| Background: Cerebral arteriosclerosis(CAS)stenosis is the primary cause of ischemic cerebral vascular disease(ICVD),and stenting is considered a safe and effective intervention in addition to pharmacological treatment.However,the early clinical outcome of patients after stenting and in-stent restenosis(ISR)after stenting are issues that clinicians cannot ignore.According to TCM,atherosclerotic cerebral infarction(ACI)patients still belong to the category of "stroke" after cerebral artery stenting,and the pathogenesis of the disease is deficiency of Qi and blood stasis.ISR after arterial stent implantation.Objective: To evaluate the early clinical efficacy and effect of Chinese medicine Tongxinluo capsule on postoperative ISR in patients after cerebral artery stenting,and to explore the potential mechanism.Methods: This study was further conducted prospectively on the basis of a retrospective study,which consisted of the following three parts.Part I: A retrospective cohort study design was used.Patients who underwent cerebral artery stenting at the Department of Neurology,First Affiliated Hospital of Shandong First Medical University from January 2020 to October 2021 were included.Patients who underwent standardized treatment(cerebral artery stenting + standard drug therapy)according to the Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke were selected and divided into a Chinese medicine group(cerebral artery stenting + standard drug therapy + Tongxinluo capsule)and a control group(cerebral artery stenting + standard drug therapy)according to whether they were treated with Tongxinluo capsule in combination after surgery.The clinical efficacy of Tongxinluo Capsules was initially evaluated in patients with large-artery atherosclerosis(LAA)type ACI after cerebral artery stenting according to the Clinical Neurological Impairment Scale for Stroke Patients(1995)at 3 months postoperatively.Part II: A retrospective cohort study design was used to include patients with CAS who underwent cerebral artery stenting at the Department of Neurology,First Affiliated Hospital of Shandong First Medical University from January 2018 to October 2021.Standardized treatment was administered to all included patients according to the Chinese Guidelines for Early Endovascular Intervention in Acute Ischemic Stroke.Patients in the Chinese medicine group were treated with the standard treatment combined with Tongxinluo capsules.The incidence of ISR at 1 year postprocedure was used as the primary efficacy outcome.The incidence of transient ischemic attack(TIA)and ischemic cerebral infarction(CIS)at4 weeks,3 months,6 months and 1 year after treatment were used as secondary efficacy indicators to investigate the effect of Tongxinluo capsules on postoperative ISR in patients with CAS.Part III: A prospective cohort study was used to investigate the effect of Tongxinluo capsules on patients after cerebral artery stent implantation,who belong to patients with Qi deficiency and blood stasis evidence.Ninety patients with ACI who belonged to Qi deficiency and blood stasis evidence after cerebral artery stent implantation at the Department of Neurology,First Affiliated Hospital of Shandong First Medical University from December 2021 to January 2023 were included.The patients were randomly divided into the control group and the Chinese medicine group using the randomized lottery method.In the control group,standardized treatment was carried out in accordance with the Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke,including dual antiplatelet aggregation,circulation improvement,oxygen free radical scavenging,risk factor control and other pharmacological treatments,rehabilitation training and health education;in the Chinese medicine group,Tongxinluo capsule(0.26g*10 capsules;usage: 3 times a day,4 capsules each time)was administered on this basis.Ltd.).The follow-up period was3 months.The clinical efficacy of the nimodipine method at 3 months after surgery was used as the main efficacy index,and the degree of improvement of the Qi deficiency and blood stasis syndrome score and the Chinese medicine syndrome score;the modified Rankin scale(m RS)score;homocysteine(Hcy),low density lipoprotein(LDL),and blood stasis syndrome score at 3 months after surgery was used as the main efficacy index.homocysteine(Hcy),low density lpoprotein(LDL),interleukin 6(IL-6)and hypersensitive C-reactive protein(Hs-CRP)levels were used as secondary efficacy indicators.The efficacy of standard treatment combined with Chinese herbal medicine Tongxinluo capsule treatment was evaluated in CAS patients with Qi deficiency and blood stasis evidence after cerebral artery stenting.Result: Part I: A total of 329 patients were included,152 in the Chinese herbal medicine group and 177 in the control group.There was no statistical difference between the two groups in terms of age,gender,risk factors,surgical site,surgical site stenosis rate and rehabilitation training time(P>0.05),which were comparable.The study showed that(1)Chinese herbal medicine Tongxinluo capsule could promote the recovery of neurological function in ACI patients 3 months after cerebral artery stenting(P=0.005)and improve their clinical efficacy(P<0.001);(2)Tongxinluo capsule reduced LDL level(P<0.001)and Hs-CRP level(P<0.001)in ACI patients 3 months after stenting;however,it had no effect on patients had no significant effect on Hcy levels at 3 months postoperatively(P>0.05).Part II: A total of 163 patients were included,including 67 patients in the Chinese medicine group and 95 patients in the control group.There was no statistical difference between the two groups in terms of age,gender,risk factors,surgical site and surgical site stenosis rate,and rehabilitation training time(P>0.05),which were comparable.The study showed that(1)the incidence of ISR 1 year after stenting(P=0.013)was significantly lower in the Chinese medicine group(2)the risk of TIA within 6 months and 1 year after stenting(6 months: P=0.021;1 year: P=0.032)was downregulated in the Chinese medicine group,but there was no statistical difference in the incidence of TIA within 1 month and within3 months between the two groups(P>0.05);(3)the incidence of CIS within1 year after stenting in patients in the Chinese herbal medicine group(P=0.019)was decreased compared with the control group,but there was no statistical difference in the incidence of CIS within 1 month,within 3months and within 6 months in the two groups(P>0.05).Part III: A total of 90 patients with Qi deficiency and blood stasis evidence were included,including 45 patients in the Chinese medicine group and 45 patients in the control group.5 patients were excluded during the follow-up(3 in the Chinese medicine group and 2 in the control group);1case in the Chinese medicine group was shed.Finally,84 cases were completed,including 41 cases in the Chinese medicine group and 43 cases in the control group.There was no statistical difference between the two groups in terms of age,gender,risk factors,surgical site and surgical site stenosis rate,and rehabilitation training time(P>0.05),which were comparable.The study showed that(1)there was no statistical difference in NIHSS scores before treatment between the two groups(P=0.651),and the NIHSS scores of patients in the Chinese medicine group were further reduced at 3 months after surgery compared with the control group(P=0.001);(2)there was no statistical difference in m RS scores before treatment between the two groups(P=0.694).The m RS scores of patients in the Chinese medicine group were further reduced at 3 months after surgery compared with the control group(P=0.003);(3)The Chinese medicine evidence points of patients in the Chinese medicine group were reduced at 3 months after surgery compared with the control group(P<0.001),and the clinical efficacy of Chinese medicine was significantly improved compared with the control group(P<0.001).(4)LDL(P<0.001),Hs-CRP(P=0.856)and IL-6(P<0.001)levels were significantly lower in patients in the TCM group compared with the control group at 3 months postoperatively,and there was no statistical difference in Hcy levels between the two groups(P>0.05).Conclusion: Standard treatment combined with Tongxinluo capsule treatment can help improve the early efficacy after stenting in ACI patients with qi deficiency and blood stasis evidence,and improve the early patient’s daily living ability;secondly,standard treatment combined with Tongxinluo can significantly reduce the TCM evidence score after cerebral artery stenting in ACI patients with qi deficiency and blood stasis evidence,and improve the TCM clinical efficacy;furthermore,standard treatment combined with Tongxinluo can reduce the In addition,standard treatment combined with Tongxinluo could reduce LDL and Hs-CRP levels after cerebral artery stenting in ACI patients,and down-regulate IL-6 levels after cerebral artery stenting in ACI patients with Qi deficiency and blood stasis.In addition,standard treatment combined with Tongxinluo was effective in reducing the incidence of ISR in CAS patients1 year after cerebral artery stenting. |
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