随机控制试验:非复杂性憩室炎可不使用抗生素


  【24drs.com】根据一篇随机控制试验(RCT)结果,对于首次发生非复杂性憩室炎的患者,抗生素并不会改善结果;作者们结论指出,Hinchey第1a期的憩室炎患者可以先单纯观察就好。
  
  在6个月的追踪期间,该研究的初级终点、达到恢复的时间中位数方面,观察治疗组是14天(四分位范围,6 – 35天),接受抗生素治疗组是12天(四分位范围,7 – 30天)。相较于抗生素治疗,观察方法与完全恢复的风险比值为0.91有关(单边95%信赖区间的下限为:0.78; P = .151)。
  
  研究者写道,不用抗生素治疗是有争议的,因为即使有两篇观察型研究与一篇随机控制试验指出抗生素没有效益,指引并未修改。之前的随机控制试验评估了623名患者,但是研究方法设计有一些缺点,因而无法改变临床实务。
  
  荷兰阿姆斯特丹大学学术医学中心外科Lidewine Daniels医师与荷兰憩室炎疾病协同研究组的研究团队,在9月30日的英国外科期刊在线发表他们的结果。
  
  目前这篇试验标题为「Diverticulitis: Antibiotics or Close Observation(简称为DIABOLO)」,是一篇多中心、开放卷标、务实的、两种治疗策略的随机控制试验,这篇研究包括了528名第一次发作左侧非复杂性(修改版Hinchey分期1a-b且Ambrosetti's憩室炎分期「轻度」)急性憩室炎之患者。
  
  其中266名患者根据荷兰抗生素策略委员会与美国结肠与直肠外科协会的建议给予抗生素,这些患者接受10天的amoxicillin-clavulanic acid,起始剂量是每天静脉注射4次1200 mg、至少48小时,之后,如果耐受良好,可以换成每天口服3次625 mg;过敏的患者可以换成并用ciprofloxacin和metronidazole。抗生素组的所有患者都需住院,以接受静脉注射抗生素。
  
  观察组中,符合下列规范的262名患者于门诊接受治疗:可耐受正常饮食、体温低于38°、视觉评估量表的疼痛分数低于4分,没有使用比paracetamol更强的止痛药、可以如同生病前一样程度的自我支持,最后,是患者的接受度。
  
  这些患者在2个月与6个月时回门诊,之后在12个月与24个月时以电话追踪。
  
  观察组最初住院期间中位数,比静脉注射抗生素组短(2天 vs 3天;P = .006)。
  
  在6个月追踪期间,其它次级结果在这两组之间并无差异。观察组的复杂性憩室炎比率为3.8%,抗生素组是2.6%(P = .377)。发生持续性憩室炎的人数在观察组有19名患者(7.3%),抗生素组则是有11人(4.1%) 。
  
  在经历复发憩室炎的患者比率这方面,观察组与抗生素组差不多(3.4% vs 3.0%;P = .494)。
  
  乙状结肠切除率相似(3.8% vs 2.3%;P = .323),不论是紧急切除(0.8% vs 1.1%;P = .553)或选择性切除(3.1% vs 1.1%;P = .254),乙状结肠切除的最常见原因是结肠阻塞(观察组的10名患者有3名如此、抗生素组的6名患者有2人如此)与穿孔(观察组的10名患者有2名如此、抗生素组的6名患者有2人如此)。
  
  在发生轻微(P = .086)或严重(P = .354)不良反应的发生率上,并无显著差异,不过,抗生素组比较常发生抗生素相关的不良反应(观察组:0.4%,抗生素组:8.3%;P = .006),所有的抗生素相关不良反应都是轻微的,只有1例除外;两组的死亡率也没有差异(1.1% vs 0.4%;P = .432)。
  
  研究者提醒,需等进行更大型的研究之后,Hinchey 1a期的憩室炎患者才能停用抗生素。
  
  作者们解释,没有关于Hinchey 1b期疾病采观察处置或采抗生素处置的其它报告,对于非复杂性急性憩室炎之治疗,省略抗生素仅适用于Hinchey 1a期患者,直到有更大型的Hinchey 1b期患者之研究。他们结论指出,此外,对于有明显共病症或发炎性肠道疾病的患者,以及那些怀孕或免疫功能不佳的患者,无法根据目前的研究结果判断。体温大于39°C、败血症且/或血液培养阳性的患者,需给予抗生素治疗。
  
  资料来源:http://www.24drs.com/
  
  Native link:Skip Antibiotics in Uncomplicated Diverticulitis, RCT Shows

Skip Antibiotics in Uncomplicated Diverticulitis, RCT Shows

By Troy Brown, RN
Medscape Medical News

In patients with a first episode of uncomplicated diverticulitis, antibiotics did not improve outcomes, according to the results of a randomized controlled trial (RCT). The authors conclude patients with Hinchey stages 1a diverticulitis can be treated with observation alone.

The median time to recovery during 6 months of follow-up, which was the primary endpoint, was 14 days (interquartile range, 6 - 35 days) for patients in the observational treatment group compared with 12 days (interquartile range, 7 - 30 days) among those who received antibiotic treatment. Compared with antibiotic treatment, an observational approach was associated with a hazard ratio for full recovery of 0.91 (lower limit of one-sided 95% confidence interval, 0.78; P = .151).

"Treatment without antibiotics is controversial, as guidelines have remained unchanged despite evidence from two observational studies and one [randomized controlled trial (RCT)] indicating that antibiotics have no benefit," the researchers write. "The previous RCT evaluated 623 patients, but some drawbacks of its methodological design may account for the lack of change in clinical practice."

Lidewine Daniels, MD, from the Department of Surgery, Academic Medical Centre, University of Amsterdam, the Netherlands, and colleagues from the Dutch Diverticular Disease Collaborative Study Group report their findings in an article published online September 30 in the British Journal of Surgery.

The current trial, called Diverticulitis: Antibiotics or Close Observation, or DIABOLO, was a multicenter, open-label, pragmatic, RCT of two accepted treatment strategies. The study included 528 patients with a first episode of left-sided, uncomplicated (modified Hinchey stages 1a-b and Ambrosetti's 'mild' diverticulitis stage), acute diverticulitis.

Of those, 266 patients received antibiotic treatment according to the practice guidelines of the Dutch Antibiotic Policy Committee and the American Society of Colon and Rectal Surgeons. Patients received a 10-day course of amoxicillin-clavulanic acid, beginning with 1200 mg intravenously four times daily for at least 48 hours, after which they could be switched to 625 mg orally three times daily, if tolerated. Patients who were allergic switched to the combination of ciprofloxacin and metronidazole. All patients in the antibiotic group were admitted to the hospital for intravenous antibiotic administration.

In the observation group, 262 patients received treatment in an outpatient setting once they met the following criteria: toleration of a normal diet, temperature lower than 38°pain score measured on a visual analogue scale lower than 4 with nothing stronger than paracetamol for pain, capable of the same level of self-support as before their illness, and patient acceptance.

Patients visited the outpatient clinic at 2 and 6 months and followed up by telephone at 12 and 24 months.

The median duration of initial hospital stay was shorter in the observation group as a result of the intravenous administration of antibiotics in the antibiotic group (2 vs 3 days; P = .006).

Other secondary outcomes did not differ significantly between the groups during 6 months' follow-up. Complicated diverticulitis rates were 3.8% in the observation vs 2.6% in the antibiotic group (P = .377). Ongoing diverticulitis occurred in 19 patients (7.3%) in the observation group compared with 11 (4.1%) in the antibiotic group.

The proportion of patients who experienced recurrent diverticulitis was similar in the observation group compared with the antibiotic group (3.4% vs 3.0%; P = .494).

Sigmoid resection rates were similar (3.8% vs 2.3%; P = .323) for both emergency (0.8% vs 1.1%; P = .553) and elective (3.1% vs 1.1%; P = .254) resection. The most common reasons for sigmoid resection were colonic obstruction (3 of 10 patients in the observation group and 2 of 6 in the antibiotic group) and perforation (2 of 10 patients in the observation group and 2 of 6 patients in the antibiotic group).

There were no significant differences in the occurrence of mild (P = .086) or serious (P = .354) adverse events, although antibiotic-related adverse events occurred more frequently in the antibiotic group (0.4% in the observation group vs 8.3% in the antibiotic group; P = .006). All but one antibiotic-related adverse events were mild. Mortality rates did not differ between the groups (1.1% vs 0.4%; P = .432).

The researchers caution that antibiotics should be withheld only in patients with Hinchey 1a diverticulitis until larger studies have been conducted.

"There are no other reports on observational versus antibiotic management of Hinchey 1b disease. Omitting antibiotics in the treatment of uncomplicated acute diverticulitis should be limited to Hinchey 1a until larger Hinchey 1b samples have been examined," the authors explain. "Moreover, recommendations for patients with significant co-morbidity or inflammatory bowel disease, and those who are pregnant or immunocompromised, cannot be made based on the present results. Patients with body temperature exceeding 39?°C, sepsis and/or positive blood cultures warrant antibiotic treatment," they conclude.

The authors have disclosed no relevant financial relationships.

Br J Surgery. Published online September 30.

    
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