急性缺血中风临床路径多中心实施及评价
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摘要
脑血管病目前已成为我国城市和农村人口的第一位致残和死亡原因,且发病有逐年增多的趋势。我国现存脑血管病患者700余万人,其中约70%为缺血中风。专家预测,到2020年,卒中的患病人数将增加一倍,病死率为30-50%,在存活的中风患者中,约有四分之三不同程度地丧失劳动能力。中风的复发率也很高,五年的复发率为40%。目前,全国每年用于治疗中风病的费用估计要在100亿元以上,加上各种间接经济损失,每年因本病支出接近200亿元人民币,给国家和众多家庭造成沉重的经济负担。临床路径作为一种管理模式,由于其可以控制成本和时间的特点,逐渐被引入医疗领域,并逐渐显现出其特有的优势,本研究依托于“2007年度国家中医药管理局公益性行业专项”“基于糖尿病周围神经病变等7个病种中医最佳诊疗方案的临床路径共性技术研究”子课题“急性缺血中风临床路径建与评价的示范性研究”,在前期文献调研、专家咨询法制定的急性缺血中风临床路径诊疗方案的基础上,进行多中心临床实施,同时进行回顾性调查,最终通过历史对照研究从多个角度评价急性缺血中风临床路径的疗效。
目的：
在本科室通过文献法及专家法制定的急性缺血中风临床路径诊疗方案基础上,采用多中心历史对照的研究方法从临床疗效、卫生经济学指标等方面评价急性缺血中风临床路径。
方法：
2010.1.18-2010.8.30全国六个分中心同时纳入前瞻性及回顾性病例,前瞻性病例实施急性缺血中风临床路径,回顾性病例作为对照组,最终进行历史对照,从临床疗效、卫生经济学方面分析急性缺血中风临床路径。1.疗效：(1)本研究把以下情况定义为有效：①患者入院时意识水平为昏迷、昏睡或嗜睡,转为出院时意识清醒；②清醒患者出院时NIHSS评分比入院时NIHSS评分下降2分；③清醒患者出院时NIHSS评分少于或等于3分。同时把未能符合上述条件或死亡的病例定义为无效。(2)并发症发生率：(3)关键环节执行度即关键环节变异情况。2.卫生经济学：住院时间、总住院费用及平均住院费用。3.人本评估：病人满意度、医护满意度。
结果：
急性缺血中风临床路径共6个分中心,前瞻性研究计划各分中心分别纳入患者40例,计划共纳入患者共240例。实际2010.1.18-2010.8.30共纳入患者312例,其中11名患者中途退出路径；4名患者因需行支架等手术退出路径,1名患者因“脊髓型颈椎病”需行手术治疗退出路径；2名患者分别因“病窦综合症”及“肺部感染”转科治疗；2名患者由于病情危重,应家属要求签字自动出院；另外2名患者由于同时患有重症肌无力和不能排除多发性硬化所以不能实施路径治疗方案。2例患者在最终质控中发现不符合纳入标准,发病时间大于14天。最终纳入路径患者299例患者。回顾性研究同时期纳入728例患者,由于回顾性研究主要作为前瞻性研究对照,故回顾性研究主要进行描述性分析。
前瞻性研究有效率72.2%,回顾性研究有效率55.1%,二者差异有统计学意义(P<0.05)；并发症方面：前瞻性研究中发生脑疝患者0例,回顾性研究发生脑疝患者11例(1.5%),二者差异有统计学意义(P<0.05),前瞻性研究发生泌尿系感染患者6例(2.0%),回顾性研究发生泌尿系感染43例(5.9%),二者差异有统计学意义(P<0.05)；卫生经济学指标方面,前瞻性研究299例患者,平均住院天数为17.18日,回顾性研究782例患者,平均住院天数为21.4天,二者差异有统计学意义(P<0.05),提示临床路径的实施可以有效降低患者住院天数。前瞻性研究平均住院费用为12081元,回顾性728例患者中,平均住院费用为17965.7元,中位数为12289元,日平均住院费用,前瞻性研究日均住院费用为736.6元,中位数为444元,回顾性研究日均住院费用为882元,中位数为706元,二者差异有统计学意义(P<0.05),提示临床路径的实施可以降低患者总住院费用及日均住院费用。前瞻性研究中,入院24小时行NIHSS评分、完成颅脑影像学检查、48小时内抗血小板聚集、洼田饮水评价及入院后行TCD、彩超、康复、活血化瘀、针灸、通腑的比率均较回顾性研究高,差异均有统计学意义(P<0.05)。
另外,前瞻性研究内部分析结果显示：急性缺血中风患者疗效的影响因素为洼田饮水试验的分级及是否发生并发症,并发症发生率方面,进展性卒中与洼田饮水分级及阴阳类证有一定相关性。路径过程中发生变异多的患者住院费用比变异少的患者高,阴类证患者的住院费用较阳类证患者高。
人文满意度评价方面,患者满意度主要从医疗过程、等候时间、服务态度及整体满意四个方面进行评价,结果显示四个方面患者的满意度均较高,绝大多数患者选择了较满意及很满意,总体满意度较好,较满意及很满意在总体满意度方面占90%以上。医护人员满意度主要从医疗过程、等候时间、服务态度及整体满意几个方面进行评价,结果显示医务人员满意度四个方面的满意度均在90%以上,证明急性缺血中风临床路径在临床应用中操作简单,得到医务人员的认同。
结论：
急性缺血中风临床路径的实施可以有效改善患者疗效,减少部分并发症的发生,降低患者住院天数及住院费用；同时提高医护人员对于指南的执行度,提高患者及医护人员的满意度。
Background
Cerebralvascular disease (CVD) has become the first cause of death and disability in both urban and rural areas. The patients suffered the cerebralvascular disease are increasing year by year. There are over7million patients of CVD in china, of which about70%are ischemic stroke. According to the experts, the amount of stroke patients will be twice as it was now until2020and the death rate is about30%-50%. Among the survivial patients, about3/4lost labour. Meanwhile, the recurrence rate of stroke is also high which is40%in5years. Nowadays, the direct cost of stroke is about10billion every year and the total cost is about20billion which is a great burden to the country. Clinical pathway, as a management pattern which can control both the time and cost, has been induced to the medical area. Based on the hypothesis that the clinical pathway of acute ischemic stroke can reduce the cost and hospitalization days on the condition of guaranteeing the effect, this study applied the historical control study to evaluate the effect of clinical pathway.
Object i ve
Based on the protocol of acute ischemic stroke clinical pathway of our department through the literature research and experts consensus, applying the multiple center historical study to evaluate the clinical pathway of acute ischemic stroke.
Method
Multiple center perspective study and retrospective study have been applied during2010.1-2010.10.The prespective study apply the acute ischemic stroke clinical pathway and the retrospective study as the control group. At last, evaluate the effect of clinical pathways through the comparation of perspective study and retrospective study.
Results
299patients are enrolled to the prospective study and728patients are enrolled to the retrospective study. The comparasion of the perspective study and the retrospective study showed that the application of acute ischemic stroke clinical pathways can elevate the effective rate and reduce the occurrence rate of complications (hernia, pneumonia and urinary tract infection). At the same time, it can reduce the cost and the hospitalization days.
And the inner analysisi of the perspective study showed that swallowing level and the complications are related to the effect. Pneumonia and the progressive stroke is the most common complications and of which the swallow level and the yin-yang syndrome are the influencial factors of progressive storke. As to the cost and hospitalization days, the amount of the variations is the influential factors of the cost but not related to the hospitalization days.
As to the degree of satisfaction,both the patients and the doctors feel good about the linical pathway and the total degeree of satisfaction is over90%.
Conclusion
The application of clinical pathway can improve the effect of acute ischemic stroke, decrease the occurrence rate of some complications and reduce the cost and the hospitalization days.
目的：
在本科室通过文献法及专家法制定的急性缺血中风临床路径诊疗方案基础上,采用多中心历史对照的研究方法从临床疗效、卫生经济学指标等方面评价急性缺血中风临床路径。
方法：
2010.1.18-2010.8.30全国六个分中心同时纳入前瞻性及回顾性病例,前瞻性病例实施急性缺血中风临床路径,回顾性病例作为对照组,最终进行历史对照,从临床疗效、卫生经济学方面分析急性缺血中风临床路径。1.疗效：(1)本研究把以下情况定义为有效：①患者入院时意识水平为昏迷、昏睡或嗜睡,转为出院时意识清醒；②清醒患者出院时NIHSS评分比入院时NIHSS评分下降2分；③清醒患者出院时NIHSS评分少于或等于3分。同时把未能符合上述条件或死亡的病例定义为无效。(2)并发症发生率：(3)关键环节执行度即关键环节变异情况。2.卫生经济学：住院时间、总住院费用及平均住院费用。3.人本评估：病人满意度、医护满意度。
结果：
急性缺血中风临床路径共6个分中心,前瞻性研究计划各分中心分别纳入患者40例,计划共纳入患者共240例。实际2010.1.18-2010.8.30共纳入患者312例,其中11名患者中途退出路径；4名患者因需行支架等手术退出路径,1名患者因“脊髓型颈椎病”需行手术治疗退出路径；2名患者分别因“病窦综合症”及“肺部感染”转科治疗；2名患者由于病情危重,应家属要求签字自动出院；另外2名患者由于同时患有重症肌无力和不能排除多发性硬化所以不能实施路径治疗方案。2例患者在最终质控中发现不符合纳入标准,发病时间大于14天。最终纳入路径患者299例患者。回顾性研究同时期纳入728例患者,由于回顾性研究主要作为前瞻性研究对照,故回顾性研究主要进行描述性分析。
前瞻性研究有效率72.2%,回顾性研究有效率55.1%,二者差异有统计学意义(P<0.05)；并发症方面：前瞻性研究中发生脑疝患者0例,回顾性研究发生脑疝患者11例(1.5%),二者差异有统计学意义(P<0.05),前瞻性研究发生泌尿系感染患者6例(2.0%),回顾性研究发生泌尿系感染43例(5.9%),二者差异有统计学意义(P<0.05)；卫生经济学指标方面,前瞻性研究299例患者,平均住院天数为17.18日,回顾性研究782例患者,平均住院天数为21.4天,二者差异有统计学意义(P<0.05),提示临床路径的实施可以有效降低患者住院天数。前瞻性研究平均住院费用为12081元,回顾性728例患者中,平均住院费用为17965.7元,中位数为12289元,日平均住院费用,前瞻性研究日均住院费用为736.6元,中位数为444元,回顾性研究日均住院费用为882元,中位数为706元,二者差异有统计学意义(P<0.05),提示临床路径的实施可以降低患者总住院费用及日均住院费用。前瞻性研究中,入院24小时行NIHSS评分、完成颅脑影像学检查、48小时内抗血小板聚集、洼田饮水评价及入院后行TCD、彩超、康复、活血化瘀、针灸、通腑的比率均较回顾性研究高,差异均有统计学意义(P<0.05)。
另外,前瞻性研究内部分析结果显示：急性缺血中风患者疗效的影响因素为洼田饮水试验的分级及是否发生并发症,并发症发生率方面,进展性卒中与洼田饮水分级及阴阳类证有一定相关性。路径过程中发生变异多的患者住院费用比变异少的患者高,阴类证患者的住院费用较阳类证患者高。
人文满意度评价方面,患者满意度主要从医疗过程、等候时间、服务态度及整体满意四个方面进行评价,结果显示四个方面患者的满意度均较高,绝大多数患者选择了较满意及很满意,总体满意度较好,较满意及很满意在总体满意度方面占90%以上。医护人员满意度主要从医疗过程、等候时间、服务态度及整体满意几个方面进行评价,结果显示医务人员满意度四个方面的满意度均在90%以上,证明急性缺血中风临床路径在临床应用中操作简单,得到医务人员的认同。
结论：
急性缺血中风临床路径的实施可以有效改善患者疗效,减少部分并发症的发生,降低患者住院天数及住院费用；同时提高医护人员对于指南的执行度,提高患者及医护人员的满意度。
Background
Cerebralvascular disease (CVD) has become the first cause of death and disability in both urban and rural areas. The patients suffered the cerebralvascular disease are increasing year by year. There are over7million patients of CVD in china, of which about70%are ischemic stroke. According to the experts, the amount of stroke patients will be twice as it was now until2020and the death rate is about30%-50%. Among the survivial patients, about3/4lost labour. Meanwhile, the recurrence rate of stroke is also high which is40%in5years. Nowadays, the direct cost of stroke is about10billion every year and the total cost is about20billion which is a great burden to the country. Clinical pathway, as a management pattern which can control both the time and cost, has been induced to the medical area. Based on the hypothesis that the clinical pathway of acute ischemic stroke can reduce the cost and hospitalization days on the condition of guaranteeing the effect, this study applied the historical control study to evaluate the effect of clinical pathway.
Object i ve
Based on the protocol of acute ischemic stroke clinical pathway of our department through the literature research and experts consensus, applying the multiple center historical study to evaluate the clinical pathway of acute ischemic stroke.
Method
Multiple center perspective study and retrospective study have been applied during2010.1-2010.10.The prespective study apply the acute ischemic stroke clinical pathway and the retrospective study as the control group. At last, evaluate the effect of clinical pathways through the comparation of perspective study and retrospective study.
Results
299patients are enrolled to the prospective study and728patients are enrolled to the retrospective study. The comparasion of the perspective study and the retrospective study showed that the application of acute ischemic stroke clinical pathways can elevate the effective rate and reduce the occurrence rate of complications (hernia, pneumonia and urinary tract infection). At the same time, it can reduce the cost and the hospitalization days.
And the inner analysisi of the perspective study showed that swallowing level and the complications are related to the effect. Pneumonia and the progressive stroke is the most common complications and of which the swallow level and the yin-yang syndrome are the influencial factors of progressive storke. As to the cost and hospitalization days, the amount of the variations is the influential factors of the cost but not related to the hospitalization days.
As to the degree of satisfaction,both the patients and the doctors feel good about the linical pathway and the total degeree of satisfaction is over90%.
Conclusion
The application of clinical pathway can improve the effect of acute ischemic stroke, decrease the occurrence rate of some complications and reduce the cost and the hospitalization days.
引文
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