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ObjectiveTo further assess the safety of clinical application of Shujin Jianyao pills after marketing and find its potential risk factors as early as possible， to obtain the real world medication situation of Shujin Jianyao pills and its incidence of adverse reactions and clinical characteristics， and to explore the factors affecting the occurrence of adverse drug reactions （ADR）. MethodIn this study， prospective， large-sample， multi-center and intensive whole-hospital monitoring with continuous registration was carried out， combined with telephone follow-up visits 2-4 weeks after the end of medication， for whole treatment course monitoring among patients. In addition， the three-level quality control was strictly implemented in the monitoring process. The study used a proprietary electronic data management system for data management， and SAS 9.4 and R software were used for statistical analysis. ResultFrom May 2018 to July 2020， the study completed the safety monitoring of 3 033 patients taking Shujin Jianyao pills in 30 clinical departments of 25 hospitals in China. A total of 36 ADR cases （49 times） were confirmed by expert assessment on data and supervision quality and expert interpretation of ADR. ConclusionAccording to the World Health Organization （WHO）， the symptoms of adverse reactions were mainly classified into occasional adverse reactions （0.1%≤ADR<1%： abdominal distension， oral ulcer， dry mouth， constipation） and rare adverse reactions （0.01%≤ADR<0.1%： loss of appetite， rash， fatigue， increased ALT， increased creatinine， dizziness， stomachache， stomach distension， liver discomfort， pruritus， dysphoria， acid regurgitation， numbness in mouth， abdominal pain， sore throat， earache， tinnitus）. Moreover， through the synthetic minority oversampling technique （SOMTE） combined with logistic regression， the following factors might affect ADR： taking Shujin Jianyao pills for 1-14 days， aged 46-65， 66-80 and 81 and above as well as combined use of atorvastatin， cobamamide， calcitriol capsules， Gushukang capsules， glucosamine， nifedipine， methylcobalamin， metformin， Tenghuang Jiangu pills， Bugu tablets， and diclofenac sodium sustained-release tablets. This study provided a real world basis for the safety and standardized use of Shujin Jianyao pills in clinical practice.
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Background@#and Purpose Previous studies suggested increased visit-to-visit variability of total cholesterol (TC) is associated with stroke. This study aimed to investigate the associations of various lipids measurements variability and the risk of stroke and stroke type (ischemic and hemorrhagic stroke). @*Methods@#Fifty-one thousand six hundred twenty participants in the Kailuan Study without history of myocardial infarction, stroke, and cancer who underwent three health examinations during 2006 to 2010 were followed for incident stroke. Variability in TC, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) measurements were measured using the coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), and average real variability (ARV). @*Results@#During a median of 6.04 years of follow-up, 1,189 incident stroke (1,036 ischemic and 160 hemorrhagic stroke) occurred. In the multivariable-adjusted model, the hazard ratio (HR) comparing participants in the highest versus lowest quartile of CV of HDL-C were 1.21 (95% confidence interval [CI], 1.02 to 1.45; P for trend=0.013) for ischemic stroke. The highest quartile of CV of LDL-C was associated with 2.17-fold risk of hemorrhagic stroke (HR, 2.17; 95% CI, 1.25 to 3.75; P for trend=0.002) compared with the lowest quartile. We did not observe any significant association between TC and triglycerides variability with any of stroke. Consistent results were obtained when calculating variability index using SD, VIM, or ARV. @*Conclusions@#These findings suggest the high visit-to-visit HDL-C and LDL-C variability were associated with an increased incidence of ischemic and hemorrhagic stroke, respectively.
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Objective To establish a specialized division of labor system for cerebrovascular disease clinical research and verify the effectiveness of specialized division of labor system in the management of cerebrovascular disease clinical research.Methods Using Delphi method to establish the specialized division of labor system of clinical research,identify personnel responsibilities,access mechanism and access standards.Compare two clinical studies that using and not using this system in terms of clinical research management efficiency,effectiveness of the clinical research progress and quality control.Results Specialized division of labor system can reduce the time spent for research design and preparation,improve the research progress and data integrity,reduce the protocol deviation and the loss of subject follow up.Conclusions Specialized division of labor system can improve the efficiency of clinical research management and improve the research progress and quality.
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@#Objective To analyze the features of poststroke depression (PSD) between men and women after acute ischemic stroke in China. Methods A total of 1917 ischemic stroke patients were enrolled from the Prospective Cohort Study on Incidence and Outcome of Patients with Poststroke Depression in China. The incidence of PSD and the features were compared between male and female patients. The factors related with PSD of every gender were extracted with Logistic regression analysis. Results The incidence of PSD was higher in women than in men (32.9% vs. 26.6%, P<0.01). There was no difference in the stroke score between women and men (P>0.05). The score of Hamilton Depression Scale was higher in the women than in the men, and the features were similar. Logistic regression analysis indicated that the history of heart disease, history of mental disorders and stroke score related with PSD in women, while the age, history of mental disorders, smoking and stroke score in men. Conclusion The incidence and related factors of PSD 2 weeks after ischemic stroke are different between men and women.
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Objective To explore the risk factors and their prognostic value in Chinese female patients with ischemic stroke.Methods A total of 4 442 female patients with ischemic stroke were enrolled in the study from the Chinese National Stroke Registry System.According to the modified Rankin Scale (mRS) score,patients were divided into the group A (with good outcomes,mRS =0-2) and the group B (with bad outcomes,mRS =3-6),with the follow-up for 12 months.The risk factors were collected at month 3 and month 12,including age,family history,body mass index (BMI),hypertension,diabetes mellitus (DM),hyperlipidemia,atrial fibrillation (AF),coronary heart disease (CHD),smoking and moderate or heavy alcohol intake.The multivariate logistic regression was performed to determine the prognostic value of those risk factors.Results Patients in the group B were older than those in the group A [month 3:(71.3 ± 11.4) years oldvs (65.5±11.8) years old and month 12:(71.9±11.3) years old vs (65.1 ±11.6)years old,with both P ＜0.001].Patients in the group B were found to have higher ratio of BMI ＜25 kg/m2(66.3％ vs 62.0％,P =0.006;66.6％ vs 61.8％,P =0.002) and more likely to have the history of DM (27.0％ vs 23.3％,26.6％ vs 23.6％,respectively; both P ＜ 0.05),A F (18.0％ vs 6.2％,17.9％ vs 6.3％,respectively; both P ＜0.001) and CHD (21.4％ vs 14.4％,21.8％ vs 14.2％,respectively; both P ＜ 0.001) than those in the group A.The multivariate logistic regression analysis showed that women's age (OR =1.04,1.05,95％ CI 1.03-1.05,1.04-1.06,respectively),the histories of DM (both OR =1.35,95％ CI 1.15-1.58,respectively) and AF (OR =2.91,2.84,95％ CI 2.33-3.64,2.27-3.56,respectively) were significantly associated with the bad outcomes at month 3 and month 12.The history of CHD was associated with the bad outcomes at month 12 (OR =1.20,95％ CI 1.00-1.43),while the history of hyperlipidemia might improve the outcome at month 12 (OR =0.75,95％ CI 0.60-0.94).Conclusions The risk factors may have different prognostic value in female patients with ischemic stroke.The diagnosis and treatment for DM,AF and CHD may be helpful to improve the prognosis in Chinese female patients with ischemic stroke.
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Objective To analyze the risk factors and early prognosis factors of cerebral venous sinus thrombosis (CVST). Methods 68 patients with CVST were analyzed retrospectively. The patients were divided into early favorable prognosis group and early unfavorable prognosis group according to modified Rankin Scale (mRS). The clinical data and prognosis were analyzed by univariate analysis and multi-variate logistic regression analysis. Results and Conclusion On discharge, there were 37(54.4%) cases and 31(45.6%) cases in the early fa-vorable prognosis group and the early unfavorable prognosis group respectively. Univariate analysis showed that 8 factors, including preg-nancy-associated factors, central nervous system infection, hyperhomocysteinemia, ocular symptoms, disturbance of consciousness, limb pa-ralysis, secondary cerebral infarction and ventricular compression/midline shift/encephaledema were associated with the early prognosis. Multivariate logistic regression analysis showed that pregnancy-associated factors, central nervous system infection, hyperhomocysteinemia, disturbance of consciousness and ventricular compression/midline shift/encephaledema were the independent factors.
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Objective To observe the short-term and long-term impacts of in-hospital pneumonia on outcomes of patients hospitalized with acute ischemic stroke.Methods All consecutive patients older than 18 years with acute ischemic stroke were prospectively recruited to this study,including 132 clinical centers in 32 provinces and 4 municipalities (including Hong Kong region) in China from September 2007 to August 2008.Case report form was designed.Data of pneumonia and survival outcomes at baseline ; discharge ; 3,6 and 12 months after admission were recorded.Multivariable logistic regression was used for statistical correlation analysis.Results A total of 1373 (11.88％) patients from 11 560 acute ischemic stroke patients were notified with in-hospital pneumonia.The case fatality rate was 14.4％ (1664 patients) within 12 months after stroke onset.The fatality rate in patients with pneumonia was higher than that of patients without pneumonia.In-hospital pneumonia was an independent risk factor for death at discharge (adjusted OR =5.916 ; 95％ CI 4.470-7.831),at 3 months (adjusted OR =3.641 ; 95％ CI 3.035-4.367),6 months (adjusted OR =3.445 ; 95％ CI 2.905-4.086),and 12 months (adjusted OR =3.543 ; 95％ CI 3.016-4.161) after onset.Conclusion In-hospital pneumonia is an adverse factor for the short-term and longterm survival of acute ischemic patients in China.