王繼光（編譯）
上海交通大學(xué)附屬瑞金醫(yī)院、上海高血壓研究所
Norm R.C. Campbell, MD;1 Mark Gelfer, MD;2 George S. Stergiou, MD, FRCP;3 Bruce S. Alpert, MD;4 Martin G. Myers, MD, FRCPC;5 Michael K. Rakotz, MD;6,7 Raj Padwal, MSc, MD;8 Aletta Elisabeth Schutte, PhD;9 Eoin O’Brien, DSc, FRCP;10 Daniel T. Lackland, DrPH;11 Mark L. Niebylski, PhD, MBA, MS;11 Peter M. Nilsson, MD, PhD;11 Kimbree A. Redburn, MA;11 Xin-Hua Zhang, MD, PhD;11 Louise Burrell, MBChB, MRCP, MD, FRACP;12 Masatsugu Horiuchi, MD, PhD, FAHA;12 Neil R. Poulter, MBBS, MSc, FRCP, FMed Sci;12 Dorairaj Prabhakaran, MD, DM, MSc, FRCP, FNASc;12 Agustin J. Ramirez, MD, PhD;12 Ernesto L. Schiffrin, CM, MD, PhD, FRSC, FRCPC, FACP;12 Rhian M. Touyz, MBBCh, PhD, FRCP, FRSE;12 Ji-GuangWang, MD, PhD;12 Michael A.Weber, MD;12
From the Departments of Medicine, Physiology and Pharmacology and Community Health Sciences, O' Brien Institute for Public Health and Libin Cardiovascular Institute of Alberta, University of Calgary,Calgary, AB;1 Department of Family Practice, University of British Columbia, Vancouver, BC, Canada;2 Hypertension Center STRIDE-7, Sotiria Hospital, Third University Department of Medicine, Athens, Greece;3 AAMI Sphygmomanometer Committee, Pediatric Exercise Science, Memphis, TN, USA;4 Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada;5 Improving Health Outcomes at American Medical Association;6 Department of Family and Community Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA;7 Clinical Pharmacology and General Internal Medicine, University of Alberta, Edmonton, AB, Canada;8 MRC Research Unit on Hypertension and Cardiovascular Disease, Hypertension in Africa Research Team, North-West University, Potchefstroom, South Africa;9 Molecular Pharmacology, University College Dublin, Dublin, Ireland;10 World Hypertension League, Corvallis, Montana, USA;11 and International Society of Hypertension, University of Glasgow, Glasgow, UK12
幾乎所有的自動血壓計都采用示波測量技術(shù)[1,2]。使用示波法血壓計測量血壓時，實際測量的是血壓計袖帶所采集的合成脈搏波上最大震蕩值相對應(yīng)的血壓，相當(dāng)于平均動脈壓。然后，采用每個生產(chǎn)商和設(shè)備獨有的計算公式，找到合成脈搏波中相應(yīng)的點，確定收縮壓和舒張壓水平。因此，需要驗證自動的示波法血壓計所測量的血壓與聽診法測量的血壓是否一致。也有一些自動血壓計使用聽診法測量血壓，用麥克風(fēng)評估柯氏音[2]。麥克風(fēng)與人耳相比，所采集的聲波長度和聲音強度都不一樣，因此這種自動血壓計有時會把噪聲當(dāng)做柯氏音。因此，使用麥克風(fēng)評估柯氏音的自動血壓計也同樣需要進行準(zhǔn)確性驗證。
目前，包括國際驗證標(biāo)準(zhǔn)在內(nèi)的多個驗證方案均可用來評價自動血壓計的準(zhǔn)確性，既可用于一般人群，也可用于兒童、妊娠女性、心律失?；颊叩忍厥馊巳?sup>[1,3-7]。驗證時需要考慮的因素包括：
麥克風(fēng)的敏感性、袖帶大小、計算公式以及血壓讀數(shù)的可靠性和重復(fù)性等。
許多生產(chǎn)商開發(fā)的血壓計都由獨立的研究者根據(jù)一個或多個驗證方案進行過嚴(yán)格驗證。科學(xué)家、臨床醫(yī)師和社會大眾可以相信這些血壓計在其驗證的人群中使用時大體是準(zhǔn)確的。還有一些血壓計也進行了獨立臨床驗證，盡管其結(jié)果沒有發(fā)表。
許多政府審批機構(gòu)并不要求生產(chǎn)商根據(jù)上述驗證標(biāo)準(zhǔn)／方案對血壓計的準(zhǔn)確性進行獨立驗證，僅需生產(chǎn)商提供內(nèi)部進行的準(zhǔn)確性驗證結(jié)果。有些驗證研究因為人數(shù)較少，無法涵蓋各種臂圍大小的人群，因此無法確保臂圍較小或較大人群測量血壓的準(zhǔn)確性[8]。目前市場上可以購買到的血壓計，不論用于家庭血壓監(jiān)測，還是用于診室和醫(yī)院血壓測量，普遍存在以下問題：（1）未根據(jù)國際標(biāo)準(zhǔn)或所在國方案進行獨立的臨床驗證；（2）進行了獨立驗證研究，但未能通過驗證；（3）當(dāng)臂圍較小或較大時，無法準(zhǔn)確測量，但仍然在市場上推廣[2]。這些血壓計的準(zhǔn)確性無法保證，如果使用那些未能通過獨立臨床驗證的血壓計，還可能因為血壓測量不準(zhǔn)確而做出錯誤的醫(yī)療決策。
血壓計袖帶的生產(chǎn)和銷售也有問題。不管是自動血壓計，還是手動聽診血壓計，都同樣存在問題。除非可以根據(jù)臂圍大小進行調(diào)整的袖帶[9,10]，均需根據(jù)被測量者的臂圍選擇大小合適的袖帶，才能保證血壓測量的準(zhǔn)確性[11]。
通常，為了準(zhǔn)確測量血壓，需要在袖帶上標(biāo)注可以準(zhǔn)確測量血壓的臂圍范圍。但有些袖帶沒有標(biāo)注，或者標(biāo)注不準(zhǔn)確。有些袖帶盡管宣稱“一個尺寸適用于所有臂圍”，但可能并未在很大范圍臂圍人群中進行相應(yīng)的驗證研究。臨床醫(yī)生可以手工標(biāo)注袖帶大致能夠準(zhǔn)確測量血壓的臂圍范圍，也可以通過測量患者的臂圍，選擇大小合適的袖帶。但這樣做很費時間，臨床工作中很少使用。因此應(yīng)確保在生產(chǎn)袖帶時即明確標(biāo)注袖帶可以準(zhǔn)確測量血壓的臂圍范圍，這一關(guān)鍵步驟，簡單，而且可以有效解決問題。另外，很重要的是，必需確保血壓計袖帶的尺寸范圍足夠大，而且在相應(yīng)的袖帶大小范圍內(nèi)進行了驗證。
正是因為存在臂圍大小問題，導(dǎo)致腕式血壓計越來越廣泛使用?？赡苁且蚱涫褂梅奖悖ɡ纾瑹o需測量臂圍），價格低廉，而且圓錐形手臂的肥胖者也可以使用。然而，在使用腕式血壓計時，會有一些問題，比如需將手腕放置在心臟水平，大多數(shù)情況下都做得不好。另外，這些價格低廉的血壓計大都沒有根據(jù)上述標(biāo)準(zhǔn)或方案進行驗證。因此通常并不建議將腕式血壓計作為血壓測量的第一選擇，因其可能高估或低估血壓水平。
世界高血壓聯(lián)盟、國際高血壓學(xué)會等高血壓組織的建議
建議1：呼吁私營機構(gòu)只生產(chǎn)和銷售： （1）根據(jù)國際標(biāo)準(zhǔn)或方案進行過獨立驗證的自動血壓計，而且其準(zhǔn)確性驗證的結(jié)果（a）已在同行評議的科學(xué)雜志發(fā)表； （b）對公眾開放；或（c）已由政府機構(gòu)審核，以及（2）已在相應(yīng)臂圍人群中進行過準(zhǔn)確性驗證的明確標(biāo)注適用范圍的袖帶（表）。
建議2：呼吁政府機構(gòu)制定相關(guān)政策及法規(guī)，只允許銷售：（1）根據(jù)國際標(biāo)準(zhǔn)或方案進行過獨立驗證的自動血壓計，而且其準(zhǔn)確性驗證的結(jié)果（a）已在同行評議的科學(xué)雜志發(fā)表；（b）對公眾開放；或者（c）已由政府機構(gòu)審核，以及（2）已在相應(yīng)臂圍人群中進行過準(zhǔn)確性驗證的明確標(biāo)注適用范圍的袖帶（表）。
建議3：仍堅持推薦使用上臂式或肱動脈血壓計測量血壓。
建議4：在建議（1）和（2）有效實施的同時，呼吁設(shè)計一個簡單且易于理解的標(biāo)示，讓健康管理專業(yè)人員或者公眾能夠輕松地找到他們可以使用的自動血壓計，以及大小合適的袖帶。這個標(biāo)示應(yīng)該由獨立的非營利組織提供給血壓計制造商，而且國際通用。
Disclosures
Dr Mark Niebylski and Kimbree Redburn are paid WHL consul- tants but report no other conflicts. Dr Ji-Guang Wang reports receiving research grants and consulting fees from several BP measuring device companies including A&D, AVITA, Honsun, Omron, and Rossmax but reports no other conflicts. Dr Michael Weber is a consultant for and received travel support from Omron but reports no other conflicts. All other primary authors including those from WHL and the ISH report no conflicts of interest.
A Call to Regulate Manufacture and Marketing of Blood Pressure Devices and Cuffs: A Position Statement From the World Hypertension League, International Society of Hypertension and Supporting Hypertension Organizations
Nearly all automated blood pressure (BP) measurement devices assess BP by the oscillometric technique.1,2 Oscillometric BP readings are derived by measuring the maximal oscillations of the composite pulse wave in the BP cuff, which corresponds to the mean arterial pressure. Systolic and diastolic BP are then estimated by points along the composite pulse wave, using an algorithm that is proprietary to each manufacturer and device. Hence, there is a need to ensure that the estimated BP by automated oscillometric devices reflects BP measured by auscultation. A few automated devices use auscultation to assess Korotkoff sounds by using a microphone.2 Microphones may capture different sound wave lengths and sound intensity than the human ear and there is a potential for sound artifacts to be recorded by automated devices as Korotkoff sounds. Therefore, automated devices that operate using microphones to assess Korotkoff sounds also require an assessment of their ability to estimate BP accurately.
An international validation standard and several protocols have been developed to test the ability of automated devices to assess BP accurately in the general public, as well as in special populations, such as children or pregnant women, and special conditions such as arrhythmias.1,3–7 Factors that need to be considered for validation include microphone sensitivity, cuff size, appropriate algorithms, and the reliability and reproducibility of BP readings.
Many manufacturers have developed devices that have been rigorously tested by independent investigators by using one or more of these test procedures. Scientists, clinicians, and the public can be reassured that these devices are likely to be accurate in the populations tested. Other devices have been tested independently but the test results were not published.
Many government approval agencies do not require independent validation of accuracy according to established validation standards/protocols as mentioned above; rather, they rely only on the manufacturers to show that they have done accuracy tests internally. Furthermore, some validation testing may not include enough people with a wide range of arm sizes to ensure accurate readings in people with small or large arm sizes.8 Thus, many devices currently available on the market for self-monitoring of BP at home or for professional use in the office or hospital have: (1) not been tested independently according to the international standard or a national protocol; (2) have failed independent validation studies; or (3) may not produce accurate readings in those with small or large arms but are still marketed.2 The accuracy of these devices is not assured, and, for devices that fail validation standards, inaccurate BP readings and thereby incorrect treatment decisions are likely.
The manufacture and sale of BP measurement cuffs are also problematic. The issues apply not only to automated but also manual auscultatory devices. With the exception of cuffs that automatically adjust for awide range of arm sizes,9,10 an accurate BP assessmentrequires the selection of an appropriate cuff size according to the individual's arm circumference.11 In general, this requires cuffs to be marked with the range of arm circumferences on which the cuff will be able to be used to assess BP accurately. However, some cuffs are not marked, and some may be inaccurately marked. Further, claims that “one size cuff fits all” may not have been validated in studies that had patients with a wide range of arm sizes. Clinicians can manually mark cuffs for the range of arm sizes on which they are likely to be accurate and can also manually assess individual arm circumferences to see what cuff would be proper. Unfortunately, these procedures are time-consuming and rarely done in clinical practice. Ensuring that all BP cuffs, when manufactured, are accurately marked for the range of arm sizes to be used for accurate BP assessment is a crucial and simple step for resolving this problem. Ensuring that the devices have a wide range of cuff sizes and that the devices are validated with the range of cuffs sizes available is also important.
Notwithstanding the relevant issues regarding arm sizes, the use of wrist devices to assess BP is becoming more popular. This is likely attributable to ease of use (eg, namely, no need to measure arm circumferences), cost, and usability in obese individuals with coneshaped upper arms. There are, however, several challenges when using these devices, including that the wrist be held at heart level—an aspect that is not adhered to in many instances. Furthermore, a large proportion of these low-cost devices are not validated according to the described procedures, and, as a rule, are generally not advised to be used as a first option because of overestimation or underestimation of BP.
Recommendation 1: Call on the private sector to manufacture and sell only: (1) automated BP devices that have been independently tested to meet the international validation standard or national protocols for accuracy with the detailed results either (a) published in peer-reviewed scientific journals, (b) publically accessible, or (c) verified by a government agency, and (2) arm size–marked BP cuffs that have been demonstrated to be accurate in people with arm sizes in the range indicated (Table).
Recommendation 2: Call on governmental organizations to develop policies and regulations to allow only the sale of: (1) automated BP devices that have been independently tested to meet the international validation standard or national protocols for accuracy with the detailed results either (a) published in peer-reviewed scientific journals, (b) publically accessible, or (c) verified by a government agency, and (2) arm size–marked BP cuffs that have been demonstrated to be accurate in people with arms sizes in the range indicated.
Recommendation 3: Continue to recommend upperarm or brachial BP devices for BP measurement.
Recommendation 4: Call for the development of a simple and easy-to-understand branded symbol that would clearly identify automated BP devices with appropriate cuff sizes to be used by healthcare professionals and the public while recommendations 1 and 2 are being implemented. The use of the branded symbol should be provided to BP monitor manufacturers by an independent, not-for-profit body and to be used internationally.
[1] Stergiou GS, Parati G, Asmar R, et al; European Society of Hyperten- sion Working Group on Blood Pressure Monitoring. Requirements for professional office blood pressure monitors. J Hypertens. 2012;30:537– 542.
[2] Medaval Web site. 2015. http://medaval.org. Accessed August 17, 2015.
[3] O' Brien E, Petrie J, Littler W, et al. The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8:607–619.
[4] O' Brien E, Pickering T, Staessen J, et al. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002;7:3–17.
[5] ANSI/AAMI/ISO. ANSI/AAMI/ISO 81060-2:20132: Non-invasive sphygmonanometers–Part 2: clinical investigation of automated measurement type. American National Standard 1 A.D.
[6] Standards Australia. Sphygmomanometers. Australian Standard AS 3655-1989. Book. 1989. North Syndey NSW Australia, Standards Australia.
[7] DIN Deutsches Institut for Normung. Non-invasive sphygmo- manometers: clinical investigation. DIN Deutsches Institut for Nor- mung E DIN 58130. 1995. Berlin, Germany.
[8] Friedman BA, Alpert BS, Osborn D, et al. Assessment of the validation of blood pressure monitors: a statistical reappraisal. Blood Press Monit. 2008;13:187–191.
[9] Stergiou GS, Tzamouranis D, Nasothimiou EG, Protogerou AD. Can an electronic device with a single cuff be accurate in a wide range of arm size? Validation of the Visomat Comfort 20/40 device for home blood pressure monitoring. J Hum Hypertens. 2008;22:796–800.
[10] Alpert BS, Dart RA, Sica DA. Public-use blood pressure measurement: the kiosk quandary. J Am Soc Hypertens. 2014;8:739–742.
[11] Ringrose J, Millay J, Babwick SA, et al. Effect of overcuffing on the accuracy of oscillometric blood pressure measurements. J Am Soc Hypertens. 2015;9:563–568.
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