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口服甲硝唑能否替代急性阑尾炎的胃肠外给药治疗?一项针对伴有局限性腹膜炎的单纯性或复杂性阑尾炎治疗的新政策:一项随机对照临床试验。

Can oral metronidazole substitute parenteral drug therapy in acute appendicitis? A new policy in the management of simple or complicated appendicitis with localized peritonitis: a randomized controlled clinical trial.

作者信息

Banani S A, Talei A

机构信息

Department of Pediatric Surgery, Shiraz University of Medical Sciences, Iran.

出版信息

Am Surg. 1999 May;65(5):411-6.

Abstract

To demonstrate the efficacy of oral metronidazole (OM) in simple or complicated appendicitis with localized peritonitis, a randomized prospective study was carried out in 1083 patients, ranging in age from 4 to 50 years (mean age, 21.38). The patients were randomly divided into two groups. The study group (SG) (524 patients) received OM (500 mg for adults, 7-10 mg/kg if less than 15 years) 2-3 hours before operation. The drug was continued 4 to 5 hours after operation, every 8 hours, for three doses if the appendix was mild to severely inflamed. In the case of complicated appendicitis (114 patients), the same dose was given for 3 to 6 days, depending on the absence or presence of pus. Ceftizoxime was administered to the control group (CG) (559 patients) 2 to 3 hours before operation and then postoperatively every 6 hours for three doses if the appendix was mild to severely inflamed. The complicated cases in the CG (120 patients) received a combination of penicillin, chloramphenicol, and gentamicin for 3 to 6 days, depending on the absence or presence of pus. The serum concentration of metronidazole measured in 43 patients was at bactericidal level in 40 (mean +/- SD standard deviation, 10.65 +/- 4.89 microg/mL). The rate of wound infection was not significantly different in the SG and the CG with the same degree of pathology (3.17% vs 2.96% if uncomplicated; 15.78% vs 14.16% if complicated, respectively). Pelvic collection occurred in four adults and one child in the CG with perforated appendicitis (4.16%). The same complication developed in two adults and two children in the SG with perforated appendicitis (3.5%). All six adults and one of the children in the SG had to be re-explored, whereas the remaining two children responded to conservative management (OM and gentamicin). In uncomplicated cases, hospital stay and hospital charge were both almost the same in both groups. However, length of hospitalization was nearly 1 day shorter and hospital cost per day was about 30 per cent less in complicated cases in the SG as compared with the CG. Conclusively, OM may not only substitute parenteral antibiotics in acute appendicitis as a prophylactic agent, but it may also be used as a cost-effective drug and is more convenient to the patient.

摘要

为证明口服甲硝唑(OM)在治疗伴有局限性腹膜炎的单纯性或复杂性阑尾炎中的疗效,对1083例年龄在4至50岁(平均年龄21.38岁)的患者进行了一项随机前瞻性研究。患者被随机分为两组。研究组(SG)(524例患者)在手术前2至3小时服用OM(成人500毫克,15岁以下7 - 10毫克/千克)。如果阑尾炎症为轻度至重度,术后4至5小时继续用药,每8小时一次,共三剂。对于复杂性阑尾炎患者(114例),根据有无脓液,给予相同剂量的药物3至6天。对照组(CG)(559例患者)在手术前2至3小时给予头孢唑肟,如果阑尾炎症为轻度至重度,术后每6小时给药一次,共三剂。CG组中的复杂性病例(120例)根据有无脓液,给予青霉素、氯霉素和庆大霉素联合用药3至6天。对43例患者测定的甲硝唑血清浓度,40例达到杀菌水平(平均±标准差,10.65±4.89微克/毫升)。在病理程度相同的情况下,SG组和CG组的伤口感染率无显著差异(单纯性阑尾炎分别为3.17%对2.96%;复杂性阑尾炎分别为15.78%对14.16%)。CG组中有4例成人和1例儿童发生穿孔性阑尾炎盆腔积液(4.16%)。SG组中有2例成人和2例儿童发生穿孔性阑尾炎出现相同并发症(3.5%)。SG组中的所有6例成人和1例儿童都必须再次进行探查,而其余2例儿童对保守治疗(OM和庆大霉素)有反应。在单纯性病例中,两组的住院时间和住院费用几乎相同。然而,与CG组相比,SG组复杂性病例的住院时间缩短近1天,每日住院费用降低约30%。总之,OM不仅可替代胃肠外抗生素作为急性阑尾炎的预防用药,而且它可能是一种具有成本效益的药物,对患者来说也更方便。

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