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1.
Article in English | WPRIM | ID: wpr-928964

ABSTRACT

OBJECTIVE@#To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.@*METHODS@#A prospective, multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3, 2016 to February 17, 2019. A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors. Additionally, stroke recurrence was defined as a primary outcome indicator.@*RESULTS@#A total of 327 (12.78 %) patients endured recurrence events, 1,681 (65.72%) were men, and the average age was 63.33 ± 9.45 years. Totally 1,741 (68.06%) patients suffered first-ever ischemic stroke, 1,772 (69.27%) patients reported to have hypertension, and 1,640 (64.11%) of them reported dyslipidemia, 1,595 (62.35%) patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification. Specifically, 1,271 (49.69%) patients were considered as qi-deficient constitution, and 1,227 (47.97%) patients were determined as stagnant blood constitution. There were 1,303 (50.94%) patients diagnosed as blood stasis syndrome, 1,280 (50.04%) patients exhibited phlegm and dampness syndrome and 1,012 (39.56%) patients demonstrated qi deficiency syndrome. And 1,033 (40.38%) patients declared intracranial artery stenosis, and 478 (18.69%) patients reported carotid artery stenosis. The plaque in 1,508 (41.36%) patients were of mixed. Particularly, 41.09% of them demonstrated abnormal levels of glycated hemoglobin levels.@*CONCLUSIONS@#Recurrence in minor and small-artery stroke cannot be ignored. Hypertension, dyslipidemia, abnormal HbA1c, intracranial artery stenosis and carotid plaque were more common in stroke patients. Particularly, phlegm-dampness and blood stasis syndromes, as well as qi deficiency and blood stasis constitutions, were still the main manifestations of stroke. (Trial registration at ClinicalTrials.gov No. NCT03174535).


Subject(s)
Aged , Constriction, Pathologic , Female , Hospitals , Humans , Hypertension , Ischemic Stroke , Male , Medicine, Chinese Traditional , Middle Aged , Prospective Studies , Stroke/epidemiology , Syndrome
2.
Article in Chinese | WPRIM | ID: wpr-927966

ABSTRACT

To evaluate the pharmacoeconomic value of Qidong Yixin Oral Liquid in the treatment of viral myocarditis(Qi-Yin deficiency syndrome) by supplementing Qi, nourishing the heart, calming the mind, and relieving palpitation, the present study performed the Meta-analysis based on the published papers on Qidong Yixin Oral Liquid by AMSTAR and carried out pharmacoeconomic evaluation using TreeAge Pro by the cost-effectiveness analysis. The results showed that the quality of the included papers was good. After four weeks of treatment, Qidong Yixin Oral Liquid combined with the conventional treatment regimen was superior to the conventional treatment in improving creatine kinase isoenzyme, and the difference was statistically significant. Furthermore, the treatment cost was also higher than that of conventional treatment, with an incremental cost-effectiveness ratio of CNY 95.89, accounting for 0.30% of per capita disposable income. The results of sensitivity analysis showed that the research results were robust. Therefore, based on the assumption that the per capita disposable income in 2020 was the threshold of patients' willingness to pay, it is more economical for patients with viral myocarditis to use Qidong Yixin Oral Liquid combined with conventional secondary prevention regimen than conventio-nal secondary prevention regimen alone. The economic evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis will help physicians and patients choose optimal treatment options, improve rational clinical medication, and provide references for the efficient allocation and utilization of medical resources in China.


Subject(s)
Cost-Benefit Analysis , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Humans , Myocarditis/drug therapy , Qi , Yin Deficiency/drug therapy
3.
Article in Chinese | WPRIM | ID: wpr-906377

ABSTRACT

Objective:To explore the clinical diagnosis and treatment characteristics as well as the optimal schemes of Lianhua Qingwen Capsule in the treatment of upper respiratory tract infection (URTI) in the real world. Method:The information of 454 patients receiving Lianhua Qingwen Capsule for URTI was collected from the electronic medical data warehouse constructed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, which covered 16 large-scale tertiary Class A hospital information systems (HISs). The harvested information was subjected to descriptive analysis, Apriori algorithm-based analysis and Louvain (BGLL) algorithm-based complex network analysis to explore the clinical medication schemes. Result:The commonly adopted medication schemes were heat-clearing and detoxicating Chinese medicinal injections combined with expectorants, analgesic-antipyretic drugs, or antibacterial agents in western medicine. Besides, the combination with heat-clearing and phlegm-resolving Chinese medicinals, vitamins, or hypotensive, lipid-lowering, hypoglycemic, coronary circulation-improving, or antiplatelet aggregation drugs targeting the underlying diseases was also detectable. Conclusion:The complex network analysis based on BGLL clustering method can be used to find out the medication rules of Lianhua Qingwen Capsule for URTI. The traditional Chinese medicine has been widely employed for resolving phlegm and relieving cough due to its good efficacy. The combination with antibiotics follows the guidelines for the use of antimicrobial agents. Drug safety is one of the most concerned aspects in clinical drug combination. The uncovering of these rules has provided a direction for exploring the optimal treatments.

4.
Article in Chinese | WPRIM | ID: wpr-921765

ABSTRACT

This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.


Subject(s)
Anti-Arrhythmia Agents , Humans , Medicine, Chinese Traditional , Qi , Treatment Outcome , Ventricular Premature Complexes , Yin Deficiency
5.
Article in Chinese | WPRIM | ID: wpr-921764

ABSTRACT

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.


Subject(s)
China , Drugs, Chinese Herbal , Information Storage and Retrieval , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control
6.
Article in Chinese | WPRIM | ID: wpr-921728

ABSTRACT

This paper discusses the rational use of traditional Chinese medicine based on chemical composition, body state and biological effect. The essence and connotations of traditional Chinese medicine are explained by modern scientific theory and technical means, and the mechanism of traditional Chinese medicine in the treatment of diseases is defined in modern medicine language, which is conducive to promoting rational and safe clinical use of drugs. Based on the chemical composition of traditional Chinese medicine,the selected genuine medicinal materials were collected and processed in a standardized way, and then used in the combination with other traditional Chinese medicines, with the aim to improve the efficacy of traditional Chinese medicine in clinical indications, increase the advantages, eliminate the disadvantages, and adapt to flexible and safe clinical drug demands. Based on the body state elements, clinical diagnosis and treatment shall be patient-centered, and doctors shall distinguish the differences of pathogenesis, symptoms and diseases, and consider the drug contraindications of special groups. According to the " dose-effect-toxicity" relationship, doctors shall select the appropriate dosage form, control the drug dosage, balance the benefits and risks of drugs, and carry out appropriate medical treatment. Based on the biological effect elements and the regulatory mechanism of traditional Chinese medicine on the target and pathway of disease, traditional Chinese medicine shall strengthen the precise positioning, provide accurate treatment; evaluate the safety of traditional Chinese medicine combination, explore the adverse reaction mechanism, strengthen the clinical safety monitoring of traditional Chinese medicine, and guide the clinical rational use of drugs, in the expectation of ensuring the safe use of traditional Chinese medicine and maximize the clinical efficacy of traditional Chinese medicine.


Subject(s)
Contraindications, Drug , Drug Dosage Calculations , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Practice Patterns, Physicians'
7.
Article in Chinese | WPRIM | ID: wpr-827948

ABSTRACT

Guizhi Fuling Capsules is a new-type traditional Chinese medicine preparation made by modern process method. It was widely used to treat uterine fibroids, pelvic inflammation, dysmenorrhea, endometriosis, mammary gland hyperplasia and other gynecological diseases. Under the combination of disease and syndrome, the diagnosis and treatment model of "Yizheng Tongbing, Yibing Tongzhi" with Chinese patent medicine has been widely used in clinical practice. Meanwhile, the effectiveness and safety have been given more and more attention. Based on the effectiveness of Guizhi Fuling Capsules, this paper preliminarily summarized the dominant diseases in randomized controlled trials and systematic reviews of Guizhi Fuling Capsules. On the basis of the basic theory of traditional Chinese medicine and modern pharmacological mechanism, the clinical efficacy and mechanism of Guizhi Fuling Capsules were explored. Finally, according to the traditional Chinese medicine theory of "Yizheng Tongbing, Yibing Tongzhi", all the clinical evidences were integrated to form an integrated evidence chain, so as to provide guidance for the safe and rational use of Guizhi Fuling Capsules.


Subject(s)
Capsules , Drugs, Chinese Herbal , Dysmenorrhea , Female , Humans , Medicine, Chinese Traditional , Pelvic Inflammatory Disease , Wolfiporia
8.
Article in Chinese | WPRIM | ID: wpr-774530

ABSTRACT

To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.


Subject(s)
Adolescent , Adult , Adverse Drug Reaction Reporting Systems , Bayes Theorem , Capsules , Drug-Related Side Effects and Adverse Reactions , Epidemiology , Drugs, Chinese Herbal , Humans , Risk Management , Young Adult
9.
Article in Chinese | WPRIM | ID: wpr-771662

ABSTRACT

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Humans , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic , Wolfiporia , Chemistry
10.
Chinese Medical Journal ; (24): 4493-4498, 2013.
Article in English | WPRIM | ID: wpr-327542

ABSTRACT

<p><b>BACKGROUND</b>Graves' ophthalmopathy/orbitopathy (GO) patients often suffer ocular surface damages and tear fluid proteins play a significant role in maintaining healthy ocular surfaces, while changes in tear protein components reflect the changes ocular surface abnormalities. In this study proteomics techniques were used to investigate tear protein compositions in GO patients.</p><p><b>METHODS</b>We carried out a case-control study by comparing tear fluid contents of GO patients with that of healthy subjects. In the first step the tears were subjected to SDS-PAGE electrophoresis and then single protein bands were analyzed by to in-gel trypsin digestion and nano-flow liquid mass spectrometry (LC-MS/MS) using a MS software.</p><p><b>RESULTS</b>In tear samples of GO subjects, the protein fractions of inflammation-related protein immunoglobulin kappa chain C region (IgKC) and serum albumin were essentially reduced, whereas a novel isoform of complement component 3 (C3), which we detected in control subjects, was completely absent in the GO patients' tears.</p><p><b>CONCLUSIONS</b>Reduced protein concentrations of particularly IgKC and complement C3 as well as albumin in the tears of GO patients may contribute to changes in their ocular surfaces via diminished reactive oxygen species (ROS) depletion and adaptive immune responses. The completely absent of C3 in the GO patients' tears, may imply that an important inflammatory signaling pathway is affected, which needs further investigation.</p>


Subject(s)
Adolescent , Adult , Case-Control Studies , Chromatography, Liquid , Eye Proteins , Metabolism , Female , Graves Ophthalmopathy , Metabolism , Humans , Male , Middle Aged , Tandem Mass Spectrometry , Young Adult
11.
Article in Chinese | WPRIM | ID: wpr-680488

ABSTRACT

Objective To evaluate the efficacy of methylprednisolone pulse therapy in the treatment of thyroid-associated oph- thalmology. Design Meta analysis. Participants Published literatures about methylprednisolone pulse therapy for thyroid-associated ophthalmopathy. Methods A meta-analysis of published randomized clinical trials was used. Published literatures were selected for study based on a computerized search of the literature and a manual search of the bibliographies of relevant papers. Studies meeting se- lected criteria were reviewed systematically by meta-analysis. Data was extracted on the basis of the intention-to-treat principle. Treat- ment effect was measnred as relative risk(RR) of response rates. Main Outcome Measures The effective rate and the relative risk(RR). Results A total of 6 articles were included in this meta-analysis. The RR (95%CI) were 7.50 (1.14, 49.26) when comparing methylpred- nisolone pulse therapy with placebo, 3.33 (0.51, 21.89) when comparing methylprednisolone pulse therapy with surgical decompression, and 1.50 (1.12, 2.00) when comparing methylprednisolone pulse therapy with oral steroids. The combination of methylprednisolone pulse therapy and orbital radiotherapy was significantly effective than oral steroids combined with orbital radiotherapy which pooled RR (95% CI) was 1.42 (1.11, 1.81). Conclusions Methylprednisolone pulse therapy appears to be an effective treatment for thyroid-associated ophthalmology, and seems to have increased effect when given with orbital radiotherapy.

12.
Article in Chinese | WPRIM | ID: wpr-680223

ABSTRACT

Objective To investigate the radiologic and angiographic findings of dilated superior ophthalmic vein(SOV)associat- ed with orbital arteriovenous malformations(AVM).Design Retrospective case series.Participants Six cases of orbital AVM patients, with clinical symptoms and signs mimicking a carotid cavernous fistula(CCF).Methods Examinations of the six cases,such as CT, MRI,and selective cerebral angiography,were summarized and analyzed.Main Outcome Measures Images findings and hemodynam- ics.Results All patients were found with dilated SOV on CT and MRI.Additional radiographic findings included proptosis and AVM. All six AVM were located at the orbit,and one of them was also found with AVM in brain.The main draining vein was SOV in all cas- es.The branches contributing to the fistula's blood supply were the middle meningeal artery,the internal maxillary artery,and the oph- thalmic artery.Conclusions Orbital AVM can cause similar clinical signs and radiologic features to those associated with a CCF.How- ever,the bulging cavernous sinus cannot be found in most AVM.Angiography is necessary for definitive management,non-invasive techniques have an important role in pre-angiographic diagnostic decisions.(Ophthalmol CHN,2007,16:395-398)

13.
Chinese Medical Journal ; (24): 1006-1010, 2004.
Article in English | WPRIM | ID: wpr-284860

ABSTRACT

<p><b>BACKGROUND</b>Non-penetrating trabecular surgery is a new filtrating surgery without opening in ternal trabecular structures. This study was to estimate the overall efficacy of non-penetrating trabecular surgery for open angle glaucoma.</p><p><b>METHODS</b>The published articles selected for this study were obtained by a computerised Medline and China Biological Medicine Disk search of the literature and a manual search of the bibliographies of relevant articles. Articles meeting the inclusion criteria were reviewed systematically, and the reported data were aggregated using the statistical techniques of meta-analysis.</p><p><b>RESULTS</b>A total of 37 articles were included in the meta-analysis. The pooled complete success rates of non-penetrating trabecular surgery with different techniques were: deep sclerectomy single, 69.7% (95% CI: 58.5% - 81.0%); deep sclerectomy with collagen implant, 59.4% (95% CI: 47.0% - 71.8%); deep sclerectomy with reticulated hyaluronic acid implant, 71.1% (95% CI: 56.8% - 85.3%); and viscocanalostomy, 72.0% (95% CI: 57.6% - 86.4%). The overall weighted complete success rate of non-penetrating trabecular surgery was 67.8% (95% CI: 61.4% - 74.3%).</p><p><b>CONCLUSIONS</b>Non-penetrating trabecular surgery is the best available therapy method for medically uncontrolled open angle glaucoma with a complete success rate of over 60%. But the different techniques cannot belie the complete success rate of non-penetrating trabecular surgery.</p>


Subject(s)
Filtering Surgery , Methods , Glaucoma, Open-Angle , General Surgery , Humans , Intraocular Pressure , Sclerostomy , Trabeculectomy
14.
Article in Chinese | WPRIM | ID: wpr-680304

ABSTRACT

Objective:To prepare a novel vascular endothelial growth inhibitor-soluble chimeric protein VEGI~+,so as to lay a basis for studying its biological activity.Methods:Chimeric molecule VEGI~+ was constructed by grafting oligopeptide CTTH- WGFTLC to extraeellular region of VEGI(VEGI_(23-174)).Before ligation into pET30a(+)expression vector,PCR product of the recombinant gene was cloned into pGEM-T vector and verified by restriction enzyme digestion and DNA sequencing,then pET30a-VEGI was used to transfect BL21(modified E.coli strain).The chimeric protein was purified by metal affinity chro- matography.Western blotting and coomassie blue staining were used for protein identification.Results:The chimeric molecule VEGI~+ was confirmed by restriction enzyme digestion and DNA sequencing.The constructed pET30a-VEGI was confirmed by enzymatic digestion.The expression was mainly in the form of inclusion body.SDS-PAGE electrophoresis and Western blotting revealed a chimeric protein about 23000,with a purity of about 90%.Conclusion:We have successfully constructed the recom- binant plasmid pET30a-VEGI~+ and expressed it in E.coll.And we have obtained high purity of soluble chimeric protein VEGI~+ through affinity chromatography.

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