Department of Infectious Diseases, University Hospital Centre Rijeka, Rijeka, Croatia.
Clin Drug Investig. 2003;23(9):591-6. doi: 10.2165/00044011-200323090-00005.
To investigate the clinical and bacteriological efficacy of 5- and 7-day pefloxacin therapy in patients with acute infectious diarrhoea.
Eighty-two adult patients with acute infectious diarrhoea were randomly divided into three groups: group 1 (n = 20) received 5 days of treatment with pefloxacin, group 2 (n = 27) was assigned to a 7-day pefloxacin protocol, and group 3 (n = 35) was treated symptomatically. The daily dose of pefloxacin was 400mg orally. Clinical and bacteriological response was analysed on the third, fifth and seventh days of treatment as well as 1 and 4 weeks after the end of treatment. The study was an open-labelled, prospective clinical trial.
In the 47 patients (100%) of both pefloxacin groups a clinical improvement was noted on the third day compared with the control group, where this occurred on day 7. Bacteriological eradication was verified on the fifth day in 18 patients (90%) from group 1 and in 25 patients (93%) from group 2; they all had negative stool cultures 1 and 4 weeks after therapy was completed. Only 22 patients (63%) in the control group had negative stool cultures on the seventh day of treatment, but 4 weeks later all of them were negative.
There was no difference in clinical (p = 0.232) and bacteriological (p = 0.972) efficacy between the 5- and 7-day pefloxacin treatment protocols. However, both protocols differed significantly in clinical improvement (p < 0.001) and bacteriological eradication (p = 0.017) from the control group.
研究 5 天和 7 天培氟沙星治疗急性感染性腹泻的临床和细菌学疗效。
82 例成人急性感染性腹泻患者随机分为三组:第 1 组(n = 20)接受培氟沙星 5 天治疗,第 2 组(n = 27)接受 7 天培氟沙星方案,第 3 组(n = 35)接受对症治疗。培氟沙星的日剂量为 400mg 口服。在治疗的第 3、5 和 7 天以及治疗结束后 1 和 4 周时分析临床和细菌学反应。该研究是一项开放标签、前瞻性临床试验。
在两组培氟沙星组的 47 例患者(100%)中,与对照组相比,第 3 天临床改善,而对照组在第 7 天改善。第 5 天,第 1 组 18 例(90%)和第 2 组 25 例(93%)患者的细菌学清除得到证实;他们在治疗结束后 1 和 4 周时粪便培养均为阴性。对照组仅 22 例(63%)患者在第 7 天治疗时粪便培养阴性,但 4 周后均为阴性。
5 天和 7 天培氟沙星治疗方案在临床(p = 0.232)和细菌学疗效方面无差异。然而,与对照组相比,两种方案在临床改善(p < 0.001)和细菌学清除(p = 0.017)方面均有显著差异。