ABSTRACT
Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.
Subject(s)
Humans , Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Injections , Medicine, Chinese TraditionalABSTRACT
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.
Subject(s)
Consensus , Drugs, Chinese Herbal , Therapeutic Uses , Injections , Medicine, Chinese Traditional , Reference StandardsABSTRACT
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.
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This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs. Sixty-two percent(4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%(2 752/7 189) from western medicine hospitals; 84%(6 003/7 189) of the patients were from tertiary hospitals as compared with 16%(1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed, stash time after allocating transfusion, duration of injection, and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice, for instance, non-intravenous infusion, >14 d treatment course, use of non-designated solvent, and a single dose>40 mL or<10 mL. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China, and the other three most frequent combined drugs deproteinized calf blood extractive injection, Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing＋Aspirin＋Alprostadil was the most common combined use in our study, but the recommended clopidogrel＋Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.
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Objective To investigate the clinical efficacy and safety evaluation of fibrinolytic,anticoagulant and antiplatelet drug combination treatment in patients with progressive ischemic stroke (PIS). Methods Ninety cases with PIS were randomly divided into the treatment group (47 cases) and the control group (43 cases). The patients in the control group were given combination therapy of Diemailing, Nadroparin calcium and Ozagrel,while the combination therapy of Defibrase, Diemailing, Nadroparin Calcium and Ozagrel were given in the treatment group. The plasma fibrinogen (Fib), prothrombin time (PT), part enabled prothrombin time (APTT), liver and kidney function were observed. The clinical efficacy was evaluated after 14 days treatment. Results After treatment,the total effective rate of the treatment group was 89.4% ,which was significantly higher than that of the control group (67.4%) (P ＜ 0.05). After treatment, the PT and APTT levels of the treatment group were respectively (19.76± 5.53)s and (35.43 ± 6.03)s,the control group were respectively(17.26 ± 1.49)s and (35.71±5.64) s, the PT and APTT increased significantly compared with the pre-treatment condition in both groups (P ＜ 0.05), while the difference between the two groups was not statistically significant (P ＞ 0.05). The Fib level was (1.51 ±0.42)g/L in the treatment group,and (3.10 ±0.69)g/L in the control group. In the treatment group the Fib level was significantly lower than the control group and the condition before treatment(P ＜0.05). We found no significant difference between conditions before or after the treatment in the control group (P ＞ 0.05). The incidence of adverse clinical events showed no significantly difference between the treatment group and control (P ＞0.05). Conclusions Applying of fibrinolytic, anticoagulant and antiplatelet drug combination treatment in patients with PIS has a good efficacy and safety,which is good for clinical application.
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Objective To observe the protective effects of Diemailing Injection(DMLI) on experimental myocardial infarction in rats and its mechanism.Methods The experimental myocardial infarction model was induced by left anterior descending coronary occulusion for 24 h in rats.The rats were randomly divided into sham group,myyocardial infaction model group,DMLI groups with different doses(2.5,5.0,10.0 mL?kg~(-1))(n=20).The changes of myocardial infarction size(MIS),aspartate aminotransferase(AST),actate dehydrogenase(LDH),creatine phosphokinase(CK),superoxide dismutase(SOD) and glutathione peroxidase(GSH-Px) activities and malondialdehyde(MDA) content in serum,endothelin(ET) and angiotensinⅡ(AngⅡ) levels in plasma,and low shearing specific viscosity,middle shearing specific viscosity and high shearing specific viscosity of blood and specific viscosity of plasma were determined.At the same time,myocardial free fatty acid(FFA) contents of infarction and noninfarction area were determined.Results In rats treated by DMLI(in doses of 2.5,5.0 and 10.0 mL?kg~(-1) i.v after coronary occulusion),the MIS was significantly reduced(P
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Objective To observe the protective effects of Diemailing Injection (DMLI) on myocardial ischemia-reperfusion injury in rats. Methods The myocardial ischemia-reperfusion model was induced by 30 min left anterior descending coronary occulusion and 24 h reperfusion in open-chest anesthetized rats. The changes of aspartate aminotransferase (AST), lactate dehydrogenase (LDH), MB isoenzyme of creatine kinase (CK-MB), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities and malondialdehyde (MDA) contents in serum, and prostacycline (PGI2) and thromboxane A2 (TXA2) levels in plasma were determined. Results In rats treated by DMLI (with dose of 2. 5, 5 and 10 mL ? kg-1 i. v. at 30 min after coronary occulusion), the myocardial ischemia size (MIS) was significantly reduced, the AST, LDH and CK-MB activities in serum and the TXA2 level in plasma were declined, while PGI2 level in plasma and PGI2/TXA2 ratio were increased significantly. In addition, the LPO content in serum declined, SOD and GSH-Px activities in serum were increased markedly. Conclusion DMLI has protective effects on myocardial ischemia-reperfusion injury through improving free radicals metabolism, decreasing TXA2 level in plasma, increasing PGI2 level in plasma and PGI2/TXA2 ratio.
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Objective To observe the clinical curative effect of Die-Mailing in treating cases of pulmonary heart disease with heart failure.Methods 92 cases were divided at random into 2 groups:conventional therapy group(46 cases) were treated with Die-Mailing injection on the base of routine therapy.Control group(46 cases) were treated with only routine therapy.Results Effect rate of conventional group was 93.5%(43/46),while the effect rate of control group was 71.7%(33/46).Conclusion The treatment of the Die-Mailing injection based on the conventional treatment can be effective to control pulmonary heart disease and heart failure.