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The construction of the comprehensive evaluation index system of the famous classical formula preparations after the marketing has both theoretical and practical significance. In this study， literature related to the post-marketing comprehensive evaluation of traditional Chinese medicine（TCM） compound preparations was retrieved from China National Knowledge Infrastructure（CNKI）， China Science and Technology Journal Database（VIP）， Wanfang Data Knowledge Service Platform（WanFang） and SinoMed from January 1， 2000 to April 30， 2022. CiteSpace 6.1.R2， a scientometrics software， was used to visualize the keywords involved， and to analyze the dynamic evolution trend and research hotspots in this field. Then， the existing comprehensive post-marketing evaluation index system of TCM compound preparations was screened and extracted， and the research status was systematically analyzed by mathematical statistics. It was found that there were problems such as the generalized boundaries between assessment dimensions and assessment elements， the lack of data sources for individual evaluation indexes， unset weight of some index system and insufficient application degree. In addition， according to the characteristics of famous classical formulas， the authors discuss the importance of evidence evaluation based on combination of disease and syndrome， pharmacovigilance of famous classical formulas preparations， and whole-process quality control of famous classical formulas， and put forward the construction strategy of comprehensive post-marketing evaluation of the famous classical formula preparations， which is oriented by clinical value， centered on evidence evaluation， and guaranteed by the whole-process quality control.
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Resumo A sociedade contemporânea convive com incertezas e vulnerabilidades que exigem a atuação dos sistemas regulatórios na fiscalização do comércio eletrônico de medicamentos não registrados e/ou falsificados. Investiga-se o trabalho dos profissionais da vigilância sanitária federal na fiscalização de medicamentos na internet e os elementos que orientam sua decisão técnica. A metodologia utilizada foi a pesquisa qualitativa, do tipo estudo de caso único, ancorada na abordagem ergológica, entre dezembro de 2020 e setembro de 2021, por meio de entrevistas e observação participante. Os mapas ergodialógicos, elaborados no Atlas.ti, subsidiaram a análise das práticas discursivas classificadas conforme esquema tripolar saber-agir-valor, resultando em três categorias. O profissional é sempre convocado a fazer escolhas e gerir situações imprevisíveis, havendo inquietações sobre a capacidade institucional para compreender e agir sobre o problema. O trabalho adquire, assim, o sentido de "enxugar gelo", em função do volume de demandas e dos poucos efeitos da fiscalização no mercado eletrônico de medicamentos. As normas, o conhecimento técnico, a experiência e a responsabilidade social, dentre outros elementos, estão presentes na tomada de decisão dos profissionais, conscientes de que, ao agir, protegem a saúde da população. Constata-se que diferentes saberes, científicos ou empíricos, podem qualificar melhor o sistema decisório na fiscalização, tornando-o mais efetivo, assertivo e transparente.
Abstract Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. Ergodialogical maps, developed using Atlas.ti, underlined the analysis of discursive practices classified according to the tri-polar knowledge-action-value schema, resulting in three categories. Professionals are always called upon to decide on and manage unpredictable situations, questioning the institutional capacity to understand and act on the problem. The work thus takes on the sense of "rolling a stone uphill" due to the volume of demands and the limited effects of surveillance on the e-commerce of medicines. Norms, technical knowledge, experience, and social responsibility, among other elements, inform the decision-making process of professionals, who are aware that, by acting, they protect public health. Different forms of knowledge, scientific or experiential, can better qualify decision-making in surveillance, making it more effective, assertive, and transparent.
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BAKCGROUND: Tocilizumab (TCZ) is a new therapeutic alternative for severe cases of COVID-19 pneumonia. AIM: To evaluate the cumulative incidence (CI) of suspected adverse drug reactions (ADR) from TCZ in adult patients with COVID-19. MATERIAL AND METHODS: An active pharmacological surveillance protocol was carried out in patients older than 18 years old, who received at least one dose of TCZ between May and August 2020 at a clinical hospital. Non-infectious ADRs were categorized according to the Common Terminology Criteria for Adverse Events and the development of infection was classified as present or absent. Causality and preventability of ADRs were determined with the Naranjo Algorithm and the modified Schumock & Thornton criteria, respectively. RESULTS: The CI of ADRs caused by TCZ was 69.6% (95% confidence intervals (CI): 63.5-76.6). A rise in alanine and aspartate aminotransferases and the development of infections were the most frequent adverse events. Seventy-four percent were considered mild in severity. Sixty two percent of suspected non-infectious ADRs were classified as probable and all the infectious events as Possible. Of the ADRs observed, 33% were preventable. CONCLUSIONS: The occurrence of ADRs after the use of TCZ is frequent, of mild severity, and in one third of the cases, preventable. We suggest monitoring blood count, liver function tests and ruling out infection prior to TCZ administration.
Subject(s)
Humans , Adolescent , Adult , Drug-Related Side Effects and Adverse Reactions , COVID-19 Drug Treatment , Aspartate Aminotransferases , Alanine , Antibodies, Monoclonal, HumanizedABSTRACT
AIM: To evaluate the clinical efficacy and safety of He-wei-zhi-xie (HWZX) capsules in diarrhea patients. METHODS: The clinical study was conducted in 35 clinical trials centers from October 2015 to December 2017 by multicenter, prospective, open and uncontrolled design methods. The primary efficacy endpoint is the effective rate of diarrhea, the secondary endpoints include recovery rate of diarrhea, recovery time of diarrhea, number of irregular stools and Leeds dyspepsia questionnaire. The pharmacodynamics model of time course was established by nonlinear mixed effect model, and the effect of covariates on pharmacodynamic parameters was investigated. The safety measures were the incidence of adverse events, adverse reactions and the laboratory test indicators. RESULTS: A total of 2 285 cases were included in full analysis set. The effective rate of diarrhea was 90.8%, and the diarrhea recovery rate was 77.3%. The median time of recovery was 3 days, and the Leeds score was reduced by 3.6 points. It is found that baseline has a significant effect on model parameter E
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The paper is to explore how to carry out post-market technical evaluation of dietary supplements in China by referring to the experiences at home and abroad. Experiences of major countries and regions in the post-market evaluation of similar products of dietary supplements and China’s experience in drugs were systematically reviewed. Combined with the actual situation of the health food industry in China， suggestions were put forward for the post-market technical evaluation of health foods in China. There are many useful experiences worth learning from， such as the mandatory reporting responsibility of enterprises in the United States， a special scientific committee which provides long-term technical support in the European Union， post-market monitoring by enterprises in Australia， the establishment of relevant monitoring systems in Taiwan， the relatively mature regulatory system， evaluation system and management system in the field of drugs and medical devices， and the establishment of adverse reaction monitoring bases in the field of cosmetics， the responsibility of post-mark adverse reaction monitoring of food for special medical purposes by medical institutions， and the post-market management in various fields giving priority to safety. In combination with the current situation of China’s health food industry， five specific suggestions， such as promoting the construction of laws and regulations， are put forward.
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RESUMO Objetivo. Identificar as estratégias de atuação dos sistemas regulatórios na vigilância e controle de medicamentos abaixo do padrão, falsificados e não registrados em nível regional-global, especialmente quanto aos processos de recall. Métodos. Foi realizada uma revisão integrativa da literatura nas bases de dados MEDLINE via PubMed, Embase e SciELO. Foram selecionados estudos publicados no período de 2007 a 2019, em inglês, português e espanhol, que abordavam estratégias desenvolvidas pelos sistemas regulatórios dos países, com foco no recall de medicamentos abaixo do padrão, falsificados e não registrados. Resultados. Dos 483 estudos inicialmente identificados, foram incluídas 21 publicações de alcance global, regional ou nacional. As estratégias de prevenção, detecção e resposta, incluindo o recall, foram agrupadas em dois modelos (passivo-reativo e proativo) de atuação dos sistemas regulatórios na vigilância e controle de medicamentos. Esses modelos parecem combinar estratégias passivas e proativas, complementares ou concorrentes, variando conforme o nível de desenvolvimento dos países e a capacidade regulatória. Embora seja considerado a resposta mais eficaz de proteção da população, o recall não foi implementado de forma uniforme no âmbito dos sistemas regulatórios, segundo os estudos. Conclusões. A complexidade e a magnitude do problema dos medicamentos abaixo do padrão, falsificados e não registrados exigem esforços, investimentos e mudanças profundas na abordagem, nos processos e nas capacidades dos sistemas regulatórios, podendo as estratégias de vigilância e controle do mercado convergir para um modelo híbrido, multisetorial, multidisciplinar, global e sistêmico de proteção da saúde humana.
ABSTRACT Objective. To identify the strategies employed by regulatory systems for the market surveillance and control of substandard, falsified, and unregistered medicines at the regional-global levels, especially regarding drug recall procedures. Method. An integrative literature review was performed. Searches were performed in MEDLINE via PubMed, Embase, and SciELO to select articles published from 2007 to 2019 in English, Portuguese, and Spanish, covering national regulatory system initiatives, with a focus on the recall of substandard, falsified, and unregistered medicines. Results. Of 483 articles initially identified, 21 global, regional, or national scope studies were selected. Prevention, detection, and response strategies, including drug recall, were grouped according to two broad market surveillance and control models (passive-reactive and proactive) used by regulatory systems. These models seem to combine passive and proactive, complementary or concurring actions that varied according to country development level and regulatory capacity. Although considered the most effective response for protection of populations, medicine recall was not implemented in a uniform manner in different regulatory systems as indicated by the studies. Conclusions. Addressing the complexity and magnitude of the problem of substandard, falsified, and unregistered medicines will demand effort, investment, and profound changes in the approaches, processes, and capacity of regulatory systems, with market surveillance and control strategies possibly converging toward a hybrid, multisectoral, multidisciplinary, global, and systemic model of human health protection.
RESUMEN Objetivo. Identificar las estrategias de actuación de los sistemas regulatorios en la vigilancia y control de los medicamentos subestándar, falsificados y no registrados a nivel regional-mundial, especialmente en lo que se refiere a los procesos de retirada de medicamentos del mercado (recall). Métodos. Se realizó una revisión bibliográfica integral en las bases de datos de MEDLINE a través de PubMed, Embase y SciELO. Se seleccionaron los estudios publicados entre 2007 y 2019, en inglés, portugués y español, en los que se abordaban las estrategias elaboradas por los sistemas regulatorios de los países, con énfasis en la retirada de los medicamentos subestándar, falsificados y no registrados. Resultados. De los 483 estudios identificados inicialmente, se incluyeron 21 publicaciones de ámbito nacional, regional o mundial. Las estrategias de prevención, detección y respuesta, incluida la retirada de medicamentos, se agruparon en dos modelos de actuación (pasivo-reactivo y proactivo) de los sistemas de regulación en la vigilancia y el control de los medicamentos. Estos modelos parecen combinar estrategias pasivas y proactivas, complementarias o concurrentes, que varían según el nivel de desarrollo de los países y su capacidad de regulación. Aunque la retirada de productos se considera la respuesta más eficaz para proteger a la población, según los estudios esta no se ha aplicado de manera uniforme en los sistemas de regulación. Conclusiones. La complejidad y la magnitud del problema de los medicamentos subestándar, falsificados y no registrados exigen esfuerzos, inversiones y cambios profundos en el enfoque, los procesos y las capacidades de los sistemas de regulación; y las estrategias de vigilancia y control del mercado pueden converger hacia un modelo híbrido, multisectorial, multidisciplinar, mundial y sistémico de protección de la salud humana.
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ABSTRACT Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.
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Resumo A fiscalização sanitária busca proteger a saúde da população impedindo que medicamentos fora do padrão, falsificados ou não registrados sejam consumidos e causem danos à saúde. Este ensaio objetiva contribuir para o debate acerca da fiscalização sanitária de medicamentos, num contexto de exposição contínua dos indivíduos a riscos que interferem no processo saúde-doença. Baseado nas reflexões sobre o risco sanitário e a sociedade de risco, associado à filosofia da vida de Canguilhem e à ergologia de Schwartz, discorre sobre a necessidade de se compreender a atividade humana e o trabalho para agir sobre o risco. Foram identificados possíveis desafios para a ação da fiscalização sanitária: (1) revisão conceitual; (2) atualização normativa; (3) desenvolvimento de mecanismos e ferramentas regulatórias; e (4) ampliação da capacidade técnica - formativa. Para enfrentá-los, considera-se um caminho promissor o envolvimento e a participação dos diversos atores nos espaços de cooperação e colaboração, bem como a construção de fórum permanente de debates ou de câmeras técnicas/setoriais. Estudos que dão visibilidade ao trabalho concreto das equipes de fiscalização sanitária e que analisam a atividade humana na relação entre o prescrito e o real podem ajudar a compreender a experiência de lidar com o risco, a adequação das normas, as necessidades de formação, entre outros.
Abstract Drug health surveillance protects the health of the population by preventing substandard, falsified, or unregistered drugs from being consumed and causing harm. This essay discusses drug health surveillance in a context of continuous exposure of individuals to risks that directly interfere with the health-disease process. Based on reflections about health risk and risk society, associated with Canguilhem's philosophy of life and Schwartz's ergology, it argues for the need to understand human activity and work to act on risk. Possible challenges for health inspection action include: (1) conceptual review; (2) regulatory updating; (3) development of regulatory mechanisms and tools; and (4) expansion of technical and training capacity. To face them, the involvement and participation of the various actors in cooperation and collaboration spaces, as well as the construction of a permanent forum of discussion or technical/sectorial meetings, is considered promising. Studies that highlight the concrete work of supervision teams and that analyze human activity in the relationship between the prescribed and the real can help to understand the experience of dealing with risk, the adequacy of standards, training needs, among others.
Subject(s)
Humans , Male , Female , Work , Pharmaceutical Preparations , Health Risk , Sanitary Supervision , Health-Disease ProcessABSTRACT
Abstract The globalization of the pharmaceutical market has enabled access to a considerable number of new medicinal products. Consequently, the circulation of substandard medicinal products has also increased. To minimize this problem, post-marketing quality sampling and testing programs are performed to monitor and confirm that the medicinal products available in the market meet appropriate quality requirements. In this review, the post-approval sampling and testing procedures of six regulatory authorities were compared with the goal of strengthening these market surveillance systems. Similarities were observed between the procedures adopted by different regulatory authorities. However, the agencies were not always transparent about the results of these monitoring procedures. A probable mismatch between the registration procedures and the quality requirements listed in official compendiums was observed, which resulted in dissonance and contradiction between the specifications approved by the regulatory authorities and those required in the pharmacopeias. Therefore, strengthening harmonization projects related to these activities can help minimize such difficulties.
Subject(s)
Pharmaceutical Preparations/analysis , Pharmaceutical Preparations/standards , Sampling Studies , Quality Control , Total Quality Management , MarketingABSTRACT
Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.
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Post-marketing surveillance is the principal means to ensure drug use safety. The spontaneous report is the essential method of post-marketing surveillance for drug safety. Often, most spontaneous reports come from medical staff and sometimes come from patients who use the drug. The posts published by individuals on social media platforms that contain drugs and related adverse reaction content have gradually been seen as a new data source similar to spontaneous reports from drug users in recent years. Those user-generated posts potentially provide researchers and regulators with new opportunities to conduct post-marketing surveillance for drug safety from patients' perspectives mostly rather than medical professionals and can afford the possibility theoretically to discover drug-related safety issues earlier than traditional methods. Social media data as a new data source for safety signal detection and signal reinforcement have the unique advantages, such as population coverage, type of drugs, type of adverse reactions, data timeliness and quantity. Most of the social media data used in post-marketing surveillance research for drug safety are still text data in English, and even multiple languages are used by different people worldwide on several social media platforms. Unfortunately, there is still a controversy in the academic circles whether social media data can be used as reliable data sources for routine post-marketing surveillance for drug safety. A couple of obstacles of data, methods and ethics must be overcome before leveraging social media data for post-marketing surveillance. The number of Chinese social media users is large, and the social media data in the Chinese language is rapidly snowballing, which can be employed as the potential data source for post-marketing surveillance for drug safety. However, due to the Chinese language's specific characteristics, the text's diversity is different from the English text, and there is not enough accepted corpus in medical scenarios. Besides, the lack of domestic laws and regulations on privacy and security protection of social media data poses more challenges for applying Chinese social media data for post-market surveillance. The significance of social media data to post-marketing surveillance for drug safety is undoubtedly significant. It will be an essential development direction for future research to overcome the challenges of using social media data by developing new technologies and establishing new mechanisms.
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Humans , Information Storage and Retrieval , Marketing , Social MediaABSTRACT
OBJECTIVE：To learn from the experie nce of post-marketing risk management of biopharmaceuticals in the United States，and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS ：By studying guidance documents and website information issued by FDA ，the risk management of biopharmaceuticals after marketing in the United States was analyzed. Taking infliximab as an example ，the specific implementation situation was introduced ，the management characteristics were summarized ，and the enlightenment and relevant suggestions were put forward for the risk management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS ：The post-marketing risk management of biopharmaceuticals in the United States mainly includes two aspects as “risk evaluation and mitigation strategy （REMS）”and “post-marketing study and clinical trials system ”. The latter included post-marketing requirement （PMR） and post-marketing commitment（PMC）. Taking infliximab as an example ，since it was approved by FDA in August 1998，its manufacturer submitted REMS to FDA in 2009 and obtained approval ，and proposed post-marketing studies and clinical trials for five times. It can be seen that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role participation in risk management ， realize effective communication with patients ， and continuously supervise the risk of biopharmaceuticals，so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals ，China has not yet formulated systematic and specific implementation rules and guidelines ，and there is still lack in post-marketing risk management. It is suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the United States ，involve stakeholders in post-marketing management ，enhance patients ’awareness of drug use risks through effective communication，and further improve the post-marketing research management system to guarantee patients ’safety of drug use.
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Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.
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Classic prescriptions, hospital preparations and famous traditional Chinese medicine(TCM) experience prescriptions are the main sources of new drug development and innovation. The multi-components and multi-targets treatment characteristics of TCM are advantages, but at the same time, broad indications, unclear clinical positioning and lack of evidence-based evidence support are the key problems affecting the play of TCM efficacy and restricting its promotion and application. The hot in recent research was to how to break through the bottleneck, precise clinical positioning, highlight the advantages of the classic TCM prescriptions, and complete the transformation from clinical practice, clinical research to clinical evidence, but at the same time, it is also the difficulty. The clinical research model of the combination of disease and syndrome can fully reflect the ancient medical case evidence of classic TCM prescriptions, the historical experience of human used and the characteristics of syndrome differentiation and treatment, and highlight the advantages of Chinese medicine. At the same time, under the modern disease classification system and research mode, is conducive to established the standardized clinical evidence report and evaluation system, is conducive to promote the integration of clinical research evidence, and avoids excessive attenuation of information. Based on the previous work of our team, the intention of this study was to make a comment about the key points of the post-marketing evaluation of the classic TCM prescriptions under the combination of disease and syndrome and includes key points:(1)With the syndrome as the carrier, connected with the classical prescription and clinical diseases, focused on the clinical positioning on macroscopically.(2)The combination of syndrome visualization, standardization and pharmacological molecular basis, focus on clinical precise positioning in microscopic.(3)Innovating therapeutic effect evaluation methods, reflecting the curative effect characteristics based on syndrome differentiation.(4)The combination of "randomized controlled evidence-based studies" and "real world evidence-based evaluation", focusing on clinical advantages, fully evidence-based evidence.(5)Make full use of clinical registration studies and pay attention to safety.
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Humans , Drugs, Chinese Herbal/therapeutic use , Marketing , Medicine, Chinese Traditional , Prescriptions , Reference StandardsABSTRACT
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 TopicABSTRACT
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)
Humans , Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of LifeABSTRACT
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)
Humans , China , Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
Traditional Chinese medicine(TCM) is an important feature of cancer treatment in China. The methods to tap the advantages of TCM, reasonably evaluate and accurately apply Chinese patent medicines have become current research hotspots and difficulties. TCM takes syndrome differentiation and treatment as the core, with the characteristics of overall regulation and multi-targets efficacy. Therefore, the post-marketing survival benefit evaluation of Chinese patent medicines for cancer is different from that in modern medicine. The primary treatment goals in cancer patients include to improve the disease control rate and prolong their survival time. At present, Chinese patent medicines for cancer patients are lacking indepth studies on survival benefit at the post-marketing stage. In addition, the characteristics of individualized treatment with TCM have also increased the complexity of clinical research on TCM. Therefore, it is of certain practical significance and necessity to evaluate the survival benefit of Chinese patent medicines for cancer after marketing. Based on this, in this paper, we first summarized the technical methodological means of survival benefit evaluation at this stage, and then explored the post-marketing survival benefit evaluation of Chinese patent medicines for cancer from three aspects: the evaluation of cancer treatment effect based on survival time and quality of life, treatment-related toxicity and the auxiliary effect of TCM, and the improvement effect for tumor-related symptoms. Based on the practices of early clinical researches, and according to the insufficient efficacy evaluation of current clinical research on Chinese patent medicines, this paper proposed to improve the evaluation system for clinical researches on Chinese patent medicines, establish the evaluation method with TCM characteristics, clarify the dominant population, lay a theoretical foundation for the evaluation of post-marketing survival benefits of Chinese patent medicines for cancer in the future, and promote the modernization process of TCM.
Subject(s)
Humans , China , Drugs, Chinese Herbal/therapeutic use , Marketing , Medicine, Chinese Traditional , Neoplasms/drug therapy , Nonprescription Drugs/therapeutic use , Quality of LifeABSTRACT
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)
Humans , Drugs, Chinese Herbal , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs , Prospective StudiesABSTRACT
OBJECTIVE@#To evaluate the safety and effectiveness of Qishe Pill () on neck pain in real-world clinical practice.@*METHODS@#A multi-center, prospective, observational surveillance in 8 hospitals across Shanghai was conducted. During patients receiving 4-week Qishe Pill medication, Visual Analogue Scale (VAS) and Neck Disability Index (NDI) assessments have been used to assess their pain and function, while safety monitoring have been observed after 2 and 4 weeks.@*RESULTS@#Results from 2,023 patients (mean age 54.5 years) suggest that the drug exposure per unit of body mass was estimated at 3.41 ± 0.62 g/kg. About 8.5% (172/2,023) of all participants experienced adverse events (AEs), while 3.8% (78/2,023) of all participants experienced adverse reaction. The most common AEs were gastrointestinal events and respiratory events. The VAS score (pain) and NDI score (function) significantly decreased after 4-week treatment. An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3-4 g/kg, at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.@*CONCLUSION@#These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function. (Registration No. NCT01875562).