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1.
World J Clin Cases ; 12(2): 335-345, 2024 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-38313632

RESUMO

BACKGROUND: Yangxue Qingnao Granules (YXQN) is a Chinese patent medicine that has been commonly used in the clinical treatment of migraine. AIM: To assess the efficacy and safety of YXQN alone for the treatment of migraine. METHODS: We searched 10 databases to identify relevant randomized controlled trials (RCTs) published before September 2022. Two review authors independently searched and screened the literature, extracted the data, and assessed the methodological quality of the studies using criteria from ROB 2.0, and analyzed the data using Review Manager 5.4 software. RESULTS: A total of 12 RCTs including 767 participants with migraine met the selection criteria. We divided these studies into comparisons of YXQN with placebo, routine treatment drugs, and other Chinese patent medicines. The meta-analysis showed the following: (1) Efficacy: The YXQN group outperformed the placebo group [relative risk (RR) = 0.29, 95% confidence interval (95%CI): 0.15-0.43, P < 0.00001], routine treatment group (RR = 0.18, 95%CI: 0.09-0.27, P < 0.0001), and Chinese patent medicine group (RR = 0.27, 95%CI: 0.13-0.41, P < 0.001); (2) frequency of headache: There was a significant difference between YXQN vs placebo [mean difference (MD) = -1.25, 95%CI: -1.60 to -0.90, P < 0.00001], routine treatment drugs (MD = -0.85, 95%CI: -1.15 to -0.56, P < 0.00001), and Chinese patent medicine (MD = -0.91, 95%CI: -1.35 to -0.46, P < 0.0001); (3) headache duration: We found great heterogeneity between studies, with no differences between YXQN and placebo (MD = -0.61, 95%CI: -1.53 to -0.31, P = 0.19) and routine treatment drugs (MD = -0.22, 95%CI: -0.89 to 0.46, P < 0.53). YXQN was more effective than other Chinese patent medicines in reducing headache duration (MD = -1.24, 95%CI: -1.70 to -0.77, P < 0.00001); and (4) headache severity: There was no significant difference between YXQN vs placebo (MD = -1.67, 95%CI: -3.52 to 0.19, P = 0.08), routine treatment drugs (MD = -0.53, 95%CI: -2.02 to 0.96, P = 0.68), and other Chinese patent medicines (MD = -0.49, 95%CI: -2.83 to 1.85, P = 0.68). Mild gastrointestinal adverse reactions were reported in three cases. CONCLUSION: This study revealed that YXQN is effective and safe for treatment of migraine.

2.
J Transl Int Med ; 11(2): 98-101, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37408578

RESUMO

To further improve clinical workers' Traditional Chinese Medicine (TCM) treatment level for headache attack, the TCM Guidelines for Acute Primary Headache has been developed based on the development methodology of the World Health Organization Standard Version guide. The grading of recommendations assessment, development and evaluation (GRADE) method was adopted for the development of evidence, evidence classification, and recommendations that can be systematically evaluated. For evidence lacking clinical research support, the quality of evidence was evaluated and recommended based on the evidence level standard of ancient books of traditional Chinese medicine, and The Appraisal of Guidelines for Research and Evaluation II (AGREE II) and The Reporting Items for Practice Guidelines in Healthcare (RIGHT) were referred to. This guideline plan mainly introduces the guideline formulation process of constructing clinical questions and selecting outcome indicators, evidence retrieval, generation of recommendations, etc.

3.
Chin J Integr Med ; 29(5): 441-447, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-35723812

RESUMO

OBJECTIVE: To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients. METHODS: By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup. RESULTS: Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens. CONCLUSIONS: There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.


Assuntos
AVC Isquêmico , Humanos , Síndrome , Medicina Tradicional Chinesa , Fígado , Fenótipo
5.
Phytomedicine ; 107: 154459, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36183476

RESUMO

BACKGROUND: Hypertension is one of the most significant public health challenges worldwide. An increasing number of patients prefer to incorporate traditional Chinese medicine into their hypertensive care. The Songling Xuemaikang capsule (SXC), a Chinese herbal formula, is widely used in China for essential hypertension. PURPOSE: To assess the efficacy and safety of SXC for essential hypertension. STUDY DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: We conducted a systematic literature search of seven databases to identify randomized controlled trials of SXC for hypertension. The outcome measures included blood pressure parameters and patient-reported outcomes. Potential heterogeneity between the studies was resolved by subgroup and sensitivity analyses. The quality of the results was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. RESULTS: A total of 34 trials with 4306 patients were included. The results showed that SXC plus antihypertensive drugs produced a greater effect on reducing systolic blood pressure (SBP) (MD: -7.54 mmHg; 95% CI: -8.92, -6.17; p < 0.00001), diastolic blood pressure (DBP) (MD: -6.42 mmHg; 95% CI: -7.54, -5.29; p < 0.00001), 24-hour SBP (MD: -6.88 mmHg; 95% CI: -8.36, -5.39; p < 0.00001), and 24-hour DBP (MD: -4.31 mmHg; 95% CI: -6.55, -2.07; p = 0.0002) and improving hypertensive symptoms (SMD: -1.09; 95% CI: -1.34, -0.84; p < 0.00001) than antihypertensive drugs alone. SXC monotherapy was less effective than antihypertensive drugs for 24-hour SBP reduction (MD: 2.07 mmHg; 95% CI: 0.19, 3.96; p = 0.03). No significant difference was observed in the incidence of adverse events between the SXC and control groups. CONCLUSION: SXC is beneficial for essential hypertension; it can lower BP, improve hypertensive symptoms and is well tolerated.


Assuntos
Anti-Hipertensivos , Hipertensão , Anti-Hipertensivos/efeitos adversos , Pressão Sanguínea , Medicamentos de Ervas Chinesas , Hipertensão Essencial/tratamento farmacológico , Humanos , Hipertensão/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
Front Pharmacol ; 13: 916421, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36091794

RESUMO

Background: Due to limited time windows and technical requirements, only a small percentage of patients can receive reperfusion therapy for acute ischemic stroke (AIS). Previous studies have shown that LongShengZhi (LSZ) capsule can improve neurological outcomes in patients after AIS, yet those results have not been finally verified through rigorous randomized controlled trials. Thus, this trial was designed to further clarify the efficacy and safety of LSZ capsule for patients with AIS. Methods: LSZ capsule on Functional Recovery after Acute Ischemic Stroke (LONGAN) trial is a prospective, multicenter, randomized, placebo-controlled, double-blind, parallel-group, superiority trial that enrolls patients from stroke and rehabilitation units in China. We will enroll 1,376 patients aged 18 years or older with AIS within 7 days of symptom onset and a National Institute of Health Stroke Scale (NIHSS) score of 4-15. Eligible patients will be randomized to receive either 2 g LSZ capsules three times a day or placebo LSZ capsules for 90 days. The primary outcome is the proportion of patients with favorable outcomes, as measured by the modified Rankin Scale (mRS) 90 days after randomization. The main safety outcome is the proportion of severe adverse events. Conclusion: This study will be the first randomized, double-blind trial to evaluate the efficacy and safety of LSZ capsule in patients with AIS. In order to improve the transparency and reproducibility of the trial, the data will be analyzed in accordance with this pre-specified plan for statistical analysis to reduce bias due to selective analysis and reporting. This trial aims to provide high-quality evidence for the efficacy and safety of LSZ capsule for AIS.

7.
Phytomedicine ; 106: 154391, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35994847

RESUMO

BACKGROUND: Elderly patients with ischemic stroke (IS) have worse functional outcomes and poorer quality of life after suffering a stroke than younger patients. The identification of effective agents is critical to optimizing the therapy of IS in elderly patients. PURPOSE: To examine the efficacy of diterpene ginkgolides meglumine injection (DGMI) vs. Ginaton in treating patients with IS, across different age subgroups. METHODS: Efficacy was determined through the post hoc analysis of a randomized controlled study, which had a cohort of 998 patients with IS. Participants were pooled and grouped by age (elderly [aged ≥ 65 yr] vs. non-elderly [aged < 65 yr]). The primary efficacy outcome was the proportion of patients with modified Rankin Scale (mRS) score ranging from 0 to 1 at 90 d. The secondary outcomes were neurological deficit (tested using the National Institutes of Health Stroke Scale [NIHSS] score) and quality of life (tested using the EuroQol-5 Dimension [EQ-5D] and EQ visual analog scale [EQ-VAS] questionnaires). RESULTS: There were 399 (40%) patients in the elderly group (average age = 69.8±3.3 yr) and 599 (60%) patients in the non-elderly group (average age = 55.8±6.8 yr). The randomized treatment groups had similar baseline characteristics. For the elderly group, 174 (94%) of the 185 participants in the DGMI group and 169 (79%) of the 214 participants in the Ginaton group achieved the main outcome of a mRS score of 0-1 after three months (odds ratio [OR] = 0.87 [95% confidence interval [CI] = 0.81-0.93], p<0.001). For the non-elderly group, 301 (96%) of the 314 participants in the DGMI group and 237 (83%) of the 214 participants in the Ginaton group achieved the main outcome of a mRS score of 0-1 after three months (OR = 0.88 [95% CI = 0.84-0.92], p<0.001). The overall mean EQ-5D index score and EQ-VAS of the DGMI group were higher than that of the Ginaton group for elderly patients. After controlling other covariates including treatments, gender, weight, height and medical history, the results of mRS score, NIHSS score, EQ-5D index score, and EQ-VAS based on generalized linear model were similar to those of the single covariate analysis. CONCLUSIONS: DGMI demonstrated a superior efficacy to Ginaton for patients with IS in both elderly and non-elderly ages.


Assuntos
AVC Isquêmico , Acidente Vascular Cerebral , Idoso , Ginkgolídeos/farmacologia , Ginkgolídeos/uso terapêutico , Humanos , Meglumina/farmacologia , Meglumina/uso terapêutico , Pessoa de Meia-Idade , Qualidade de Vida , Acidente Vascular Cerebral/tratamento farmacológico
8.
Artigo em Inglês | MEDLINE | ID: mdl-34899950

RESUMO

METHODS: Individualized treatment of traditional Chinese medicine (TCM) provides a theoretical basis for the study of the personalized classification of complex diseases. Utilizing the TCM clinical electronic medical records (EMRs) of 7170 in patients with IS, a patient similarity network (PSN) with shared symptoms was constructed. Next, patient subgroups were identified using community detection methods and enrichment analyses were performed. Finally, genetic data of symptoms, herbs, and drugs were used for pathway and GO analysis to explore the characteristics of pathways of subgroups and to compare the similarities and differences in genetic pathways of herbs and drugs from the perspective of molecular pathways of symptoms. RESULTS: We identified 34 patient modules from the PSN, of which 7 modules include 98.48% of the whole cases. The 7 patient subgroups have their own characteristics of risk factors, complications, and comorbidities and the underlying genetic pathways of symptoms, drugs, and herbs. Each subgroup has the largest number of herb pathways. For specific symptom pathways, the number of herb pathways is more than that of drugs. CONCLUSION: The research of disease classification based on community detection of symptom-shared patient networks is practical; the common molecular pathway of symptoms and herbs reflects the rationality of TCM herbs on symptoms and the wide range of therapeutic targets.

9.
Sci Rep ; 11(1): 17532, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34475426

RESUMO

The functional significance of the zinc-finger of the cerebellum (ZIC) gene family in gliomas remains to be elucidated. Clinical data from patients with gliomas, containing expression levels of ZIC genes, were extracted from CCLE, GEPIA2 and The Human Protein Atlas (HPA). Univariate survival analysis adjusted by Cox regression via OncoLnc was used to determine the prognostic significance of ZIC expression. We used cBioPortal to explore the correlation between gene mutations and overall survival (OS). ZIC expression was found to be related to immune cell infiltration in gliomas via TIMER analysis. GO term and KEGG pathway enrichment analyzes were performed with Metascape. PPI networks were constructed using STRING. The expression levels of ZIC1/3/4/5 in gliomas were significantly different from those in normal samples. High expression levels of ZIC1/5 were associated with poor OS in brain low-grade glioma (LGG) patients, while low ZIC3 expression combined was related to favorable OS in glioblastoma multiforme (GBM). ZIC alterations were associated with poor prognosis in LGG patients and related to favorable prognosis in GBM patients. We observed that the expression of ZICs was related to immune cell infiltration in glioma patients. ZICs were enriched in several pathways and biological processes involving Neuroactive ligand-receptor interaction (hsa04080). The PPI network revealed that some proteins coexpressed with ZICs played a role in the pathogenesis of gliomas. Differences in the expression levels of ZIC genes could provide a significant marker for predicting prognosis in gliomas.


Assuntos
Biomarcadores Tumorais/metabolismo , Neoplasias Encefálicas/mortalidade , Proteínas de Ligação a DNA/metabolismo , Glioblastoma/mortalidade , Glioma/mortalidade , Proteínas do Tecido Nervoso/metabolismo , Fatores de Transcrição/metabolismo , Biomarcadores Tumorais/genética , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/metabolismo , Neoplasias Encefálicas/patologia , Biologia Computacional/métodos , Proteínas de Ligação a DNA/genética , Bases de Dados Genéticas , Bases de Dados de Proteínas , Regulação Neoplásica da Expressão Gênica , Glioblastoma/genética , Glioblastoma/metabolismo , Glioblastoma/patologia , Glioma/genética , Glioma/metabolismo , Glioma/patologia , Proteínas de Homeodomínio/genética , Proteínas de Homeodomínio/metabolismo , Humanos , Proteínas do Tecido Nervoso/genética , Proteínas Nucleares/genética , Proteínas Nucleares/metabolismo , Prognóstico , Taxa de Sobrevida , Fatores de Transcrição/genética
10.
Front Pharmacol ; 12: 743883, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34531755

RESUMO

Background: Given the complexity of stroke treatment and the current widespread use of traditional Chinese medicine (TCM) in the absence of robust, large, long-term effectiveness and safety studies, and the lack of nationwide epidemiology and clinical characteristics of patients with stroke receiving TCM treatment, the acquisition of data from longitudinal cohorts is essential. We intend to generate the major clinical characteristics of patients with stroke who receive TCM treatment and to investigate the effectiveness and safety of TCM in the Chinese population. Methods: The China Stroke Registry for Patients with Traditional Chinese Medicine (CASES-TCM) study is a prospective, multicenter, observational disease registry aiming to register 20,000 hospitalized patients. Eligible adult patients with clearly diagnosed acute ischemic stroke or intracerebral hemorrhage within 7 days of symptom onset will be consecutively registered from 126 participating sites across China. Baseline data will be recorded, and all patients will be regularly followed up at 3, 6, 12, and 24 months after stroke onset. Collected data will be entered into a web-based system with high-level data security. The primary outcomes include the distribution of scores on the modified Rankin Scale at the 3-months follow-up, and recurrent stroke events within the 12-months follow-up. Conclusion: To our knowledge, the CASES-TCM study is the first and largest nationwide registry to document comprehensive data on TCM treatment in patients with acute stroke. The findings of this study will be valuable to improve our knowledge about TCM treatment for patients with stroke and its subsequent outcomes in the actual clinical setting, consequently facilitating and standardizing the optimization of individualized interventions with TCM for stroke prevention and treatment in China. Study registration: This study was registered with Clinicaltrials.gov (URL: https://clinicaltrials.gov/, Unique identifier: NCT04921397).

11.
Chin Herb Med ; 13(3): 351-358, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36118932

RESUMO

Objective: To study the therapeutic effect of Huoxue Tongluo Decoction (HXTLD) on erectile dysfunction caused by ischemic stroke and identify the mechanisms involved. Methods: Network pharmacology was used to predict the key active ingredients and targets of HXTLD. Surgical methods were used to create a rat model of ischemic stroke. The rats were then given a suspension of HXTLD by ig administration. Erectile function was evaluated by Apomorphine (APO) induction. Real-time fluorescence quantitative reverse transcription-polymerase chain reaction (Real-time PCR) and Western blotting were used to detect the expression of related mRNAs and proteins in rat penile corpus cavernous tissue and brain tissue. Hematoxylin & Eosin (HE) staining was used to investigate structural changes in the penile cavernous tissue. Results: Network pharmacology showed that tumor necrosis factor (TNF), nitric oxide synthase 3 (eNOS), and vascular endothelial growth factor (VEGF) were the key targets of HXTLD in the treatment of erectile dysfunction caused by ischemic stroke. Experimental studies showed that HXTLD improved erectile dysfunction caused by ischemic stroke. HE results showed that HXTLD improved the structure of the corpus cavernosa. HXTLD also inhibited the expression of TNF and VEGF proteins in penile tissue (P < 0.05) and enhanced the expression of eNOS protein in penile tissue (P < 0.05). Conclusion: HXTLD improved the erectile function of rats with erectile dysfunction caused by ischemic stroke by regulating the mRNA and protein levels of TNF, eNOS and VEGF.

12.
PLoS One ; 15(1): e0227924, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31951629

RESUMO

INTRODUCTION: Previous studies have provided equivocal evidence of antidepressant use on subsequent cognitive impairment; this could be due to inconsistent modeling approaches. Our goals are methodological and clinical. We evaluate the impact of statistical modeling approaches on the associations between antidepressant use and risk of Mild Cognitive Impairment (MCI) in older adults with depression. METHODS: 716 participants were enrolled. Our primary analysis employed a time-dependent Cox proportional hazards model. We also implemented two fixed-covariate proportional hazards models-one based on having ever used antidepressants during follow-up, and the other restricted to baseline use only. RESULTS: Treating antidepressant use as a time-varying covariate, we found no significant association with incident MCI (HR = 0.92, 95% CI: 0.70, 1.20). In contrast, when antidepressant use was treated as a fixed covariate, we observed a significant association between having ever used antidepressants and lower risk of MCI (HR = 0.40, 95% CI: 0.28, 0.56). However, in the baseline-use only model, the association was non-significant (HR = 0.84, 95% CI: 0.60, 1.17). DISCUSSION: Our results were dependent upon statistical models and suggest that antidepressant use should be modeled as a time-varying covariate. Using a robust time-dependent analysis, antidepressant use was not significantly associated with incident MCI among cognitively normal persons with depression.


Assuntos
Antidepressivos/efeitos adversos , Cognição/fisiologia , Disfunção Cognitiva/tratamento farmacológico , Depressão/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Cognição/efeitos dos fármacos , Disfunção Cognitiva/complicações , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/fisiopatologia , Estudos de Coortes , Depressão/complicações , Depressão/epidemiologia , Depressão/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Modelos Estatísticos , Modelos de Riscos Proporcionais , Fatores de Risco
13.
Chin J Integr Med ; 24(6): 409-414, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28741060

RESUMO

OBJECTIVE: To study the efficacy of modified Wuzhuyu Decoction Granule (, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. METHODS: This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group (51 cases) and a placebo group (27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale (VAS) scores. All outcome assessments were conducted respectively at baseline, the 4th, 8th and 12th week, and the end of follow-up. RESULTS: In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4th week and that of analgesics consumption since the 8th week (both P<0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8th week and that of analgesics consumption since the 12th week (both P<0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8th week (P<0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption (P>0.05). CONCLUSIONS: MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.


Assuntos
Meridianos , Transtornos de Enxaqueca/tratamento farmacológico , Adulto , Analgésicos/uso terapêutico , Demografia , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Humanos , Masculino , Medição da Dor , Pacientes Desistentes do Tratamento , Placebos , Síndrome , Resultado do Tratamento
14.
Trials ; 18(1): 479, 2017 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-29037226

RESUMO

BACKGROUND: Xingnaojing injection (XNJ) is widely used for the treatment of stroke in China. However, there is currently a lack of high-quality evidence of its efficacy for acute ischemic stroke. The main objective of this study is to determine whether the addition of XNJ to standard care improves the 3-month functional outcome in patients with acute ischemic stroke (AIS). METHODS/DESIGN: The XMAS study is a multicenter, prospective, randomized controlled, open-label trial with a blinded endpoints design. A total of 720 patients will be randomly allocated to either the intervention or the control group in a 1:1 ratio. The intervention group receives XNJ combined with standard care, and the control group receives standard care alone. XNJ will be administered intravenously every 12 h for 10 days. The primary outcome is the proportion of patients who are independent at 3 months after stroke onset defined as a modified Rankin Scale score of 0 to 2. Secondary outcomes include early neurological deterioration at 48 h, the change in National Institutes of Health Stroke Scale score, patient-reported outcome, symptomatic intracranial hemorrhage at 10 days, the Barthel Index score, deaths from any cause and cardiovascular events at 3 months. DISCUSSION: The results of this trial will provide critical evidence for XNJ in the treatment of AIS as a complementary approach that can be initiated after reperfusion therapy or when the AIS is not eligible for thrombolytic treatment. TRIAL REGISTRATION: Clinical Trials.gov, ID: NCT02728180 . Registered on 28 March 2016.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/fisiopatologia , China , Avaliação da Deficiência , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recuperação de Função Fisiológica , Projetos de Pesquisa , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
15.
BMC Complement Altern Med ; 16: 356, 2016 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-27618916

RESUMO

BACKGROUND: The primary objective of this study was to assess whether Zhengtian Capsule was non-inferior to flunarizine in efficacy and safety profile for prevention of migraine in adults. METHODS: This was a double-dummy, double-blind, multicenter, positive drug (flunarizine), parallel randomized controlled, non-inferior clinical trial. Patients (n = 360) were randomized in a 1:1 to receive either Zhengtian Capsule or flunarizine, including 12 weeks' intervention and 4 weeks' follow-up. The primary outcome measure was responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period). The secondary outcome measures included migraine attack frequency, the number of migraine days, pain evaluated by visual analogue scale (VAS) score, duration of migraine attacks, the times of using analgesics, patient-reported outcome (PRO) measure of migraine and the scores of short-form 36 Health Survey Scale (SF-36). Weight variation in both groups was also evaluated. Adverse events were monitored throughout the trial. RESULTS: Zhengtian Capsule was non-inferior to flunarizine in responder rate at week 12 and follow-up period (P = 0.002, P < 0.001). There was fewer migraine days in Zhengtian Capsule group at follow-up period compared with flunarizine (P = 0.001). For the total duration of migraine attacks, there was significant group difference at week 4 which favored the control group (P = 0.009). For the total score of PRO scale, there was statistical difference between the two groups at follow-up period (P = 0.021). There were also group differences between the two groups in the dimensions of somatization symptoms at week 4 (P = 0.022) and functional status at week 12 and follow-up period (P < 0.001, P < 0.001). However, there were no significant differences between the two groups in migraine attack frequency, VAS scores reduction, consumption of acute pain drugs and the dimension scores of SF-36 at any time interval of the treatment period (P > 0.05). No severe adverse events occurred in the trial. Flunarizine was found associated with a weight gain. CONCLUSION: Zhengtian Capsule was non-inferior to flunarizine with regard to the primary endpoint. In addition, it could reduce migraine days and improve the functional status and somatization symptoms of migraine patients with good safety profile. TRIAL REGISTRATION: This trial was registered at Chinese Clinical Trial Register (ChiCTR), ChiCTR-TRC-13004412.


Assuntos
Analgésicos/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Flunarizina/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Adulto , Analgésicos/efeitos adversos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Flunarizina/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor
16.
BMC Complement Altern Med ; 15: 407, 2015 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-26572875

RESUMO

BACKGROUND: Ischemic stroke (IS) is a common disease, often resulting in death or disability. Previous studies on prognosis of stroke mainly focused on the baseline condition or modern expensive tests. However, the change of clinical symptoms during acute stage is considerably neglected. In our study, we aim to develop a new prognostic scale to predict the 90-day outcome of IS patients. METHODS: In this retrospective cohort study, a secondary data analysis was performed on 489 patients extracted from 1046 patients of 4 hospitals. A new prognostic scale was constructed to predict the recovery of IS mainly based on the National Institutes of Health Stroke Scale (NIHSS) score, traditional Chinese Medicine (TCM) symptoms & signs and the changes during the first 3 days of patients in the 3 TCM hospitals. Receiver Operating Characteristic (ROC) curve was used to determine the cutoff point for prediction. In the end, the scale was used to test the outcome of IS patients in Xuanwu hospital. RESULTS: The new prognostic scale was composed of 8 items including age degree (OR = 3.32; 95 % CI: 1.72-6.42), history of diabetes mellitus (DM) (OR = 2.20; 95 % CI: 1.19-4.08), NIHSS score (OR = 3.08; 95 % CI: 2.16-4.40), anxiety (OR = 3.17; 95 % CI: 1.90-5.29) and irritability (OR = 4.61; 95 % CI: 1.36-15.63) on the 1st day of illness onset, change in NIHSS score (OR = 2.49; 95 % CI: 1.31-4.73), and circumrotating (OR = 7.80; 95 % CI: 1.98-30.64) and tinnitus (OR = 13.25; 95 % CI: 1.55-113.34) during the first 3 days of stroke onset. The total score of the scale was 16.5 and the cutoff point was 9.5, which means patients would have poor outcome at 90 days of stroke onset if the score was higher than 9.5. The new scale was validated on the data of Xuanwu hospital, and the value of its sensitivity, specificity and overall accuracy were 69.6 %, 83.3 % and 75.0 % respectively. CONCLUSIONS: The 8-item scale, mainly based on TCM symptoms, NIHSS score and their changes during the first 3 days, can predict the 90-day outcome for IS patients while it still needs to be further validated and optimized clinically.


Assuntos
Medicina Tradicional Chinesa , Acidente Vascular Cerebral/diagnóstico , Idoso , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/reabilitação , Feminino , Indicadores Básicos de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Recuperação de Função Fisiológica , Estudos Retrospectivos , Reabilitação do Acidente Vascular Cerebral , Estados Unidos
17.
Neurosci Bull ; 28(5): 611-7, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22965744

RESUMO

OBJECTIVE: To compare electroencephalogram (EEG) symmetry values between stroke patients with different 28-day outcomes, and to assess correlations between clinical characteristics and 28-day outcomes. METHODS: Twenty-two patients presenting with acute ischemic stroke and persistent neurological deficits at EEG recording were incrementally included. At 28 days after admission, the modified Rankin scale (mRS) was used to evaluate the outcomes, based on which the patients were divided into two a posteriori groups, mRS = 6 and mRS <6. Student's t-test was used to compare these two groups in terms of brain symmetry index (BSI), National Institutes of Health stroke scale (NIHSS), Glasgow coma scale (GCS) and acute physiology and chronic health evaluation II (APACHE II) assessed at admission. Then EEG parameters, NIHSS, GCS and APACHE II were correlated with the mRS. RESULTS: There were significant differences in BSI, NIHSS, GCS, and APACHE II between the two groups. Survivors had lower BSI, NIHSS and APACHE II, and higher GCS values, compared with patients who died within 28 days after admission. Besides, BSI at admission had a positive correlation with mRS at 28 days (r = 0.441, P = 0.040). NIHSS and APACHE II were also correlated with mRS (r = 0.736, P <0.000 1; r = 0.667, P = 0.001, respectively). GCS at admission had a negative correlation with mRS (r = -0.656, P = 0.001). CONCLUSION: A higher BSI predicts a poorer short-term prognosis for stroke patients. Acute EEG monitoring may be of prognostic value for 28-day outcomes. The early prediction of functional outcomes after stroke may enhance clinical management and minimize short-term mortality.


Assuntos
Eletroencefalografia/métodos , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/tendências
18.
Artigo em Inglês | MEDLINE | ID: mdl-23304233

RESUMO

Objective. To evaluate the efficacy of traditional Chinese herbal ChuanXiong Ding Tong herbal formula granule (CXDT-HFG) for migraine patients with "the Syndrome of Liver Wind and Blood Stasis." Methods. 150 migraine patients were recruited and assigned randomly in a double-blind, placebo-controlled study to receive CXDT-HFG (n = 99) plus necessary analgesics, or placebo (n = 51) plus necessary analgesics for 16 weeks (12 weeks' intervention and 4 weeks' follow up). Outcome measures included migraine days, frequency of migraine attacks, analgesics consumption for acute treatment, and the proportion of responders as well as the visual analogue scale (VAS) scores and intensity for pain. Results. Compared with the placebo group, the CXDT-HFG group showed significant reduction in migraine days and attacks frequency at week 12 and follow-up period (P < 0.05) as well as in the reduction of VAS scores at follow-up period.There was significant difference in the proportion of responders between the two groups at follow-up period (P = 0.014). However there were no significant differences between the two groups in analgesics consumption (P > 0.05). Conclusion. CXDT-HFG was more effective than placebo in decreasing days of migraine attacks, frequency, VAS scores, and relieving pain intensity for migraine patients.

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