RESUMO
This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.
Assuntos
Medicamentos de Ervas Chinesas , Humanos , Feminino , Masculino , Adolescente , Criança , Estudos Prospectivos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/administração & dosagem , Pré-Escolar , Lactente , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Hospitais , InjeçõesRESUMO
The articles involving Xiangju Capsules were retrieved, and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) of this drug. Multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning. The dimensions are graded A, B, C, or D. Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions, rash, itching, dizziness, and headache. Based on the available studies, the risk is controllable and the safety is grade A. Meta-analysis showed that Xiangju Capsules + conventional western medicine could recover the Lund-Kennedy score, Lund-Mackay score, and CT score, relieve headache, nasal congestion, olfactory disturbance, and facial pain, with the effectiveness is grade B. The incremental cost-effectiveness ratio of Xiangju Capsules + conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan, about 0.82% of the per capita disposable income. The results of sensitivity analysis showed that the research results were relatively robust. Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients' willingness to pay, it is more economical to use Xiangju Capsules + conventional western medicine. The drug belongs to grade A of the national medical insurance, with an average daily cost of 3.06 yuan, and the economy is grade B. This formula is modified from classic formulas and characteristic empirical formulas, be capable of improving immunity and preventing repeated attacks. It can be used for acute and chronic rhinitis-rhinosinusitis. It had a wide range of applicability, especially for the patients with head and face tenderness. Service innovation was reflected in the measures to guarantee supply, capacity, scalability, and coverage of grass-roots sales channels. The industrial innovation was improved through the management of medicinal resources, pharmaceutical industry, production technology, quality control, scientific research and development, and this formula won three national invention patents. Comprehensively, the innovation of Xiangju Capsules is grade B. According to the survey of 188 medical practitioners and 196 patients in 20 provinces, municipalities, and autonomous regions of China, the drug was characterized by easy preparation and administration, individualized medication, simple technology and management, convenient use, storage, and transport, and controllable adverse reactions, with the suitability is grade B. Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis, respectively, being well affordable. It was sold in 35 000 medical institutions in China. The dosage form was suitable for transportation, storage, and grass-root application. With rich, sustainable, and available medicinal resources, the accessibility of Xiangju Capsules is grade A. This drug can be used for both acute and chronic rhinitis-rhinosinusitis, clearing heat and expelling pus, and strengthening the exterior to prevent relapse. After this drug was available on the market, over 4 000 cases were studied, with rich experience in human use accumulated, and characteristics of traditional Chinese medicine is grade B. Overall, the clinical value of Xiangju Capsules is class B. It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.
Assuntos
Rinite , Sinusite , Humanos , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Medicina Tradicional Chinesa , Cefaleia , China , CápsulasRESUMO
To expeditiously assess the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema, we screened out the papers with randomized controlled trials(RCTs) for studying the efficacy of Binghuang Fule Ointment in the treatment of eczema from CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase and then performed Meta-analysis of the included studies via RevMan 5.4. A total of 19 studies were included, involving 1 919 cases(973 cases in the experimental group and 946 cases in the control group). Meta-analysis results showed that Binghuang Fule Ointment combined with conventional western medicine had better efficacy score index(clinical effectiveness ≥60%)(RR=1.32, 95%CI[1.13, 1.55], P=0.000 4) and lower recurrence rate(RR=0.37, 95%CI[0.20, 0.65], P=0.000 7) than conventional western medicine alone. The adverse reactions(RR=1.05, 95%CI[0.52, 2.15], P=0.88) did not show significant difference between the two groups. The application of Binghuang Fule Ointment alone had better efficacy score index(clinical effectiveness≥60%)(RR=1.20, 95%CI[1.09, 1.33], P=0.000 3) than conventional western medicine alone and the adverse reactions(RR=0.92, 95%CI[0.45, 1.89], P=0.82) insignificantly different from conventional western medicine alone. Binghuang Fule Ointment alone or combined with conventional western medicine demonstrated better effective in remission of symptoms and signs(clinical effectiveness)(RR=1.41, 95%CI[1.07, 1.85], P=0.01) than conventional western medicine alone. Compared with the single application of western medicine, Binghuang Fule Ointment alone or combined with conventional western medicine has better curative effect, low recurrence rate, and equivalent safety in the treatment of eczema. Nevertheless, owing to the low quality of the included papers, randomized controlled trials with large sample size, multiple centers, high methodological quality are needed to further verify the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema.
Assuntos
Medicamentos de Ervas Chinesas , Eczema , Medicamentos de Ervas Chinesas/efeitos adversos , Eczema/tratamento farmacológico , Humanos , Pomadas , Resultado do TratamentoRESUMO
This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.
Assuntos
Medicina Tradicional Chinesa , Transtornos de Enxaqueca , Cápsulas , Humanos , Fígado , Transtornos de Enxaqueca/tratamento farmacológico , SíndromeRESUMO
Multiple methods should be incorporated into the research on pharmacovigilance of traditional Chinese medicine(TCM for a comprehensive and objective evaluation. The arrival of the era of medical big data allows it to be deeply integrated into medical research. The real world study(RWS) represented by hospital information system(HIS) provides a data basis for exploring the pharmacovigilance of TCM. Prescription sequence analysis(PSA) and prescription sequence symmetry analysis(PSSA) developed based on the former serve as a methodological basis for clinical safety evaluation of Chinese patent medicines after marketing. By collating the related studies of HIS, PSA and PSSA and employing the propensity score matching( PSM) method and nested case-control study(NCCS), this paper formed a HIS-, PSA-and PSSA-based technical system for clinical safety evaluation of Chinese patent medicines in the real world, in order to provide a methodological demonstration for the future research on the pharmacovigilance of TCM.
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Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Farmacovigilância , Estudos de Casos e Controles , Prescrições , Análise de SequênciaRESUMO
The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts. A variety of methods are employed for the mining of risk signals or analysis and screening of relevant signals to accurately determine the correlation between medication and adverse reactions. The safety signal acquisition and mining techniques are the technical basis for the safety risk management of medicine products after Chinese medicines are marketed, which is critical in drug safety alerts. To accurately collect the safety signals of Chinese medicines and effectively and rapidly track, determine, and assess the sources of signals are important technical links in drug risk management. The ultimate purpose of safety signal discovery is to achieve normalized risk management through downgrading drugs from a high-risk level to a low-risk level.The five main steps in the standard drug risk management are listed below: to extensively collect predicted risk signals; to accurately identify drug risks by the techniques such as data mining; to evaluate the risks with process-based quality risk control; to employ management measures minimizing the impact of drug risks for risk management; to update and apply risk assessment to clinical evaluation after medication.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas , Mineração de Dados , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Medicina Tradicional Chinesa , Controle de QualidadeRESUMO
Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos , Livros , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , União Europeia , Humanos , Medicina Tradicional ChinesaRESUMO
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.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Contraindicações de Medicamentos , Cálculos da Dosagem de Medicamento , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Padrões de Prática MédicaRESUMO
This study aimed to provide researchers with a better understanding of the research status, progress and problems of Chinese medicine-induced kidney injury. The mapping knowledge domain(MKD) was chosen to visualize the research process, hotspots,and frontiers, thus providing a reference for follow-up research. The relevant articles were retrieved from China National Knowledge Infrastructure(CNKI) from its inception to November 20, 2020, and 683 were finally included for visualization, with a knowledge map covering the keywords, research institutions and authors plotted by Cite Space. Since 2006, the annual number of published articles regarding Chinese medicine-induced kidney injury has steadily declined. The top five keywords sorted by frequency of co-occurrence were tubulointerstitial nephritis(TIN), aristolochic acid(AA), Akebiae Caulis, experimental research, and descriptive research. Akebiae Caulis appeared at the highest frequency of co-occurrence among Chinese medicines and exhibited the highest burst intensity. The burst ended in 2020, when the Chinese medicine with the highest burst intensity changed to Tripterygii wilfordii and its preparations. It could be seen that Akebiae Caulis was the hotspot in the research of Chinese medicine-induced kidney injury, and T. wilfordii became the research frontier. The current research has mainly focused on " organic anion transporters" and " metabolomics". The decline in articles about Chinese medicine-induced kidney injury was attributed to the reduced clinical case reports after the in-depth study of Chinese medicine-induced kidney injury. However, more clinical studies need to be conducted based on the concept and method of pharmacovigilance to construct a pharmacovigilance system of Chinese medicine for actively and passively monitoring and collecting the clinical cases with Chinese medicine-induced kidney injury, figuring out the incidence and characteristics of adverse reactions caused by Chinese medicine, and carrying out comprehensive and multi-dimensional safety research.
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Medicina Tradicional Chinesa , Publicações , China , Rim , Projetos de PesquisaRESUMO
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.
Assuntos
Medicamentos de Ervas Chinesas , Medicamentos sem Prescrição , China , Armazenamento e Recuperação da Informação , Medicina Tradicional Chinesa , Controle de QualidadeRESUMO
2019 novel coronavirus(2019-nCoV) has occurred for 2 months, and seriously affected the people's health in the world. Therefore, scientific prevention and control strategies and effective intervention measures are the only ways to solve the world problem. In the determination of intervention measures, not only the effectiveness evaluation, but also accessibility, treatment cost, inventory and production capacity and other relevant sociological issues shall be considered, especially in low and middle-income countries and regions. With the introduction of clinical epidemiological experiment design and evidence-based medicine evidence evaluation into the evaluation of curative effect of traditional Chinese medicine(TCM), TCM has officially entered the studies of syndrome regularity of new public health emergencies(such as SARS and influenza) clearly diagnosed by modern medicine for many years, as well as the development of relevant guidelines, consensus and paths. The results of curative effect show that TCM could significantly alleviate symptoms, control disease and tendency, reduce the occurrence of critical illness, and improve the clinical efficacy and the prognosis and quality of life of patients, which fully reflects the consciousness and self-confidence of traditional Chinese medicine workers. For the evidence-based evaluation of TCM intervention in new public health emergencies, the basic principles and general methods of clinical epidemiology and evidence-based medicine shall be followed to obtain high-quality evidence; besides, we shall also fully realize that clinical scientific study is carried out with the epidemic treatment as the primary task. The scientific hypothesis comes from the clinical problems unsolved. The scientific study conclusions aim to give feedbacks to clinical diagnosis and treatment regimens. The core elements of clinical trials are population(P), intervention(I), control(C), outcome(O), which are abbreviated as "PICO". The evaluation of intervention measures for new public health emergencies with traditional Chinese medicine shall have clear study objectives and a high quality, with a correct analysis method as the guarantee of real and reliable results. Then, the selection of patients, the de-finition of intervention measures and control measures, the development of end-point indicators, the clinical quality control under special epidemics, the data verification, and the data analysis methods to be adopted are all characteristics and key points that need special consideration. It is suggested that scientific experimental design, rigorous collection and scientific data analysis shall be conducted to reflect the therapeutic value of traditional Chinese medicine, so that the study results could be adopted and shared, and become the scientific evidence for China and even the global to republish the diagnosis and treatment regimens.
Assuntos
Betacoronavirus , Infecções por Coronavirus , Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Pandemias , Pneumonia Viral , COVID-19 , China , Emergências , Medicina Baseada em Evidências , Humanos , Saúde Pública , Qualidade de Vida , SARS-CoV-2RESUMO
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.
Assuntos
Inteligência Artificial , Medicamentos de Ervas Chinesas , China , Humanos , Medicina Tradicional Chinesa , Medicamentos sem PrescriçãoRESUMO
In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Teorema de Bayes , Cápsulas , Humanos , Redes Neurais de ComputaçãoRESUMO
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.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Teorema de Bayes , Feminino , Humanos , Pessoa de Meia-Idade , Farmacovigilância , Gestão de RiscosRESUMO
This study is a randomized controlled trial of Reyanning Mixture in the treatment of acute tonsillitis. According to the ratio of 1â¶1â¶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.
Assuntos
Medicamentos de Ervas Chinesas , Tonsilite/tratamento farmacológico , Antibacterianos/uso terapêutico , Método Duplo-Cego , Febre/tratamento farmacológico , HumanosRESUMO
To systematically review the effectiveness and safety of Reduning Injection in the treatment of acute tracheal-bronchitis.Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,Web of Science) were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to April 2019.Randomized controlled trials( RCTs) for the treatment of acute tracheal-bronchitis with Reduning Injection were collected. Two researchers independently conducted literature screening,data extraction and risk assessment for bias. Rev Man 5.3 software was used for data analysis. Fourteen studies were included,and the total sample size was 1 652 at last. Meta-analysis results show that in the aspect of total clinical effective rate,Reduning Injection was superior to ribavirin( RR = 1. 37,95%CI[1. 28,1. 47],P<0. 000 01); Reduning Injection combined with conventional therapy was better than conventional therapy alone( RR = 1. 14,95% CI[1. 09,1. 19],P <0. 000 01); Reduning Injection combined with azithromycin was better than azithromycin therapy alone( RR = 1. 21,95% CI[1. 07,1. 37],P = 0. 002). In the aspect of clinical symptoms,the time in average fever disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-1.68,95%CI[-1. 72,-1. 49],P<0. 000 01); the time in cough disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-2. 57,95%CI[-2. 91,-2. 24],P<0. 000 01); the time in lung rales disappearance,Reduning Injection therapy was superior to ribavirin therapy( MD =-2. 26,95% CI[-2. 71,-1. 80],P<0. 000 01),and Reduning Injection combined with conventional therapy was superior to conventional therapy( MD =-1. 77,95% CI[-1. 95,-1. 59],P<0. 000 01). Based on the findings,Reduning Injection can improve the total effective rate,reduce the average time of disappearance in fever,cough and lung rales,with mild adverse reactions and a low incidence. However,the quality of the literatures included is not high,it is necessary to adopt large-sample-size,rigorously designed clinical trial protocols in line with the international standards,in a bid to improve the quality of evidence.
Assuntos
Bronquite/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Azitromicina/uso terapêutico , Quimioterapia Combinada , Humanos , InjeçõesRESUMO
To evaluate the efficacy and safety of Kangfu Xiaoyan Suppository in the treatment of pelvic inflammatory disease. Four Chinese databases,namely CNKI,VIP,WanFang and SinoMed,and three English databases Cochrane Library,namely Medline,and ClinicalTrail.gov were systematically and comprehensively retrieved from the establishment of each database to June 2018. The quality of the included studies was evaluated by using the risk assessment tools developed by the Cochrane Collaboration,and RevMan 5. 3 software was used for Meta-analysis. A total of 675 articles were retrieved,and finally 56 studies were included. The total sample size was 6 228,the test group included 3 267 cases,and the control group included 2 961 cases. The overall quality of the included studies was generally low. According to the intervention measures and outcome indicators,the included studies were divided into different subgroups for analysis. The main results of Meta-analysis showed that the recurrence rate of Kangfu Xiaoyan Suppository combined with antibiotics was lower than that of antibiotics alone. Kangfu Xiaoyan Suppository combined with antibiotics was superior to antibiotics alone in terms of abdominal pain,leucorrhea abnormality relief time,mass absorption time and pain relief time. In terms of safety,Kangfu Xiaoyan Suppository combined with antibiotics had a lower incidence of adverse reactions than antibiotics alone. Based on the results of this study,it is indicated that Kangfu Xiaoyan Suppository had a certain effect on the treatment of pelvic inflammatory disease,especially with a lower recurrence rate. The long-term effect is remarkable. No serious adverse reaction was observed. Restricted by the quality of the studies included,the above conclusion need to be further verified in high-quality,largesize,multi-center clinical researches.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Doença Inflamatória Pélvica/tratamento farmacológico , Antibacterianos , Feminino , Humanos , SupositóriosRESUMO
Acute upper respiratory infection is one of the common infectious diseases,especially in the elderly people. Qingkailing Injection has the effect of clearing away heat and detoxifying. It can be used for external wind heat,upper respiratory tract infection,viral cold,etc. Based on 2 147 cases of upper respiratory tract infection patients using Qingkailing Injection in the medical electronic data warehouse of the information system of 16 large class-A hospitals constructed by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,description analysis,Apriori calculation and recurrent network analysis were used to analyze the effect of Qingkailing Injection on upper respiratory tract infection. The clinical characteristics and the law of combined use of drugs can provide reference for the mining of clinical diagnosis and treatment characteristics and the construction of optimal and effective programs and paths. 2 147 patients with upper respiratory tract infection who used Qingkailing Injection were mostly middle-aged and elderly people over 45 years old,often combined with hypertension,ischemic cerebrovascular disease,coronary heart disease,diabetes,etc.; in treatment,it was more common to use Qingkailing Injection in combination with hormones,antipyretics and analgesics,antibiotics,nutritional support agents,antitussive,expectorant and antiasthmatic drugs,as well as traditional Chinese medicine Jiebiao agents and blood management agents. The combination of potassium chloride injection and cephalosporin injection is the most commonly used in combination with two kinds of Western medicine( 33. 2%); the combination of Shuanghuanglian and Ganmao Qingre Granules is the most commonly used in combination with two kinds of traditional Chinese medicine( 9. 13%); through the calculation of complex network group module,it is found that Qingkailing Injection is often associated with antibiotics,antipyretic and analgesic drugs,antitussive,expectorant and antiasthmatic drugs,antiviral drugs and anti infection drugs. Drugs,nutritional support agents,bronchodilators,immunomodulators and other chemical drugs are often used in combination with Chinese medicine,such as Jiebiao agents,expectorants,Qingre agents,resuscitation agents,Qufeng agents,tonics,Liqi agents,which may be related to both the treatment of upper respiratory tract infection and the basic diseases of middle-aged and elderly patients,with the theoretical characteristics of " combination of disease and syndrome,corresponding formula and syndrome". Based on the real world big data complex network group module mining results provide clues for the clinical optimization scheme and path construction,and provide signals and ideas for further causal research.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Infecções Respiratórias/tratamento farmacológico , Idoso , China , Humanos , Injeções , Medicina Tradicional Chinesa , Pessoa de Meia-IdadeRESUMO
Pudilan Xiaoyan Oral Liquid has effects in clearing away heat and detoxifying,and is used to treat pharynx and throat swelling caused by the syndrome of excessive heat and toxin accumulation. Its efficacy is to relieve swelling and pain( redness,swelling and hot pain). It is included in the Chinese Pharmacopoeia of 2015 Edition,and has been listed in provincial health insurance directories of Shaanxi,Jiangsu,Liaoning,Hunan,Tianjin,Xinjiang and Hebei. It has been recommended by health departments of Beijing,Chongqing and other provinces as a preferred drug for the prevention and treatment of H1 N1 and HFMD,and listed in the diagnosis and Treatment Guide of HFMD by the Ministry of Health,the Clinical Application Guide of Chinese Patent Medicine edited by the Lung Department Disease Branch of China Association of Chinese Medicine,and the Clinical Practice Guide of Single Administration/Combined Administration of Antibiotics in Treatment of Common Infectious Diseases by China Association of Chinese Medicine. To further improve the clinician's understanding of drugs and better guide the rational clinical application,we invited front-line clinical experts from respiratory department,infectious department and dermatology of traditional Chinese and Western medicine to develop and compile the expert consensus. The consensus fully considered the clinical evidence and the expert clinical experience to give recommendations for clinical problems with evidence support and consensus suggestions for clinical problems without evidence support by the nominal group method.This consensus is based on clinical research evidence and expert experience in a simple and clear format,which provides a preliminary reference for the clinical use of the drug.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa , China , Consenso , Humanos , Medicamentos sem PrescriçãoRESUMO
Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.