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目的根据国家中医药管理局“十一五”重点专科(专病)工作计划和要求,对中西医结合颅脑损伤诊疗方案进行验证,确定其临床疗效和安全性,为进一步优化诊疗方案奠定基础。方法采用非随机、多中心、治疗前后自身对照法,中、重型颅脑损伤患者,接受西医常规治疗,并按诊疗方案进行中医综合治疗。以3周为1个疗程,治疗并观察4个疗程,观察其治疗前后Glasgow(GCS)评分、日常生活活动能力评分、神经功能缺损程度评分及安全指标等,并进行疗效分析及安全性评估。结果颅脑损伤方案能显著改善颅脑损伤患者GCS评分(中型)、神经功能缺损评分及日常生活活动能力评分,总有效率达58.1%,无安全不良事件发生。结论颅脑损伤验证方案能够有效地改善颅脑损伤患者临床症状,是一套疗效可靠、安全的中西医结合综合治疗方案,值得临床推广。
Objective To validate the diagnosis and treatment program of craniocerebral injury with integrated traditional Chinese and western medicine according to the work plan and requirements of the State Administration of Traditional Chinese Medicine “Eleventh Five-Year ” key specialty (special disease), to determine its clinical efficacy and safety. In order to further optimize the diagnosis and treatment plan Lay the foundation. Methods Non-randomized, multicenter, self-control, moderate and severe craniocerebral injury patients before and after treatment were routinely treated by western medicine and were treated by traditional Chinese medicine according to the diagnosis and treatment plan. Three courses and one course of treatment were followed up for 4 courses. The Glasgow (GCS) score, daily living activity score, neurological deficit score and safety index were observed before and after treatment. The curative effect and safety evaluation were also evaluated. Results The craniocerebral injury program can significantly improve the GCS score (middle), neurological deficit score and daily living activity score of patients with craniocerebral injury, with a total effective rate of 58.1% and no adverse safety events. Conclusion The craniocerebral injury verification scheme can effectively improve the clinical symptoms of patients with craniocerebral injury. It is a reliable and safe combination of traditional Chinese and western medicine, worthy of clinical promotion.