闌尾炎一定要用手術治療嗎?


  【24drs.com】根據一篇新研究,以電腦斷層(CT)證實,無併發症的闌尾炎,使用抗生素治療和闌尾切除術一樣有效。在一年的追蹤期間,隨機分組接受抗生素治療的大多數患者並不需要闌尾切除術,而那些接受闌尾切除術者也沒有顯著併發症。儘管如此,當以非劣性試驗比較這兩種治療時,研究者發現,抗生素治療並沒有達到預先設定的非劣性標準。
  
  芬蘭Turku大學醫院Paulina Salminen博士等人在6月16日的JAMA期刊發表了「Appendicitis Acuta (APPAC)」多中心試驗的結果。
  
  研究者隨機指派病患到手術組接受闌尾切除術或者到抗生素組接受廣效抗生素(ertapenem、levofloxin和metronidazole)治療,研究者指出,許多病患選擇接受手術,研究者難以招募有意願被指定到抗生素組的病患,接受闌尾切除術者中,15人(5.5%)接受的是腹腔鏡闌尾切除術。
  
  作者們寫道,就我們所知,APPAC試驗是迄今有關抗生素治療闌尾炎的最大型多中心、開放標籤、非劣性[隨機控制試驗]。進行研究設計時,我們假設避免手術會有充分的好處,抗生素組的可接受失敗率為24%。然而,我們發現失敗率是27.3% (95%信賴區間為22.0%-33.2%)而無法建立抗生素治療闌尾炎的非劣性論述。
  
  研究者也發現,72.7%(95%信賴區間為66.8% - 78.0%)的病患是無併發症的急性闌尾炎,只接受抗生素治療後即恢復。隨機指派到抗生素組的8名病患被誤認為是有併發症的闌尾炎而進行了不必要的闌尾切除術,這8個病患的資料可能會干擾了這篇研究結果。
  
  抗生素組病患的平均住院天數比手術組患者長,不過,研究者指出,抗生素組患者的最短住院天數是由治療規範指定,未來可能可以縮短。
  
  以前的試驗曾經提出抗生素治療在闌尾炎治療中的角色,不過,這些試驗的信賴度受限於僅有急性闌尾炎診斷、抗生素治療時間、主要終點的確認不佳,也因此,之前這些試驗的結果各異就不意外了。
  
  闌尾炎可能是沒有併發症與急性的,也可能併發穿孔、腹內膿瘍和/或糞石。例如,之前一篇研究發現,糞石患者比較可能發生有併發症的急性闌尾炎,而無法使用抗生素治療。
  
  目前這篇研究試圖避免這個問題,所以只納入由電腦斷層確認診斷為無併發症急性闌尾炎的患者,例如,他們排除了糞石患者。
  
  電腦影像讓篩選病患成為可行的,作者們解釋電腦斷層的好處指出,我們研究的另一個特點是,藉由電腦斷層而使陰性闌尾切除術比率降低,使用電腦斷層也使我們可以辨識無併發症的急性闌尾炎,我們在這篇研究中成功地以抗生素治療了大部分患者。
  
  目前這篇研究的另一個強度是研究者選用的抗生素,他們在文章中強調,成功地以抗生素治療闌尾炎需要選擇廣效性抗生素,以治療引起闌尾炎的許多病原菌。
  
  作者們建議,電腦斷層證實無併發症之急性闌尾炎患者,應告知患者,使其有機會在抗生素治療與闌尾切除術之間有所選擇。
  
  伊利諾州芝加哥西北大學Feinberg醫學院的Edward Livingston醫師、馬里蘭州巴爾的摩約翰霍普金斯醫學院的Corrine Vons博士同意,並執筆編輯評論指出,無併發症闌尾炎患者放棄進行闌尾切除術的時機已來臨,這個手術已經用於患者超過100年,隨著像電腦斷層這種精密診斷工具的發展以及有效的廣效抗生素治療,目前用於多數急性闌尾炎病例的闌尾切除術,對於無併發症的闌尾炎就是不必要的了。
  
  不過,德州休士頓貝勒醫學院外科醫師、未參與本篇研究的Monica E. Lopez醫師仍未被說服,整體而言,她不認為這篇研究的結果會改變實務。
  
  資料來源:http://www.24drs.com/
  
  Native link:Does Appendicitis Have to Be Treated With Surgery?

Does Appendicitis Have to Be Treated With Surgery?

By Lara C. Pullen, PhD
Medscape Medical News

Antibiotic treatment of patients with computed tomography (CT)-proven, uncomplicated appendicitis may be as effective as appendectomy, according to a new study. The majority of patients randomly assigned to receive antibiotic treatment did not require an appendectomy during 1 year of follow-up, and those who did receive an appendectomy did not have significant complications. Despite this, when the two treatments were compared in a noninferiority trial, the investigators found that antibiotic treatment did not meet the prespecified criterion for noninferiority.

Paulina Salminen, MD, PhD, from the Turku University Hospital in Finland, and colleagues published the results of the Appendicitis Acuta (APPAC) multicenter trial in the June 16 issue of JAMA.

The researchers randomly assigned patients to either a surgery group to receive an appendectomy performed using the standard open technique or to an antibiotic group to receive broad-spectrum antibiotics (ertapenem, levofloxin, and metronidazole). The investigators note that many patients elected to receive surgery, and the investigators had difficulty recruiting patients willing to be assigned to the antibiotic group. Of those who underwent appendectomy, 15 (5.5%) patients underwent laparoscopic appendectomy.

"To our knowledge, the APPAC trial is the largest multicenter, open-label, noninferiority [randomized controlled trial] of antibiotic treatment for appendicitis conducted to date. When the trial was designed, we assumed that there would be sufficient benefits from avoiding surgery and that a 24% failure rate in the antibiotic group would be acceptable. Instead, we found a failure rate of 27.3% (95% confidence interval, 22.0%-33.2%) and were not able to establish the noninferiority of antibiotic treatment for appendicitis," the authors write.

The investigators did find that 72.7% (95% confidence interval, 66.8% - 78.0%) of patients with uncomplicated acute appendicitis recovered after receiving only antibiotic therapy. Eight patients randomly assigned to the antibiotic group were mistakenly identified as having complicated appendicitis and received an appendectomy that may not have been required. These eight patients may have confounded the results of the study.

Patients in the antibiotic group had a longer median length of hospital stay than patients in the surgery group. The investigators note, however, that the minimal length of hospital stay for patients in the antibiotic group was specified in the treatment protocol and could likely be shortened in the future.

Previous trials have addressed the role of antibiotic therapy as a treatment for appendicitis. These trials were limited, however, by their reliance on clinical diagnosis of acute appendicitis, duration of antibiotic treatment, and poor determination of the primary endpoint. Not surprisingly, the results from these previous trials have been mixed.

Appendicitis may present as uncomplicated and acute, or it may be complicated by a perforation, intraabdominal abscess, and/or appendicoliths. A previous study, for example, found that patients with appendicoliths were more likely to have complicated acute appendicitis and to fail antibiotic treatment.

The current study attempted to avoid this problem by enrolling only patients with a CT-confirmed diagnosis of uncomplicated acute appendicitis. They excluded, for example, patients with appendicoliths.

CT imaging made such patient selection feasible. The authors explained the benefits of CT imaging: "Another feature of our study was the low negative appendectomy rate attributable to CT imaging. Use of CT also enabled us to identify uncomplicated acute appendicitis that was successfully treated with antibiotics alone in the majority of patients enrolled in our study," the authors write.

Another strength of the current study was the investigators' choice of antibiotics. They emphasized in their article that successful antibiotic treatment of appendicitis requires the selection of an antibiotic that provides broad-spectrum coverage of the many pathogens that might cause appendicitis.

The authors suggest that patients diagnosed with CT-proven uncomplicated acute appendicitis be given the opportunity to make an informed decision between antibiotic treatment and appendectomy.

Edward Livingston, MD, from Northwestern University Feinberg School of Medicine in Chicago, Illinois, and Corrine Vons, MD, PhD, from Johns Hopkins School of Medicine in Baltimore, Maryland, agree and penned an accompanying editorial to that effect. They write that, "[t]he time has come to consider abandoning routine appendectomy for patients with uncomplicated appendicitis. The operation served patients well for more than 100 years. With development of more precise diagnostic capabilities like CT and effective broad-spectrum antibiotics, appendectomy may be unnecessary for uncomplicated appendicitis, which now occurs in the majority of acute appendicitis cases."

Monica E. Lopez, MD, a surgeon at Baylor College of Medicine in Houston, Texas, who was not involved in the study, remains, however, unconvinced: "Overall, I don't think the findings of the study warrant a change in practice," she explained in an email to Medscape Medical News.

Dr Salminen reported receiving personal fees for lectures from Merck and Roche. The other authors, the editorialists, and Dr Lopez have disclosed no relevant financial relationships.

JAMA. 2015;313:2340-2348.

    
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2016/10/24 下午 05:46:10
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