目的观察活血化瘀法治疗脑出血患者的临床疗效与安全性。方法采用多中心、前瞻性、随机开放对照盲终点评估的研究设计,通过中心随机法将228例脑出血患者分为试验组和对照组,每组114例。两组均采用西医内科基础治疗,试验组在此基础上,自...目的观察活血化瘀法治疗脑出血患者的临床疗效与安全性。方法采用多中心、前瞻性、随机开放对照盲终点评估的研究设计,通过中心随机法将228例脑出血患者分为试验组和对照组,每组114例。两组均采用西医内科基础治疗,试验组在此基础上,自入组第1天起予醒脑静注射液20 m L静脉滴注14天,并辨证口服或鼻饲中药风、痰、火证免煎颗粒21天,21天后口服脑血疏口服液10 m L,每日3次,服用至发病3个月。分别采用改良Rankin量表(Modified Rankin Scale,MRS)、Barthel指数(Barthel index,BI)、美国国立卫生院神经功能缺损评分(National Institute of Health Stroke Scale,NIHSS)及基于中风病患者报告的临床结局评价量表(patient reported outcome,PRO)评价患者病残程度、日常生活活动能力、神经功能缺损情况、临床治疗有效率及其生理功能、心理精神状态、社会关系和治疗满意度。在入组当日及第7天行头颅CT,评价血肿吸收情况,并进行安全性评价。结果试验组和对照组分别有108例和112例患者完成观察。治疗3个月后,两组总有效率比较,差异无统计学意义(P>0.05)。发病3个月后,试验组MRS评分低于对照组(P<0.01)。治疗7天后,两组治疗前后血肿体积差值比较,差异有统计学意义(P<0.05)。入组第7、14、21天及第3个月,两组NIHSS量表评分均较入组当日下降(P<0.05);与对照组比较,在入组第7、21天及第3个月时试验组NIHSS评分下降程度更明显(P<0.05);在发病3个月时,与对照组比较,试验组BI指数升高(P<0.01),PRO量表中生理功能、社会关系和治疗满意度维度得分及总分减低(P<0.05,P<0.01)。研究期间,试验组不良事件发生7例(6.14%),对照组不良事件发生5例(4.39%),两组比较,差异无统计学意义(P>0.05)。结论活血化瘀法治疗方案能降低脑出血患者发病3个月时的致残率,有效促进出血后7天内的血肿吸收,能改善脑出血患者神经功能缺损情况,提高脑出血患者发病3个月时的生活能力。展开更多
Objective： To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation （TRABC） in treatment of hypertensive intracerebral hemorrhage （HICH）. Methods： This was...Objective： To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation （TRABC） in treatment of hypertensive intracerebral hemorrhage （HICH）. Methods： This was a multi-center prospective randomized open-label blinded-endpoint （PROBE） trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale （mRS）. Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale （NIHSS） scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded. Results： After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups （P〈0.01）. Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group （P=0.038）. Average Barthel scores in the treatment group after treatment was 89.11 ＋ 19.93, and in the control group 82.18 ＋ 24.02 （P=0.003）. NIHSS scores of the two groups after treatment decreased significantly compared with before treatment （P=0.001）. Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment （P〈0.05）. There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group. Conclusion： The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.展开更多
文摘目的观察活血化瘀法治疗脑出血患者的临床疗效与安全性。方法采用多中心、前瞻性、随机开放对照盲终点评估的研究设计,通过中心随机法将228例脑出血患者分为试验组和对照组,每组114例。两组均采用西医内科基础治疗,试验组在此基础上,自入组第1天起予醒脑静注射液20 m L静脉滴注14天,并辨证口服或鼻饲中药风、痰、火证免煎颗粒21天,21天后口服脑血疏口服液10 m L,每日3次,服用至发病3个月。分别采用改良Rankin量表(Modified Rankin Scale,MRS)、Barthel指数(Barthel index,BI)、美国国立卫生院神经功能缺损评分(National Institute of Health Stroke Scale,NIHSS)及基于中风病患者报告的临床结局评价量表(patient reported outcome,PRO)评价患者病残程度、日常生活活动能力、神经功能缺损情况、临床治疗有效率及其生理功能、心理精神状态、社会关系和治疗满意度。在入组当日及第7天行头颅CT,评价血肿吸收情况,并进行安全性评价。结果试验组和对照组分别有108例和112例患者完成观察。治疗3个月后,两组总有效率比较,差异无统计学意义(P>0.05)。发病3个月后,试验组MRS评分低于对照组(P<0.01)。治疗7天后,两组治疗前后血肿体积差值比较,差异有统计学意义(P<0.05)。入组第7、14、21天及第3个月,两组NIHSS量表评分均较入组当日下降(P<0.05);与对照组比较,在入组第7、21天及第3个月时试验组NIHSS评分下降程度更明显(P<0.05);在发病3个月时,与对照组比较,试验组BI指数升高(P<0.01),PRO量表中生理功能、社会关系和治疗满意度维度得分及总分减低(P<0.05,P<0.01)。研究期间,试验组不良事件发生7例(6.14%),对照组不良事件发生5例(4.39%),两组比较,差异无统计学意义(P>0.05)。结论活血化瘀法治疗方案能降低脑出血患者发病3个月时的致残率,有效促进出血后7天内的血肿吸收,能改善脑出血患者神经功能缺损情况,提高脑出血患者发病3个月时的生活能力。
基金Supported by the Beijing Committee on Science and Technology,Project on Research on Two Standards of Traditional Chinese Medicine Treatment for Stroke(No.D101107049310003)
文摘Objective： To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation （TRABC） in treatment of hypertensive intracerebral hemorrhage （HICH）. Methods： This was a multi-center prospective randomized open-label blinded-endpoint （PROBE） trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale （mRS）. Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale （NIHSS） scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded. Results： After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups （P〈0.01）. Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group （P=0.038）. Average Barthel scores in the treatment group after treatment was 89.11 ＋ 19.93, and in the control group 82.18 ＋ 24.02 （P=0.003）. NIHSS scores of the two groups after treatment decreased significantly compared with before treatment （P=0.001）. Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment （P〈0.05）. There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group. Conclusion： The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.
