| Research backgroundIn 2016,the Lancet published a new analysis of global causes of death by the international burden of disease group:cerebrovascular disease is the leading cause of death among Chinese people,accounting for 20.1%of all causes of death.Ischemic stroke,accounting for 70%to 80%of all strokes,has become the leading cause of death in China’s population,with an annual growth rate of 8.7%.Stroke is the dominant disease of TCM treatment,and TCM treatment can make up for the deficiency of TCM treatment when combined with western medicine.The formula of invigorating qi and activating blood has been widely used in the treatment of cerebral apoplexy.Many animal experiments,clinical studies and microscopic studies have shown that it is effective and safe.In order to clarify the precise positioning of traditional Chinese medicine qilong capsule in clinical treatment,improve clinical efficacy and highlight its clinical advantages,clinical research was carried out to provide reference for the accurate treatment of ischemic stroke in the acute stage.Research purposeThe clinical efficacy and effectiveness of the two groups of drugs were compared by observing the degree of disability,neurological deficit,daily life ability,physical and chemical examination indexes and the influence on platelet activation indexes before and after the treatment of acute ischemic stroke patients with qilong capsule and relapsed dilong capsule.Research methods1.Research design:The study was designed as a prospective,multicenter,nonrandomized controlled study.2.Research object:This study of traditional Chinese medicine industry in 2015 special"characteristics of traditional Chinese medicine and health management of recurrent ischemic stroke risk assessment system research and development and application demonstration" project of data acquisition part of the data on the basis of the data in the table,watch cases from November 2016-January 2019 12 hospitals nationwide encephalopathy secco admitted during the period of the acute phase of ischemic stroke patients in hospital.The program was reviewed and approved by the ethics committee of the institute of clinical basic medicine,Chinese academy of traditional Chinese medicine,and informed consent was signed with all participants,3.Inclusion and exclusion criteriaInclusion criteria:TOAST belongs to LAA or SA type;Aged between 35 and 85;Onset within 2 weeks;TCM syndrome differentiation is qi deficiency and blood stasis;Signing informed consent,etcExclusion criteria:western medicine was diagnosed as acute stage of ischemic apoplexy with unclear consciousness;TCM diagnosis of apoplexy in the viscera;Patients with other mental diseases or unable to cooperate with investigators;Have bleeding tendency or have had serious bleeding within 3 months;Patients with severe liver or kidney function impairment;Pregnant or lactating women,or have family planning within nearly 1 year;Those who cannot take medicine or cooperate with the clinical data collection4.Clinical data collection and biological sample retentionThe baseline demographic information,basic disease information,stroke incidence information.TCM syndromes and TCM constitution of 100 patients in qilong group and dilong group were recorded.Two groups of patients were recorded with medication or treatment information,nerve function defect before and after treatment.In the form of paper case collection form,relevant information answered by the subject is filled in by the clinician,and then recorded into the electronic case system.Twenty-four patients in the qilong group and 24 patients in the dilong group were paired with the same sex and age 3 years old,and biological samples before and after treatment were collected.After packaging,freezing and transportation,centralized detection was performed to determine the content of p-selectin and coagulin5.Quality control of clinical researchResearch program training,strict control of the admission standard.Clinical data were filled in timely,complete and standardized.Follow-up improves response and reduces loss of follow-up.Develop SOP for biological sample retention,packaging and transportation.Electronic data entry,review and standardization.6.Statistical analysisSPSS 22.0 statistical software was used for statistical processing of the study data.The counting data is expressed as a percentage,and the chi-square test is adopted.The measurement data were expressed as x S,and the t-test was used to compare the data that met the normality and homogeneity of variance,while the rank-sum test was used to compare the data that did not meet the normality or homogeneity of variance.Research results1.Baseline condition of 100 patients in qilong group:males were significantly more than females,and the ratio of males to females was about 2:1.The mean age is 63 years old,and most of them are from 60 to 85 years old.The mean BMI was 25.2kg/m2,mainly distributed in the range of BMI 24kg/m2.The mean course was 4.89 days,mainly distributed within 1 week.Concomitant disease basically has hypertension,diabetic wait.The mean score of NIHSS before treatment was 3.2.The baseline NIHSS scores of 100 patients in the control group were basically the same as those in the qilong group in terms of gender,age,BMI,course of disease,combined disease and before treatment,with statistical significance after statistical analysis(all P>0.05)and comparability.3.Physical distribution of patients with acute ischemic stroke with qi deficiency and blood stasis:blood stasis(99,20.16%)is the most followed by qi deficiency and blood stasis(98,19.96%).4.The NIHSS scores of qilong group before and after treatment were statistically different(P<0.05).After treatment,the total effective rate of qilong group was 50%,and the change rate of NIHSS was 27.14%.The total effective rate in the control group was 53%,and the change rate of NIHSS was 35.10%.After chi-square test,there was no significant difference in overall efficacy between the two groups(P>0.05).5.For the patients with qi deficiency and blood stasis syndrome and blood stasis in the acute stage of ischemic stroke,the comparison of the change rate of NIHSS between groups was statistically significant(P=0.023),and the change rate of NIHSS in qilong group(52.84%)was higher than that in the control group(33.07%)There was no significant difference in the NIHSS rate between the two groups(P>0.05).6.P-selectin and coagulin were detected in 24 cases of qilong group before and after treatment.The content of p-selectin decreased,and the change rate of p-selectin was 48.685%.The change distribution of coagulin content in 12 cases showed an increasing trend,with an increasing rate of 36.352%,and a decreasing rate of 29.370%in 12 cases7.Among the 24 control patients,p-selectin was detected in 23 cases and thrombolysin in 24 cases.The decrease trend of p-selectin content,the change rate of p-selectin,the change distribution of coagulin content,the increase rate and the decrease rate of p-selectin content in 23 cases were similar to those in qilong group.After statistical analysis of the rate of change of the two test indicators,there was no statistical difference between the two groups(all P>0.05).Conclusion1.Qilong capsule has a definite effect on the improvement of nerve function defect of qi deficiency and blood stasis syndrome in the acute stage of ischemic apoplexy2.For patients with acute ischemic apoplexy with qi deficiency and blood stasis syndrome and blood stasis,early intervention of qilong capsule is superior to compound dilong capsule in improving the efficacy of NIHSS.3.Early intervention of qilong capsule on qi deficiency and blood stasis syndrome in the acute stage of ischemic apoplexy can reduce the content of p-selectin and play a role in inhibiting platelet activation.But the distribution of the influence on the content of coagulin is different. |
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