中西医结合治疗症状性颅内动脉狭窄临床随访研究
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摘要
目的：
症状性颅内动脉粥样硬化性狭窄是导致缺血性卒中的主要原因之一。血管内支架成形术已被应用于症状性颅内动脉狭窄的治疗。目前国内仅有少数有关症状性颅内动脉狭窄血管内治疗的短中期随访研究的报道,缺乏有关中长期随访研究,鲜有中西医结合治疗的临床研究。本研究将对单中心血管内支架成形术结合中医阴阳类证分型治疗症状性颅内动脉狭窄围手术期的临床疗效进行评价,分析影响因素,总结中长期随访结果,分析病变特点、中医阴阳类证分型治疗对临床终点事件的影响。
方法：
对2005年10月至2011年7月收治的症状性颅内动脉狭窄的患者采用血管内支架成形术结合中医阴阳类证分型治疗的方案,所有病例均为内科保守治疗后仍有症状的患者,根据中医辩证标准分为阴类证和阳类证,分别予以相应的中药治疗；常规予以西医内科治疗；在中西医结合内科治疗基础上,予以血管内支架成形术。回顾性分析症状性颅内动脉狭窄的患者围手术期和中长期随访结果,总结入组病例的临床表现、影像学特点、狭窄病变形态学特征和中医阴阳类证分型治疗的异同,对上述因素对手成功率、临床终点事件的影响进行分析。
结果：
共有75例症状性颅内动脉狭窄患者(79处病变)入组。其中77处病变成功接受支架成形术治疗,技术成功率为97.5%。围手术期(30天内)发生并发症共9例(11.4%)。其中非致残性并发症2例(2.5%),致残性并发症为7例(8.9%),死亡为4例(5.1%),出血性卒中为5例(6.3%),其中3例与球囊选择和导丝穿孔有关；缺血性卒中为3例(4%),其中按SAMPPRIS试验研究的颅内动脉支架置入手术技术成熟标准,2例缺血性卒中发生在非手术成熟期,1例发生在手术成熟期。手术成熟期的围手术期缺血性卒中发生率低于SAMMPRIS试验研究。
支架置入30天后共随访68例,失访7例,随访周期6-78个月,平均30.4个月；随访期间再发中风10例,同侧中风7例,其中脑梗死4例,死亡1例,TIA3例,非同侧中风3例。随访期间中药服用率为72.5%。本研究第1、3个月累积中风发生率为0.054和0.07,UCLA随访研究分别为0.203和0.24,WASID试验为0.12和0.16；本研究第24月累积中风发生率为0.2,UCLA随访研究结果为0.245；本研究累积中风发生时间明显滞后于UCLA和WASID研究,中长期累积中风发生率低于UCLA随访研究。动脉粥样硬化危险因素、病变狭窄的严重程度、以及中医阴阳类证对手术成功率、安全性和临床预后无明显影响。79处病变中,接受影像学随访h26例,其中5处发生支架内再狭窄,其发生率达19.9%,症状性再狭窄占11.5%。
结论：
中西医结合治疗症状性颅内动脉狭窄围手术期仍有较高的并发症率,应谨慎开展血管内支架成形术。结合中药治疗可能降低围手术期缺血性卒中并发症的发生；中长期随访结果显示,症状性重度颅内动脉狭窄患者,在血管内支架成形术治疗后并未呈现较中度狭窄者为高的卒中复发风险；与单纯药物治疗比较,重度狭窄患者通过血管内支架成形术获益明显。中长期随访结果提示,血管内治疗中西医结合内科治疗可能有助于减少缺血性中风的再发。中医药在症状性颅内动脉狭窄支架围手术期及疗效方面作用需进一步研究。
Objectives
Symptomatic intracranial atherosclerotic stenosis is the primary cause of ischemic stroke. Endovascular stent angioplasty has been used as a treatment of symptomatic intracranial arterial stenosis. Currently, there are only a few short or medium term follow-up study reports about the endovascular treatment for symptomatic intracranial arterial stenosis, medium or long term follow-up studies are lacking, and the clinical studies about the treatments integrating traditional Chinese and western medicine are rare. The aim of our study is to evaluate the clinical efficiency of Yin and Yang symptom divisions of the traditional Chinese medicine in the perioperative period of endovascular stent angioplasty for symptomatic intracranial arterial stenosis, and to analyze the influencing factors, summarize the results of medium or long term follow-up, dissect the pathology characteristics and the influences of Yin and Yang symptom divisions of the traditional Chinese medicine on the clinical endpoint events.
Methods
For the patients with symptomatic intracranial arterial stenosis received from October2005to July2010, the integrated treatments of endovascular stent angioplasty and Yin and Yang symptom divisions of the traditional Chinese medicine were adopted, all the cases were the patients who still showed symptoms after conservative medical therapy, and they were divided into Yin symptoms and Yang symptoms according to the symptoms categorizing standards of the traditional Chinese medicine, and they were given corresponding traditional Chinese medicines. At the same time, the regular western internal medicine therapy was provided, too. And on the basis of the combined treatment of the traditional Chinese medicine and western medicine, endovascular stent angioplasty was operated. The curative effects of the perioperative period and medium and long term follow-up of the patients with symptomatic intracranial arterial stenosis was analyzed retrospectively; the clinical symptoms of the patients included in the team, the iconographical features, the morphological characteristics of the stenosis and the similarity and difference of the treatment of Yin and Yang symptom divisions of the traditional Chinese medicine were summarized; and the influences of the above factors on the operation success rate and clinical endpoint events were analyzed.
Results:
Totally75cases (79lesions) with symptomatic intracranial arterial stenosis were included in the study.77lesions were given endovascular stent angioplasty successfully, and the procedural success rate was97.5%. In the perioperative period (within30days),9(11.4%) complications cases occurred. Among them,2(2.5%) were non disabling complication cases,7(8.9%) were disabling complication cases,4(5.1%) were death cases,5(6.3%) were hemorrhagic stroke cases,3cases were related with balloon choice and guidewire perforation;3(4%) were ischemic stroke cases, according to the mature technology standards for the intracranial artery stent placement surgery based on the SAMPPRIS study.2ischemic stroke cases occurred in the non mature state of operation,1case occurred in the mature state of operation. The incidence of ischemic stroke in the perioperative period of the mature state of operation was lower than that of the SAMMPRIS trial.
30days after period of stent treatment,68cases were followed up,7cases lost connection. Follow-up period was6-78months, an average30.4months; In the follow up period, stroke reoccurrence were10cases, with7cases of ipsilateral recurrent stroke,4cases of cerebral infarction,1cases of death,3cases of TIA, and3cases of lateralrecurrent stroke. The Chinese medicine taking rate in the follow-up period was72.5%. The cumulative stroke incidences of this study in the1st and the3rd months were0.054and0.07, The UCLA follow up study were0.203and0.24, WASID trail reports were0.12and0.16, the cumulative stroke incidences in the1st and the3rd months were0.203and0.245respectively. And the results of the WASID study reports were0.12and0.16. The cumulative incidence of stroke occurring in the follow-up period of this research was lower than the research results of the UCLA and the WASID. The atherosclerosis risk factors, the severity of the stenosis, and the Yin and Yang symptoms of traditional Chinese medicine had no obvious effect on operation's success rate and safety and clinical prognosis. Among the follow-up79lesions,26cases received radiological follow-up, of which,5cases of stent restenosis occurred, the incidence rate was19.9%, with symptomatic restenosis accounting for11.5%.
Conclusions
The patients with symptomatic intracranial arterial stenosis treated with integrated treatment of western medicine and traditional Chinese medicine still facing the risk of high incidence of perioperative period complications, so the application of endovascular stent angioplasty on such patients should be more cautious. The traditional Chinese medicine treatment can lower the incidence of perioperative period ischemic strokes. The medium and long term follow-up results showed that, for the patients with severe stenosis did not show a higher incidence of post-operation recurrent stroke comparing with the patients with moderate stenosis. For patients with severe stenosis, endovascular stent angioplasty shows a much higher efficiency comparing with medicine treatment. The integrated treatment of traditional Chinese and western medicine might help to reduce the post-operation recurrent ischemic strokes. Further study might be needed to evaluate the efficiency of traditional Chinese medicine in the stents perioperative period for symptomatic intracranial artery stenosis.
症状性颅内动脉粥样硬化性狭窄是导致缺血性卒中的主要原因之一。血管内支架成形术已被应用于症状性颅内动脉狭窄的治疗。目前国内仅有少数有关症状性颅内动脉狭窄血管内治疗的短中期随访研究的报道,缺乏有关中长期随访研究,鲜有中西医结合治疗的临床研究。本研究将对单中心血管内支架成形术结合中医阴阳类证分型治疗症状性颅内动脉狭窄围手术期的临床疗效进行评价,分析影响因素,总结中长期随访结果,分析病变特点、中医阴阳类证分型治疗对临床终点事件的影响。
方法：
对2005年10月至2011年7月收治的症状性颅内动脉狭窄的患者采用血管内支架成形术结合中医阴阳类证分型治疗的方案,所有病例均为内科保守治疗后仍有症状的患者,根据中医辩证标准分为阴类证和阳类证,分别予以相应的中药治疗；常规予以西医内科治疗；在中西医结合内科治疗基础上,予以血管内支架成形术。回顾性分析症状性颅内动脉狭窄的患者围手术期和中长期随访结果,总结入组病例的临床表现、影像学特点、狭窄病变形态学特征和中医阴阳类证分型治疗的异同,对上述因素对手成功率、临床终点事件的影响进行分析。
结果：
共有75例症状性颅内动脉狭窄患者(79处病变)入组。其中77处病变成功接受支架成形术治疗,技术成功率为97.5%。围手术期(30天内)发生并发症共9例(11.4%)。其中非致残性并发症2例(2.5%),致残性并发症为7例(8.9%),死亡为4例(5.1%),出血性卒中为5例(6.3%),其中3例与球囊选择和导丝穿孔有关；缺血性卒中为3例(4%),其中按SAMPPRIS试验研究的颅内动脉支架置入手术技术成熟标准,2例缺血性卒中发生在非手术成熟期,1例发生在手术成熟期。手术成熟期的围手术期缺血性卒中发生率低于SAMMPRIS试验研究。
支架置入30天后共随访68例,失访7例,随访周期6-78个月,平均30.4个月；随访期间再发中风10例,同侧中风7例,其中脑梗死4例,死亡1例,TIA3例,非同侧中风3例。随访期间中药服用率为72.5%。本研究第1、3个月累积中风发生率为0.054和0.07,UCLA随访研究分别为0.203和0.24,WASID试验为0.12和0.16；本研究第24月累积中风发生率为0.2,UCLA随访研究结果为0.245；本研究累积中风发生时间明显滞后于UCLA和WASID研究,中长期累积中风发生率低于UCLA随访研究。动脉粥样硬化危险因素、病变狭窄的严重程度、以及中医阴阳类证对手术成功率、安全性和临床预后无明显影响。79处病变中,接受影像学随访h26例,其中5处发生支架内再狭窄,其发生率达19.9%,症状性再狭窄占11.5%。
结论：
中西医结合治疗症状性颅内动脉狭窄围手术期仍有较高的并发症率,应谨慎开展血管内支架成形术。结合中药治疗可能降低围手术期缺血性卒中并发症的发生；中长期随访结果显示,症状性重度颅内动脉狭窄患者,在血管内支架成形术治疗后并未呈现较中度狭窄者为高的卒中复发风险；与单纯药物治疗比较,重度狭窄患者通过血管内支架成形术获益明显。中长期随访结果提示,血管内治疗中西医结合内科治疗可能有助于减少缺血性中风的再发。中医药在症状性颅内动脉狭窄支架围手术期及疗效方面作用需进一步研究。
Objectives
Symptomatic intracranial atherosclerotic stenosis is the primary cause of ischemic stroke. Endovascular stent angioplasty has been used as a treatment of symptomatic intracranial arterial stenosis. Currently, there are only a few short or medium term follow-up study reports about the endovascular treatment for symptomatic intracranial arterial stenosis, medium or long term follow-up studies are lacking, and the clinical studies about the treatments integrating traditional Chinese and western medicine are rare. The aim of our study is to evaluate the clinical efficiency of Yin and Yang symptom divisions of the traditional Chinese medicine in the perioperative period of endovascular stent angioplasty for symptomatic intracranial arterial stenosis, and to analyze the influencing factors, summarize the results of medium or long term follow-up, dissect the pathology characteristics and the influences of Yin and Yang symptom divisions of the traditional Chinese medicine on the clinical endpoint events.
Methods
For the patients with symptomatic intracranial arterial stenosis received from October2005to July2010, the integrated treatments of endovascular stent angioplasty and Yin and Yang symptom divisions of the traditional Chinese medicine were adopted, all the cases were the patients who still showed symptoms after conservative medical therapy, and they were divided into Yin symptoms and Yang symptoms according to the symptoms categorizing standards of the traditional Chinese medicine, and they were given corresponding traditional Chinese medicines. At the same time, the regular western internal medicine therapy was provided, too. And on the basis of the combined treatment of the traditional Chinese medicine and western medicine, endovascular stent angioplasty was operated. The curative effects of the perioperative period and medium and long term follow-up of the patients with symptomatic intracranial arterial stenosis was analyzed retrospectively; the clinical symptoms of the patients included in the team, the iconographical features, the morphological characteristics of the stenosis and the similarity and difference of the treatment of Yin and Yang symptom divisions of the traditional Chinese medicine were summarized; and the influences of the above factors on the operation success rate and clinical endpoint events were analyzed.
Results:
Totally75cases (79lesions) with symptomatic intracranial arterial stenosis were included in the study.77lesions were given endovascular stent angioplasty successfully, and the procedural success rate was97.5%. In the perioperative period (within30days),9(11.4%) complications cases occurred. Among them,2(2.5%) were non disabling complication cases,7(8.9%) were disabling complication cases,4(5.1%) were death cases,5(6.3%) were hemorrhagic stroke cases,3cases were related with balloon choice and guidewire perforation;3(4%) were ischemic stroke cases, according to the mature technology standards for the intracranial artery stent placement surgery based on the SAMPPRIS study.2ischemic stroke cases occurred in the non mature state of operation,1case occurred in the mature state of operation. The incidence of ischemic stroke in the perioperative period of the mature state of operation was lower than that of the SAMMPRIS trial.
30days after period of stent treatment,68cases were followed up,7cases lost connection. Follow-up period was6-78months, an average30.4months; In the follow up period, stroke reoccurrence were10cases, with7cases of ipsilateral recurrent stroke,4cases of cerebral infarction,1cases of death,3cases of TIA, and3cases of lateralrecurrent stroke. The Chinese medicine taking rate in the follow-up period was72.5%. The cumulative stroke incidences of this study in the1st and the3rd months were0.054and0.07, The UCLA follow up study were0.203and0.24, WASID trail reports were0.12and0.16, the cumulative stroke incidences in the1st and the3rd months were0.203and0.245respectively. And the results of the WASID study reports were0.12and0.16. The cumulative incidence of stroke occurring in the follow-up period of this research was lower than the research results of the UCLA and the WASID. The atherosclerosis risk factors, the severity of the stenosis, and the Yin and Yang symptoms of traditional Chinese medicine had no obvious effect on operation's success rate and safety and clinical prognosis. Among the follow-up79lesions,26cases received radiological follow-up, of which,5cases of stent restenosis occurred, the incidence rate was19.9%, with symptomatic restenosis accounting for11.5%.
Conclusions
The patients with symptomatic intracranial arterial stenosis treated with integrated treatment of western medicine and traditional Chinese medicine still facing the risk of high incidence of perioperative period complications, so the application of endovascular stent angioplasty on such patients should be more cautious. The traditional Chinese medicine treatment can lower the incidence of perioperative period ischemic strokes. The medium and long term follow-up results showed that, for the patients with severe stenosis did not show a higher incidence of post-operation recurrent stroke comparing with the patients with moderate stenosis. For patients with severe stenosis, endovascular stent angioplasty shows a much higher efficiency comparing with medicine treatment. The integrated treatment of traditional Chinese and western medicine might help to reduce the post-operation recurrent ischemic strokes. Further study might be needed to evaluate the efficiency of traditional Chinese medicine in the stents perioperative period for symptomatic intracranial artery stenosis.
引文
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