| ObjectiveIn recent years,with the development of interventional therapy technology,promotion and application of its trauma,less side effects,the overall treatment of good features such as clinical recognition and is widely used.In the field of ischemic cerebrovascular disease,the use of arterial angioplasty,stenting and acute ischemic cerebrovascular disease is the most widely used.However,with the depth of interventional therapy,as one of the most promising methods of treatment,stent implantation has attracted more and more attention from clinicians.There are complications such as thrombosis,cerebral hemorrhage,restenosis after stent implantation and over-perfusion,particularly after stent implantation.The incidence of restenosis(ISR)after stent implantation is not only high incidence,also affect cerebral hemodynamics,leading to the occurrence of ischemic cerebrovascular disease(ICDV),such as transient ischemic attack(TIA),symptomatic cerebral infarction and other disease.Xiongshao Capsule,as Xuefuzhuyu Decotion in two main herbs,has the effect of promoting blood circulation and removing blood stasis,and after many years of clinical research,it can significantly reduce the occurrence of restenosis after coronary intervention.In accordance with the principle of "heart and brain Tongzhi" in traditional Chinese medicine,Xiongshao Capsule was applied to patients with ischemic cerebrovascular disease and vertebrobasilar artery after stenting,to observe its efficacy for the prevent of local vascular restenosis,for the treatment of vertebral basilar artery restenosis to explore a new way to prevent the occurrence of ischemic cerebrovascular disease.Method(1)Search and collect related documents and reports,the full ues of retrieval tool,like CNKI Database,Wanfang Database,CBM Database,the electronic search of MEDLINE Database,EMBASE Database etc.The material and date were collected to analyze the incidence,the theory,the related factors and the correlative measures of restenosis after vertebral basilar artery stenting.The clinical study of traditional Chinese medicine on restenosis after coronary artery stent implantation,extended to herbs for prevention of restenosis after vertebral artery stenting.(2)The development of clinical research program,the corresponding method,process and the specific implementation measures,the design of Xiongshao Capsule clinical observation form application to this subject,meanwhile the use of the NIHSS and ADL Brath Index as neurological function score.At the same time with cooperative hospital(Capital Medical University Xuanwu Hospital)to energetic contact and cooperate to coordinate the completion of this clinical research.(3)Selection criteria:Between 18-80 years of age,in the vertebrobasilar system(including intracranial and extracranial of vertebral artery,and basilar artery)successfully received balloon dilatation and/or stent placement,postoperative routine oral Aspirin Intestine Soluble tablets 100mg qd + Clopidogrel tablets 75mg qd for 6 months,as well as TCM syndrome type is "blood stasis and/or qi deficiency"patients,a total of 80 sufferers were chosen.80 cases of percutaneous vertebral artery stent implantation was successful in patients with ICDV,were randomly divided into the conventional treatment group(control group)and the conventional medicine plus Xiongshao Capsule(Chinese medicine group).After 6 months follow-up,7 patients didn't meet the entry criteria(automatic fall off,no regular oral anticoagulation and antiplatelet drugs,no regular oral distribution of drugs),finally a total of 73 sufferers were enrolled respectively for control group 40 cases and treatment group 33 cases.Through the tests to understand the degree of ISR in two groups.(4)In accordance with design requirements collect information,carefully check to ensure that date is reliable,using ACCESS twice into the machine,the statistical analysis,comparison between the two groups complications.Result(1)Through the literature search,collation and analysis,we found the following characteristics:?Perioperative anticoagulation and antiplatelet aggregation therapy are the primary measures to prevent ISR.Once the time is more than 6 months,the main reason for the occurrence of ISR is due to excessive proliferation of vascular intima,prolonged oral administration of Clopidogrel to prevent ISR is of little significance.?Diabetes mellitus,diseased vascular distorted,postoperative residual stenosis,long segment(>10mm)stenosis is the occurrence of vertebrobasilar ISR independent risk factors.Hypertension,hyperlipidemia,homocysteine and smoking are high risk factors for ISR.?ISR is more likely to happened in younger ones,may be associated with a stronger and faster rate of intimal hyperplasia in youngers.In addition,the youngers with plaque with more fibrous tissue composition,lymphocyte infiltration,and elders with intravascular plaque prone to calcification,lymphocyte infiltration less.? The results showed that there was no significant difference incidence of ISR between the self-expandable stent and the balloon-expandable stent.Although the self-expandable stent is prone to restenosis within 6 months,however its late stability is better than the balloon dilatation stent.While there is still a research shows that the self-expandable stent with good flexibility will increase the risk of atherosclerotic plaque into the stent lumen,the radial stress of the easy promote intimal hyperplasia caused restenosis,and balloon dilatation and stent radial stress is small,may reduce the occurrence of restenosis.?From the perspective of TCM,this treatment is a kind of external trauma.As a means of palliative and injury,although it can solve the "standard" problem,but the "virtual" intervention after treatment still exists.This exogenous trauma,combined with the process of stent implantation is the process of consumption of blood injury,resulting in qi deficiency can promote blood,blood line is poor,over time stagnation in the vessel,the formation of postoperative restenosis,in line with TCM "blood stasis" category,treatment should be blood circulation.The utilize of TCM in the ISR,not only can reduce the serious complications,especially the risk of ISR,but also shorten LOS and improve the success rate of surgery.?In interventional treatment of Xiongshao Capsule restenosis after coronary intervention,Xiongshao Capsule can significantly reduce the level of Ang ? and promote the apoptosis of SMC,so as to inhibit atherosclerosis.In interventional treatment of Xiongshao Capsule restenosis after coronary intervention.(2)From December 2012 to June 2016,has been in Xiyuan Hospital and Xuanwu Hospital successfully receives stent placement patients were randomly divided into two groups.Between the two groups,the patient is generally similar and comparable in general and baseline.(3)73 cases were followed up for 6 months.The rate of vertebral artery restenosis was 12.12%in the Chinese medicine group and 32.5%in the control group.The date were analyzed by statistical software.Whether there was significant difference in the incidence of ISR between the two groups,the statistics showed significant difference(P<0.05).There was no significant difference in the incidence of symptomatic cerebral infarction and TIA between the two groups.(4)Chinese medicine group and control group on the syndrome differentiation of TCM shows:? Rough observation before treatment,Qi deficiency score was significantly low than the blood stasis score.?Before and after treatment in the two groups using paired samples T test found that the Qi deficiency syndrome score didn't change significantly,the difference was not statistically significant(P>0.05).Indicating stent implantation and postoperative medication,the impact of patients with Qi deficiency is not obvious."Blood stasis syndrome" score,before and after treatment decreased mean,the difference was statistically significant(P<0.05),indicating stent implantation and/or medication can improve the symptoms of patients with blood stasis syndrome.?Found through independent sample T test between the two groups,the mean value of the blood stasis after treatment between the two groups has statistically significant(P<0.05),which explained that the symptoms of patients with biood stasis syndrome were better than those of the control group.Conclusion:(1)After 6 months of observation,found that vasoconstriction,neointimal hyperplasia,thrombosis,vascular remodeling,and ultimately lead to ISR,the mechanism consistent with TCM "Blood stasis" category.Belong to the "Blood stasis"in TCM Syndrome Types in patients,Xiongshao Capsule can not only reduce vertebral artery ISR,which means play a preventive role,but also improve the blood stasis syndrome.(2)The score of TCM syndrome,Qi deficiency score is not high,before and after treatment is not changed,consider the following two reasons:?Patients with vertebral basilar artery stenting have been considered to have a series of symptoms due to vascular stenosis.This is similar to the partial mechanism of vascular restenosis,which accords with the category of "Blood stasis syndrome" in TCM,resulted in bias in case selection.?Consider the case of the study is less,the lack of sample.(3)No significant difference for the occurrence of symptomatic cerebral infarction and TIA.(4)Because of the limit of time and conditions,this paper selected a small number of cases,in the preliminary confirmed Xiongshao Capsule can reduce the basis of vertebral basilar artery ISR,the sample size should be further expanded,double-blind,placebo-controlled randomized controlled trial. |
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