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头孢替坦二钠治疗急性膀胱炎、肾盂肾炎随机对照临床研究

A Randomized Controlled Clinical Study of Cefotetan Disodium for Acute Cystitis and Pyelonephritis

【作者】 彭友彬

【导师】 郑俊鸿;

【作者基本信息】 汕头大学 , 泌尿外科, 2011, 硕士

【摘要】 目的:评价头孢替坦二钠治疗急性膀胱炎、急性肾盂肾炎的有效性和安全性。方法:采用随机、单盲(患者)、阳性药物平行对照试验设计,设试验组和对照组,试验组21例,采用头孢替坦二钠,对照组20例,采用已经上市的头孢美唑钠。用法均为中度感染2g/d,重度感染4g/d,分两次静脉滴注,疗程为7~10天。结果:有效性结果表明:试验组与对照组在疗程结束时,临床有效率分别为80.00%和84. 21%。以上结果两组比较差异无统计学意义(P=0.732);细菌学评价:试验组与对照组细菌阳性率分别为55.00%和47.37%,细菌清除率分别为81.82%与77.78%。差异均无统计学意义(P>0.05)。安全性结果表明:试验组与对照组共发生4例不良反应,试验组2例,其中皮疹1例,转氨酶ALT升高1例,不良反应发生率为10.0%。对照组2例,其中转氨酶AST升高1例,胃肠道不适1例,不良反应发生率为13.33%。试验组与对照组不良反应发生率比较差异无统计学意义。上述不良反应中,除1例患者因皮疹退出外,其余患者均未影响疗程,且不良反应均为轻度,未给予特殊处理,随访均恢复正常。皮疹患者停药经对症处理恢复正常。结论:头孢替坦二钠治疗急性膀胱炎、急性肾盂肾炎疗效肯定,不良反应较少,有望成为临床上治疗泌尿系感染的有效药物。

【Abstract】 Objective: To evaluate the clinical efficacy and safety of cefotetan disodium in the treatment of acute cystitis and pyelonephritis.Methods: A randomized, single-blind, controlled clinical trial was performed. The experimental group were treated with cefotetan disodium and the control group were treated with cefmetazole sodium. The dosages were 2g for moderate infection and 4g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days.Results:At the end of the treatment, clinical efficacy rate of two groups were 80.00% and 84.21%. The values of two groups has no significant differences(P=0.732). Bacteriological evaluation: the positive rates of bacteria in the experimental group and the control group were 55.00% and 47.37% respectively, and bacterial eradication rates were 81.82% and 77.78%.There was no significant difference (P> 0.05).Safety results showed that in the experimental group, there were 2 cases of adverse reactions, 1 case of rash, another case of elevated alanine aminotransferase. The rate of adverse reaction was 10.0%. In the control group, there were 2 cases of adverse events, with 1 case of elevated aspartate aminotransferase, and with 1 case of gastrointestinal discomfort. The rate of adverse reaction rate was 13.33%. The incidence of adverse reactions in the two groups showed no statistical significance. These adverse events were mild and not given special treatment, except for 1 patient withdrawal due to rash; the course of treatment for remaining patients were not affected, and the follow-up were normal. The patient with rash was given symptomatic treatment and became normal after drug withdrawal.Conclusion: Cefotetan disodium can be an effective treatment for acute cystitis and pyelonephritis. With fewer side effects, cefotetan disodium could be used for clinical use.

  • 【网络出版投稿人】 汕头大学
  • 【网络出版年期】2012年 01期
  • 【分类号】R694.3;R692.3
  • 【下载频次】94
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