体位提高颅内压联合药物治疗慢性硬膜下血肿的多中心前瞻性临床研究  

Clinical study of intracranial hypotension targeted body posture combined with pharmacotherapy in the treatment of chronic subdural hematoma

作　　者：陈嘉宇 王哲 臧迪 郑锐哲 叶相如 齐曾鑫 许泽宇 李志强 孙成丰[3] 沈良军[4] 盛罗平 徐福林 叶汝勇 周开宇[8] 汤伟军 胡跃清 施大鹏 王昱泉 乌锡真 王莹 张启麟 刘飞利 余果 陆逸平 孙一睿 张宁 黄锋 顾夏龙 张浛 丁建 毕永延 杜昊蓝 张静 吉海龙[8] 丁玎 张嵬 吴雪海 Chen Jiayu;Wang Zhe;Zang Di;Zheng Ruizhe;Ye Xiangru;Qi Zengxin;Xu Zeyu;Li Zhiqiang;Sun Chengfeng;Shen Liangjun;Sheng Luoping;Xu Fulin;Ye Ruyong;Zhou Kaiyu;Tang Weijun;Hu Yueqing;Shi Dapeng;Wang Yuquan;Wu Xizhen;Wang Ying;Zhang Qilin;Liu Feili;Yu Guo;Lu Yiping;Sun Yirui;Zhang Ning;Huang Feng;Gu Xialong;Zhang Han;Ding Jian;Bi Yongyan;Du Haolan;Zhang Jing;Ji Hailong;Ding Ding;Zhang Wei;Wu Xuehai(Department of Neurosurgery,Huashan Hospital Afiliated to Fudan University,National Medical Center for Neurological Disorders,Shanghai 200040,China;Department of Neurosurgery,Shanghai Fengxian Distrct Central Hospital,Shanghai 201400,China;Department of Neurosurgery,Ningbo Medical Center Lihuili Hospital,Ningbo 315000,China;Department of Neurosurgery,People's Hospital of Shengzhou,Shengzhou 312400,China;Department of Neurosurgery,Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University,Shanghai 201700,China;Department of Neurosurgery,Shanghai Minhang District Central Hospital,Shanghai 201112,China;Department of Neurosurgery,the First People's Hospital of Yongkang,Yongkang 321300,China;Department of Neurosurgery,Taizhou Municipal Hospital,Taizhou 318000,China;Department of Radiology,Huashan Hospital,Fudan University,Shanghai 200040,China;The Human Phenome Institute,Fudan University,Shanghai 200438,China;Shanghai Center for Mathematical Sciences,Fudan University,Shanghai 200433,China;Department of Neurosurgery,Ninghai First Hospital,Ningbo 315600,China;Institute of Neurology,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Biostatistics,Fudan University School of Public Health,Shanghai 200032,China)

机构地区：[1]复旦大学附属华山医院神经外科国家神经疾病医学中心,上海200040 [2]上海市奉贤区中心医院神经外科,上海201400 [3]宁波市医疗中心李惠利医院神经外科,宁波315000 [4]嵊州市人民医院神经外科,嵊州312400 [5]复旦大学附属中山医院青浦分院神经外科,上海201700 [6]上海市闵行区中心医院神经外科,上海201112 [7]永康市第一人民医院神经外科,永康321300 [8]台州市立医院神经外科,台州318000 [9]复旦大学附属华山医院放射科,上海200040 [10]复旦大学人类表型组研究院,上海200438 [11]复旦大学数学科学学院,上海200433 [12]宁海县第一医院神经外科,宁波315600 [13]复旦大学附属华山医院神经内科,上海200040 [14]复旦大学公共卫生学院生物统计学教研室,上海200032

出　　处：《中华外科杂志》2025年第3期212-218,共7页Chinese Journal of Surgery

基　　金：国家自然科学基金(82271224)。

摘　　要：目的比较体位联合药物与单纯药物治疗慢性硬膜下血肿的临床效果。方法第一阶段研究为回顾性病例系列研究。回顾性收集2016年12月至2020年10月于复旦大学附属华山医院神经外科接受体位联合药物治疗的30例慢性硬膜下血肿患者的临床资料。男性27例,女性3例,年龄[M(IQR)]66(16)岁(范围:28~84岁)。其中19例为单侧血肿,11例为双侧血肿。患者均接受体位治疗,方法为平卧位时使用脚垫抬高下肢20~30 cm,并通过定制的腹带进行腹部加压,每日维持体位时间争取达到目标16~18 h。对于单侧硬膜下血肿患者,头部偏向患侧,避免偏向对侧;对双侧硬膜下血肿患者无头位偏侧要求。患者同时联合口服地塞米松和阿托伐他汀治疗。通过Clopper-Pearson方法分析患者的血肿改善率,初步观察体位联合药物治疗的临床效果。于2020年8月至2021年11月开展二期多中心、前瞻性、随机对照研究,采用分层区组随机化法,将我国9个临床试验中心的慢性硬膜下血肿的患者按1∶1比例随机分配至药物治疗组(对照组)和体位联合药物治疗组(试验组),共治疗3个月,并随访至治疗后6个月。治疗有效定义为血肿完全吸收或血肿体积减小>10 ml,同时Markwalder评分系统评分较治疗前改善≥1分。观察并计算3个月的治疗有效率、转手术率和6个月血肿复发率。组间比较采用配对样本t检验、Mann-Whitney U检验、χ^(2)检验、校正χ^(2)检验或Fisher确切概率法。采用Logistic回归比较两组的治疗有效和转手术治疗率。结果回顾性研究中,30例患者在接受治疗后13~353 d完成复查。末次复查时,28例(93.3%)患者血肿完全吸收或明显改善(血肿体积明显减少伴随明显症状的缓解),Clopper-Pearson方法获得血肿改善率的双侧95%CI为77.9%~99.2%。多中心研究共纳入106例患者,其中体位联合药物治疗组55例,男性39例,女性16例,年龄74(17)岁(范围:26~92岁)。�Objective To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).MethodsFirstly,retrospective case series study was conducted.Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery,Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively.Twenty-seven patients were male,and 3 patients were female.The age of patients(M(IQR))was 66(16)years(range:28 to 84).Nineteen patients had unilateral hematoma,and 11 patients had bilateral hematoma.All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position.Patients were required to maintain the body posture as much as possible,with the maximum to 16 to 18 hours per day.Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side.For patients with bilateral hematoma,there was no need for head lateralization.Patient were treated with oral dexamethasone and atorvastatin simultaneously.The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method.Then,the multi-center,prospective,randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021.The stratified block randomization method was adopted.Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group)or body posture combined with pharmacotherapy(the experiment group)for 3 months and followed up for 6 months.Effective treatment was defined as complete absorption of hematoma,or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline.The efficacy rate and surgery convers

关 键 词：血肿 硬膜下 慢性 颅内压 体位治疗 地塞米松 阿托伐他汀 

分 类 号：R651.15[医药卫生—外科学]