Objective To explore the changes in macrophage infiltration behavior during the dynamic evolution of thrombi following the formation of acute carotid artery thrombosis occlusion(ACTO).Methods 15 healthy male New Zealand rabbits were selected to establish an ACTO model by causing injury to the rabbit carotid artery using surgical sutures treated with ferric chloride.All rabbits were randomly divided into 5 groups according to the end-point time using the random number table method,namely 24-hour group,1 week group,4week group,8 week group,and 12week group postoperatively,with 3 rabbits in each group.At 24 hours post-operation,the ACTO model was examined by DS A.At 24 hours,1 week,4 weeks,8 weeks,and 12 weeks post-operation,samples were taken from the thrombotic arterial segment of the 3 rabbits in each group and embedded in paraffin.The thrombus samples were stained with hematoxylin-eosin(HE)and Martius scarlet blue(MSB)to analyze changes in thrombus morphology and composition(including red blood cells,fibrin and collagen fibers).Orbit Imaging Analysis software was used for semi-quantitative analysis of the thrombus composition components.Using immunohistochemistry to detect the distribution of MO and M2 macrophages in thrombi,aimed to summarize the dynamic evolution of thrombus morphology,composition,and macrophage infiltration behavior at different stages following ACTO occurrence.Results The 24-hour DSA results indicated that all experimental rabbits successfully established the ACTO model.(1)HE staining showed a continuous increase in thrombus size from 24 hours to 1 week.By 4 weeks,signs of thrombus dissolution appeared,and at 8 weeks,neovascularization was observed within the thrombus.By 12 weeks,signs of fibrosis were evident in the thrombus.(2)MSB staining revealed that during the acute phase of thrombus formation(within 24 hours after surgery),red blood cells were the predominant component initially,but after this period,fibrin and collagen fibers became the main components.(3)The detection results of MO macrophages showed that 24 hours after surgery,MO macrophages in the thrombus were not evenly distributed throughout the thrombus,but mainly gathered at the thrombus edge;at 1 week after surgery,the positive area percentage of MO macrophage in the thrombus increased compared with 24 hours after surgery(thrombus edge:[41.7±27.0]％vs.[24.6±16.7]％,thrombus core:[35.7±19.6]％vs.[11.1±10.4]％,all P＜0.001),and evenly distributed within the thrombus;at 4 weeks after surgery,MO macrophages in the thrombus decreased compared with 1 week after surgery(thrombosis edge:[10.7±6.1]％vs.[41.7±27.0]％,thrombus core:[12.1±8.5]％vs.[35.7±19.6]％,all P＜0.001),the differences were statistically significant.At 4,8,and 12 weeks after surgery,MO macrophages within the thrombus did not change significantly with time(thrombus edge:[10.7±6.1]％,[8.0±7.7]％,and[8.9±5.3]％;thrombus core:[12.1±8.5]％,[9.5±4.2]％,and[15.7±11.0]％),and the differences were not statistically significant(all P＞0.05).In addition,at 12 weeks after surgery,MO macrophages at the thrombus edge was less than the thrombus core([8.9+5.3]％vs.[15.7±11.0]％,P＜0.01).The detection results of M2 macrophages showed that 24 hours after surgery,M2 macrophages in the thrombus were widely distributed throughout the thrombus;at 1 week after surgery,the positive area percentage of M2 macrophages in the thrombus increased compared with 24 hours after surgery(thrombus edge:[22.1±11.3]％vs.[11.4±8.7]％,P＜0.001;thrombus core:[24.5±9.8]％vs.[7.6±6.0]％,P＜0.001);at 4 weeks after surgery,M2 macrophage in the thrombus decreased compared with 1 week after surgery(thrombosis edge:[10.6±3.7]％vs.[22.1±11.3]％,P＜0.001;thrombus core:[9.2±4.3]％vs.[24.5±9.8]％,P＜0.001);at 8 weeks after surgery,M2 macrophages in the thrombus increased compared with 4 weeks after surgery([17.9±8.8]％vs.[9.2±4.3]％,P＜0.001),and the differences were statistically significant.However,M2 macrophages in the thrombus did not change significantly from 8 weeks to 12 weeks after surgery(thrombus edge:[9.4±6.3]％vs.[8.5±5.3]％,P＞0.05;thrombus core:[17.9±8.8]％vs.[14.4±10.0]％,P＞0.05).In addition,at 8 and 12 weeks after surgery,M2 macrophages in the thrombus core was greater than the thrombus edge(8 weeks after surgery:[17.9±8.8]％vs.[9.4±6.3]％,P＜0.001;12weeks after surgery:[14.4±10.0]％vs.[8.5±5.3]％,P＜0.001).Conclusions This study successfully established an ACTO animal model and demonstrated for the first time the dynamic evolution of macrophages within 12 weeks post-thrombus formation.Macrophages may played a significant role in both thrombus formation and fibrinolysis,as well as in the promotion of thrombus dissolution and the formation of new blood vessels within the thrombus which may potentially promote the spontaneous reperfusion of the occluded vessels.The results of this study need further verification.

Objective:To explore the relationship between neutrophil to lymphocyte ratio(NLR) and first pass effect (FPE) during mechanical thrombectomy in patients with acute anterior circulation large vessel occlusive stroke.Methods:Four hundred and six patients with acute anterior circulation large vessel occlusive stroke, admitted to and received mechanical thrombectomy in our hospital from January 2018 to June 2021, were chosen in our study. They were divided into FPE group ( n=186) and non-FPE group ( n=220) according to whether the occluded vessels were successfully or completely re-canalized after the first mechanical thrombectomy. The baseline data, clinical characteristics and operation related data were recorded and compared. The factors with P<0.05 in univariate analysis were included in multivariate Logistic regression analysis to identify the independent factors for FPE. The receiver operating characteristic (ROC) curve was plotted to compare the effectiveness of various factors in predicting FPE. Results:Univariate analysis showed that there were significant differences in gender, proportion of different collateral circulation grading, neutrophil count, lymphocyte count, platelet to lymphocyte ratio (PLR), and NLR between the two groups ( P<0.05). As compared with non-FPE group, FPE group had significantly higher ASPECTS scores at admission, significantly shorter time from femoral artery puncture to recanalization, significantly higher proportion of vascular recanalization, statistically higher proportion of patients using balloon guiding catheter, significantly lower ratio of contrast extravasation, significantly lower incidences of spontaneous intracerebral hemorrhage and mortality, and statistically higher rate of good prognosis 90 d after surgery ( P<0.05). The results of multivariate Logistics regression analysis showed that gender ( OR=0.686, 95%CI: 1.131-3.491, P=0.017), ASPECTS scores ( OR=0.143, 95%CI: 0.094-0.220, P<0.001), NLR ( OR=1.722, 95%CI: 1.413-2.098, P<0.001), and PLR ( OR=1.007, 95%CI: 1.003-1.014, P<0.001) were independent factors for FPE. ROC curve results showed that the areas under the curve predicted by gender, ASPECTS scores, PLR, NLR and combination of multiple factors (gender+ASPECTS scores+PLR+NLR) were 0.60, 0.17, 0.71, 0.77 and 0.91, respectively; among them, NLR had the highest efficacy in single-factor prediction for FPE, with cut-off value of 5.86, specificity of 83.3%, and sensitivity of 62.3%. Conclusion:High NLR at admission in patients with acute anterior circulation large vessel occlusive stroke is likely to have FPE failure during mechanical thrombectomy.

Objective:To investigate the effect of thrombus burden on the clinical outcome of endovascular recanalization in large vessel occlusive stroke.Methods:Patients with acute anterior circulation occlusion who underwent endovascular treatment within 24 hours after onset in Zhengzhou University People′s Hospital from January 2018 to December 2019 were retrospectively collected. According to the clot burden score (CBS) of DSA, total objectives were divided into CBS≥6 group (24 cases) and CBS<6 group (38 cases). Clinical data of the two groups were collected and the modified Rankin scale (mRS) was used to evaluate the clinical outcome at 90 days after surgery. Independent sample t-test, Wilcoxon rank sum test and χ 2 test were used to compare the clinical data between the two groups. Independent risk factors affecting the clinical outcome were analyzed by binary logistic regression. Results:There were no statistically significant differences in basic demographic data, stroke risk factors and other factors between the CBS≥6 group and CBS<6 group ( P>0.05).The proportion of using tirofiban after surgery in the CBS≥6 group (63.2%, 24/38) was lower than that in the CBS<6 group (87.5%, 21/24) (χ2=4.380, P=0.044). The discharge NIHSS score of the CBS≥6 group was [5.0 (3.3, 7.8) points] lower than CBS<6 group [8.5 (1.8, 14.5) points] ( Z=5.221, P=0.022). The proportion of postoperative mRS 0-2 was (91.7%, 22/24) in the CBS≥6 group higher than CBS<6 group(39.5%, 15/38) (χ2=20.486, P=0.001), there were no statistically significant differences between the two groups ( P<0.05). The results of binary logistics regression analysis showed the CBS groups (OR=0.042, 95%CI 0.007-0.244 , P=0.001) was an independent risk factor affecting good outcome. Subgroup analysis of whether tirofiban was used or not showed there was no statistically significant difference in clinical prognosis between the two groups ( P>0.05). Conclusions:The clinical outcome of CBS≥6 group is significantly better than that of CBS<6 group, and patients with small thrombus burden are more likely to get a good clinical outcome of 90 days.

Objective:To investigate the safety and efficacy of endovascular treatment in acute anterior circulation massive cerebral infarction and its prognostic factors.Methods:A retrospective analysis was performed on clinical data of 34 patients with acute anterior circulatory massive cerebral infarction who received intravascular treatment in our hospital from February 2018 to December 2019. The perioperative hemorrhage rate and mortality rate were analyzed in these patients. Modified Rankin scale (mRS) scores were taken as the evaluation standard in the prognoses of these patients during the 90 d of follow up, and the influencing factors affecting the prognoses of patients with massive cerebral infarction were analyzed.Results:The operation was successful in 30 patients (88.2%); the operation time was (97.41±54.58) min, and the number of thrombolysis was (1.91±0.75) times. Distal embolization occurred in 4 patients (11.8%); there were 3 patients with non-symptomatic hemorrhage (8.8%) and 3 patients with symptomatic hemorrhage (8.8%). Cerebral hernia occurred in 7 patients (20.6%); there were 5 deaths (14.4%). During the 90 d of follow up, 13 patients (38.2%) had good prognosis, and 21 (61.8%) had poor prognosis; there were statistically significant differences in NIHSS scores at admission, infarction locations in diffusion weighted imaging, vascular occlusion locations in DSA, pecentages of patients accepted preoperative intravenous thrombolysis and patients with cerebral hernia between the two groups ( P<0.05). NIHSS scores at admission ( OR=0.817, 95% CI: 0.682-0.980, P=0.029), thrombus load scale scores ( OR=5.981, 95%CI: 1.827-19.575, P=0.003), vascular occlusion locations in DSA ( OR=0.031, 95% CI: 0.003-0.311, P=0.003) and pecentage of patients accepted preoperative intravenous thrombolysis ( OR=0.092, 95% CI: 0.010-0.838, P=0.034) were independent factors influencing the prognoses of emergency intravascular treatment. Conclusions:Endovascular recanalization can achieve a relatively good prognosis in patients with massive cerebral infarction. Patients with low NIHSS scores, high thrombotic load scale scores, and middle cerebral artery occlusion, and patients accepted direct intravascular treatment have relatively good prognosis.

Objective To evaluate the feasibility of transvenous embolization treatment for cerebral arteriovenous malformations(bAVM). Methods From November 2016 to April 2017, the information of 6 patients with brain arteriovenous malformation in our center accepting the intravenous radical embolization were collected, who were ruptured bAVM, bAVM with a single drainage vein, not suitable for surgery confirmed by neurosurgeon consultation or explicitly refused craniotomy. The modified Rankin Scale score of five patients were smaller than three before treatment.The location of draining vein flowing venous sinus was shown by rotational DSA and 3D reconstructed images.A liquid embolic agent was injected via Sonic catheter to completely embolism the brain arteriovenous malformation under controlling blood pressure and blocking the blood provisionally.The perioperative complications and modified Rankin Scale score were observed and recorded 30 days after treatment. Results The transvenous embolization treatment was successfully performed in six patients with 7 embolization procedures.There were no definite operation-related complications. the mRS of all cases were ≤1 within 30 days after operation. Conclusion The embolization technique via the internal jugular vein is feasible for bAVM patients with a single drainage vein,while the long-term outcome need more evaluations.

Objective To evaluate the mid-and long-term follow-up outcome of revascularization and stenting of nonacute intracranial vertebrobasilar artery occlusion. Methods Consecutive data of 27 patients who suffered from nonacute intracranial vertebrobasilar artery occlusion beyond 24 hours and underwent endovascular revascularization, were retrospectively collected and analyzed. Complications and recurrent ischemic events during the follow-up period were recorded. The modified Rankin scale(mRS) scores were used and compared between pre-and postoperation. Results All 27 patients except one(96.3%) obtained successful recanalization. After the procedure, 13 patients showed improvement, 11 were stable, and 3 worse. The decline of median mRS scores, which was 4(interquarter range-IR, 2-5) preoperatively and 3(IR, 1-5) on discharge. Five patients suffered from procedural complications and three of them resulted in aggravation. Nineteen patients received imaging follow-up during the median 10 months, 6 restenosis occurred and 3 of them were symptomatic. During median 55 months clinical follow-up after operation, 2 ipsilateral stroke and 2 ipsilateral transient ischemic attack occurred. The mRS scores decreased significantly in the first one year after procedure. Conclusions Revascularization and stenting of nonacute intracranial vertebrobasilar artery occlusion can prevent recurrent ipsilateral ischemic event and improve disability recovery in the first one year.

OBJECTIVE:To guarantee the reliability of cold chain drug storage device and the quality of the drugs in the hospi-tal. METHODS:The establishment and effects of drug cold chain monitoring platform in our hospital were introduced as well as re-lated improvement and measures. RESULTS:The cold chain monitoring platform was established in our hospital through equipping with related equipment, constructing platform network, determining monitoring point, setting early warning condition, etc. All-weather and real-time monitoring of temperature and humidity were realized for different districts of the hospital and different cold chain equipments. The platform could provide the information about operating condition of equipment,and complete drug re-frigeration temperature record;equipment failure could be dissolved in time based on early warning message. Through analyzing rea-sons of early warning message,the unqualified equipment was updated in time,which further improve the system and procedure of cold chain monitoring platform. Within 2 years after the implementation of the platform,53 sets of special refrigerator for drug were updated. Monthly early warning message and the rate of refrigeration equipment early warning decreased from 6869 and 100% in Sept. 2014 at the early stage of short message warning function to 1083 and 40% in Feb. 2016,respectively. CONCLU-SIONS:The establishment of drug cold chain monitoring platform guarantees the reliability of cold drug storage condition so as to ensure the quality of drug in the hospital.

Objective To compare the perioperative complications of prophylactic use of three antiplatelet strategies in unruptured intracranial aneurysms treated by stent assisted coiling. Methods A total of 203 consecutive patients were brought into this retrospective study including the following three groups:the loading group (n=54), with a loading dose of 300 mg to 600 mg clopidogrel at 2 h to 24h before the stenting; tirofiban group (n=50), a loading dosage of tirofiban (8 μg/kg/min over 3 min) followed by a 0.1μg/kg/min maintenance dosage; dual antiplatelet group (n=99), dual oral antiplatelet drugs (clopidogrel 75 mg + aspirin 100 mg) pretreated for 3-5 days before the operation. Events of hemorrhage and thromboembolism were recorded and the complications were compared to assess the safety and efficacy of various antiplatelet strategies. Chi-square or Fisher exact tests were used for categorical variables. Results The hemorrhagic rates were 11.1% in loading group, 2.0% in dual antiplatelet group, and 0% in tirofiban group, respectively, while the thromboembolic rates were 7.4% in loading group, 4.0% in dual antiplatelet group, and 0% in tirofiban group, respectively. For total complications, significant difference (P<0.05) existed among the three groups, and the complication rate in loading group was significantly higher than that of the dual group (P=0.016) and tirofiban group (P=0.001), while there was no significant difference between tirofiban group and dual antiplatelet group(P>0.05). The hemorrhagic rate in loading group was significantly higher than that of the dual group (P=0.023) and tirofiban group (P=0.027), while there was no significant difference between tirofiban group and dual antiplatelet group (P>0.05). In subgroup analysis of the loading group, the postoperative thromboembolic rate was significantly higher in those exposed to low molecular weight heparin than those not (P=0.039) with no increase of hemorrhagic events (P>0.05). Conclusions When compared with the dual antiplatelet strategy, tirofiban strategy may be used as a new prophylactic protocol in unruptured intracranial aneurysms treated by stent assisted coiling. Those treated by low molecular weight heparin postoperatively after receiving dual antiplatelet therapy may increase the hemorrhagic risk, although there was a significant decrease in thromboembolic events postoperatively.

OBJECTIVE:To improve the drug turnover rate and the work efficiency of drug storehouse,and to reduce the cost of drug storage. METHODS:Based on ABC dynamic classification,original drug procurement management module in HIS was im-proved. Scientific,accurate and reasonable drug procurement plan was generated by the system automatically through setting pro-curement proportion coefficient. Drug procurement by type was achieved through adding classification scanning function,based on distribution mode and drug property classification. Related index were compared before and after improvement to evaluate the ef-fects of the improvement. RESULTS:Compared with before improvement,average monthly inventory amount of drugs in our hos-pital reduced by 6.44%,turnover rate increased by 47.13%(increasing from 4.18% to 6.15%),and the time for developing pro-curement plan decreased by 75.00%(decreasing from 8 h to 2 h). CONCLUSIONS:The improvement of drug procurement man-agement module effectively reduce drug inventory and improve turnover rate of drugs and work efficiency.

Sample size is one of important factors determining the results of a clinical trial, and the choice of sample size estimation methods is related to the specific design of clinical trials. On clinical safety reevaluation of postmarketing Chinese medicine, we often design cohort study, case-control study, nested case-control study or hospital centralized monitoring, which need large sample sizes. In evaluating the effectiveness of postmarketing Chinese medicine widely applied in the large population, pragmatic randomized controlled trial (PRCT) is more suitable than explanatory randomized controlled trial (ERCT). ERCT is necessary to conduct confirmatory study for new indications of postmarketing Chinese medicine. According to the specific purpose, design type and evaluation index, we choose the suitable sample size estimation method, and determine the corresponding parameters. We must estimate and determine the suitable sample size according to the specific clinical evaluation design, with comprehensive consideration of the test power, research cost and practical operability.
Cohort Studies ; Drug Therapy ; standards ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; standards ; therapeutic use ; Humans ; Product Surveillance, Postmarketing ; Public Health ; Randomized Controlled Trials as Topic ; Sample Size