People with hypertension trained to monitor their own blood pressure and adjust their own medication achieve greater control over their disease than do patients whose hypertension is managed through conventional care, according to new research.

The findings, published online July 8 in the Lancet (doi:10.1016/S0140-6736(10)60964-6), underscore earlier research (JAMA 2008;299:2857-67) suggesting that with appropriate clinical support and feedback – in this case, through telemonitoring of home blood pressure measurements – self-management can be an effective strategy for reducing hypertension.

The study’s lead author, Dr. Richard J. McManus of the Primary Care Clinical Sciences and Health Economics Unit of the University of Birmingham, England, attributed the results to more changes, often including the addition of medications, to the treatment plans of self-monitoring patients.

For their research, funded by government grants, Dr. McManus and colleagues enrolled 527 men and women with blood pressure higher than 140/90 mm Hg (but less than 200/100 mm Hg) despite treatment with up to two antihypertensive drugs, who were able to participate in a self-monitoring program.

A total of 263 patients were then randomly assigned to self-management and 264 to conventional care under their primary care physicians. Of these, 480 patients (234 self-managed and 246 control) were included in the analysis. Neither investigators nor patients could be blinded to treatment assignment; the treatment group underwent initial training sessions in the use of a sphygmomanometer and in transmitting their readings to the research team using a modem. This group could titrate its medications according to a fixed scheme, and also was able to demand prescriptions according to the results of their self-monitoring, bypassing their general practitioners.

After adjustment for factors including diabetes, chronic kidney disease and sex, mean systolic blood pressure decreased after six months by a mean of 12.9 mm Hg from baseline in the self-management group and by 9.2 mm Hg in the control group. From baseline to 12 months, mean systolic blood pressure in the two groups decreased by 17.6 mm Hg and 12.2 mm Hg, respectively.

However, the decrease in mean diastolic blood pressure did not differ as much between the intervention and control groups, with smaller differences from baseline to 6 months (decreases of 5.2 mm Hg and 3.9 mm Hg) and baseline to 12 months (7.6 mm Hg and 5.0 mm Hg). “This finding might be caused by lack of power,” the investigators wrote.

Adverse effects were similar between the groups – except for leg swelling, which was higher in the self-management group, “probably caused by increased use of calcium antagonists” in that group, the researchers wrote.

The self-management group, after 12 months, was using more varied medication than the control group, which the investigators saw as an important factor in the results. Though all study subjects were taking only one or two antihypertensive drugs at baseline, by 12 months more participants had been prescribed at least three drugs in the self-monitoring group than in the control group, and were more likely to have been prescribed thiazides and calcium antagonists.

One related issue, not addressed in the study, was cost, as the self-management group received more prescriptions. Dr. McManus and colleagues wrote that they had investigated the cost-effectiveness of the intervention and would report it separately.

Compliance was good in the self-management group, with approximately three-quarters of patients completing at least 90% of the expected number of readings. When readings were particularly high or low (over 200/100 mm Hg or systolic under 100 mm Hg), as 60% of the self-management group experienced at least once, most contacted the research team, as instructed. Only 3% of the self-monitoring patients had to be contacted by researchers about a high or low reading.

But the study’s authors acknowledged that such compliance would be difficult to attain in the hypertension population at large and that a weakness of the study was its paucity of low-income and ethnic minority patients.

“Self-management will not be suitable for all patients,” they wrote. “However, even if only 20% of individuals with hypertension self-managed their disorder, this proportion would still represent around 4% of the UK population, i.e., more than 2 million individuals.”

Dr. McManus acknowledged having received a consultancy fee from the firm Tplus Medical to advise on telemonitoring services. One of his coauthors on the study acknowledged receiving donations of blood pressure devices from Microlife and BpTRU for research purposes.

In an editorial (doi:10.1016/S0140-6736(10)61050-1) accompanying the study, Dr. Gbenga Ogedegbe of New York University cautioned that until these findings “are replicated by other investigators, especially in low-income, low-literate patients who receive care in low-resource, non-academic settings,” it would be premature to advocate self-monitoring strategies for hypertension on a wide scale. Dr. Ogedegbe declared no conflicts of interest.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

一项新的研究表明，高血压患者可以被训练为自我监测其血压并相应调整用药，这将使患者对其疾病的控制效果远远好过通过常规护理方式所达到的效果。

 

该研究结果在线发表于7月8日的《柳叶刀》(Lancet)(doi:10.1016/S0140-6736(10)60964-6)，突出强调了一项有适当临床支持和反馈的早期研究(JAMA 2008;299:2857-67)——在该研究中，通过远程监控来测定患者在家中的血压情况，这种自我管理方式可以成为一种降血压的有效策略。

 

该项研究的主要作者是英国伯明翰大学的初级护理临床科学和卫生经济中心的Richard J. McManus博士，他将这些结果归因于在自我监测患者的治疗计划方面所作出的更多变更(通常包括增加药物治疗)。

 

在政府拨款的支持下，McManus博士及其同事招募了527例血压超过140/90 mmHg但低于200/100 mmHg的高血压患者。尽管使用了多达两种抗高血压药进行治疗，这些患者仍然能对血压进行自我监测。

 

263例被随机分配至自我监测组，264例被分配至初级护理医师监护下的常规护理组。这些患者中，480例(234例为自我监测组，246例为对照组)被纳入分析。研究者和患者均清楚分组方式；自我监测组通过使用血压测量仪来完成开始的训练期，并通过调制解调器来将他们每次测量血压的读数传送给研究小组。该组患者可以依据一种固定的程序来调整其药物剂量，并能按照其自我监测的结果来获得处方，从而绕过他们的全科医师。

 

在对包括糖尿病、慢性肾脏疾病和性别在内的多种因素进行调整后，自我监测组患者在治疗6个月后其平均收缩压由基线值平均下降了12.9 mmHg，而对照组(即常规护理组)下降了9.2 mmHg。而经过12个月的治疗后，这两个组的平均收缩压分别由基线值下降了17.6 mmHg和12.2 mmHg。

 

不过，自我监测组和对照组在平均舒张压的降幅上并无明显差异。在治疗6个月后，这两个组的平均舒张压由基线值分别下降了5.2 mmHg 和3.9 mmHg；而12个月治疗之后，两者分别下降了7.6 mmHg和5.0mm Hg。研究者写道：“这一发现可能是因检验效能不足所致”。

 

除了自我监测组的患者有下肢肿胀以外，这两组的不良反应也较为相似。这种肿胀可能是该组患者“增加使用钙拮抗剂所致”，研究者写道。

 

经过12个月的治疗后，自我监测组可以使用比对照组更多样的药物治疗，研究者把这一发现视为研究结果中的一项重要因素。尽管所有的受试对象在起初的基线水平时仅使用一种或两种抗高血压药，而12个月后，与对照组相比，自我监测组中更多的受试者能使用至少3种抗高血压药，并且更倾向于使用噻嗪类利尿药和钙拮抗剂。

 

研究中没有提到的一个相关问题——治疗成本，因为自我监测组接受了更多的处方。McManus博士及其同事写道，他们研究过这一干预措施的成本效益分析，将对其进行单独报告。

 

自我监测组的依从性良好，大约3/4的患者能完成至少90%的预期血压读数。当读数特别高或特别低时(超过200/100 mmHg或收缩压在100 mmHg以下)，大多数自我监测组的患者都能按照要求联系研究小组；其中，60%的自我监测组患者至少经历一次这种情况。然而，仅有3%的对照组患者在血压读数很高或很低时才会去联系研究小组。

 

但这项研究的作者认为，将很难在大规模的高血压人群中达到这一依从性，并且该项研究的一个不足之处在于，其受试对象中缺乏低收入和少数民族患者。

 

作者在文中写道：“自我管理并非对所有患者都适合。然而，即使只有20%的高血压患者能自我监测其血压，这一比例仍然能代表大约4%的英国人口，换言之，超过200万的人群。”

 

McManus博士表示收到Tplus医疗公司的顾问费以提供远程监控服务方面的建议。本研究中的一名合著者表示收到Microlife和BpTRU公司捐赠的血压监测仪用于本项研究。

 

在一篇随刊编者按(doi:10.1016/S0140-6736(10)61050-1) 中，来自纽约大学的Gbenga Ogedegbe博士提醒人们，只有当这些结果“由其他研究者(特别是在那些医疗资源贫瘠、非学术环境中得到医疗护理的低收入、低文化程度患者)重复出来之后”，才能把这种自我监测治疗策略进行推广，否则将是为时过早的主张。Ogedegbe博士表示无其他利益冲突关系。

 

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