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[JAMA在线发表]:围手术期个体化血压治疗策略能够减少术后器官功能障碍
2017年10月09日 时讯速递, 进展交流 暂无评论

Original Investigation

Caring for the Critically Ill Patient

September 27, 2017

Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial

Emmanuel Futier, Jean-Yves Lefrant, Pierre-Gregoire Guinot, et al.

JAMA. Published online September 27, 2017. doi:10.1001/jama.2017.14172

Importance 背景

Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain.

围手术期低血压伴随术后罹患率及病死率增加,但适当的治疗策略尚不清楚。

Objective 目的

To evaluate whether an individualized blood pressure management strategy tailored to individual patient physiology could reduce postoperative organ dysfunction.

评价根据患者生理学进行的个体化血压治疗策略能否减少术后器官功能障碍。

Design, Setting, and Participants 设计,场景和研究人群

The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study was a multicenter, randomized, parallel-group clinical trial conducted in 9 French university and nonuniversity hospitals. Adult patients (n = 298) at increased risk of postoperative complications with a preoperative acute kidney injury risk index of class III or higher (indicating moderate to high risk of postoperative kidney injury) undergoing major surgery lasting 2 hours or longer under general anesthesia were enrolled from December 4, 2012, through August 28, 2016 (last follow-up, September 28, 2016).

术中去甲肾上腺素控制动脉血压(INPRESS)研究是一项多中心,随机,平行对照临床试验,在法国9所大学与非大学医院内进行。入选的成年患者(n = 298)具有术后并发症的高风险,术前急性肾损伤风险指数为III级或更高(提示术后肾损伤中至高危),在全麻下接受大手术(持续时间不少于2小时)。研究时间从2012年12月4日至2016年8月28日(最后随访于2016年9月28日)。

Interventions 干预措施

Individualized management strategy aimed at achieving a systolic blood pressure (SBP) within 10% of the reference value (ie, patient’s resting SBP) or standard management strategy of treating SBP less than 80 mm Hg or lower than 40% from the reference value during and for 4 hours following surgery.

个体化治疗策略旨在使收缩压(SBP)在术中及术后4小时达到参考值(即患者静息状态下SBP)的10%以内,或标准治疗策略即当SBP < 80 mmHg或低于参考值40%时开始治疗。

Main Outcomes and Measures 主要预后指标

The primary outcome was a composite of systemic inflammatory response syndrome and dysfunction of at least 1 organ system of the renal, respiratory, cardiovascular, coagulation, and neurologic systems by day 7 after surgery. Secondary outcomes included the individual components of the primary outcome, durations of ICU and hospital stay, adverse events, and all-cause mortality at 30 days after surgery.

主要预后终点为复合终点,包括术后7天全身炎症反应综合征,及肾脏、呼吸、心血管、凝血和神经系统中至少1个器官系统功能障碍。次要预后终点包括主要预后终点的单项指标,ICU住院日,总住院日,不良事件,以及术后30天全因病死率。

Results 结果

Among 298 patients who were randomized, 292 patients completed the trial (mean [SD] age, 70 [7] years; 44 [15.1%] women) and were included in the modified intention-to-treat analysis. The primary outcome event occurred in 56 of 147 patients (38.1%) assigned to the individualized treatment strategy vs 75 of 145 patients (51.7%) assigned to the standard treatment strategy (relative risk, 0.73; 95% CI, 0.56 to 0.94; P = .02; absolute risk difference, −14%, 95% CI, −25% to −2%). Sixty-eight patients (46.3%) in the individualized treatment group and 92 (63.4%) in the standard treatment group had postoperative organ dysfunction by day 30 (adjusted hazard ratio, 0.66; 95% CI, 0.52 to 0.84; P = .001). There were no significant between-group differences in severe adverse events or 30-day mortality.

在接受随机分组的298名患者中,292名完成了试验方案(平均 [SD] 年龄,70 [7] 岁;44 名 [15.1%] 为女性),纳入修订意向治疗分析。个体化治疗策略组147名患者中56 名 (38.1%) 出现主要预后终点事件,而标准治疗策略组145名患者中有75 名 (51.7%)(相对危险度,0.73; 95% CI, 0.56 to 0.94; P = .02;绝对危险差异,−14%, 95% CI, −25% to −2%)。至30天时,个体化治疗策略组68名 (46.3%) 患者以及标准治疗组 92名 (63.4%) 发生术后器官功能障碍(校正后风险比,0.66; 95% CI, 0.52 to 0.84; P = .001)。两组患者间严重不良事件发生率或30天病死率并无显著差异。

 

Conclusions and Relevance 结论和意义

Among patients predominantly undergoing abdominal surgery who were at increased postoperative risk, management targeting an individualized systolic blood pressure, compared with standard management, reduced the risk of postoperative organ dysfunction.

在主要接受腹部手术切术后风险增加的患者中,与常规治疗相比,针对个体化收缩压的治疗能够降低术后器官功能障碍的风险。

Trial Registration

clinicaltrials.gov Identifier: NCT01536470

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