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2013+ACP+阻塞性睡眠呼吸障碍指南 Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians Amir Qaseem, MD, PhD, MHA; Jon-Erik C. Holty, MD, MS; Douglas K. Owens, MD, MS; Paul Dallas, MD; Melissa Starkey, PhD; and Paul Shekelle, MD...

2013+ACP+阻塞性睡眠呼吸障碍指南
Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians Amir Qaseem, MD, PhD, MHA; Jon-Erik C. Holty, MD, MS; Douglas K. Owens, MD, MS; Paul Dallas, MD; Melissa Starkey, PhD; and Paul Shekelle, MD, PhD, for the Clinical Guidelines Committee of the American College of Physicians* Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recom- mendations on the management of obstructive sleep apnea (OSA) in adults. Methods: This guideline is based on published literature from 1966 to September 2010 that was identified by using MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. A supplemental MEDLINE search identified additional articles through October 2012. Searches were limited to English-language publications. The clinical outcomes eval- uated for this guideline included cardiovascular disease (such as heart failure, hypertension, stroke, and myocardial infarction), type 2 diabetes, death, sleep study measures (such as the Apnea– Hypopnea Index), measures of cardiovascular status (such as blood pressure), measures of diabetes status (such as hemoglobin A1c levels), and quality of life. This guideline grades the evidence and recommendations using ACP’s clinical practice guidelines grading system. Recommendation 1: ACP recommends that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight. (Grade: strong recommendation; low-quality evidence) Recommendation 2: ACP recommends continuous positive airway pressure treatment as initial therapy for patients diagnosed with OSA. (Grade: strong recommendation; moderate-quality evidence) Recommendation 3: ACP recommends mandibular advancement devices as an alternative therapy to continuous positive airway pressure treatment for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with continuous positive airway pressure treatment. (Grade: weak recommendation; low-quality evidence) For author affiliations, see end of text. This article was published at www.annals.org on 24 September 2013. Obstructive sleep apnea (OSA) is a common disorderthat affects persons in all age groups, especially middle-aged and elderly persons (Table 1). Evidence shows that OSA rates are increasing, and this is probably because of escalating obesity rates (1). The goal of OSA treatment is to alleviate airway obstruction during sleep. The stan- dard first-line OSA treatment involves continuous positive airway pressure (CPAP) devices, which deliver compressed air into the airway to keep it open. Many patients do not tolerate CPAP and often do not adhere to the instructions for many reasons, including discomfort, skin irritation, noise, and claustrophobia (2–4). To improve adherence, many technological modifications have been made to CPAP devices (mostly in alterations of when air pressure is delivered), although the utility of the modified devices is unknown. Because adherence is often an issue in OSA treatment, additional patient education or interventions may be warranted. Dental or mandibular advancement de- vices (MADs) that are worn while the patient is sleeping have been used to treat OSA. Alternative therapeutic strat- egies include surgical interventions to remove obstructive tissue, positional therapy, pharmacologic treatment, and weight-loss interventions for obese patients. All interventions have the potential for adverse effects, and the purpose of this American College of Physicians (ACP) guideline is to present information on both the benefits and harms of interventions to assess the net bene- fits of available treatments. The target audience for this guideline includes all clinicians, and the target patient pop- ulation comprises all adults with OSA. METHODS This guideline is based on a systematic evidence review sponsored by the Agency for Healthcare Research and * This paper, written by Amir Qaseem, MD, PhD, MHA; Jon-Erik C. Holty, MD, MS; Douglas K. Owens, MD, MS; Paul Dallas, MD; Melissa Starkey, PhD; and Paul Shekelle, MD, PhD, was developed for the Clinical Guidelines Committee of the American College of Physicians. Individuals who served on the Clinical Guidelines Committee from initiation of the project until its approval were Paul Shekelle, MD, PhD (Chair); Roger Chou, MD; Molly Cooke, MD; Paul Dallas, MD; Thomas D. Denberg, MD, PhD; Nick Fitterman, MD; Mary Ann Forciea, MD; Robert H. Hopkins Jr., MD; Linda L. Humphrey, MD, MPH; Tanveer P. Mir, MD; Douglas K. Owens, MD, MS; Holger J. Schu¨nemann, MD, PhD; Donna E. Sweet, MD; David S. Weinberg, MD, MSc; and Timothy Wilt, MD, MPH. Approved by the ACP Board of Regents on 17 November 2012. See also: Web-Only CME quiz Clinical Guideline © 2013 American College of Physicians This online-first version will be replaced with a final version when it is included in an issue. The final version may differ in small ways. Ann Intern Med. 2013;159. www.annals.org Downloaded From: http://annals.org/ on 09/24/2013 www.medlive.cn Quality (AHRQ) (5) that addressed the following key questions related to OSA management: 1. What is the comparative effect of different treat- ments for OSA in adults? a. Does the comparative effectiveness of treatments vary based on presenting patient characteristics, OSA se- verity, or other pretreatment factors? Are any of these char- acteristics or factors predictive of treatment success? i. Characteristics: Age, sex, race, weight, bed partner, airway, other physical characteristics, and specific comor- bid conditions. ii. Obstructive sleep apnea severity or characteristics: Baseline questionnaire (and similar tools) results, formal testing results (including hypoxemia levels), baseline qual- ity of life, positional dependency. iii. Other: Specific symptoms. 2. In patients with OSA who are prescribed nonsurgi- cal treatments, what are the associations of pretreatment, patient-level characteristics with treatment adherence? 3. What is the effect of interventions to improve ad- herence to device use (positive airway pressure, oral appli- ances, and positional therapy) on clinical and intermediate outcomes? The Tufts Evidence-based Practice Center conducted the systematic evidence review. The literature search in- cluded studies identified using MEDLINE (1966 to Sep- tember 2010), the Cochrane Central Register of Con- trolled Trials, and the Cochrane Database of Systematic Reviews and included peer-reviewed studies on adult hu- man patients published in English (6). Further details about the methods and inclusion and exclusion criteria applied in the evidence review are available in the full AHRQ report (5). No randomized, controlled trial (RCT) on OSA treatment with regard to mortality outcomes was identified. The ACP supplemented the AHRQ review (MEDLINE search, 1946 to October 2012) to identify English-language observational studies in humans report- ing death or cardiovascular or cerebrovascular illness asso- ciated with OSA treatment strategies (that is, CPAP, sur- gery, or MADs), as well as more recent relevant RCTs. To guide our recommendations, we prioritized outcomes on the basis of clinical importance, starting with death and including cardiovascular outcomes. In the absence of sta- tistically significant effects on clinical outcomes, we con- sidered symptoms (such as Epworth Sleepiness Scale [ESS] scores) and other physiologic measures (such as the Apnea– Hypopnea Index [AHI]). This guideline rates the evidence and recommendations using ACP’s grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system (Table 2). Details of ACP’s guideline development process can be found in the methods paper (7). COMPARATIVE EFFECTIVENESS OF OSA TREATMENTS Evidence on the comparative effectiveness of OSA treatments is summarized in the Appendix Table (available at www.annals.org). CPAP for OSA Treatment Although moderate-quality evidence showed that CPAP improves sleep measures compared with control or sham devices in patients with at least moderate OSA (AHI score �15 events/h), there was little or no evidence on the effects of CPAP on other important clinical outcomes. CPAP Versus Control Treatment Twenty-two studies (reported in 23 articles) compared CPAP with control treatment, including patients with mean baseline AHI scores between 10 and 65 events per hour. These studies apply to many patients with OSA, and follow-up ranged from 1 to 24 months. Moderate-quality evidence showed that CPAP reduced AHI scores, im- proved ESS scores, reduced arousal index scores, and raised the minimum oxygen saturation compared with control Table 1. Terms and Definitions Related to OSA Term Definition Apnea Complete airflow cessation during sleep Hypopnea Reduced airflow during sleep AHI A measure of the number of apnea and hypopnea episodes per hour of monitored sleep. According to the American Academy of Sleep Medicine, an OSA diagnosis is defined by �15 events/h (with or without OSA symptoms) or �5 events/h with OSA symptoms. Severity of OSA classified according to AHI is defined as mild if 5–14 events/h, moderate if 15–30 events/h, and severe if �30 events/h. ESS A self-administered questionnaire in which patients rate their chances of dozing in various situations. Arousal index The frequency of arousals per hour of sleep, measured by electroencephalography. AHI � Apnea–Hypopnea Index; ESS � Epworth Sleepiness Scale; OSA � ob- structive sleep apnea. Table 2. The American College of Physicians’ Guideline Grading System* Quality of Evidence Strength of Recommendation Benefits Clearly Outweigh Risks and Burden or Risks and Burden Clearly Outweigh Benefits Benefits Finely Balanced With Risks and Burden High Strong Weak Moderate Strong Weak Low Strong Weak Insufficient evidence to determine net benefits or risks * Adopted from the classification developed by the GRADE (Grading of Recom- mendations Assessment, Development, and Evaluation) workgroup. Clinical Guideline Clinical Practice Guideline on Management of OSA in Adults This online-first version will be replaced with a final version when it is included in an issue. The final version may differ in small ways. Annals of Internal Medicine www.annals.org Downloaded From: http://annals.org/ on 09/24/2013 www.medlive.cn treatment (Appendix Table). Ten studies assessed the ef- fect of CPAP on quality of life; however, they could not be compared because of the use of various quality-of-life sub- scales (8–17). Most studies found no statistically signifi- cant improvement with CPAP; however, some showed im- provement in physical and vitality scales of the Short Form-36 Health Survey. Eight studies (9–11, 13, 15–18) evaluated neurocognitive and psychological test results, and most showed no improvement. None of the 7 studies (9, 10, 19–23) that addressed blood pressure differences or the 1 study (20) that assessed hemoglobin A1c level differences found any statistically significant differences between CPAP and control treatment. A recent RCT in patients with OSA who did not have daytime sleepiness (24) showed no statistically significant difference in the inci- dence of hypertension or cardiovascular events for patients treated with CPAP compared with control treatment (in- cidence density ratio, 0.83 [95% CI, 0.63 to 1.1]; P � 0.20). Another RCT treated patients with acute stroke and OSA (AHI scores�10 events/h) with either CPAP or stan- dard of care (25). Authors reported a statistically significant improvement in National Institutes of Health Stroke Scale scores at day 8 between patients randomly assigned to CPAP who were excellent users (CPAP device use�4 h for the first night and mean use �4 h/night for the first 3 nights; National Institutes of Health Stroke Scale score of 2.3 in 10 excellent CPAP users out of 25 total CPAP users) compared with those randomly assigned to standard of care (National Institutes of Health Stroke Scale score of 1.4 in 25 patients) (P � 0.022). Only 1 study examined a clinical outcome and found no statistically significant improve- ment of heart failure symptoms with CPAP compared with no specific treatment (8). The literature review identified no RCTs evaluating the effect of CPAP on mortality rates. The ACP’s supple- mental search also identified no long-term RCT of CPAP in the general OSA population but did identify 1 recent trial that randomly assigned patients with OSA who previ- ously had a stroke to CPAP treatment versus conservative therapy; however, no statistically significant improvement in cardiovascular mortality rates was reported at 24 months (0% vs. 4.3%; P � 0.161) (26). Five out of 8 identified observational studies of CPAP in general OSA populations reported statistically significant reductions in overall mor- tality rates associated with CPAP (or CPAP adherence) compared with no CPAP (or CPAP nonadherence) (27– 35). Four out of 6 observational studies reported statisti- cally significant reductions in cardiovascular mortality rates associated with CPAP (or CPAP adherence) (27, 29, 31, 32, 36, 37). Eight observational studies reported multivar- iate mortality analyses (overall or cardiovascular-specific death), and 7 of them reported statistically significant re- ductions in mortality rates associated with CPAP therapy (27, 30–32, 36–39). CPAP Versus Sham CPAP Twenty-four trials (reported in 30 articles) compared CPAP devices with sham CPAP treatment and included patients with mean baseline AHI scores between 22 and 68 events per hour. Follow-up ranged from 1 week to 3 months. These studies apply to many patients with OSA and included both fixed CPAP devices and autotitrating CPAP (auto-CPAP) devices, which involve a modification in which the machine increases positive pressure in re- sponse to airflow resistance. Moderate-quality evidence showed that CPAP was more effective than sham CPAP and reduced AHI scores, improved ESS scores, and re- duced arousal index scores compared with sham CPAP (Appendix Table). One study (40) found better quality-of- life scores for auto-CPAP than for sham CPAP, although 5 other studies showed no benefit (41–45). No significant differences were found between CPAP and sham CPAP for oxygen saturation, sleep efficiency, Multiple Sleep Latency Test results, or sleep quality assessed by the Functional Outcomes of Sleep Questionnaire (5). Data on blood pres- sure were inconsistent across the 12 trials that assessed it (46–57), and no study compared CPAP with sham CPAP in regard to death or cardiovascular illness. Oral CPAP Versus Nasal CPAP Evidence from 3 small trials (46–48) to determine the comparative efficacy of oral CPAP versus nasal CPAP was insufficient. The trials reported inconsistent results, and effect estimates were generally imprecise, mostly because of the small sample sizes. Auto-CPAP Versus Fixed CPAP Twenty-one RCTs (58–78) compared auto-CPAP with fixed CPAP in patients with mean AHI scores be- tween 15 and 55 events per hour and included many obese and overweight patients. These studies are mostly applica- ble to patients with AHI scores greater than 15 events per hour and body mass indices (BMIs) greater than 30 kg/m2. Follow-up ranged from 3 weeks to 9 months. Despite some miniscule differences in ESS (0.5 point), minimum oxygen saturation (1%), and adherence (11 minutes), these differences are probably not clinically significant. Overall, moderate-quality evidence showed that auto-CPAP and fixed CPAP have similar adherence and treatment effects for patients with OSA (Appendix Table). The authors of the original evidence review published an updated review that included 3 additional studies and reported similar findings, concluding that the 2 treatments are similarly effective (79). Bilevel CPAP Versus Fixed CPAP Bilevel CPAP devices are designed to alleviate the dif- ficulty and discomfort of exhaling against the fixed pressure of CPAP by delivering lower pressure during exhalation rather than during inhalation. Evidence from 5 trials (80, Clinical GuidelineClinical Practice Guideline on Management of OSA in Adults www.annals.org Annals of Internal Medicine This online-first version will be replaced with a final version when it is included in an issue. The final version may differ in small ways. Downloaded From: http://annals.org/ on 09/24/2013 www.medlive.cn 81) to determine the comparative efficacy of bilevel CPAP versus fixed CPAP was insufficient. The studies were small and highly clinically heterogeneous, and most had impre- cise treatment effect estimates and showed null findings. No study showed a difference in adherence between the devices. Flexible Bilevel CPAP Versus Fixed CPAP Flexible bilevel CPAP delivers reduced positive airway pressure at the end of inspiration and beginning of expira- tion, which is determined partly by the user’s respiration. This differs from the fixed positive airway pressure deliv- ered by CPAP and was designed to improve comfort. Ev- idence from 1 moderate-quality study (52) to determine the comparative efficacy of flexible bilevel CPAP versus fixed CPAP was insufficient. C-Flex Versus Fixed CPAP C-Flex (Philips Healthcare, Andover, Massachusetts) CPAP is a proprietary technology that slightly reduces the pressure at the beginning of exhalation. Four trials (53, 54, 82, 83) compared fixed CPAP with C-Flex CPAP in pa- tients with mean baseline AHI scores between 35.4 and 53.3 events per hour. Follow-up ranged from 1.5 to 6 months. Low-quality evidence showed that C-Flex CPAP and fixed CPAP are similarly tolerated and efficacious for OSA treatment (Appendix Table). CPAP With or Without Humidification Evidence from 5 studies (55, 84–87) to determine the benefit of CPAP with or without humidification was insuf- ficient. The studies were low- to moderate-quality, small, and clinically heterogeneous and reported inconsistent re- sults. Although 2 trials reported improved adherence to humidification, the other 3 trials reported no significant difference. MADs for OSA Treatment MADs Versus No Treatment Five trials (11, 12, 56, 88, 89) compared several MADs with no treatment in patients with mean baseline AHI scores between 19 and 34 events per hour. These studies generally apply to patients with AHI scores of 15 events or greater per hour, although patients with comor- bid conditions or excessive sleepiness were excluded from some trials. Follow-up ranged from 4 to 23 weeks. Moderate-quality evidence showed that MAD use im- proved the signs and symptoms of sleep apnea, including AHI score, arousal index score, and minimum oxygen sat- uration (Appendix Table) compared with no treatment. No clear survival benefits or reductions in cardiovascular illness were associated with MADs. MADs Versus Inactive Oral Devices Five studies (reported in 7 publications) (56, 57, 90– 94) compared MADs with inactive (sham) oral devices in patients with mean baseline AHI scores between 25 and 36 events per hour and excluded patients with significant co- morbid conditions or periodontal disease. Follow-up ranged from 8 days to 6 weeks. Moderate-quality evidence showed that MAD use improves the signs and symptoms of sleep apnea (including AHI, ESS, and arousal index scores and minimum oxygen saturation) compared with inactive (sham) oral devices (Appendix Table). One study each showed improvements in quality of life and neurocog- nitive test results (56, 57, 90). MADs Versus CPAP Ten studies (reported in 11 articles) (11, 12, 95–103) compared the efficacy of CPAP with MADs in patients with mean baseline AHI scores between 18 and 40 events per hour. Follow-up ranged from 1 to 10 months. Moderate-quality evidence showe
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