Abstract：
BACKGROUND: Colonic diverticular disease is common and its incidence increases with age, with uncomplicated diverticulitis being the most common acute presentation (1). This typically results in inpatient admission, placing a significant burden on healthcare services (2). We aimed to determine the safety and effectiveness of using intravenous or oral antibiotics in the treatment of uncomplicated diverticulitis on 30-day unplanned admissions, c-reactive protein (CRP), White Cell Count (WCC), pain resolution, cessation of pain medication, return to normal nutrition, and return to normal bowel function.
METHODS: This single centre, 2-arm, parallel, 1:1, unblinded non-inferiority randomized controlled trial compared the safety and efficacy of oral antibiotics versus intravenous antibiotics in the outpatient treatment of uncomplicated colonic diverticulitis. Inclusion criteria were patients older than 18 years of age with CT proven acute uncomplicated colonic diverticulitis (Modified Hinchey Classification Stage 0-1a). Patients were randomly allocated receive either intravenous or oral antibiotics, both groups being treated in the outpatient setting with a Hospital in the Home (HITH) service. The primary outcome was the 30-day unplanned admission rate, secondary outcomes were biochemical markers, time to pain resolution, time to cessation of pain medication, time to return to normal function and time to return to normal bowel function.
RESULTS: In total 118 patients who presented with uncomplicated colonic diverticulitis were recruited into the trial. Fifty-eight participants were treated with IV antibiotics, and 60 were given oral antibiotics. We found there was no significant difference between groups with regards to 30-day unplanned admissions or inflammatory markers. There was also no significant difference with regards to time to pain resolution, cessation of pain medication use, return to normal nutrition, or return to normal bowel function.
CONCLUSIONS: Outpatient management of uncomplicated diverticulitis with oral antibiotics proved equally as safe and efficacious as intravenous antibiotic treatment in this randomized non-inferiority control trial.
METHODS: This single centre, 2-arm, parallel, 1:1, unblinded non-inferiority randomized controlled trial compared the safety and efficacy of oral antibiotics versus intravenous antibiotics in the outpatient treatment of uncomplicated colonic diverticulitis. Inclusion criteria were patients older than 18 years of age with CT proven acute uncomplicated colonic diverticulitis (Modified Hinchey Classification Stage 0-1a). Patients were randomly allocated receive either intravenous or oral antibiotics, both groups being treated in the outpatient setting with a Hospital in the Home (HITH) service. The primary outcome was the 30-day unplanned admission rate, secondary outcomes were biochemical markers, time to pain resolution, time to cessation of pain medication, time to return to normal function and time to return to normal bowel function.
RESULTS: In total 118 patients who presented with uncomplicated colonic diverticulitis were recruited into the trial. Fifty-eight participants were treated with IV antibiotics, and 60 were given oral antibiotics. We found there was no significant difference between groups with regards to 30-day unplanned admissions or inflammatory markers. There was also no significant difference with regards to time to pain resolution, cessation of pain medication use, return to normal nutrition, or return to normal bowel function.
CONCLUSIONS: Outpatient management of uncomplicated diverticulitis with oral antibiotics proved equally as safe and efficacious as intravenous antibiotic treatment in this randomized non-inferiority control trial.
摘要：
背景：结肠憩室病很常见，其发病率随年龄增长而增加，无并发症的憩室炎是最常见的急性表现（1）。这通常会导致住院，给医疗服务带来沉重负担(2)。我们的目的是确定使用静脉或口服抗生素治疗30天非计划入院的无并发症憩室炎的安全性和有效性。C反应蛋白(CRP),白细胞计数(WCC),疼痛解决，停止止痛药，恢复正常营养,恢复正常的肠道功能.
方法：这个单一的中心，双臂，平行,1：1，非盲性非劣效性随机对照试验比较了口服抗生素与静脉抗生素在非复杂性结肠憩室炎门诊治疗中的安全性和有效性。纳入标准是年龄大于18岁的患者，CT证实为急性非复杂性结肠憩室炎（改良的Hinchey分类0-1a期）。患者被随机分配接受静脉或口服抗生素，两组均在门诊患者中接受居家医院（HITH）服务。主要结果是30天计划外入院率，次要结果是生化标志物，解决疼痛的时间，停止止痛药的时间，恢复正常功能的时间和恢复正常肠道功能的时间。
结果：共有118名表现为无并发症结肠憩室炎的患者被纳入试验。58名参与者接受了静脉抗生素治疗，60例口服抗生素。我们发现，在30天计划外入院或炎症标志物方面，组间没有显着差异。关于疼痛缓解的时间也没有显着差异，停止使用止痛药，恢复正常营养,或者恢复正常的肠道功能.
结论：在这项随机非劣效性对照试验中，门诊用口服抗生素治疗无并发症憩室炎与静脉用抗生素治疗一样安全有效。
方法：这个单一的中心，双臂，平行,1：1，非盲性非劣效性随机对照试验比较了口服抗生素与静脉抗生素在非复杂性结肠憩室炎门诊治疗中的安全性和有效性。纳入标准是年龄大于18岁的患者，CT证实为急性非复杂性结肠憩室炎（改良的Hinchey分类0-1a期）。患者被随机分配接受静脉或口服抗生素，两组均在门诊患者中接受居家医院（HITH）服务。主要结果是30天计划外入院率，次要结果是生化标志物，解决疼痛的时间，停止止痛药的时间，恢复正常功能的时间和恢复正常肠道功能的时间。
结果：共有118名表现为无并发症结肠憩室炎的患者被纳入试验。58名参与者接受了静脉抗生素治疗，60例口服抗生素。我们发现，在30天计划外入院或炎症标志物方面，组间没有显着差异。关于疼痛缓解的时间也没有显着差异，停止使用止痛药，恢复正常营养,或者恢复正常的肠道功能.
结论：在这项随机非劣效性对照试验中，门诊用口服抗生素治疗无并发症憩室炎与静脉用抗生素治疗一样安全有效。
