Mitochondria are not only the main source of cellular energy but also participate in regulating key physiological processes such as intracellular oxidative stress,signal transduction,and apoptosis,which are crucial fo...Mitochondria are not only the main source of cellular energy but also participate in regulating key physiological processes such as intracellular oxidative stress,signal transduction,and apoptosis,which are crucial for maintaining the structure and function of the skin.Increasing evidence suggests that abnormalities in mitochondrial structure,function,and regulation are closely related to the occurrence and development of skin photoaging.However,the critical role of mitochondria in skin photoaging has yet to be thoroughly explored and studied.In this review,we summarize the roles of mitochondria in the occurrence and development of skin photoaging,aiming to provide new ideas and methods for the prevention and treatment of skin photoaging.展开更多
Objective:Effective Chronic Kidney Disease(CKD)management is particularly important in cold regions of China,where climate and lifestyle factors play significant roles.However,there is a lack of relevant studies in th...Objective:Effective Chronic Kidney Disease(CKD)management is particularly important in cold regions of China,where climate and lifestyle factors play significant roles.However,there is a lack of relevant studies in this area.Therefore,the purpose of this study was:(1)to assess the status of self-management capacity in individuals with CKD in cold regions of China and analyze the factors influencing it;(2)to identify strategies to improve CKD management in primary care settings in these regions;and(3)to understand patients'attitudes toward eHealth services.Methods:This was a regional,cross-sectional observational study.A questionnaire measuring CKD patients'self-management abilities was derived from the Perceived Kidney Disease Self-Management Scale,the Kidney Disease Behavioral Inventory(KDBI),and the Health Literacy Questionnaire.Data were collected from hospitalized CKD patients in Heilongjiang Province and analyzed using One-Way Analysis of Variance(ANOVA),Hierarchical Regression Analysis,and K-prototype cluster analysis.Results:A total of 957 participants were tested.Of these,70.64%had less than a bachelor's degree,and 56.27%had been diagnosed with hypertensive or diabetic nephropathy.The KDBI scale showed a lower overall score compared to the PKDSMS.Factors such as CKD stage 4(F=2.367,P=0.042),last year's medical expenses(F=3.974,P=0.004),and poor self-rated health(F=33.352,P<0.01)were found to influence scores on both scales.The health literacy questionnaire revealed significant differences(P<0.01)in health knowledge,except by sex.Additionally,healthcare expenditures and poor self-rated health were negatively associated with self-management capacity.Conclusion:This study provides valuable insights into the self-management challenges faced by CKD patients in cold regions of China.Despite some difficulties in improving self-management,patients showed positive attitudes toward enhancing CKD management services in primary care and developing digital management tools.These findings offer useful references and recommendations for future clinical practice and research in this field.展开更多
In this article,we comment on an article by Wang et al published in the World Journal of Diabetes.Existing treatments with oral medications can partially mitigate the toxicity of elevated blood glucose levels in patie...In this article,we comment on an article by Wang et al published in the World Journal of Diabetes.Existing treatments with oral medications can partially mitigate the toxicity of elevated blood glucose levels in patients with type 2 diabetes mellitus.However,these patients often require lifelong,costly medications,and many struggle with poor compliance.To address the limitations of pharmacological treatments,laparoscopic jejunal-ileal lateral anastomosis has become increasingly common in clinical practice and generally yields favorable outcomes.This procedure stimulates the secretion of larger amounts of glucagon-like peptide-1 by intestinal L cells,which in turn promotes pancreatic islet cell proliferation,reduces insulin resistance,and effectively controls glucose and lipid metabolism disorders.Nonetheless,further research is needed to fully explore its indications,contraindications,the enhancement of patients'quality of life and patients’satisfaction with the subjective experience of treatment and long-term effects.展开更多
These Chinese National Guidelines(GB/T 35892-20181)were issued February 06,2018 and became effective September 01,2018.The authors recognized the urgent need for an authentic English translation to inform the internat...These Chinese National Guidelines(GB/T 35892-20181)were issued February 06,2018 and became effective September 01,2018.The authors recognized the urgent need for an authentic English translation to inform the international community of the compliance requirements in China.It was appreciated that the final translation must reflect the specialist understanding of those working under the Guideline whilst remaining faithful to the meaning of the original Chinese text.A three-step translation process was therefore determined.Step 1:A professional interpretation service(KL Communications,UK)was commissioned to prepare a literal translation of the Chinese text.Supportive documents were provided which explained specialist terminology.This translation was checked by two bilingual experts.Step 2:A workshop was held in Nanjing in May 2019 to which were invited experts in laboratory animal welfare and ethical use.These included international native English-speaking and Chinese-speaking delegates.The delegates worked in multilingual teams to review sections of the literal translation ahead of the workshop,and to agree an authentic interpretation during the workshop.Step 3:Following the workshop,three bilingual experts(two native Chinese speakers and one native English speaker)reviewed the entire document to ensure consistency of terminology and general accuracy.This document is thus not a“literal translation”but an“accurate interpretation”of the original text.Any challenge of work being performed under these Guidelines should rely on the Chinese text in the first place.However,this translation may be used as mitigating evidence,especially where those performing the work are non-Chinese speakers.展开更多
<strong>Background:</strong> Photodynamic therapy (PDT) is the generation of cytotoxic agents through the dynamic interaction between a photosensitizer excited by light at a specific wavelength. When assoc...<strong>Background:</strong> Photodynamic therapy (PDT) is the generation of cytotoxic agents through the dynamic interaction between a photosensitizer excited by light at a specific wavelength. When associated with phthalocyanines, they are efficient in incorporating target cells and exhibiting high rates of triplet generation. This study aimed to characterize PDT associated with the phototherapeutic agent Phthalomethyl D, developed by the authors, in the process of repair, healing and immune improvement for possible application against SARS-CoV-2. <strong>Methods: </strong>Sixty-nine mice were used, divided into 2 groups: GI, treated with ILIB laser, without a phototherapeutic agent, and subjected to surgery for viral induction;GII, same as GI plus association of Phthalomethyl D. They were divided into subgroups and reevaluated at 7, 14, and 21 days, and then divided into 3 subgroups of 6 animals each, subjected to treatment at 24 h, 48 h, 72 h, 5 and 7 days. <strong>Results:</strong> Both groups had a high rate of partial incision closure and acute inflammatory control. Microscopically, there was a greater amount of amorphous fundamental substance, fibrocytes, fibroblasts, and giant cells and reduction in the number of keratinocytes, in the amount of keratin, and epidermal thickness in GII than in GI. <strong>Conclusions:</strong> PDT with Phthalomethyl D stimulates the processes of healing/repair and immunomodulation during viral infection, initially favoring the inflammatory response and, after 21 days, contributing to the anti-inflammatory response profile, making this approach possible in the treatment of individuals infected with SARS-CoV-2.展开更多
Background: Gastric cancer is the third most incident malignancy and the fifth leading cause of death in the world. In Brazil, it is the fourth most common tumour in men and the fifth in women. Familial aggregation of...Background: Gastric cancer is the third most incident malignancy and the fifth leading cause of death in the world. In Brazil, it is the fourth most common tumour in men and the fifth in women. Familial aggregation of this tumour is being studied and discussed by experts. Aim: Determine the frequency of family history of cancer in patients with gastric cancer, suggesting familial aggregation or increased risk for hereditary cancer syndromes. Methods: This is a retrospective cross-sectional study carried out from January 2011 to March 2015 at the Department of Abdominal and Pelvic Surgery of the Brazilian National Cancer Institute (INCA). Data were collected from electronic medical records and analyzed using SPSS Statistics? version 20. Results: 873 patients with gastric adenocarcinoma were analyzed. A family history of cancer was reported by 451 patients (51.6%), which reported cancer in 878 relatives, of which 110 (12.6%), reported having more than three relatives with any type of cancer. The most prevalent malignancies among these relatives were gastric cancer (21.3%) and breast cancer (9.5%). Conclusion: Most of the patients had cancer family history, being gastric cancer the most common. The high percentage of cancer family history confirms the importance of collecting this information, whose lack reflects professional negligence, as family history study can serve as a low-cost tool, favoring prevention and early diagnosis, situations where morbidity and mortality are smaller, thus reducing health costs and assistance and preserving lives.展开更多
Medical progress is based on research.Life sciences and medical research contribute to the improvement of people’s health,alleviation of suffering,and increases in well-being.Life sciences and medical research involv...Medical progress is based on research.Life sciences and medical research contribute to the improvement of people’s health,alleviation of suffering,and increases in well-being.Life sciences and medical research involving human participants cannot be undertaken without the support and dedication of participants.The safety,health,and welfare of participants are primary considerations in clinical research,taking precedence over the benefits to science and society.The rights and interests of participants include the right to health,the right to informed consent,the right to compensation,the right to privacy protection,the right to voluntary participation,the right to withdraw at any time,the study/trial free right,and the right to timely treatment.Protecting the rights of participants is the responsibility of sponsors,contract research organizations,medical institutions,researchers,ethics review committees,and other research parties.In life sciences and medical research involving humans,participants typically expend time and energy,and participating in clinical research involves a degree of inconvenience in participants’work and life.When participating in studies in which safety and effectiveness have not been fully and effectively verified,participants are often exposed to uncertain types and levels of risk.Participants in such studies bear known and unknown risks,and may suffer research-related damages.Guaranteeing,protecting,and implementing participants’right to compensation are essential responsibilities in life sciences and medical research involving human participants.The current paper examines the right of compensation for research participants.We undertook in-depth analysis of the concepts,categories(conventional compensation,research-related damages),principles(necessity,timeliness,appropriateness,fairness),and elements(method,amount,plan,consent,notification,reference)of compensation,as well as compensation under special circumstances(people who have not given informed consent,participants with impaired informed consent capacity,participants who withdraw from a study).Additionally,we examined processes for research-related damages(claims,opinions,negotiation,implementation).This paper proposes measures for the compensation rights of participants,which cover five domains(sponsor/contract research organizations,research institutions,research management departments,the principal researchers and their teams,and ethics review committees),to ensure the implementation of compensation and strengthen the protection of the compensation rights of participants.展开更多
Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort study.Methods： The survival outcome of patients receiving...Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort study.Methods： The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone.The study design was adopted with ＂continuous administration of Chinese medicine for 3 months＂ as the exposure factor.Patients who met this exposure factor were assigned to the IM cohort（Group A,110 patients）.Patients who did not meet this exposure factor were assigned to the Western medicine cohort（Group B,225 patients）.The overall survival（OS）,progression-free survival（PFS）,and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were compared.Results： The median OS in Group A and B were 18 months [95% confidence interval（CI） 15-21] and 16 months（95% CI 14-18）,respectively,and the median PFS in Group A and B were 6 months（95% CI 4-7） and 5 months（95% CI 4-6）,respectively.No statistically significant differences were observed between the groups（P=0.186,P=0.223）.Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups： female patients,patients with lesions in the right half of the colon,and those who received first-line treatment（P〈0.05）.In the subgroup of elderly patients（age〉65 years）,the OS in Group A was longer than that in Group B（P〈0.05）.Conclusion： IM could prolong the survival of patients with m CRC.（Registry No.Chi CTR-IOR-17010497）展开更多
In recent years, the paradigm of real-world study （RWS） has been at the forefront oI climcal research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of...In recent years, the paradigm of real-world study （RWS） has been at the forefront oI climcal research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real- world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.展开更多
The recently published article by Narchi et al[1]brings an important empirical insight into a very complex issue of parental consent for lumbar puncture(LP)in children;quite worrisome observation from authors'clin...The recently published article by Narchi et al[1]brings an important empirical insight into a very complex issue of parental consent for lumbar puncture(LP)in children;quite worrisome observation from authors'clinical practice that almost half of the parents refused to give consent for the LP is confirmed.[1]However,the concept of(parental)consent,used by Narchi et al,[1]would need to be further elaborated with introduction of two other important concepts in pediatrics-child's assent and parental permission.The concepts were endorsed by the policy statement of the American Academy of Pediatrics(published in 1995;reaffirmed in 2011).[2]Accordingly,only the patients with appropriate decisional capacity could give their informed consent.In all other situations,parents provide informed permission for an intervention on their child,with assent of the child if appropriate.[2]Most of children from age seven are thought to understand basic information if adequately presented,[3]The need for assent was also supported by the Confederation of European Specialists in Pediatrics,stating that all children have a right to give their assent(or dissent)and may refuse interventions that are not necessary to save their lives or prevent serious harm.[4]Furthermore,the responsibility to make decision in children is shared between physicians and parents.The later should provide informed permission before interventions(except in emergency situations),which includes all the elements of informed consent,reflecting the child's best interests.展开更多
In today’s world,medical science has entered an era of rapid development.Numerous new drugs,devices,technologies,and diagnosis and treatment methods continue to emerge,bringing great benefits to our human health.Howe...In today’s world,medical science has entered an era of rapid development.Numerous new drugs,devices,technologies,and diagnosis and treatment methods continue to emerge,bringing great benefits to our human health.However,there are potential risks in the above innovative research and development process,and some can even endanger the health or life of the test subjects.As a result,medical ethics plays an increasingly important role during the rapid development of innovative clinical research,acting as a“brake”on this high-speed vehicle.This article will illustrate some medical problems and solutions that are common in today’s clinical research in the following aspects.展开更多
文摘Mitochondria are not only the main source of cellular energy but also participate in regulating key physiological processes such as intracellular oxidative stress,signal transduction,and apoptosis,which are crucial for maintaining the structure and function of the skin.Increasing evidence suggests that abnormalities in mitochondrial structure,function,and regulation are closely related to the occurrence and development of skin photoaging.However,the critical role of mitochondria in skin photoaging has yet to be thoroughly explored and studied.In this review,we summarize the roles of mitochondria in the occurrence and development of skin photoaging,aiming to provide new ideas and methods for the prevention and treatment of skin photoaging.
基金supported by the Natural Science Foundation of China(7247042122)the Key Research and Development Project of Heilongjiang Province,China(2024ZX12C06).
文摘Objective:Effective Chronic Kidney Disease(CKD)management is particularly important in cold regions of China,where climate and lifestyle factors play significant roles.However,there is a lack of relevant studies in this area.Therefore,the purpose of this study was:(1)to assess the status of self-management capacity in individuals with CKD in cold regions of China and analyze the factors influencing it;(2)to identify strategies to improve CKD management in primary care settings in these regions;and(3)to understand patients'attitudes toward eHealth services.Methods:This was a regional,cross-sectional observational study.A questionnaire measuring CKD patients'self-management abilities was derived from the Perceived Kidney Disease Self-Management Scale,the Kidney Disease Behavioral Inventory(KDBI),and the Health Literacy Questionnaire.Data were collected from hospitalized CKD patients in Heilongjiang Province and analyzed using One-Way Analysis of Variance(ANOVA),Hierarchical Regression Analysis,and K-prototype cluster analysis.Results:A total of 957 participants were tested.Of these,70.64%had less than a bachelor's degree,and 56.27%had been diagnosed with hypertensive or diabetic nephropathy.The KDBI scale showed a lower overall score compared to the PKDSMS.Factors such as CKD stage 4(F=2.367,P=0.042),last year's medical expenses(F=3.974,P=0.004),and poor self-rated health(F=33.352,P<0.01)were found to influence scores on both scales.The health literacy questionnaire revealed significant differences(P<0.01)in health knowledge,except by sex.Additionally,healthcare expenditures and poor self-rated health were negatively associated with self-management capacity.Conclusion:This study provides valuable insights into the self-management challenges faced by CKD patients in cold regions of China.Despite some difficulties in improving self-management,patients showed positive attitudes toward enhancing CKD management services in primary care and developing digital management tools.These findings offer useful references and recommendations for future clinical practice and research in this field.
文摘In this article,we comment on an article by Wang et al published in the World Journal of Diabetes.Existing treatments with oral medications can partially mitigate the toxicity of elevated blood glucose levels in patients with type 2 diabetes mellitus.However,these patients often require lifelong,costly medications,and many struggle with poor compliance.To address the limitations of pharmacological treatments,laparoscopic jejunal-ileal lateral anastomosis has become increasingly common in clinical practice and generally yields favorable outcomes.This procedure stimulates the secretion of larger amounts of glucagon-like peptide-1 by intestinal L cells,which in turn promotes pancreatic islet cell proliferation,reduces insulin resistance,and effectively controls glucose and lipid metabolism disorders.Nonetheless,further research is needed to fully explore its indications,contraindications,the enhancement of patients'quality of life and patients’satisfaction with the subjective experience of treatment and long-term effects.
基金Astra Zeneca R&DUniversities Federation for Animal Welfare+3 种基金Royal Society for the Prevention of Cruelty to AnimalsNovo Nordisk PharmaceuticalsGovernment of the United KingdomAAALAC International。
文摘These Chinese National Guidelines(GB/T 35892-20181)were issued February 06,2018 and became effective September 01,2018.The authors recognized the urgent need for an authentic English translation to inform the international community of the compliance requirements in China.It was appreciated that the final translation must reflect the specialist understanding of those working under the Guideline whilst remaining faithful to the meaning of the original Chinese text.A three-step translation process was therefore determined.Step 1:A professional interpretation service(KL Communications,UK)was commissioned to prepare a literal translation of the Chinese text.Supportive documents were provided which explained specialist terminology.This translation was checked by two bilingual experts.Step 2:A workshop was held in Nanjing in May 2019 to which were invited experts in laboratory animal welfare and ethical use.These included international native English-speaking and Chinese-speaking delegates.The delegates worked in multilingual teams to review sections of the literal translation ahead of the workshop,and to agree an authentic interpretation during the workshop.Step 3:Following the workshop,three bilingual experts(two native Chinese speakers and one native English speaker)reviewed the entire document to ensure consistency of terminology and general accuracy.This document is thus not a“literal translation”but an“accurate interpretation”of the original text.Any challenge of work being performed under these Guidelines should rely on the Chinese text in the first place.However,this translation may be used as mitigating evidence,especially where those performing the work are non-Chinese speakers.
文摘<strong>Background:</strong> Photodynamic therapy (PDT) is the generation of cytotoxic agents through the dynamic interaction between a photosensitizer excited by light at a specific wavelength. When associated with phthalocyanines, they are efficient in incorporating target cells and exhibiting high rates of triplet generation. This study aimed to characterize PDT associated with the phototherapeutic agent Phthalomethyl D, developed by the authors, in the process of repair, healing and immune improvement for possible application against SARS-CoV-2. <strong>Methods: </strong>Sixty-nine mice were used, divided into 2 groups: GI, treated with ILIB laser, without a phototherapeutic agent, and subjected to surgery for viral induction;GII, same as GI plus association of Phthalomethyl D. They were divided into subgroups and reevaluated at 7, 14, and 21 days, and then divided into 3 subgroups of 6 animals each, subjected to treatment at 24 h, 48 h, 72 h, 5 and 7 days. <strong>Results:</strong> Both groups had a high rate of partial incision closure and acute inflammatory control. Microscopically, there was a greater amount of amorphous fundamental substance, fibrocytes, fibroblasts, and giant cells and reduction in the number of keratinocytes, in the amount of keratin, and epidermal thickness in GII than in GI. <strong>Conclusions:</strong> PDT with Phthalomethyl D stimulates the processes of healing/repair and immunomodulation during viral infection, initially favoring the inflammatory response and, after 21 days, contributing to the anti-inflammatory response profile, making this approach possible in the treatment of individuals infected with SARS-CoV-2.
文摘Background: Gastric cancer is the third most incident malignancy and the fifth leading cause of death in the world. In Brazil, it is the fourth most common tumour in men and the fifth in women. Familial aggregation of this tumour is being studied and discussed by experts. Aim: Determine the frequency of family history of cancer in patients with gastric cancer, suggesting familial aggregation or increased risk for hereditary cancer syndromes. Methods: This is a retrospective cross-sectional study carried out from January 2011 to March 2015 at the Department of Abdominal and Pelvic Surgery of the Brazilian National Cancer Institute (INCA). Data were collected from electronic medical records and analyzed using SPSS Statistics? version 20. Results: 873 patients with gastric adenocarcinoma were analyzed. A family history of cancer was reported by 451 patients (51.6%), which reported cancer in 878 relatives, of which 110 (12.6%), reported having more than three relatives with any type of cancer. The most prevalent malignancies among these relatives were gastric cancer (21.3%) and breast cancer (9.5%). Conclusion: Most of the patients had cancer family history, being gastric cancer the most common. The high percentage of cancer family history confirms the importance of collecting this information, whose lack reflects professional negligence, as family history study can serve as a low-cost tool, favoring prevention and early diagnosis, situations where morbidity and mortality are smaller, thus reducing health costs and assistance and preserving lives.
文摘Medical progress is based on research.Life sciences and medical research contribute to the improvement of people’s health,alleviation of suffering,and increases in well-being.Life sciences and medical research involving human participants cannot be undertaken without the support and dedication of participants.The safety,health,and welfare of participants are primary considerations in clinical research,taking precedence over the benefits to science and society.The rights and interests of participants include the right to health,the right to informed consent,the right to compensation,the right to privacy protection,the right to voluntary participation,the right to withdraw at any time,the study/trial free right,and the right to timely treatment.Protecting the rights of participants is the responsibility of sponsors,contract research organizations,medical institutions,researchers,ethics review committees,and other research parties.In life sciences and medical research involving humans,participants typically expend time and energy,and participating in clinical research involves a degree of inconvenience in participants’work and life.When participating in studies in which safety and effectiveness have not been fully and effectively verified,participants are often exposed to uncertain types and levels of risk.Participants in such studies bear known and unknown risks,and may suffer research-related damages.Guaranteeing,protecting,and implementing participants’right to compensation are essential responsibilities in life sciences and medical research involving human participants.The current paper examines the right of compensation for research participants.We undertook in-depth analysis of the concepts,categories(conventional compensation,research-related damages),principles(necessity,timeliness,appropriateness,fairness),and elements(method,amount,plan,consent,notification,reference)of compensation,as well as compensation under special circumstances(people who have not given informed consent,participants with impaired informed consent capacity,participants who withdraw from a study).Additionally,we examined processes for research-related damages(claims,opinions,negotiation,implementation).This paper proposes measures for the compensation rights of participants,which cover five domains(sponsor/contract research organizations,research institutions,research management departments,the principal researchers and their teams,and ethics review committees),to ensure the implementation of compensation and strengthen the protection of the compensation rights of participants.
基金Supported by National Natural Science Foundation of China(No.81373824)Beijing Health Development Research Project(No.2016-1-4147)Project of the Chinese Academy of Traditional Chinese Medicine(No.ZZ070854)
文摘Objective： To investigate the efficacy of integrated Chinese and Western medicine（IM） in the treatment of metastatic colorectal cancer（m CRC） in a cohort study.Methods： The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone.The study design was adopted with ＂continuous administration of Chinese medicine for 3 months＂ as the exposure factor.Patients who met this exposure factor were assigned to the IM cohort（Group A,110 patients）.Patients who did not meet this exposure factor were assigned to the Western medicine cohort（Group B,225 patients）.The overall survival（OS）,progression-free survival（PFS）,and 1 st year,2 nd year,and 3 rd year survival in the two cohorts were compared.Results： The median OS in Group A and B were 18 months [95% confidence interval（CI） 15-21] and 16 months（95% CI 14-18）,respectively,and the median PFS in Group A and B were 6 months（95% CI 4-7） and 5 months（95% CI 4-6）,respectively.No statistically significant differences were observed between the groups（P=0.186,P=0.223）.Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups： female patients,patients with lesions in the right half of the colon,and those who received first-line treatment（P〈0.05）.In the subgroup of elderly patients（age〉65 years）,the OS in Group A was longer than that in Group B（P〈0.05）.Conclusion： IM could prolong the survival of patients with m CRC.（Registry No.Chi CTR-IOR-17010497）
文摘In recent years, the paradigm of real-world study （RWS） has been at the forefront oI climcal research worldwide, particularly in the field of traditional Chinese medicine. In this paper, basic features and nature of real- world clinical studies are discussed, and ethical issues in different stages of RWS are raised and reviewed. Moreover, some preliminary solutions to these issues, such as protecting subjects during the process of RWS and performing ethical review, are presented based on recent practices and basic ethical rules to improve the scientific validity and ethical level of RWS.
文摘The recently published article by Narchi et al[1]brings an important empirical insight into a very complex issue of parental consent for lumbar puncture(LP)in children;quite worrisome observation from authors'clinical practice that almost half of the parents refused to give consent for the LP is confirmed.[1]However,the concept of(parental)consent,used by Narchi et al,[1]would need to be further elaborated with introduction of two other important concepts in pediatrics-child's assent and parental permission.The concepts were endorsed by the policy statement of the American Academy of Pediatrics(published in 1995;reaffirmed in 2011).[2]Accordingly,only the patients with appropriate decisional capacity could give their informed consent.In all other situations,parents provide informed permission for an intervention on their child,with assent of the child if appropriate.[2]Most of children from age seven are thought to understand basic information if adequately presented,[3]The need for assent was also supported by the Confederation of European Specialists in Pediatrics,stating that all children have a right to give their assent(or dissent)and may refuse interventions that are not necessary to save their lives or prevent serious harm.[4]Furthermore,the responsibility to make decision in children is shared between physicians and parents.The later should provide informed permission before interventions(except in emergency situations),which includes all the elements of informed consent,reflecting the child's best interests.
文摘In today’s world,medical science has entered an era of rapid development.Numerous new drugs,devices,technologies,and diagnosis and treatment methods continue to emerge,bringing great benefits to our human health.However,there are potential risks in the above innovative research and development process,and some can even endanger the health or life of the test subjects.As a result,medical ethics plays an increasingly important role during the rapid development of innovative clinical research,acting as a“brake”on this high-speed vehicle.This article will illustrate some medical problems and solutions that are common in today’s clinical research in the following aspects.
