.05）. Conclusion The laboratory study confirms that Jieze No. 1 has an inhibitory effect on Uu strain. Jieze No. 1 combined with azithromycin can effectively treat cervicitis caused by Uu. Especially it takes a remarkable effect on drug-resistant strains.