NORFLOXACIN PREVENTS SPONTANEOUS BACTERIAL PERITONITIS RECURRENCE IN CIRRHOSIS - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
NORFLOXACIN PREVENTS SPONTANEOUS BACTERIAL PERITONITIS RECURRENCE IN CIRRHOSIS - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
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DOI：
10.1002/hep.1840120416
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发表时间：
1990-10-01
期刊：
影响因子：
13.5
通讯作者：
RODES, J
中科院分区：
文献类型：
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作者：
GINES, P;RIMOLA, A;RODES, J
80名自发性细菌性腹膜炎后康复的肝硬变患者参加了一项多中心双盲试验，目的是比较长期服用诺氟沙星(每天400毫克；40名患者)和安慰剂(40名患者)在预防自发性细菌性腹膜炎复发方面的作用。在入选时，两组在临床和实验室数据、腹水蛋白和中性粒细胞浓度、自发性细菌性腹膜炎的既往发作次数以及自发性细菌性腹膜炎的致病微生物方面相似。在整个研究过程中，诺氟沙星对6名定期评估诺氟沙星对粪便菌群影响的患者进行了选择性肠道净化(从粪便菌群中消除需氧革兰氏阴性杆菌，而对其他微生物没有显著变化)。安慰剂组14名患者(35%)和诺氟沙星组5名患者(12%)在随访期间出现自发性细菌性腹膜炎复发(CHI.2=5.97p=0.014)(平均随访期=6.4.+-)。0.6mo；范围=1至19mo)。在安慰剂组的14例自发性细菌性腹膜炎复发中有10例，在诺氟沙星组的5例自发性细菌性腹膜炎复发中只有1例是由需氧革兰氏阴性杆菌引起的(P=0.0029)。随访1年时，诺氟沙星组和安慰剂组自发性细菌性腹膜炎复发的总概率分别为20%和68%(p=0.0063)，由需氧革兰氏阴性杆菌引起的自发性细菌性腹膜炎复发的概率在1年分别为3%和60%(p=0.0013)。只有一名接受诺氟沙星治疗的患者出现了与治疗相关的副作用(口腔和食道念珠菌病)。提示诺氟沙星长期选择性肠道去污是预防肝硬变患者需氧革兰氏阴性杆菌所致自发性细菌性腹膜炎复发的安全有效措施。
Eighty cirrhotic patients who had recovered from an episode of spontaneous bacterial peritonitis were included in a multicenter, double-blind trial aimed at comparing long-term norfloxacin administration (400 mg/day; 40 patients) vs. placebo (40 patients) in the prevention of spontaneous bacterial peritonitis recurrence. At entry, both groups were similar with respect to clinical and laboratory data, ascitic fluid protein and polymorphonuclear concentrations, number of previous episodes of spontaneous bacterial peritonitis and causative organisms of the index spontaneous bacterial peritonitis. Norfloxacin administration produced a selective intestinal decontamination (elimination of aerobic gram-negative bacilli from the fecal flora without significant changes in other microorganisms) throughout the study in six patients in whom the effect of norfloxacin on the fecal flora was periodically assessed. Fourteen patients from the placebo group (35%) and five from the norfloxacin group (12%) developed spontaneous bacterial peritonitis recurrence during follow-up (.chi.2 = 5.97; p = 0.014) (mean follow-up period = 6.4 .+-. 0.6 mo; range = 1 to 19 mo). Ten of the 14 spontaneous bacterial peritonitis recurrences in the placebo group and only one of the five spontaneous bacterial peritonitis recurrences in the norfloxacin group were caused by aerobic gram-negative bacilli (.chi.2 = 8.87; p = 0.0029). The overall probability of spontaneous bacterial peritonitis recurrence at 1 yr of follow-up was 20% in the norfloxacin group and 68% in the placebo group (p = 0.0063) and the probability of spontaneous bacterial peritonitis recurrence caused by aerobic gram-negative bacilli at 1 yr of follow-up was 3% and 60%, respectively (p = 0.0013). Only one patient treated with norfloxacin experienced side effects related to treatment (oral and esophageal candidiasis). These results indicate that long-term selective intestinal decontamination with norfloxacin is an effective and safe measure to prevent spontaneous bacterial peritonitis recurrence caused by aerobic gram-negative bacilli in cirrhosis.