隨機控制試驗:非複雜性憩室炎可不使用抗生素


  【24drs.com】根據一篇隨機控制試驗(RCT)結果,對於首次發生非複雜性憩室炎的患者,抗生素並不會改善結果;作者們結論指出,Hinchey第1a期的憩室炎患者可以先單純觀察就好。
  
  在6個月的追蹤期間,該研究的初級終點、達到恢復的時間中位數方面,觀察治療組是14天(四分位範圍,6 – 35天),接受抗生素治療組是12天(四分位範圍,7 – 30天)。相較於抗生素治療,觀察方法與完全恢復的風險比值為0.91有關(單邊95%信賴區間的下限為:0.78; P = .151)。
  
  研究者寫道,不用抗生素治療是有爭議的,因為即使有兩篇觀察型研究與一篇隨機控制試驗指出抗生素沒有效益,指引並未修改。之前的隨機控制試驗評估了623名患者,但是研究方法設計有一些缺點,因而無法改變臨床實務。
  
  荷蘭阿姆斯特丹大學學術醫學中心外科Lidewine Daniels醫師與荷蘭憩室炎疾病協同研究組的研究團隊,在9月30日的英國外科期刊線上發表他們的結果。
  
  目前這篇試驗標題為「Diverticulitis: Antibiotics or Close Observation(簡稱為DIABOLO)」,是一篇多中心、開放標籤、務實的、兩種治療策略的隨機控制試驗,這篇研究包括了528名第一次發作左側非複雜性(修改版Hinchey分期1a-b且Ambrosetti's憩室炎分期「輕度」)急性憩室炎之患者。
  
  其中266名患者根據荷蘭抗生素策略委員會與美國結腸與直腸外科協會的建議給予抗生素,這些患者接受10天的amoxicillin-clavulanic acid,起始劑量是每天靜脈注射4次1200 mg、至少48小時,之後,如果耐受良好,可以換成每天口服3次625 mg;過敏的患者可以換成併用ciprofloxacin和metronidazole。抗生素組的所有患者都需住院,以接受靜脈注射抗生素。
  
  觀察組中,符合下列規範的262名患者於門診接受治療:可耐受正常飲食、體溫低於38°、視覺評估量表的疼痛分數低於4分,沒有使用比paracetamol更強的止痛藥、可以如同生病前一樣程度的自我支持,最後,是患者的接受度。
  
  這些患者在2個月與6個月時回門診,之後在12個月與24個月時以電話追蹤。
  
  觀察組最初住院期間中位數,比靜脈注射抗生素組短(2天 vs 3天;P = .006)。
  
  在6個月追蹤期間,其他次級結果在這兩組之間並無差異。觀察組的複雜性憩室炎比率為3.8%,抗生素組是2.6%(P = .377)。發生持續性憩室炎的人數在觀察組有19名患者(7.3%),抗生素組則是有11人(4.1%) 。
  
  在經歷復發憩室炎的患者比率這方面,觀察組與抗生素組差不多(3.4% vs 3.0%;P = .494)。
  
  乙狀結腸切除率相似(3.8% vs 2.3%;P = .323),不論是緊急切除(0.8% vs 1.1%;P = .553)或選擇性切除(3.1% vs 1.1%;P = .254),乙狀結腸切除的最常見原因是結腸阻塞(觀察組的10名患者有3名如此、抗生素組的6名患者有2人如此)與穿孔(觀察組的10名患者有2名如此、抗生素組的6名患者有2人如此)。
  
  在發生輕微(P = .086)或嚴重(P = .354)不良反應的發生率上,並無顯著差異,不過,抗生素組比較常發生抗生素相關的不良反應(觀察組:0.4%,抗生素組:8.3%;P = .006),所有的抗生素相關不良反應都是輕微的,只有1例除外;兩組的死亡率也沒有差異(1.1% vs 0.4%;P = .432)。
  
  研究者提醒,需等進行更大型的研究之後,Hinchey 1a期的憩室炎患者才能停用抗生素。
  
  作者們解釋,沒有關於Hinchey 1b期疾病採觀察處置或採抗生素處置的其他報告,對於非複雜性急性憩室炎之治療,省略抗生素僅適用於Hinchey 1a期患者,直到有更大型的Hinchey 1b期患者之研究。他們結論指出,此外,對於有明顯共病症或發炎性腸道疾病的患者,以及那些懷孕或免疫功能不佳的患者,無法根據目前的研究結果判斷。體溫大於39°C、敗血症且/或血液培養陽性的患者,需給予抗生素治療。
  
  資料來源: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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