中医综合治疗方案治疗急性缺血性中风阴类证的疗效和安全性评价(英文)

Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke

背景:中风病的发病率较高,中医药治疗中风的疗效如何需要进一步的研究。目的:研究中西医综合治疗方案治疗急性缺血性中风阴类证的有效性,并进行安全性评估。设计、场所、对象和干预措施:采用前瞻性、多中心、中央随机、平行对照临床试验的设计方法,来自广东省中医院等22家医院的537例患者分别用中西医综合(试验组274例,A组)和西医加相应的中药安慰剂(对照组263例,B组)治疗,连续治疗21 d。于治疗第21天和发病后60、90 d,对相关指标进行检测。主要结局指标:疗效评价包括病死率,不同时点神经功能缺损水平(National Institutes of Health StrokeScale,NIHSS),生活能力(Barthel Index,BI),残障水平(modified Rankin criteria,mRS),生活质量(StrokeSpecific Quality of Life,SSQOL)及中医症征积分(Stroke Scale of Traditional Chinese Medicine,SSTCM)等方面;安全性评价指标为试验中出现的不良反应。结果:因误操作产生空号16个,全国22家医院实际进入随机化分配606例。剔除15例,脱落54例,符合方案并随访完整的共537例。两组在性别、年龄、脉搏、心率、血压、伴发病、病情程度等方面具有可比性(P>0.05)。A组死亡5例,B组死亡7例,两组死亡率比较差异无统计学意义。中医方案可改善患者21 d的神经功能缺损程度(P<0.05);90 d随访时,综合方案组患者生活能力改善(P<0.05),独立生活能力提高(P<0.05);21、60、90 d的中医症状程度减轻。随着随访时间的延长,中医综合治疗方案有提高患者生存质量的趋势,但两组比较差异无统计学意义。两组共发生76例次不良反应和(或)不良事件,主要为消化道反应、皮肤瘙痒或皮疹、出血倾向、转氨酶升高等,两组不良反应发生率比较,差异无统计学意义,不良反应与中医药治疗方案无关。结论:多中心随机对照试验证明,整合了中西医优势的中医综合治疗方案疗效确切,疗效优势在治疗21 d后逐渐显现,表现为降低患者的神经功能缺损,提高生活能力,降低残障水平。

Background：The morbidity of stroke is high.Traditional Chinese medicine is commonly used for patients with ischemic stroke in China,but the efficacy need be further proved. Objective：To assess the efficacy and safety of an herbal medicine treatment regimen integrating traditional Chinese medicine and Western medicine for ischemic stroke patients with yin pattern syndrome. Design,setting,participants and interventions：A multicenter,randomized and controlled clinical trial was adopted.A total of 537 patients with acute ischemic stroke were enrolled in 22 hospitals from July 2005 to October 2006,among whom 274 were assigned to group A（herbal group） and administered with Western medicine plus herbal medicine treatment,and the other 263 in group B（control group） with Western medicine plus placebo.The patients in two groups were all treated for 21 days. Main outcome measures：The primary endpoint of outcome measures was Barthel index.The secondary endpoints included National Institutes of Health Stroke Scale,the modified Rankin criteria.Stroke Specific Quality of Life,and Stroke Scale of Traditional Chinese Medicine.The adverse effects of the treatment were also observed. Results：A total of 622 randomization numbers were applied by the centers and 16 numbers were lost for mishandling,so a total of 606 patients were included.Fifteen patients were excluded（5 in group A,and 10 in group B）,and 54（25 in group A,and 29 in group B） lost in follow-up.A total of 537 patients completed the trial and a per-protocol set analysis was conducted.There were no statistical differences in age,sex, pulse rate,heart rate,respiratory rate,blood pressure,medical history,neurological deficit scores,scores on Glasgow Coma Scale,and lesion size of intracerebral ischemia between the two groups at baseline（P〉0.05）.Twelve patients,including 5 in group A and 7 in group B,died during the 90 days of research period, and no significant difference was found between the two groups.Compared with Western medicine alone, herbal medicine treatment could improve the neurological deficit at day 21,activities of daily living at day 90 of follow-up,and the patient-reported outcome at days 21,60,and 90（P〈0.05）.Independent living ability of the patients was also improved（67.9%of group A vs 59.3%of group B,0-1 at modified Rankin criteria）. Moreover,the herbal medicine treatment showed a tendency in improving quality of life at a time-dependent manner.Adverse events,including gastrointestinal adverse events,skin symptoms,hemorrhagic tendency, and aminotransferase increase,happened in 76 cases from both groups,and no significant difference was found between the two groups.Correlation analysis showed that aminotransferase increase was not related to the herbal medicine treatment,but to the lipid-lowering drugs. Conclusion：The present research demonstrates that the herbal medicine treatment shows effects on neurological deficit and patient-reported outcome at day 21,activities of daily living and handicap at day 60, and handicap,activities of daily living and patient-reported outcome at 3-month follow-up.