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Health related quality of life aspects not captured by EQ-5D-5L: Results from an international survey of patients.健康相关生活质量方面未被 EQ-5D-5L 所捕获:来自一项国际患者调查的结果。
Health Policy. 2019 Feb;123(2):159-165. doi: 10.1016/j.healthpol.2018.12.003. Epub 2018 Dec 14.
2
Optimising the antibiotic treatment of uncomplicated acute appendicitis: a protocol for a multicentre randomised clinical trial (APPAC II trial).优化单纯性急性阑尾炎的抗生素治疗:一项多中心随机临床试验方案(APPAC II试验)。
BMC Surg. 2018 Dec 17;18(1):117. doi: 10.1186/s12893-018-0451-y.
3
Methods of conservative antibiotic treatment of acute uncomplicated appendicitis: A systematic review.急性单纯性阑尾炎的保守抗生素治疗方法:系统评价。
J Trauma Acute Care Surg. 2019 Apr;86(4):722-736. doi: 10.1097/TA.0000000000002137.
4
Laparoscopic versus open surgery for suspected appendicitis.腹腔镜手术与开放手术治疗疑似阑尾炎
Cochrane Database Syst Rev. 2018 Nov 28;11(11):CD001546. doi: 10.1002/14651858.CD001546.pub4.
5
A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol.一项比较抗生素治疗与安慰剂治疗单纯性急性阑尾炎的随机、安慰剂对照、双盲多中心试验:APPAC III试验研究方案。
BMJ Open. 2018 Nov 3;8(11):e023623. doi: 10.1136/bmjopen-2018-023623.
6
The efficacy of antibiotic treatment versus surgical treatment of uncomplicated acute appendicitis: Systematic review and network meta-analysis of randomized controlled trial.抗生素治疗与手术治疗单纯性急性阑尾炎的疗效比较:系统评价和随机对照试验的网络荟萃分析。
Am J Surg. 2019 Jul;218(1):192-200. doi: 10.1016/j.amjsurg.2018.10.009. Epub 2018 Oct 9.
7
Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial.APPAC 随机临床试验中单纯性急性阑尾炎抗生素治疗的 5 年随访。
JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201.
8
Antibiotic Treatment for Uncomplicated Appendicitis Really Works: Results From 5 Years of Observation in the APPAC Trial.非复杂性阑尾炎的抗生素治疗确实有效:APPAC试验5年观察结果
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Non-operative treatment of appendicitis: public perception and decision-making.阑尾炎的非手术治疗:公众认知与决策
Ir J Med Sci. 2018 Nov;187(4):1029-1038. doi: 10.1007/s11845-018-1758-5. Epub 2018 Feb 8.
10
Patient Preferences for Surgery or Antibiotics for the Treatment of Acute Appendicitis.患者对急性阑尾炎手术治疗或抗生素治疗的偏好。
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抗生素治疗与阑尾切除术治疗单纯性急性阑尾炎 7 年随访的生活质量和患者满意度:一项随机临床试验的二次分析。

Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial.

机构信息

Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.

Department of Surgery, University of Turku, Turku, Finland.

出版信息

JAMA Surg. 2020 Apr 1;155(4):283-289. doi: 10.1001/jamasurg.2019.6028.

DOI:10.1001/jamasurg.2019.6028
PMID:32074268
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7042917/
Abstract

IMPORTANCE

Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known.

OBJECTIVE

To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis.

INTERVENTIONS

Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day.

DESIGN, SETTING, AND PARTICIPANTS: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019.

MAIN OUTCOMES AND MEASURES

In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated.

RESULTS

Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment.

CONCLUSIONS AND RELEVANCE

In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy.

TRIAL REGISTRATION

Clinicaltrials.gov Identifier: NCT01022567.

摘要

背景:长期结果支持将抗生素治疗用于单纯性急性阑尾炎,作为阑尾切除术的替代方法。据我们所知,治疗相关的长期患者满意度和生活质量(QOL)尚不清楚。

目的:确定抗生素治疗和阑尾切除术治疗单纯性急性阑尾炎后患者的满意度和 QOL。

干预措施:开腹阑尾切除术与静脉注射厄他培南(1 g 每日 1 次)、3 天,随后口服左氧氟沙星(500 mg 每日 1 次)和甲硝唑(500 mg 每日 3 次)7 天进行对比。

设计、地点和参与者:这是一项对 APPAC 多中心随机临床试验的观察性随访,该试验比较了阑尾切除术和抗生素治疗,共纳入 530 名年龄在 18 至 60 岁之间、经计算机断层扫描证实为单纯性急性阑尾炎的患者,随机分为阑尾切除术组(273 例[52%])或接受抗生素治疗组(257 例[49%])。试验于 2009 年 11 月至 2012 年 6 月进行,最后一次随访是在 2018 年 5 月 9 日。数据分析于 2019 年 2 月进行。

主要结果和措施:在本次分析中,作为次要的治疗后终点,评估了干预后 QOL(EQ-5D-5L)和患者满意度和治疗偏好。

结果:在该试验中,530 名入组患者(阑尾切除术组:273 名[174 名男性(64%)],中位年龄 35 岁;抗生素组:257 名[155 名男性(60%)],中位年龄 33 岁)中,423 名(80%)在中位随访 7 年后可通过电话进行访谈;206 名(80%)接受了抗生素治疗,217 名(79%)接受了阑尾切除术。在接受抗生素治疗的 206 名患者中,81 名(39%)接受了阑尾切除术。阑尾切除术组和抗生素组患者的 QOL 相似(中位健康指数值,两组均为 1.0;95%CI,0.86-1.0;P=0.96)。与接受抗生素治疗的患者相比,接受阑尾切除术的患者在治疗中更满意(阑尾切除术组 68%非常满意,21%满意,6%无所谓,4%不满意,1%非常不满意;抗生素组 53%非常满意,21%满意,13%无所谓,7%不满意,6%非常不满意;P<0.001),并且在亚组分析中,这种差异基于抗生素组中接受阑尾切除术的患者。与阑尾切除术相比,成功接受抗生素治疗的患者满意度无差异(累积优势比[COR],7.8;95%CI,0.5-1.3;P<0.36)。与接受抗生素治疗的患者相比,接受阑尾切除术或成功接受抗生素治疗的患者更满意(COR,7.7;95%CI,4.6-12.9;P<0.001;COR,9.7;95%CI,5.4-15.3;P<0.001)。在接受抗生素治疗并随后接受阑尾切除术的 81 名患者中,有 27 名(33%)会再次选择抗生素作为主要治疗方法。

结论和相关性:在本分析中,单纯性急性阑尾炎采用阑尾切除术和抗生素治疗的长期 QOL 相似。接受抗生素治疗后又接受阑尾切除术的患者比成功接受抗生素治疗或阑尾切除术的患者满意度更低。

试验注册:Clinicaltrials.gov 标识符:NCT01022567。