Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 282
Filter
1.
Article in Chinese | WPRIM | ID: wpr-879123

ABSTRACT

This paper introduced the basic definition, application scope, advantages and challenges of the master protocol, basket design, umbrella design and platform trial, and put forward the idea of using master protocol, basket design and umbrella design in Chinese medicine(CM) by considering the characteristics of CM and research experiences. The author pointed out that master protocol, basket design and umbrella design, as a high-efficiency research and design strategy, can be used in the clinical research on the treatment of the same disease with different therapies, the treatment of different diseases with the same therapy and the combination of diseases and CM syndromes. In particular, the exploration from the classification of CM syndromes can supplement the gaps in the cli-nical research on CM syndromes. In the application of such designs, it is also necessary to pay attention to their potential challenges and develop reasonable and feasible plans on research implementation, management and statistical analysis in advance to meet these challenges.


Subject(s)
Dietary Supplements , Medicine, Chinese Traditional , Precision Medicine , Records , Research Design
2.
Article in Chinese | WPRIM | ID: wpr-879121

ABSTRACT

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.


Subject(s)
Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Product Surveillance, Postmarketing , Randomized Controlled Trials as Topic
3.
Article in Chinese | WPRIM | ID: wpr-879120

ABSTRACT

Post-marketing evaluation of traditional Chinese medicine(TCM) is an important research stage in the life cycle of a drug, and the add-on-design is a common method for its post-marketing evaluation. This article introduces the basic concept of add-on-design, and points out that it is suitable for use based on the principles of medical ethics when the standard treatment should not be interrupted. The post-marketing evaluation of TCM should be carried out based on human experience and in compliance with regulations and ethics. The clinical values of TCM, such as the therapeutic effect for disease, improvement of disease symptoms, improvement in quality of life, as well as the synergism and toxicity attenuation of combined use of TCM and chemical drugs, should be fully reflected through the clinical trials designed with add-on-design. The key points of add-on-design are accurate clinical positioning, scientific estimation of sample size, and rigorous standard treatment. Standard treatment should be a recognized one, consistent and stable; appropriate and recognized efficacy indicators and targeted safety indicators should be selected; the design and operation of clinical research scheme should meet the requirements of randomization and blind method, with special emphasis on the production of qualified placebo. The add-on-design has the advantages that the rights and interests of the subjects are adequately protected. Besides, the research conclusions are easily put into clinical application. But there are also many difficulties, such as the influence of confounding bias, the "ceiling" effect of clinical efficacy, and the difficulty of interpretation of adverse events. Therefore, a rigorous research quality assu-rance system should be established, and the quality control of evaluation consistency of researchers should be emphasized to ensure strict quality control in the research process.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
4.
Article in Chinese | WPRIM | ID: wpr-879119

ABSTRACT

Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs
5.
Article in Chinese | WPRIM | ID: wpr-879117

ABSTRACT

At present, the value evaluation of Chinese patent medicines is in the exploratory stage, and a clinical value evaluation system that can reflect the characteristics of traditional Chinese medicine has not been established. This article investigates four universal drug value tools from abroad, namely, evidence rating matrix, cancer value label, patient-perspective value framework and multiple criteria decision analysis advance value framework. The evidence rating matrix is used to measure the benefits and risks of different treatment measures, and the net health benefit is used as the best estimate point to evaluate the value of treatment; the cancer value label is mainly used to weigh the economic value and innovative value of drug treatment programs of different anti-tumor drugs by matrix composed the ratio between the expected result and the cost; the patient-perspective value framework emphasizes the evaluation of the value of different healthcare intervention methods from the patient's perspective; multiple criteria decision analysis advance value framework measures the value of drugs or measures from multiple dimensions. Combined with the characteristics of the above universal drug value evaluation tools and the correlation research of domestic drug value evaluation, the paper proposes to analyze the characteristics of Chinese patent medicine value evaluation from the six dimensions of effectiveness, safety, innovation, economy, suitability and accessibility of Chinese patent medicine, and expounds the strategy of constructing Chinese patent medicine value evaluation tool, so as to provide reference for the drug value evaluation and decision-making application of Chinese patent medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
6.
Article in Chinese | WPRIM | ID: wpr-879116

ABSTRACT

The article summarized the relevant researches on the clinical orientation of Chinese patent medicines, and put forward the post-marking principle and strategies of the clinical orientation. The principle could be illustrated by four criteria: overall design, step-by-step implementation, from easiness to hardness, gradual concentration. The strategies were as follows: first carrying out the projects with little cost of money and time, and then the projects requiring much cost of money and time, so that the possibility of fai-lure would be put forward at an early stage to reduce the loss caused by research failure as much as possible by consolidating the research projects with less investment at the early stage and gradually increasing the research projects with more investment at the later stage. On this basis, the "three dimensions and four stages" key technology was proposed for the post-marketing clinical orientation of traditional Chinese medicine. Medicines, diseases and patients were the "three dimensions", so we should understand the features and interaction of the target indications, symptoms and population to establish a three-dimensional clinical positioning coordinate system. "Four stages" were the four steps of clues analyzing, hypothesis orientation, preliminary verification and clinical validation. Each latter stage should be started after full completion of the former one, and the latter stage results shall be used to validate and revise the former clinical orientational hypothesis, continuously forming a feedback circle. Based on the sufficient verification of previous study, prospective clinical trials were implemented at last to get the best evidence-based evidence of clinical orientational hypothesis.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Prospective Studies
7.
Article in Chinese | WPRIM | ID: wpr-828446

ABSTRACT

This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1∶1∶1, a total of 144 patients were randomly divided into Reyanning Mixture group(RYN), Reyanning Mixture+Amoxicillin Capsules group(RYN+Amoxil) and Amoxicillin Capsules group(Amoxil), with 48 cases in each group, in order to evaluate the efficacy and safety of RYN alone or combined with Amoxil in the treatment of acute tonsillitis, and provided high-quality evidences for treatment of infectious diseases with traditional Chinese medicine and reduced use of antibiotics. The dosage of RYN was 20 mL, 3 times a day, 100 mL/bottle, oral for 7 days, and Amoxil dosage was 0.5 g, 3 times a day, 0.5 g×12 tablets/plate, oral for 7 days. A total of 144 cases were included, 3 cases were excluded(1 case was mistakenly included, 2 cases did not take drugs after inclu-ded), and a total of 141 cases were included in the full analysis set(FAS). The results showed statistical differences in the recovery time of the disease, the disappearance rate of fever on the 3 rd day and the disappearance rate of tonsillar redness and swelling between RYN and Amoxil. There were statistical differences in the cure rate of disease, recovery time of disease, body temperature recovery time, fever disappearance rate on the 3 rd day, pharynx swelling and pain disappearance rate and tonsil swelling disappearance rate between the RYN+Amoxil and Amoxil, but with no significant difference in the above aspects compared with RYN. The DDD of antibiotic use in RYN+Amoxil was significantly lower than that in Amoxil(P<0.01). According to the findings, when RYN was used alone in the treatment of acute tonsillitis, it was superior to Amoxil in time of recovery, short-term improvement of fever and redness and swelling of tonsil. Compared with RYN+Amoxil, there was no difference in cure rate of disease, recovery time of disease, body temperature recovery time, short-term improvement of fever, swelling of pharynx and swelling of tonsil, with a better efficacy than Amoxil. The clinical effect of RYN was similar to that of combined Amoxil in the treatment of acute tonsillitis, and RYN was superior to Amoxil in the time of recovery, short-term improvement of fever and redness and swelling of tonsil, with no adverse event or adverse reaction. RYN+Amoxil can significantly reduce the DDD value of antibiotics in the treatment of acute tonsillitis, with significant clinical advantages over Amoxil.


Subject(s)
Anti-Bacterial Agents , Therapeutic Uses , Double-Blind Method , Drugs, Chinese Herbal , Fever , Drug Therapy , Humans , Tonsillitis , Drug Therapy
8.
Article in Chinese | WPRIM | ID: wpr-828445

ABSTRACT

To systematically evaluate the efficacy and safety of Ganmao Qingre Granules in treatment of children with wind-cold syndrome. The study systematically retrieved CNKI, WanFang, VIP, CBM, PubMed, EMbase and Cochrane Library for children cases with wind-cold syndrome treated with RCT. The literature inclusion criteria provided by Cochrane was used to evaluate the litera-ture quality, and Meta-analysis was conducted by RevMan 5.3 software. A total of 6 literatures were included, with a total sample size of 492 cases, including 246 cases in the experimental group and 246 cases in the control group. According to the results of Meta-analysis, the experimental group recorded the hypothermia time(MD=-0.38, 95%CI[-0.53,-0.23], P<0.01), the total clinical effective rate(RR=1.25, 95%CI[1.15, 1.36], P<0.01), the cough relief time(MD=-2.75, 95%CI[-3.05,-2.46], P<0.01), the decrease nasal congestion relief time(MD=-1.45, 95%CI[-1.69,-1.22], P<0.01), traditional Chinese medicine syndrome score(MD=-8.35, 95%CI[-9.35,-7.36], P<0.01), all of them were superior to those of the control group(Aminophenol Huangnamin Granules), with statistically significant differences. Only 2 literatures mentioned no obvious adverse reaction, and the other 4 literatures did not mention any adverse reactions. Based on the results of this study, it was indicated that Ganmao Qingre Granules were effective in the treatment of children with wind-cold syndrome, but with unclear adverse reactions. Due to the insufficient quantity and low quality of included literatures, the efficacy and safety need to be further confirmed by more high-quality clinical studies.


Subject(s)
Child , Cough , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Syndrome , Wind
9.
Article in Chinese | WPRIM | ID: wpr-828444

ABSTRACT

Kidney malignant tumor is a type of primary renal cell carcinoma, and mainly refers to renal cancer. The incidence of kidney cancer and the number of hospital cases in China have been increasing. Based on the clinical medicine information of patients in the hospital information system(HIS) database of 37 hospitals in China, the combined medication of patients with kidney malignant tumor were analyzed by Tabu search algorithm, so as to analyze the combined medication of patients with kidney malignant tumor in real world. A total of 7 095 patients with kidney malignant tumor were included, the ratio of males to females was 2.11∶1, and the ratio of male patients increased gradually with age. About 3 933 patients(55.43%) showed a superior effect among those patients. The common therapies of patients with kidney malignant tumor were anti-tumor therapies and symptomatic therapies, including anti-infection, regulation of electrolyte balance, sedation and analgesia, analgesic, regulation of gastrointestinal function. The whole population of patients with kidney malignant tumor were mostly treated with anti-tumor drugs combined with more symptomatic therapies, while the anti-tumor therapies of the superiority population of patients were less combined with other drugs, with less combined medication. The result may be related to the stage of tumor or individual response to the therapeutic regimen. No matter for the whole population or for the superiority population of patients with kidney malignant tumor, the therapies was mainly Western medicines. Based on the pathogenesis of deficiency in origin and excess in superficiality with kidney malignant tumor, Chinese subgroups with formula for clearing heat and removing toxicity, formula for vigorate Qi and replenish the blood, formula for regulate Qi and invigorate the blood, laxative and hemostatic were more commonly used. In the future, further studies shall be conducted for combined therapies for patients of different stages, so as to play the advantages of multi-target, overall regulation, toxicity reduction and efficacy enhancement of traditional Chinese medicine, improve the life quality of patients with kidney malignant tumor, prolong their life time, and improve the survival rate of patients.


Subject(s)
Asian Continental Ancestry Group , China , Drugs, Chinese Herbal , Female , Hospital Information Systems , Humans , Kidney Neoplasms , Male , Medicine, Chinese Traditional
10.
Article in Chinese | WPRIM | ID: wpr-828443

ABSTRACT

In this study, the clinical characteristics and drug combination rules of Danshen Chuanxiongqin Injection in the treatment of patients with cerebral infarction were analyzed. The inpatient information of 2 857 patients of cerebral infarction treated with Danshen Chuanxiongqin Injection in HIS database of 20 grade Ⅲ class A hospitals in China was collected, and a model was established by description analysis and Apriori algorithm, in order to explore the clinical characteristics and drug combination rules of Danshen Chuan-xiongqin Injection in the treatment of cerebral infarction. The results showed that among patients of cerebral infarction treated with Danshen Chuanxiongqin Injection, 1 727 patients were older than 65 years old, accounting for 69.61%, and 1 610 were males, accounting for 63.59%. Commonly used drugs included lipid-lowering agents, anticoagulant thrombolytic agents, antiplatelet agents, stimulants of brain metabolism, vasodilators and other Western drugs, as well as traditional Chinese medicines, such as blood-activating agents, heat-clearing agents and expectorant agents. The Western medicine with the highest use frequency in combination with Danshen Chuan-xiongqin Injection was aspirin enteric-coated tablets(1 528 cases, 53.48%). The traditional Chinese medicine with the highest use frequency in combination with Danshen Chuanxiongqin Injection was Xingnaojing Injection, with a total of 378 cases, accounting for 13.23%. Among them, the most commonly used Western drugs combined with Danshen Chuanxiongqin Injection were anticoagulant thrombolytic and antiplatelet drugs, with a usage rate as high as 83.48%. In order to further explore the drug combination rules of Danshen Chuanxiongqin Injection, the association analysis of drug combination in patients of cerebral infarction treated with Danshen Chuanxiongqin Injection was carried out. In clinical combination of two Western drugs, Atorvastatin Calcium Capsules+Cerebral Proteolytic Injection were the most common combination, with a support of 27.10%. In clinical combination with 3 Western drugs, Clopidogrel Bisulfate Tablets+Atorvastatin Calcium Capsules+Cerebral Proteolytic Injection were most commonly used, with a support of 15.90%. The results showed that the patients of cerebral infarction treated with Danshen Chuanxiongqin Injection were mainly elderly males, and often complicated with hypertension, coronary heart disease, diabetes and other basic diseases. The clinical application of Danshen Chuanxiongqin Injection was principally in line with the guidelines. In the treatment of cerebral infarction, it was often combined with Western medicine anticoagulant thrombolysis, antiplatelet drugs, traditional Chinese medicine blood-activating and stasis-dissolving prescription and other drugs with similar pharmacological effects, with an auxiliary therapeutic effect on patients of cerebral infarction complicated with other diseases, and can provide guidance for clinical medication.


Subject(s)
Aged , Aspirin , Cerebral Infarction , China , Drugs, Chinese Herbal , Humans , Male , Medicine, Chinese Traditional , Salvia miltiorrhiza
11.
Article in Chinese | WPRIM | ID: wpr-828442

ABSTRACT

In this study, Tabu search algorithm was used to analyze the effect of Xingnaojing Injection in the treatment of cerebral hemorrhage in the real world. Through the analysis of the results, the therapies based on the pathogeny of cerebral hemorrhage were screened out: Xingnaojing Injection+hemostatic drugs for promoting blood circulation and removing stasis. Cerebral hemorrhage complicated with brain edema: combined with mannitol or mannitol+aescin. The patients with relevant complications in the acute stage of cerebral hemorrhage could select according to the indications: ①Aminocycline+Oxiracetam+Piperacillin Sodium Sulbactam Sodium+Sodium Lactate Ringer; ②Aminocycline+Oxiracetam+Nifedipine+Captopril+Metoclopramide+Cimetidine; ③Insulin+Pantoprazole+So-dium Nitroprusside. The combined therapies for patients of the stable stage with complicating diseases could select according to the indications: ① Monosialotetrahexosyl Ganglioside Sodium+Deproteinized Calf Blood Serum+Nitroglycerin+Compound Potassium Dihydrogn Phosphate; ② Edaravone+Gangliosides+Captopril+Levofloxacin+Tanreqing Injection+Aminophylline. The analysis of subgroup module of drugs for promoting blood circulation and removing blood stasis suggested that the safety of traditional Chinese medicine should be paid attention to in the treatment of cerebral hemorrhage. This study was based on the data of the real world, but with some problems, such as lack of data and confounding factors. The summarized medication plan is only for the reference of clinicians. The clinical application shall be based on the specific situation of patients and the clinical benefits and risks, and pay attention to the incompatibility.


Subject(s)
Algorithms , Brain Edema , Cerebral Hemorrhage , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional
12.
Article in Chinese | WPRIM | ID: wpr-828441

ABSTRACT

In this study, Tabu search algorithm was used to analyze the drug combination of Xingnaojing Injection in the treatment of brain injury and complications in the real world, and the clinical drug combination of Xingnaojing Injection in the treatment of brain injury and complications was selected and summarized. The combination of Xingnaojing Injection, Namefen and Citicoline were recommended in the treatment of brain injury and complications. For brain edema and nerve injury, Mannitol/Glycerol Fructose/Furosemide+Tetrahexose Monosialate Ganglioside Sodium should be recommended. For those with pulmonary infection, Xingnaojing Injection+Xiyanping+Ambroxol Hydrochloride+Tanreqing Injection should be recommended. For those with shock, Hydroxyethyl Starch+Dopamine Hydrochloride/Dobutamine Hydrochloride+Sodium Bicarbonate should be recommended. The combination reflected the characteristics of Chinese and Western medicine. The above medication regimen was only for clinicians' reference. The clinical application should be based on patients' specific conditions, clinical benefits and risks, as well as the incompatibility. On the basis of the findings, further studies can be carried out for prospective clinical efficacy evaluation and safety evaluation for a specific subgroup module.


Subject(s)
Algorithms , Drugs, Chinese Herbal , Humans , Injections , Medicine, Chinese Traditional , Prospective Studies
13.
Article in Chinese | WPRIM | ID: wpr-828440

ABSTRACT

Traditional Chinese medicine(TCM) syndrome differentiation and treatment has a characteristic and advantageous efficacy in the prevention and treatment of major diseases(no matter for new or sudden infectious diseases or major chronic diseases). At present, the clinical application by Western medicine disease's name, stage, classification and other indications limits the role of TCM syndrome differentiation and treatment, and makes TCM difficult to play its advantages. Therefore, the therapeutic value and social value attribute of Chinese patent medicine after being launched in the market cannot be effectively demonstrated, or even generalized as adjuvants. Under the circumstances, it is difficult to put forward precise positioning different from chemical drugs, with fewer high-level and high-quality evidence-based evidences for precise positioning. The research on the pathological links and therapeutic mechanism of its effect on diseases is also less systematic. The development of biotechnology, such as genomics, has brought medicine into the era of precision, providing ideas and technical support for the exploration of syndrome biomarkers and the analysis of therapeutic mechanism with them as parameters. Digital China Think Tank Forum once mentioned that the development of sequencing technology provides 100% of human genetic code, while only 3% can understand it. Block data 4.0: activation data in the era of artificial intelligence puts forward the concept of activation data, which can be regarded as a theoretical hypothesis for big data, provides a new cognitive thinking and solution for increasingly prominent data paradox between bioinformation explosion and clinical big data, and is a bridge between cross-border data association and fusion. After deeply mining the dominant and recessive value of clinical data and histological data, we can make the pathogenesis of syndrome differentiation and treatment from dark knowledge to clear knowledge. Therefore, with Chinese patent medicine as the guide, the research on the efficacy and mechanism of precise positioning of traditional Chinese medicine after marketing is carried out, and the precise system of "syndrome, disease, function, pathological link and biological connotation" is constructed, which provides a powerful basis and support for increasing the scientific and technological content of varieties.


Subject(s)
Artificial Intelligence , China , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
14.
Article in Chinese | WPRIM | ID: wpr-828439

ABSTRACT

Shujin Jianyao Pills is a kind of concentrated honey pills made of 13 Chinese herbal medicines, such as Cibotii Rhizoma, Rosae Laevigatae Fructus, and Spatholobi Caulis. It has the effects in tonifying liver and kidney, strengthening muscles and bones, removing wind and dampness, activating collaterals and relieving pain. Under the leadership of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences and Wangjing Hospital of China Academy of Chinese Medical Sciences, the Expert consensus on clinical application of Shujin Jianyao Pills was developed by 22 universities, scientific research institutes and hospitals. This consensus formed 1 recommendation and 9 consensus suggestions, which were based on evidence and oriented to clinical practice. The expert consensus had a new understanding of the indications of Shujin Jianyao Pills, especially the applicable Western medicine diseases, the advantages and characteristics of treatment, the time of intervention, the applicable syndromes, the precautions and contraindications of medication. The indications were detailed and expressed as the combination of disease, symptom and syndrome. And it filled in the gaps of package inserts in applicable syndrome and special population medication in the process of drug use. The expert consensus showed the optimization of precautions and contraindications, and more detailed description of drug safety. Therefore, it provides guidance and reference for clinicians to use Shujin Jianyao Pills rationally.


Subject(s)
China , Consensus , Drugs, Chinese Herbal , Medicine, Chinese Traditional
15.
Article in Chinese | WPRIM | ID: wpr-828420

ABSTRACT

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.


Subject(s)
Cost-Benefit Analysis , Double-Blind Method , Humans , Marketing , Respiratory Tract Infections
16.
Article in Chinese | WPRIM | ID: wpr-828419

ABSTRACT

To explore the real world clinical application characteristics and the drug combination regularity of Ciwujia Injection, 12 554 cases of patients with Ciwujia Injection were extracted from the information systems of 24 class Ⅲ grade A hospitals in China, and a standardized analysis was carried out. Most of the patients were middle-aged and old-aged, and the main departments were cardiovascular department(22.50%) and neurology department(17.92%). Before 2008, 93.77% of the patients were single overdose users, which reduced to only 2.07% after 2011. The course of treatment was mostly between 8-14 days(32.98%). The top three di-seases diagnosed by Western medicine were hypertension(11.78%), cerebral infarction(9.47%), and coronary heart disease(8.15%), and the most common traditional Chinese medicine syndrome was the deficiency of liver and kidney(18.59%). The most commonly used Western medicine was Acetylsalicylic Acid(51.07%), and the most commonly used traditional Chinese medicine was Danshen Injection(9.67%). The most commonly used Western medicine in combined application was calcium channel blocker(46.88%), and the most commonly used traditional Chinese medicine in combined application was stasis removing agent(93.21%). And the drug combination with the highest support was Isosorbide Mononitrate + Acetylsalicylic Acide, with a high recovery rate after discharge(96.81%). The results showed that Ciwujia Injection had certain regularity. It considered underlying concurrent diseases, anticoagulation and blood circulation, with a wide range of effects in strengthening the body and regulating the mind. The results could expand the understanding of Ciwujia Injection and provide a more detailed real world basis and reference for optimizing therapeutic regimen in clinic.


Subject(s)
Aged , Aspirin , China , Drug Combinations , Drugs, Chinese Herbal , Eleutherococcus , Humans , Medicine, Chinese Traditional , Middle Aged
17.
Article in Chinese | WPRIM | ID: wpr-828418

ABSTRACT

To explore the population characteristics and clinical application characteristics of patients with cerebral hemorrhage treated with Xingnaojing Injection in real world. The model was established by Apriori algorithm, and the general information and medication information of 8 369 patients with cerebral hemorrhage treated with Xingnaojing Injection were analyzed by using Clementine 12.0 in the databases of information systems of 33 class Ⅲ grade A hospitals in China. The results showed that among the 8 369 patients with cerebral hemorrhage treated with Xingnaojing Injection, the median age was 59 years old. And the male to female ratio was about 1.74∶1. Most of them did manual labor(31.26%), and were hospitalized in winter(27.46%), especially during the Cold Dew(5.1%). The majority of the patients were in a stable condition(50.94%), and preferred neurosurgery department(48.82%). 29.03% of patients were hospitalized for 15-28 days, and 42.47% of patients spent 10 000-50 000 Yuan of hospitalization expenses. The single dose of Xingnaojing Injection was 10-20 mL at most(46.03%). And the course of medication was mostly 3 days or less(68.60%). Lidocain was the most frequently used Western medicine in drug combination(5.05%), and Huayu Tongmai Ji was the most frequently used traditional Chinese medicine in drug combination(10.73%). The most frequently used one type of traditional Chinese medicine combined with one type of Western medicine was Huayu Tongmai Ji + Dexamethasone(8.08%). The most frequently used two Western medicines in drug combination were Omeprazole + Dexamethasone(5.07%). Prilosec + Dexamethasone + Lidocaine(3.35%) were three Western drugs with the most frequent combination. When the dosage was 10-20 mL and the number of days of treatment was > 15 days, the largest number of the patients was cured and improved(44.78%, 45.85%). The results showed that cerebral hemorrhage patients treated with Xingnaojing Injection were mostly middle-aged and elderly people, with more males than females. Brain hemorrhage often occurred in winter and spring. Xingnaojing Injectiont was often combined with glucocorticoids, proton pump inhibitors and cardiovascular drugs to prevent cerebral hemorrhage complications. The clinical medication met the guidelines for the treatment of cerebral hemorrhage. Some patients had over-treatment use, which can provide a reference for clinicians in treating cerebral hemorrhage.


Subject(s)
Aged , Cerebral Hemorrhage , China , Drugs, Chinese Herbal , Female , Humans , Male , Medicine, Chinese Traditional , Middle Aged
18.
Article in Chinese | WPRIM | ID: wpr-828417

ABSTRACT

To analyze the clinincal application characteristics of Xiyanping Injection in real world. The data of the patients came from the hospital information systerm(HIS) of 29 tertiary hospitals in China from 2006 to 2016. It included three parts about basic information, Western medicine diagnosis information, and doctor advice information. The exploration was conducted for the characteristics of the patients and disease distribution as well as the therapeutic regimen. Apriori algorithm was adopted to establish the models, and Clementing 12.0 was used for a correlation analysis of the comprehensive therapeutic regimen of Xiyanping Injection. There were 194 873 cases in the study. The male to female ratio was 1.44∶1. The median age was 4 years old. The median daily dosage was 200 mg. 46.68% of the patients were administered with 250-500 mg, and 33.07% were 50-100 mg one day. 47.08% of the patients were administered for 4-7 d, and 32.65% of the patients were 1-3 d. In the doctor advice information, the most frequently types of Western medicine, traditional Chinese medicine were mucilagin, heat-clearing agent. Second generation cephalosporins, third generation cephalosporins, compound penicillin were the most common types of antibiotic. Interferon, nucleoside and nucleotide, human immunoglobulin were the most common types of antiviral drug. The mining association rules results were analyzed, finding the application of Xiyanping Injection in severe infectious diseases. To improve respiratory symptoms, Xiyanping Injection treaments were Budesonide + Ipratropium Bromide + Ambroxol. To severe pulmonary infection, the treaments were Dopamine + Ambroxine. To severe hand, foot and mouth disease, the treatments were Namefen + Mannitol. To pulmonary heart failure, the treatments were Dobutamine + Heparin. Based on the results of the real world HIS, we could provide clinical application the idea, and a reference for further excavation of the applicable diseases of Xiyanping Injection.


Subject(s)
Child, Preschool , China , Drugs, Chinese Herbal , Therapeutic Uses , Female , Humans , Injections , Male , Medicine, Chinese Traditional , Respiratory Tract Infections , Drug Therapy
19.
Article in Chinese | WPRIM | ID: wpr-828416

ABSTRACT

To investigate the clinical characteristics and the rule of administration of Ciwujia Injection in patients with cardiovascular disease by correlation analysis and frequency analysis. The information of 5 904 patients who used Ciwujia Injection to treat cardiovascular disease for at least three times in the hospital information system(HIS) of 19 comprehensive tertiary hospitals nationwide. The frequency analysis method was used to analyze the higher frequency variables, and the algorithm of Apriori correlation analysis method was used to analyze the clinical characteristics and medication laws of Ciwujia Injection in treating patients with cardiovascular disease. Among the 5 904 patients, the median age of the patients was 70 years, and the number of patients between 65-75 years old was up to 2 096(35.5%). There were more women than men in terms of diagnosis and treatment, and the women at age of 45-65 and 65-75 years old were more than men. The top three diagnoses by Western medicine were coronary heart disease in 8 104 cases(65.66%), dyslipidemia in 2 515 cases(20.38%), and cardiac function grade Ⅱ-Ⅲ in 581 cases(4.71%), while the largest number of syndromes in traditional Chinese medicine(TCM) at discharge was 1 109(21.37%) in other type, followed by 739 cases(14.24%) of Qi deficiency and blood stasis syndrome, and 698(13.46%) of liver and kidney Yin deficiency syndrome. The most frequently used Western medicine in combined use was Nifedipine in 2 567 cases(7.21%), and most frequently used TCM was Compound Xianzhuli Liquid leachate in 766 cases(3.53%). From the results of pharmacological analysis, the frequency of using Ciwujia Injection + stasi-seliminating agent + calcium channel blocking drugs was highest when using 1 Chinese medicine combined with 1 or 2 Western medicines. In the use of 2 Chinese medicines combined with 1 Western medicine, Ciwujia Injection + heat-clearing agent + stasis-eliminating agent + calcium channel blocker was the most common. This study demonstrated that Ciwujia Injection was more common in middle-aged and elderly patients and more in women than men. Treatment should be based on different cardiovascular disease treatment guidelines to reduce complications caused by underlying diseases, and attention should be paid to the prevention and treatment of cardio-vascular disease risk factors such as hypertension, diabetes and abnormal lipid metabolism. According to the analysis of frequency distribution and association rules, it was concluded that Ciwujia Injection was mainly used in combination with calcium channel blockers and stasis-eliminating agents in the treatment of cardiovascular disease. In the treatment of cardiovascular diseases by Ciwujia Injection in combination with other Chinese and Western medicines, in order to avoid pharmacological changes and avoid affecting the efficacy of the drug, it is necessary to closely observe whether adverse reactions occur and ensure that the medication is safe and effective. This study provides a good reference for the follow-up clinical guidance of Ciwujia Injection.


Subject(s)
Aged , Cardiovascular Diseases , Drugs, Chinese Herbal , Eleutherococcus , Female , Humans , Male , Medicine, Chinese Traditional , Middle Aged , Yin Deficiency
20.
Article in Chinese | WPRIM | ID: wpr-828415

ABSTRACT

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.


Subject(s)
Adverse Drug Reaction Reporting Systems , Aged , Bayes Theorem , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Female , Humans , Middle Aged , Pharmacovigilance , Risk Management
SELECTION OF CITATIONS
SEARCH DETAIL