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1.
Asian J Surg ; 2021 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-34629266

RESUMO

Severe brainstem hemorrhage is the most intractable type of intracerebral hemorrhage. It is still a challenge for neurosurgeons. The surgical indications for brainstem hemorrhage are still controversial clinically, and there is no uniform standard. The death rate and disability rate of patients are very high, and the prognosis is very poor. A patient with severe brainstem hemorrhage was successfully treated by utilizing the trans-cerebellomedullary fissure approach with lateral ventricular drainage in combination with clinical experience at the hospital where the author worked. The case is being reported for the first time to provide a reference for improving the treatment of brainstem hemorrhage.

2.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2984-2994, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467688

RESUMO

To systematically review the efficacy and safety of Naoxueshu Oral Liquid in treatment of hypertensive intracerebral hemorrhage, four Chinese databases, four English databases, clinical trials registration center(ClinicalTrials.gov) and Chinese clinical trial registry were retrieved. The retrieval time was from the establishment of each database to September 9, 2020. According to the set criteria, the randomized controlled trial(RCT) of Naoxueshu Oral Liquid combined with conventional Western medicine was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.4.1 was used to conduct Meta-analysis of the included studies and GRADE system was used to evaluate the evidence quality of the outcome indicators. Eleven studies were finally included, with a total sample size of 1 221 cases, 612 cases in the treatment group and 609 cases in the control group. Meta-analysis showed that Naoxueshu Oral Liquid combined with conventional Western medicine had no significant difference compare with conventional Western medicine in reducing National Institute of health stroke scale(NIHSS) after 2 weeks of treatment for hypertensive intracerebral hemorrhage(MD=-1.59,95%CI[-3.46,0.29],P=0.10), but was superior to conventional Western medicine after 30 d of treatment(MD=-1.16,95%CI [-1.39,-0.94],P<0.000 01). Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine in improving Glasgow coma scale(MD=1.00,95%CI[0,2.00],P=0.05) and reducing the incidence of secondary brain insults(RR=0.38,95%CI[0.24,0.59],P<0.000 1), but there was no significant difference in increasing Barthel index(MD=1.00,95%CI[-0.30,2.30],P=0.13). In terms of effective rate, studies using Guideline for clinical trials of new patent Chinese medicines, NHISS or Glasgow outcome scale(GOS) had shown that Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine(RR_(Guideline for clinical trials of new patent Chinese medicines)=1.27,95%CI[1.10,1.46],P=0.001;RR_(NHISS)=1.26,95%CI[1.13,1.40],P<0.000 1;RR_(GOS)=1.54,95%CI[1.22,1.93],P=0.000 2). In reduction of hematoma volume, Naoxueshu Oral Liquid combined with conventional Western medicine was superior to conventional Western medicine after 2 and 4 weeks of treatment(MD_(2 week)=-2.31,95%CI[-3.12,-1.49],P<0.000 01;MD_(4 week)=-2.04,95%CI[-2.41,-1.68],P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. In terms of adverse reactions, two of the included studies reported mild adverse reactions, and the rest of studies were not mentioned, so this study was not able to make a positive evaluation of the safety of Naoxueshu Oral Liquid. This study showed that compared with conventional Western medicine, combined Naoxueshu Oral Liquid may be better for hypertensive intracerebral hemorrhage. However, due to the high bias risk in the included studies, more large-sample and high-quality RCTs are still needed in the future.


Assuntos
Medicamentos de Ervas Chinesas , Hemorragia Intracraniana Hipertensiva , Acidente Vascular Cerebral , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Hemorragia Intracraniana Hipertensiva/tratamento farmacológico , Medicamentos sem Prescrição
3.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2995-3006, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467689

RESUMO

The effect of oral or nasal feeding with Chinese patent medicine on hypertensive intracerebral hemorrhage was systematically evaluated by using the method of network Meta-analysis. Four Chinese databases(CNKI, VIP, Wanfang, CBM), three English databases(Medline, EMbase, Cochrane Library) and ClinicalTrials.gov were retrieved through computers. According to the inclusion criteria and exclusion criteria, randomized controlled trials(RCTs) of Chinese patent medicine combined with Western medicine in the treatment of hypertensive intracerebral hemorrhage were screened out according to the inclusion criteria and exclusion criteria. The Cochrane bias risk assessment tool was used to evaluate the quality of the included studies, and Stata 16.0 software was used to analyze the outcome indicators. A total of 3 888 literatures were retrieved, and 30 studies involving 6 kinds of Chinese patent medicines were finally included. The total sample size was 2 758 cases, including 1 401 cases in the treatment group and 1 357 cases in the control group. According to the results of network Meta-analysis,(1)in terms of improving the degree of nerve function defect, the order of Chinese patent medicines was conventional Western medicine combined with Xiaoyukang Capsules>combined with Tongxinluo Capsules>combined with Naoxuekang Oral Liquid>combined with Naoxueshu Oral Liquid>combined with Angong Niuhuang Pills>conventional Western medicine;(2)in terms of reducing the amount of residual cerebral hematoma, the order of Chinese patent medicines was conventional Western medicine combined with Naoxueshu Oral Liquid>combined Xiaoyukang Capsules>combined Naoxuekang Oral Liquid>conventional Western medicine;(3)in terms of improving ability of daily living, the order of Chinese patent medicines was conventional Western medicine combined with Shenzhi Huoxue Capsules>combined with Angong Niuhuang Pills>combined with Naoxueshu Oral Liquid>conventional Western medicine;(4)in terms of improving total effective rate, the order of Chinese patent medicines was conventional Western medicine combined with Naoxueshu Oral Liquid>combined with Xiaoyukang Capsules>combined with Angong Niuhuang Pills=combined with Naoxuekang Oral Liquid>combined Tongxinluo Capsules>conventional Western medicine treatment. The results showed that in addition to conventional Western medicine therapy, the combined use with Chinese patent medicine can improve the clinical efficacy in the treatment of hypertensive intracerebral hemorrhage. However, due to the differences in the number and quality of various Chinese patent medicines included in the studies, and the lack of direct comparison of Chinese patent medicines, the ranking results still need to be verified by multi center, large-sample-size randomized double-blind trials in the future, so as to provide more reliable evidence support for clinical drug use.


Assuntos
Hemorragia Intracraniana Hipertensiva , Medicina Tradicional do Leste Asiático , China , Humanos , Metanálise em Rede , Medicamentos sem Prescrição , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2942-2948, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467684

RESUMO

To systematically search and sort out the clinical randomized controlled trial(RCT) on the prevention and treatment of acute cerebral infarction with traditional Chinese medicine(TCM) by using the method of evidence map, and to understand the evidence distribution of related studies. CNKI, Wanfang, VIP, CBM, PubMed, EMbase, Cochrane Library and Web of Science were retrieved from January 2016 to September 2020, and literatures related to the prevention and treatment of acute cerebral infarction with traditional Chinese medicine were included. Text description combined with table and bubble chart were used to analyze the distribution characteristics of evidence. A total of 1 102 clinical articles in recent five years were retrieved. The annual trend of clinical study publication, study size, TCM therapy category and main scheme, and study literature quality were analyzed. We find that TCM treatment of acute cerebral infarction has become a hot topic of clinical research, the number of literature showed a trend of increased year by year, various means of intervention of TCM in the treatment of the advantages of increasingly highlight. Follow-up clinical research should highlight the characteristics of TCM: in the analysis of outcome indicators; increase the neuropsychological patients after stroke and cognitive ability, and the theory of combined treatment of TCM disease when thoughts; At the same time, the quality of clinical research needs to be improved. At present, there is still a lack of unified standards for the production of evidence map. This study is the first to explore the application of evidence map to summarize and display the clinical research status of TCM treatment of acute cerebral infarction, and combine it with the setting of priority areas of TCM clinical research, so as to provide a reference basis for determining the priority topic selection of TCM treatment optimization research.


Assuntos
Isquemia Encefálica , Medicamentos de Ervas Chinesas , Acidente Vascular Cerebral , Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Medicina Tradicional Chinesa , Acidente Vascular Cerebral/tratamento farmacológico
5.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2963-2971, 2021 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-34467686

RESUMO

To overview the systematic reviews of Panax notoginseng saponins in the treatment of acute cerebral infarction. CNKI, CBM, Wanfang, VIP, PubMed, Cochrane Library and EMbase databases were retrieved to collect the systematic reviews of the efficacy of P. notoginseng saponins in the treatment of acute cerebral infarction. The retrieval time was from the time of database establishment to January 2021. After two researchers independently screened out the literature and extracted the data, AMSTAR-2 scale was used to evaluate the methodological quality of the included systematic reviews, GRADE system was used to grade the quality of evidences of the outcome indicators, and the efficacy evaluation was summarized. A total of 5 systematic reviews were included. AMSTAR-2 evaluation results showed that 3 items were relatively complete, while 4 items had a poor overall quality. P. notoginseng saponins combined with conventional Western medicine therapy was superior to single conventional therapy in the recovery of neurological function, enhancement of the total effective rate in clinic, and improvement of activities of daily living. GRADE evaluation results showed that the quality of evidence was from low quality to very low quality. In conclusion, in the treatment of acute cerebral infarction, P. notoginseng saponins can improve the clinical efficacy, with a good safety but a not high methodological quality and a low evidence quality. It is suggested that high-quality clinical studies shall be further carried out to provide evidence-based basis for the application of P. notoginseng saponins in the treatment of acute cerebral infarction.


Assuntos
Panax notoginseng , Saponinas , Atividades Cotidianas , Infarto Cerebral/tratamento farmacológico , Humanos , Revisões Sistemáticas como Assunto
6.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4633-4643, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581071

RESUMO

To overview of systematic reviews/Meta-analysis of Xingnaojing Injection(XNJ) in the treatment of intracerebral hemorrhage(ICH). The systematic reviews concerning XNJ in the treatment of ICH were retrieved from four Chinese databases, four English databases, Chinese Clinical Trial Registry and ClinicalTrail.gov, with the retrieval time set from their inception to September 2020. Following the independent screening and data extraction by two researchers, a measurement tool to assess systematic evaluation 2(AMSTAR 2) and grades of recommendation, assessment, development and evaluation(GRADE) system were used to evaluate the metho-dological, reporting and evidence qualities of the 10 included systematic reviews. The results showed that XNJ was superior to the wes-tern medicine or conventional treatment in improving the effective rate and National Institutes of Health stroke scale(NIHSS) score, Barthel index(BI), and Glasgow coma scale(GCS) score and Chinese stroke scale(CSS) score, and reducing the mortality and cerebral hematoma volume, without inducing obvious adverse reactions. In general, the methodological, reporting and evidence qualities of the 10 included systematic reviews were poor. The AMSTAR 2 scores showed that key items No. 2 and No. 16 failed to meet the stan-dard, resulting in poor methodological quality. There was only one outcome indicator graded by GRADE as intermediate quality, 43% indicators as low quality, 42% indicators as extremely low quality, and none as high quality. These available evidences have suggested that the methodological, reporting and evidence qualities of the systematic evaluation concerning XNJ for the treatment of ICH need to be improved. Most evidences support that XNJ was better than the western medicine or conventional treatment in the treatment of ICH, but the methodological quality and the reliability of outcome indicators in relevant systematic review were low. More high-quality studies are still required for further verification.


Assuntos
Medicamentos de Ervas Chinesas , Hemorragia Cerebral/tratamento farmacológico , Humanos , Metanálise como Assunto , Reprodutibilidade dos Testes , Revisões Sistemáticas como Assunto , Estados Unidos
7.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4591-4600, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581067

RESUMO

To evaluate the application of outcome indicators in randomized controlled trials(RCTs) concerning the treatment of tension-type headache(TTH) with traditional Chinese medicine(TCM) in recent five years, so as to provide a basis for the study of core outcome set(COS) for TCM intervention in TTH. The RCTs on TCM treatment of TTH in recent five years were systematically retrieved from CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov and China Clinical Trial Registry. After literature screening, data extraction and evaluation of the risk of bias, the outcome indicators in the included RCTs were subjected to qualitative analysis. The preliminary search yielded 19 042 articles, and 10 983 were left after the elimination of duplication. Finally, 52 RCTs(48 in Chinese and 4 in English) were included for qualitative analysis. The outcome indicators of RCTs included in this study were classified into seven domains: TCM syndrome, symptom and sign, physical and chemical detection, quality of life, long-term prognosis, economic evaluation, and safety event. The findings demonstrated that headache characteristic index in the symptom and sign domain was the index with the highest reporting frequency and reporting rate. Seventeen RCTs used TCM syndrome score as the outcome indicator. Further analysis revealed that there existed such problems in research design as non-distinction between primary and secondary outcome indicators, great difference in the adopted measurement tools for outcome indicators, and the neglect of measurement time of outcome indicators. Moreover, the syndrome indicators reflecting TCM advantages, objective evaluation indicators, safety and health-economic indicators were lacking. These limitations have affected the quality and reliability of RCTs on TTH treatment with TCM. It is suggested that the efficacy and characteristics of TCM should be combined into current clinical research, and the COS in RCTs regarding TCM treatment of TTH should be established according to internationally recognized standard procedures.


Assuntos
Medicamentos de Ervas Chinesas , Cefaleia do Tipo Tensional , Humanos , Medicina Tradicional Chinesa , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Cefaleia do Tipo Tensional/tratamento farmacológico
8.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4601-4614, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581068

RESUMO

The study aims to analyze the outcome indicators of randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of hypertensive intracerebral hemorrhage(HICH) in recent three years, and thus provide suggestions for the future studies in this field. Four English databases, four Chinese databases and two online registration websites of clinical trials were searched. The RCTs published between January 2018 and September 2020 were screened. The risk of bias was assessed and outcome measures were classified. A total of 151 839 articles were retrieved, of which 44 RCTs were included for analysis after screening. The outcome measures of the included RCTs were classified into 7 categories, among which the symptoms/signs category showed the highest reporting rate. National Institute of Health stroke scale(72.73%) was the most frequently reported outcome indicator, while the vo-lume of intracerebral hemorrhage determined by computerized tomography(36.36%) was the most frequently reported lab test outcome. Most studies collect the outcomes at the end of treatment, while 9 studies reported long-term outcomes 3 months or more after onset. Compared with those of international clinical trials, the application of some of the outcomes was reasonable, focusing on patients' symptoms, quality of life and objective outcomes. However, there were still several problems: unclear primary and secondary outcome measures, insufficient attention to long-term prognosis, insufficient attention to social function, few TCM outcomes, lack of measurement blindness and the use of unreasonable composite outcomes. It is recommended that researchers should rationally design the outcome indicators of clinical trials and develop the core outcome set.


Assuntos
Medicamentos de Ervas Chinesas , Hemorragia Intracraniana Hipertensiva , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Hemorragia Intracraniana Hipertensiva/tratamento farmacológico , Medicina Tradicional Chinesa , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4615-4622, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581069

RESUMO

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.


Assuntos
Medicamentos de Ervas Chinesas , Cefaleia do Tipo Tensional , Adulto , Álcoois Benzílicos/uso terapêutico , Medicamentos de Ervas Chinesas/efeitos adversos , Glucosídeos , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
10.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4623-4632, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581070

RESUMO

This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.


Assuntos
Medicamentos de Ervas Chinesas , Cefaleia do Tipo Tensional , Cápsulas , Bases de Dados Factuais , Humanos , Cefaleia do Tipo Tensional/tratamento farmacológico , Resultado do Tratamento
11.
Zhongguo Zhong Yao Za Zhi ; 46(18): 4644-4653, 2021 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-34581072

RESUMO

To systematically review the efficacy and safety of acupuncture combined with minimally invasive surgery or basic the-rapy in treating hypertensive intracerebral hemorrhage(HICH) patients compared with minimally invasive surgery or basic treatment. In this study, the four Chinese databases, the four English databases, Chinese Clinical Trial Registry and ClinicalTrail.gov, all above were systematically and comprehensively retrieved from the time of database establishment to September 10, 2020. Rando-mized controlled trials(RCTs) were screened out according to inclusion criteria and exclusion criteria established in advanced. The methodological quality of included studies was evaluated by the tool named "Cochrane bias risk assessment 6.1". Meta-analysis of the included studies was performed using RevMan 5.4, and the quality of outcome indicators was evaluated by the GRADE system. Finally, 17 studies were included, involving 1 852 patients with HICH, and the overall quality of the included studies was not high. According to Meta-analysis,(1)CSS score of the group of acupuncture combined with minimally invasive surgery or basic therapy was superior to the group of minimally invasive surgery or basic therapy(MD=-3.50,95%CI[-4.39,-2.61],P<0.000 01);(2)NIHSS score of the group of acupuncture combined with minimally invasive surgery or basic therapy was superior to the group of minimally invasive surgery or basic therapy(MD=-4.78,95%CI[-5.55,-4.00],P<0.000 01);(3)the cerebral hematoma volume of the group of acupuncture combined with minimally invasive surgery or basic therapy was superior to the group of minimally invasive surgery or basic therapy(MD=-4.44,95%CI[-5.83,-3.04],P<0.000 01);(4)ADL score of the group of acupuncture combined with minimally invasive surgery or basic therapy was superior to the group of minimally invasive surgery or basic therapy(MD=20.81,95%CI[17.25,24.37],P<0.000 01);(5)the GCS score of the group of acupuncture combined with minimally invasive surgery or basic therapy was superior to the group of minimally invasive surgery or basic therapy(MD=2.41,95%CI[1.90,2.91],P<0.000 01). The GRADE system showed an extremely low level of evidence for the above outcome indicators. Adverse reactions were mentioned only in two literatures, with no adverse reactions reported. The available evidence showed that acupuncture combined with minimally invasive surgery or basic therapy had a certain efficacy in patients of HICH compared with minimally invasive surgery or basic therapy. However, due to the high risk of bias in the included studies, its true efficacy needs to be verified by more high-quality studies in the future.


Assuntos
Terapia por Acupuntura , Hemorragia Intracraniana Hipertensiva , Humanos , Hemorragia Intracraniana Hipertensiva/terapia , Resultado do Tratamento
12.
Zhongguo Zhong Yao Za Zhi ; 45(16): 3749-3758, 2020 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-32893567

RESUMO

At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.


Assuntos
Medicamentos Essenciais , Avaliação da Tecnologia Biomédica , China , Medicina Tradicional Chinesa , Medicamentos sem Prescrição
13.
Zhongguo Zhong Yao Za Zhi ; 45(9): 2210-2220, 2020 May.
Artigo em Chinês | MEDLINE | ID: mdl-32495573

RESUMO

The purpose of this study was to evaluate the selection situation of outcome indexes in randomized controlled trials of traditional Chinese medicine(TCM) in the treatment of acute ischemic stroke and to provide suggestions for future research. In this study, four Chinese databases and three English databases were searched from January 2017 to June 2019. The randomized controlled trials of traditional Chinese medicine in the treatment of ischemic stroke were selected according to the pre-established selection criteria. Cochrane bias risk assessment tool was used to evaluate the quality of the included studies. A total of 20 651 related articles were searched, and 11 662 ones were left after eliminating the repetitions. Finally, 42 articles were included, including 36 articles in Chinese and 6 articles in English, 40 randomized controlled trials and 2 registration schemes of randomized controlled trials. The results showed that the outcome indexes of 42 randomized controlled trials were mainly divided into seven categories, that is clinical outcome index, blood biochemical index, mental state evaluation index, cerebral hemodynamics index, index of evaluating the degree of carotid artery stenosis, safety indicators and other indicators. The blood biochemical index was the one with highest frequency, followed by the clinical outcome index. TCM syndrome score was used as an indicator of curative outcome in 17 studies. After the analysis, it was found that there were many problems in selecting the outcome indexes for the randomized controlled trials of traditional Chinese medicine in the treatment of cerebral apoplexy. For example, the end point index and hard index were rarely selected as the main outcome indicators, and the vast majority of them were intermediate alternative indexes; recognized curative effect could not be obtained; there were too many kinds of outcome indicators and excessive heterogeneity, hindering the promotion of superior treatment measures of traditional Chinese medicine in clinical practice. Therefore, we should draw lessons from the establishment method of the international core index outcome index set, construct the core index outcome index set of traditional Chinese medicine in the treatment of ischemic stroke, and develop the outcome index set which accords with the curative effect characteristics of traditional Chinese medicine treatment mea-sures to solve the problems effectively.


Assuntos
Isquemia Encefálica , Medicamentos de Ervas Chinesas , Acidente Vascular Cerebral , Humanos , Medicina Tradicional Chinesa , Projetos de Pesquisa , Resultado do Tratamento
14.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2896-2901, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602831

RESUMO

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.


Assuntos
Medicina Tradicional Chinesa , Medicamentos sem Prescrição , Vigilância de Produtos Comercializados , Sistemas de Notificação de Reações Adversas a Medicamentos , China , Hospitais
15.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2926-2931, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602834

RESUMO

Diemailing~® Kudiezi Injection( DKI) is widely used in the treatment of cerebral infarction,coronary heart disease and angina pectoris. Long-term clinical application and related research evidence showed that DKI has a good effect in improving the clinical symptoms of cardiovascular and cerebrovascular diseases. However,this injection has not been included in any clinical practice guideline. It has been found that the use of DKI is in wrong way in clinical practice in recent years. Therefore,clinical experts from the field of cardiovascular and cerebrovascular diseases nationwide are invited to compile this expert consensus in order to guide clinicians.GRADE system is used to grade the quality of evidence according to different outcomes according to degrading factors. Then it forms the recommendation or consensus suggestion through the nominal group method. The formation of expert consensus mainly considers six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on these six aspects,if the evidence is sufficient,a " recommendation" supported by evidence is formed,and GRADE grid voting rule is adopted. If the evidence is insufficient,a " consensus suggestions" will be formed,using the majority voting rule. In this consensus,the clinical indications,efficacy,safety evidences and related preliminary data of DKI were systematically and comprehensively summarized in a concise and clear format,which could provide valuable reference for the clinical use of DKI. This consensus has been approved by China association of Chinese medicine which is numbered GS/CACM 202-2019.


Assuntos
Angina Pectoris/tratamento farmacológico , Infarto Cerebral/tratamento farmacológico , Doença das Coronárias/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , China , Consenso , Humanos , Injeções , Medicina Tradicional Chinesa
16.
Zhongguo Zhong Yao Za Zhi ; 44(17): 3825-3829, 2019 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-31602959

RESUMO

Expert consensus statement on Diemailing Kudiezi Injection in clinical practice was approved on April 17,2019 by the Standardadization Office of the Chinese Association of Chinese Medicine. This project,which started in November 2017,has been developed and completed in accordance with the standard developing procedure. This paper will give a detailed introduction to the compilation process about the consensus. The aim is to enable readers to understand the background,purpose and basis of this consensus in a timely manner. Readers can learn about diffferent stages of develping process,including project management system,drafting,consulting,expert consensus,as well as current problems and shortcomings. Such an editorial explanation is just a dynamic follow-up of the whole consensus-making process. It also plays a good supervisory role in the whole consensus-making. It could be a guarantee for the quality of the consensus. There is no doubts that the editorial explanation is an important auxiliary document in the process of consensus-making. It is the extension and supplement of consensus content and a basis for fully understanding the technical content of this consensus. Therefore it is an indispensable document in the process of consensus-making.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/normas , Consenso , Injeções
17.
Zhongguo Zhong Yao Za Zhi ; 44(2): 372-380, 2019 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-30989960

RESUMO

To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.


Assuntos
Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Injeções , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Zhongguo Zhong Yao Za Zhi ; 43(20): 4138-4151, 2018 Oct.
Artigo em Chinês | MEDLINE | ID: mdl-30486543

RESUMO

To evaluate the effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease. Four Chinese databases (CNKI, VIP, WanFang, and SinoMed) and three English databases (Cochrane Library, Medline, and ClinicalTrail.gov) were systematically and comprehensively searched from the establishment of each database to March 2018. Randomized controlled trials (RCTs) on the treatment of angina pectoris of coronary heart disease with Kudiezi injection (KDZ) were screened according to the pre-established inclusion criteria and exclusion criteria. The quality of the included studies was evaluated by using the ROB tool developed by the Cochrane Collaboration, and RevMan 5.3 software was used for Meta-analysis. A total of 712 articles were retrieved and finally 38 studies were included. The total sample size was 3 812 cases, 1 945 in the experimental group and 1 867 in the control group. The overall quality of the included studies was generally low. The results of Meta-analysis showed that: KDZ combined with conventional or western medicine was superior to conventional or western medicine alone in the effectiveness and electrocardiogram efficacy of angina pectoris and unstable angina. The descriptive analysis showed that KDZ combined with conventional treatment group was superior to conventional treatment group in agina pectoris associated indicators of angina pectoris and unstable angina. Other outcome measures were easily affected by various factors (such as too large heterogeneity of outcome indicators) and could not be concluded. Adverse reactions included in the study report were all mild adverse reactions and did not affect treatment. Based on the results of this study, it can be seen that Kudiezi injection had a certain effect on the treatment of angina pectoris of coronary heart disease, especially with significant positive effect on the improvement of the curative effect for angina pectoris and the effect of electrocardiogram. No serious adverse reactions occurred. However, due to the limited number of studies included, the generally low quality of the included studies, and the existence of published biases, the quality of the evidence in this study was low, so that caution should be taken to apply this conclusion. The effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease remained to be confirmed in the future with a well-designed and rigorous multi-center randomized controlled trials with standardized report, large sample, and enough follow-up time.


Assuntos
Angina Pectoris/tratamento farmacológico , Angina Instável/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Coração , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Ying Yong Sheng Tai Xue Bao ; 29(5): 1489-1493, 2018 May.
Artigo em Chinês | MEDLINE | ID: mdl-29797881

RESUMO

Marine ranching is an effective way to protect and restore coastal fishery resources. In order to assess the impacts of marine ranching construction on the trophic niches and interspecific competition of Sebastiscus marmoratus and Larimichthys polyactis, we analyzed the relationship between the changes of intraspecies trophic niche and the interspecific competition, based on the carbon and nitrogen stable isotope data of these two species collected from 2013 to 2016. The results showed that the intraspecies trophic niches of both species increased significantly in marine ranching area from 2013 to 2016. The total area of the convex polygon (TA) niche increased from 1.89 to 12.43 for S. marmoratus, and increased from 0.34 and 8.86 for L. polyactis, with the interspecific niche overlap area of these two species increasing from 0.13 to 7.69. The standard elliptic trophic niche increased from 1.11 to 4.94 for S. marmoratus, and from 0.14 to 4.06 for L. polyactis, with the interspecific niche overlap area increasing from 0 to 0.26. Values of the δ13C and δ15N of both species showed a tendency of decreasing with time, with significant changes of δ13C, but non-signi-ficant for δ15N. Dietary overlap between those two species increased from 68.9% to 90.6%.


Assuntos
Pesqueiros , Cadeia Alimentar , Perciformes , Animais , Isótopos de Carbono , China , Dieta , Isótopos de Nitrogênio
20.
Zhongguo Zhong Yao Za Zhi ; 42(15): 2857-2863, 2017 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-29139248

RESUMO

This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted.


Assuntos
Medicamentos de Ervas Chinesas/efeitos adversos , Vigilância de Produtos Comercializados , Humanos , Estudos Prospectivos
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