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[JAMA发表论文]:小脑出血患者手术清除血肿或保守治疗与功能预后的相关性
2019年10月30日 时讯速递, 进展交流 暂无评论

Original Investigation October 8, 2019

Association of Surgical Hematoma Evacuation vs Conservative Treatment With Functional Outcome in Patients With Cerebellar Intracerebral Hemorrhage

Joji B. Kuramatsu, Alessandro Biffi, Stefan T. Gerner, et al

JAMA. 2019;322(14):1392-1403. doi:10.1001/jama.2019.13014

Importance 背景

The association of surgical hematoma evacuation with clinical outcomes in patients with cerebellar intracerebral hemorrhage (ICH) has not been established.

对于小脑出血患者,手术清除血肿与临床预后的相关性尚不明确。

Objective 目的

To determine the association of surgical hematoma evacuation with clinical outcomes in cerebellar ICH.

确定手术清除血肿与小脑ICH临床预后之间的相关性

Design, Setting, and Participants 设计、场景与研究人群

Individual participant data (IPD) meta-analysis of 4 observational ICH studies incorporating 6580 patients treated at 64 hospitals across the United States and Germany (2006-2015).

4项ICH观察性研究纳入2006-2015年美国和德国64家医院治疗的6580名患者的个人资料(IPD)的meta分析

Exposure 暴露因素 

Surgical hematoma evacuation vs conservative treatment.

手术清除血肿与保守治疗

Main Outcomes and Measures 主要预后指标

The primary outcome was functional disability evaluated by the modified Rankin Scale ([mRS] score range: 0, no functional deficit to 6, death) at 3 months; favorable (mRS, 0-3) vs unfavorable (mRS, 4-6). Secondary outcomes included survival at 3 months and at 12 months. Analyses included propensity score matching and covariate adjustment, and predicted probabilities were used to identify treatment-related cutoff values for cerebellar ICH.

主要预后指标为3个月时根据修订Rankin评分评估的功能障碍([mRS] 评分范围: 0, 无功能缺陷 至6分, 死亡);功能良好 (mRS, 0-3) vs 功能不佳 (mRS, 4-6)。次要预后指标包括3个月和12个月的生存率。分析包括倾向性评分匹配及协变量校正,并采用预测概率确定小脑ICH治疗相关临界值。

Results 结果

Among 578 patients with cerebellar ICH, propensity score–matched groups included 152 patients with surgical hematoma evacuation vs 152 patients with conservative treatment (age, 68.9 vs 69.2 years; men, 55.9% vs 51.3%; prior anticoagulation, 60.5% vs 63.8%; and median ICH volume, 20.5 cm3 vs 18.8 cm3). After adjustment, surgical hematoma evacuation vs conservative treatment was not significantly associated with likelihood of better functional disability at 3 months (30.9% vs 35.5%; adjusted odds ratio [AOR], 0.94 [95% CI, 0.81 to 1.09], P = .43; adjusted risk difference [ARD], −3.7% [95% CI, −8.7% to 1.2%]) but was significantly associated with greater probability of survival at 3 months (78.3% vs 61.2%; AOR, 1.25 [95% CI, 1.07 to 1.45], P = .005; ARD, 18.5% [95% CI, 13.8% to 23.2%]) and at 12 months (71.7% vs 57.2%; AOR, 1.21 [95% CI, 1.03 to 1.42], P = .02; ARD, 17.0% [95% CI, 11.5% to 22.6%]). A volume range of 12 to 15 cm3 was identified; below this level, surgical hematoma evacuation was associated with lower likelihood of favorable functional outcome (volume ≤12 cm3, 30.6% vs 62.3% [P = .003]; ARD, −34.7% [−38.8% to −30.6%]; P value for interaction, .01), and above, it was associated with greater likelihood of survival (volume ≥15 cm3, 74.5% vs 45.1% [P < .001]; ARD, 28.2% [95% CI, 24.6% to 31.8%]; P value for interaction, .02).

共 578 名小脑ICH患者,倾向性评分匹配组纳入 152 名手术清除血肿患者 vs 152 名保守治疗患者 (年龄, 68.9 vs 69.2 岁; 男性, 55.9% vs 51.3%; 既往抗凝史, 60.5% vs 63.8%; ICH 量中位数, 20.5 cm3 vs 18.8 cm3)。经过校正后,与保守治疗相比,手术清除血肿并不伴随3个月时更好的功能状态 (30.9% vs 35.5%; 校正后比数比 [AOR], 0.94 [95% CI, 0.81 to 1.09], P = .43; 校正后风险差异 [ARD], −3.7% [95% CI, −8.7% to 1.2%]) 但伴随3个月 (78.3% vs 61.2%; AOR, 1.25 [95% CI, 1.07 to 1.45], P = .005; ARD, 18.5% [95% CI, 13.8% to 23.2%]) 及12个月时 (71.7% vs 57.2%; AOR, 1.21 [95% CI, 1.03 to 1.42], P = .02; ARD, 17.0% [95% CI, 11.5% to 22.6%])生存概率更高。以出血量12 - 15 cm3 作为临界值;低于这一数值范围,手术清除血肿伴随良好功能预后概率降低 (出血量 ≤12 cm3, 30.6% vs 62.3% [P = .003]; ARD, −34.7% [−38.8% to −30.6%]; 交互作用P 值, .01), 超过这一范围,手术清除血肿伴随生存概率较高 (出血量 ≥15 cm3, 74.5% vs 45.1% [P < .001]; ARD, 28.2% [95% CI, 24.6% to 31.8%]; 交互作用P 值, .02)。

Conclusions and Relevance 结论与意义

Among patients with cerebellar ICH, surgical hematoma evacuation, compared with conservative treatment, was not associated with improved functional outcome. Given the null primary outcome, investigation is necessary to establish whether there are differing associations based on hematoma volume.

对于小脑ICH患者,与保守治疗相比,手术清除血肿并不伴随功能预后改善。鉴于这一结果,有必要进行研究,确定不同血肿量时这一相关性是否有所不同。

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