急性脳卒中における意図的な血圧変化のための介入
Abstract
Background
It is unclear whether blood pressure should be altered actively during the acute phase of stroke. This is an update of a Cochrane review first published in 1997, and previously updated in 2001 and 2008.
Objectives
To assess the clinical effectiveness of altering blood pressure in people with acute stroke, and the effect of different vasoactive drugs on blood pressure in acute stroke.
Search methods
We searched the Cochrane Stroke Group Trials Register (last searched in February 2014), the Cochrane Database of Systematic reviews (CDSR) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 2), MEDLINE (Ovid) (1966 to May 2014), EMBASE (Ovid) (1974 to May 2014), Science Citation Index (ISI, Web of Science, 1981 to May 2014) and the Stroke Trials Registry (searched May 2014).
Selection criteria
Randomised controlled trials of interventions that aimed to alter blood pressure compared with control in participants within one week of acute ischaemic or haemorrhagic stroke.
Data collection and analysis
Two review authors independently applied the inclusion criteria, assessed trial quality and extracted data. The review authors cross‐checked data and resolved discrepancies by discussion to reach consensus. We obtained published and unpublished data where available.
Main results
We included 26 trials involving 17,011 participants (8497 participants were assigned active therapy and 8514 participants received placebo/control). Not all trials contributed to each outcome. Most data came from trials that had a wide time window for recruitment; four trials gave treatment within six hours and one trial within eight hours. The trials tested alpha‐2 adrenergic agonists (A2AA), angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor antagonists (ARA), calcium channel blockers (CCBs), nitric oxide (NO) donors, thiazide‐like diuretics, and target‐driven blood pressure lowering. One trial tested phenylephrine.
At 24 hours after randomisation oral ACEIs reduced systolic blood pressure (SBP, mean difference (MD) ‐8 mmHg, 95% confidence interval (CI) ‐17 to 1) and diastolic blood pressure (DBP, MD ‐3 mmHg, 95% CI ‐9 to 2), sublingual ACEIs reduced SBP (MD ‐12.00 mm Hg, 95% CI ‐26 to 2) and DBP (MD ‐2, 95%CI ‐10 to 6), oral ARA reduced SBP (MD ‐1 mm Hg, 95% CI ‐3 to 2) and DBP (MD ‐1 mm Hg, 95% CI ‐3 to 1), oral beta blockers reduced SBP (MD ‐14 mm Hg; 95% CI ‐27 to ‐1) and DBP (MD ‐1 mm Hg, 95% CI ‐9 to 7), intravenous (iv) beta blockers reduced SBP (MD ‐5 mm Hg, 95% CI ‐18 to 8) and DBP (‐5 mm Hg, 95% CI ‐13 to 3), oral CCBs reduced SBP (MD ‐13 mmHg, 95% CI ‐43 to 17) and DBP (MD ‐6 mmHg, 95% CI ‐14 to 2), iv CCBs reduced SBP (MD ‐32 mmHg, 95% CI ‐65 to 1) and DBP (MD ‐13, 95% CI ‐31 to 6), NO donors reduced SBP (MD ‐12 mmHg, 95% CI ‐19 to ‐5) and DBP (MD ‐3, 95% CI ‐4 to ‐2) while phenylephrine, non‐significantly increased SBP (MD 21 mmHg, 95% CI ‐13 to 55) and DBP (MD 1 mmHg, 95% CI ‐15 to 16).
Blood pressure lowering did not reduce death or dependency either by drug class (OR 0.98, 95% CI 0.92 to 1.05), stroke type (OR 0.98, 95% CI 0.92 to 1.05) or time to treatment (OR 0.98, 95% CI 0.92 to 1.05). Treatment within six hours of stroke appeared effective in reducing death or dependency (OR 0.86, 95% CI 0.76 to 0.99) but not death (OR 0.70, 95% CI 0.38 to 1.26) at the end of the trial. Although death or dependency did not differ between people who continued pre‐stroke antihypertensive treatment versus those who stopped it temporarily (worse outcome with continuing treatment, OR 1.06, 95% CI 0.91 to 1.24), disability scores at the end of the trial were worse in participants randomised to continue treatment (Barthel Index, MD ‐3.2, 95% CI ‐5.8, ‐0.6).
Authors' conclusions
There is insufficient evidence that lowering blood pressure during the acute phase of stroke improves functional outcome. It is reasonable to withhold blood pressure‐lowering drugs until patients are medically and neurologically stable, and have suitable oral or enteral access, after which drugs can than be reintroduced. In people with acute stroke, CCBs, ACEI, ARA, beta blockers and NO donors each lower blood pressure while phenylephrine probably increases blood pressure. Further trials are needed to identify which people are most likely to benefit from early treatment, in particular whether treatment started very early is beneficial.
PICO
Plain language summary
急性期脳卒中において血圧を意図的に変化させる薬物介入法
背景：脳卒中（脳の動脈の閉塞や破裂による突然の脳の病気）を起こしたばかりの人では、血圧が非常に高くなったり低くなったりすることが有害な場合がある。そのため、低血圧を上げる薬や高血圧を下げる薬が有効な場合がある。急性期脳卒中で入院した人の最大50％が入院時に血圧を調整する薬を服用しているが、急性期にこれらの薬を継続すべきか中止すべきかは明確ではない。このレビューでは、意図的に血圧を変化させた試験や、脳卒中前に服用していた血圧を下げる薬の継続と中止を比較した試験を対象とした。
研究の特徴：このレビューは2014年5月までのものである。17,011人の参加者を含む26件の試験を対象にした。血圧を下げることを評価した試験が24件、血圧を上げることを評価した試験が1件、脳卒中前に服用していた薬をどうするかを評価した試験が2件あった。すべての研究は、脳卒中患者の治療を日常的に行っている病院で行われた。すべての試験がすべての結果に関する情報を提供していたわけではなく、このレビューでは出版物で入手可能なデータを使用した。
主要な結果：血圧を下げることで、急性脳卒中患者の命を救ったり、障害を軽減したりするというエビデンスは十分ではない。脳卒中前に服用していた血圧を下げる薬をすぐに再開すると、障害が増加する可能性がある。
結論：急性期脳卒中において、血圧を変化させることが最も効果的であると思われる人々、治療が効果的であると思われる時期、どのようなタイプの脳卒中が効果的であると思われるか、また、日常的にそのような治療を行うのに最適な環境を特定するためには、さらなる研究が必要である。
