| BackgroundThe reasonable and standardized use of Chinese medicine has always been a difficult point in clinical research,and the diagnosis and treatment of acute stroke is complicated and diverse in real world,which further increases the difficulty of such researches.The drug instructions of Xingnaojing inj ection indicate that it can be used for both acute intracerebral hemorrhage and 1 ischemic stroke,and it is the only necessary Chinese medicine on ambulance car in Beijing for stroke first aid.However,in the real world,the diagnosis and treatment of acute stroke is complex and diverse.There is no relevant evidence for clinicians’ cognitive and attitude,early use of Xingnaojing for acute stroke.PurposeIt aims to provide a multi-angle evidence basis for the rational application of Xingnaojing injection for acute stroke as well as the design of related clinical researches.Methods1.Overview of systematic reviews and/or meta-analyses of Xingnaojing injection in adjuvant treatment for acute strokeAccording to the Cochrane handbook,we comprehensively searched 7 Chinese and English databases to identify systematic reviews and/or meta-analyses of Xingnaojing on ischemic stroke(IS)and intracerebral hemorrhage(ICH),and systematically summarized and evaluated the quality of current evidence of Xingnaojing on IS and ICH.2.Cross-sectional survey:Analysis of the characteristics of early use of Xingnaojing injection for acute stroke and its correlation with patient prognosis based on data from a third-class Chinese medicine hospitalRetrieving the HIS database of a third-class Chinese medicine hospital in Beijing from May 1,2019 to May 31,2020,and collected patients with "acute IS" or "acute ICH" as the first diagnosis that was hospitalized in the neurology and neurosurgery department.Extracted the basic information from the electronic medical records of the patients with Xingnaojing and the usage of Xingnaojing injection(dosage,course of use and time of use),combined Chinese medicine and western medicine,discharge outcome,neurological function score(National Institute of Health stroke scale,NIHSS),daily living ability score and other information etc.,Use SPSS 20.0 statistical software to analyze descriptive data based on frequency and rate,and the chi-square test or non-parametric test was used to screen the influencing factors of patient’s Barthel index(BI)and NIHSS score changes(discharge and admission are reduced by 1 point as the clinical minimum meaningful value),such as different time points use of Xingnaojing,course of treatment,combined diseases,and severity of stroke(AIS patients judged by NIHSS score;ICH patients with bleeding site and volume)and reperfusion therapy.Logistic regression model was used to analyze the relevant variables.3.Doctors’ knowledge and attitude towards the treatment of acute stroke with Xingnaojing injectionBased on the quantitative data results of Study upon,semi-structured interviews were conducted using focus group interviews.The interviewees were the three focus groups of the neurology,neurosurgery,and emergency department clinicians of the hospital.Use Nvivo12 software to conduct thematic analysis on the interview data after transcription check.4.AIS clinical auditTaking the early basic treatment of AIS by Chinese and Western medicine as the audit theme.Among the 864 AIS cases of study 2,the patients were randomly sorted using Excel according to the patient’s name,and 300 cases were randomly selected for clinical audit.2018"Guidelines for diagnose and treatment of Acute Ischemic Stroke" and the Chinese Medicine Guidelines were selected as the criteria for clinical audit.Results1.Literature overviewA total of 235 relevant literatures were retrieved,finially 10 and 13 systematic reviews of randomized controlled trials of Xingnaojing for AIS and ICH were included after screening.The methodological quality of the included literature were very low.In the included AIS literature,there were 20 important outcomes,7(35%)outcomes were rated as low-quality evidence,10(50%)outcomes were rated as very low-quality evidence and 3(15%)outcomes were rated as moderate-quality evidence.In the included ICH literature,there were 36 important outcomes,of which 2(5.6%)outcomes were rated as moderate-quality evidence,7(19.4%)outcomes were rated as low-quality evidence,and 27(75%)were rated as very low-quality evidence.Moderate quality evidence showed that compared with Danshen injection,Xingnaojing combined with conventional treatment reduced all-cause mortality in patients with AIS;compared with conventional treatment,Xingnaojing reduced all-cause mortality in patients with acute ICH.A total of 10 SRs reported slight adverse events,there was no statistical difference between the experimental group and control group,no serious adverse events were reported.All included studies did not report the different medication time of Xingnaojing for acute stroke and the severity of stroke.The quality of the included studies were low,so the current evidence did support a positive conclusion on the effectiveness and safety of Xingnaojing for acute stroke.2.The characteristics of early use of Xingnaojing for acute stroke and its correlation with the prognosis of patientsA total of 1024 patients were recruited,finally 46 patients with acute ICH and 864 patients with AIS met the criteria.2.1 Acute ICHAnalysis of medication characteristics:Among 46 patients with acute ICH,the number of patients who used Xingnaojing injection was 33,the use rate of Xingnaojing in acute ICH patients in this hospital was 71.7%.Of the 33 patients who used Xingnaojing,11 cases were sent to the emergency department by 120 ambulances(33.3%),and 1 case was started with Xingnaojing in the ambulance(accounting for 3%of all patients with ICH);20 patients were admitted to the emergency department(60.6%),a total of 22 cases(66.7%)started to use Xingnaojing in the emergency department;Among the 33 patients,51.5%(17 cases)started to use Xingnaojing within 6 hours after the stroke onset of onset;as for the combination with western medicine,the usage rate of gastrodin injection was as high as 81.8%(27 cases).Among the 33 patients with acute ICH,there were 11 cases with missing data on admission and discharge BI scores,and 22 cases with valid data.Because of the lack of information on the location and volume of bleeding in patients with ICH in the original case,which are the key factors affecting the BI of patients discharged from the hospital,the statistical analysis of factors affecting the BI of patients with ICH such as the different intervention time points of Xingnaojing has not been carried out.2.2 AISAnalysis of medication characteristics:Among the 864 AIS patients who met the inclusion criteria,167 of them used Xingnaojing injection,and the use rate of Xingnaojing in AIS patients was 19.3%inthis hospital.Among the 167 AIS patients,70.1%(117 cases)were admitted to the emergency department,27 cases were admitted to the hospital by ambulance,accounting for 16.2%,and 1 case of Xingnaojing was used in 120 ambulances(accounting for all AIS patients with 0.6%).Among 22 patients with arteriovenous thrombolysis,2 patients took Angongniuhuang Pill before intravenous thrombolysis,accounting for 9.1%,and 12 patients started to use Xingnaojing after intravenous thrombolysis,accounting for 54.5%;and used 72 hours after the onset of AIS Xingnaojing accounted for up to 28.1%(47 cases);AIS patients used Xingnaojing for the first time in neurology department accounted for up to 74.8%(125 cases);As for the combination medicine,Atorvastatin was the most frequently used western medicine accounted for 88.02%(147 cases);the most combined use of Chinese medicines was Danhong injection 51.5%(83 cases).Prognostic correlation analysis:Among the 167 patients with AIS,the NIHSS score of admission and discharge of 29 cases was missing,and there were 138 cases with valid data.Univariate analysis of chi-square test results and non-participatory tests indicated that gender,different time points use of Xingnaojing(within 6h of onset,24h of onset,and 72h of onset),hospitalized NIHSS score,combined hypertension,previous IS,and reperfusion therapy were correlated with changes in NIHSS in AIS patients.There was no statistical difference in the correlation between different medication time points and discharge BI of AIS patients.The results of binary logistic regression analysis suggested that gender,Xingnaojing’s different use time points(within 24 hours of onset,72 hours of onset),hypertension,previous IS,and reperfusion therapy have no significant effect on the changes of AIS patients’ discharge-admission NIHSS(P>0.05),while the use of Xingnaojing within 6 hours from onset of AIS and the NIHSS score of the patient’s admission were independent influencing factors for the improvement of the NIHSS neurological function(P<0.05).The neurological function of NIHSS improved 4.099 times(OR=4.099,95%CI 1.459-11.512)in patients who used Xingnaojing within 6 hours from onset of AIS(than those who used after 6 hours from onset of AIS).3.Qualitative interviewAmong the 11 clinicians involved in the interview,5 were neurologists,3 were neurosurgeons,and 3 were emergency doctors;besides,2 were with senior titles,5 were with intermediate titles,and 4 were with junior titles;2 were with Western medicine background,6 with Chinese medicine background and 3 with integrated traditional Chinese and Western medicine background;working year ranged from 2-25 years,average working year was 9.91;interview time was 2021.1.24-1.28.The results of qualitative data showed that a total of 5 themes and 180 codes have been obtained.Mandatory options:Consciousness disorder,AIS with bleeding and oozing,and Xingnaojing’s TCM syndromes such as phlegm-heat syndrome,fire syndrome,etc.,would also be the first choice for traditional Chinese medicine doctors,while western neurosurgeons doctors and non-encephalopathy emergency doctors will not use it right now(influencing factors were mainly due to the nature of the job and medical insurance restrictions);the usage and dosage were more based on personal habits(the interpretation of medical insurance was different);the timing and order of medication:after thrombolysis,use Xingnaojing immediately,or use it 24 hours after thrombolysis(for fear of drug interactions and aggravate the risk of bleeding).There is no special consideration for acute ICH;early use(on emergency ambulances):support(Traditional Chinese medicine doctors believe that it needs to be differentiated before use),Neutral(Western doctors).4.Clinical audit4.1 2018 " Guidelines for diagnose and treatment of Acute Ischemic Stroke " AuditThe conformity of imaging examination,thrombolysis,blood pressure control,and antiplatelet was 100%,while the NIHSS assessment was 99.7%;the use of neuroprotective agents which was not recommended by the guidelines was high,this conformity was 53.3%;early rehabilitation was only 13.3%;the in-hospital secondary prevention for lipid-lowering was consistent,the degrees was 100%.4.2 Clinical audit of TCM guidelinesThe conformity of TCM diagnosis was 95%,the syndrome differentiation was 96.8%,the Chinese herbal medicine prescription was 84.7%,and the conformity of Chinese patent medicine blood circulation and blood stasis removal drugs was 100%,but for time use of such medicine,the guidelines gave no clear recommendations.Conclusion1.The results of the mixed methods research suggested that based on the cross-sectional survey of 167 patients in a third-class Chinese medicine hospital,the early use of Xingnaojing injection within 6 hours from onset of AIS(compared with use after 6 hours)was relevant with the improvement of neurological function in patients with AIS,Although TCM doctors support the use of Xingnaojing as soon as possible,when Xingnaojing was conflict with thrombolysis and other reperfusion therapy,there would be medication use concerns.Further prospective studies are still needed to verify the causality and efficacy;2.Based on the results of a cross-sectional study and qualitative interviews conducted in the third-class Chinese medicine hospital,it was found that the proportion of Xingnaojing injection used for acute ICH was higher than the proportion of AIS,which was largely due to medical insurance restrictions,but there was no uniform standard for the interpretation of medical insurance;3.Clinical audit found that Xingnaojing assisted treatment for AIS,and the treatment plan of Chinese and Western medicine in the investigated hospital was in high compliance with Western medicine guidelines for thrombolysis,blood pressure,blood sugar control,antiplatelet,and lipid-lowering treatment;but neuroprotective agent use was beyond the recommendation of the guidelines,and patients in stable stage after 24 hours of onset have a low degree of bedside rehabilitation.The future multi-center clinical research should fully consider the difference between traditional Chinese medicine and Western medicine routine diagnosis and treatment in Chinese and Western medicine hospitals at the design stage. |
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