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学科主题: 临床医学
题名:
Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial
作者: Anderson, Craig S.1,2; Huang, Yining3; Wang, Ji Guang; Arima, Hisatomi1,2,5; Neal, Bruce1,2; Peng, Bin1,2,6; Heeley, Emma1,2; Skulina, Christian1,2; Parsons, Mark W.7,8; Kim, Jong Sung4,9; Tao, Qing Ling10; Li, Yue Chun11; Jiang, Jian Dong; Tai, Li Wen12; Zhang, Jin Li13; Xu, En14; Cheng, Yan15; Heritier, Stephan1,2; Morgenstern, Lewis B.16; Chalmers, John1,2; INTERACT Investigators
刊名: LANCET NEUROLOGY
发表日期: 2008-05-01
DOI: 10.1016/S1474-4422(08)70069-3
卷: 7, 期:5, 页:391-399
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Clinical Neurology
研究领域[WOS]: Neurosciences & Neurology
关键词[WOS]: SPONTANEOUS INTRACEREBRAL HEMORRHAGE ; AMERICAN-HEART-ASSOCIATION ; ACUTE STROKE ; HEMATOMA ENLARGEMENT ; PROGNOSTIC VALUE ; MANAGEMENT ; MORTALITY ; GUIDELINES ; HYPERTENSION ; STATEMENT
英文摘要:

Background There is much uncertainty about the effects of early lowering of elevated blood pressure (BP) after acute intracerebral haemorrhage (ICH). Our aim was to assess the safety and efficiency of this treatment, as a run-in phase to a larger trial.

Methods Patients who had acute spontaneous ICH diagnosed by CT within 6 h of onset, elevated systolic BP (150-220 mm Hg), and no definite indication or contraindication to treatment were randomly assigned to early intensive lowering of BP (target systolic BP 140 mm Hg; n=203) or standard guideline-based management of BP (target systolic BP 180 mm Hg; n=201). The primary efficacy endpoint was proportional change in haematoma volume at 24 h; secondary efficacy outcomes included other measurements of haematoma volume. Safety and clinical outcomes were assessed for up to 90 days. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00226096.

Findings Baseline characteristics of patients were similar between groups, but mean haematoma volumes were smaller in the guideline group (12.7 mL, SD 11.6) than in the intensive group (14.2 ml., SD 14.5). From randomisation to 1 h, mean systolic BP was 153 mm Hg in the intensive group and 167 mm Hg in the guideline group (difference 13.3 mm Hg, 95% CI 8.9-17.6 mm Hg; p<0.0001); from 1 h to 24 h, BP was 146 mm Hg in the intensive group and 157 mm Hg in the guideline group (10.8 mm Hg, 95% CI 7.7-13.9 mm Hg; p<0.0001). Mean proportional haematoma growth was 36.3% in the guideline group and 13.7% in the intensive group (difference 22.6%, 95% CI 0.6-44.5%; p=0.04) at 24 h. After adjustment for initial haematoma volume and time from onset to CT median haematoma growth differed between the groups with p=0.06; the absolute difference in volume between groups was 1.7 mL (95% CI -0.5 to 3.9, p=0.13). Relative risk of haematoma growth >= 33% or >= 12.5 mL was 36% lower (95% CI 0-59%, p=0.05) in the intensive group than in the guideline group. The absolute risk reduction was 8% (95% CI -1.0 to 17%, p=0.05). Intensive BP-lowering treatment did not alter the risks of adverse events or secondary clinical outcomes at 90 days.

Interpretation Early intensive BP-lowering treatment is clinically feasible, well tolerated, and seems to reduce haematoma growth in ICH. A large randomised trial is needed to define the effects on clinical outcomes across a broad range of patients with ICH.

Funding National Health and Medical Research Council of Australia.

语种: 英语
WOS记录号: WOS:000255514800011
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/58327
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.Univ Newcastle, John Hunter Hosp, New Lambton, Australia
2.Univ Newcastle, Hunter Med Res Inst, New Lambton, Australia
3.Univ Ulsan, Asan Med Ctr, Seoul, South Korea
4.Cent Hosp, Shanghai, Peoples R China
5.Baotou Cent Hosp, Baotou, Peoples R China
6.Hebei Med Univ, Second Hosp, Nanjing, Peoples R China
7.Chinese PLA No 263 Hosp, Beijing, Peoples R China
8.Tianjin Med Univ, Gen Hosp, Tianjin, Peoples R China
9.Kyushu Univ, Grad Sch Med Sci, Fukuoka 812, Japan
10.Univ Sydney, George Inst Int Hlth, Sydney, NSW 2050, Australia
11.Royal Prince Alfred Hosp, Sydney, NSW, Australia
12.Peking Univ, First Hosp, Beijing 100871, Peoples R China
13.Shanghai Jiao Tong Univ, Rui Jin Hosp, Shanghai Inst Hypertens, Shanghai, Peoples R China
14.Beijing Union Med Coll Hosp, Beijing, Peoples R China
15.Guangzhou Med Coll, Second Affiliated Hosp, Guangzhou, Peoples R China
16.Univ Michigan, Sch Med, Ann Arbor, MI 48109 USA

Recommended Citation:
Anderson, Craig S.,Huang, Yining,Wang, Ji Guang,et al. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial[J]. LANCET NEUROLOGY,2008,7(5):391-399.
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