To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on...To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.展开更多
Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic disea...Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic diseases.Upon exposure to oxidative stress or the inducers of ROS,the cellular nucleus undergoes some biological processes via different signaling pathways,such as stress adaption through the forkhead box O signaling pathway,inflammatory response through the IκB kinase/nuclear factor-κB signaling pathway,hypoxic response via the hypoxia-inducible factor/prolyl hydroxylase domain proteins pathway,DNA repair or apoptosis through the p53 signaling pathway,and antioxidant response through the Kelch-like ECH-associated protein 1/nuclear factor E2-related factor 2 signaling pathway.These processes are involved in many diseases.Therefore,oxidative stress has gained more attraction as a targeting process for disease treatment.Meanwhile,anti-oxidative stress agents have been widely explored in pre-clinical trials.However,only limited clinical trials are performed to evaluate the efficacy of anti-oxidative stress agents or antioxidants in diseases.In this letter,we further discuss the current clinical trials related to anti-oxidative stress treatment in different diseases.More pre-clinical studies and clinical trials are expected to use anti-oxidative stress strategies as disease treatment or dietary supplementation to improve disease treatment outcomes.展开更多
This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phas...This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.展开更多
<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and ...<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and roles of study nurses in IBD drug clinical trials. </span><b><span style="font-family:Verdana;">Methods</span></b><span style="font-family:Verdana;">: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. </span><b><span style="font-family:Verdana;">Results</span></b><span style="font-family:Verdana;">: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. </span><b><span style="font-family:Verdana;">Conclusions</span></b><span style="font-family:Verdana;">: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.</span></span>展开更多
Objective To provide a basis for future regulation reform of drug clinical trials in China in the context of the continuous deepening of drug regulation reform. Methods Literature review and regulation study were cond...Objective To provide a basis for future regulation reform of drug clinical trials in China in the context of the continuous deepening of drug regulation reform. Methods Literature review and regulation study were conducted to analyze the course and development trend of drug clinical trial regulation in China. Results and Conclusion It is found that the regulation system and the standardization for clinical trials in China are gradually improving, but there is still a gap compared with developed countries. In the future, the regulation authorities still need to further improve relevant regulations, clarify regulation responsibilities, and to improve the drug clinical trial review system to ensure the quality of clinical trials and the safety and effectiveness of listed drugs.展开更多
Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and...Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized.Results and Conclusion There has been an upsurge in clinical drug trials in China.Hospital pharmacists play increasingly important roles in all aspects of clinical trials,such as stakeholder liaisons,protocol developers,ethics committee members,research team members,study drug managers,and subject intervention agents.Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team.Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals.Pharmacists should be the designers,researchers,managers and supervisors of clinical drug trials.We expect that all clinical trial projects will include hospital pharmacists in their research teams soon.展开更多
Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main...Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main goals are to determine safety and effectiveness of the intervention. If preclinical studies show that the therapy is safe and effective, clinical trials are started. Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, and V clinical studies. Understanding the basis of clinical trial phases will help researchers plan and implement clinical study protocols and, by doing so, improve the number of therapies coming to market for patients.展开更多
<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the cli...<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the clinical trial participation of patients with IBD. A clinical experiment guidance will be proved by this study to maximized the benefits to patients and to help the clinical trial to conduct successfully. <strong>Method: </strong>An anonymous questionnaire was designed and was administrated to the patients with IBD who were randomly delivered in the inpatient or outpatient departments. The survey result was analyzed. <strong>Result:</strong> Total 372 available questionnaires were returned. Among these patients, 26.3% patients with IBD indicated willingness to participate, 57.3% indicated a situation dependence, and 41.04% indicated unwillingness. Among the potential factors that may influence the patient’s willingness to participate the clinical, trusted physician’s recommendation, no proved drugs to use and accessing to free medication to release financial burden were statistically significant. <strong>Conclusion:</strong> The overall willingness of IBD patients to participate in drug clinical trials is not high. Among the patients who are willing to participate in clinical trials, the main reasons for their participation are that they trust doctors’ recommendation, can get free medication and examination, and can reduce the economic burden. Efficacy and safety were the main influencing factors in patients who were case-dependent and unwilling to participate in clinical trials.展开更多
Objective:To evaluate the efficacy and safety of leuprolide acetate in the treatment of endometriosis. Methods:The patients with endometriosis were randomly divided into leuprolide(n = 75) and control(n=74) groups.The...Objective:To evaluate the efficacy and safety of leuprolide acetate in the treatment of endometriosis. Methods:The patients with endometriosis were randomly divided into leuprolide(n = 75) and control(n=74) groups.They were treated with either sustained-release injection of leuprolide acetate or Enatntone injection(control) for 3 times totally.After treatment,the ovarian mass volume was measured under B ultrasound.The changes in hormone levels of estrodial(E_2),FSH and LH,the pelvic signs,the scores of the patient's subjective symptoms during menstruation and non-menstrual days were observed. Results:The rate of changes in ovarian mass volume had no statistically significant difference between the two groups(P=0.495-0.965).The average reduction of ovarian mass volume was 47.91%in leuprolide group,and 53.51%in the control group 12 weeks after first medication.The distinct improvement rate and improvement rate of total symptom scores during menstruation and non-menstrual days had no significant difference between the two groups.The hormone levels of E_2,FSH and LH were not significantly different between the two groups.The differences in the incidence of adverse reactions were not significant between the two groups. Conclusion:Leuprolide acetate produced by Livzon China is effective and safe in the treatment of endometriosis.展开更多
The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the dise...The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. Placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. Placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. Placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.展开更多
Obesity is a chronic disease which requires treatment.As lifestyle interventions alone hardly ever result in long-term weight loss,pharmacotherapy is an important adjunct to lifestyle measures to improve the induction...Obesity is a chronic disease which requires treatment.As lifestyle interventions alone hardly ever result in long-term weight loss,pharmacotherapy is an important adjunct to lifestyle measures to improve the induction and maintenance of weight loss.Owing to the limited options currently available for the pharmacological treatment of obesity,it is imperative to develop new safe compounds.This study aims to review the current medications approved by European Medicines Agency and United States Food and Drug Administration(FDA)for the treatment of obesity,focusing essentially on their benefits and risks,as well as on the new drugs which are presently under clinical trials.Moreover,it lists the anti-obesity agents that have been recently withdrawn from the market.A revision of the scientific literature was carried out,through a search on Pubmed for papers published from January 2010 to January2013.Orlistat(Xenical) is currently the only long-term pharmacotherapy for obesity available in the European market,as rimonabant and sibutramine were with-drawn in 2008 and 2010,respectively,due to serious psychiatric and cardiovascular adverse effects.Lorcaserin(BelviqTM) and the association of phentermine and topiramate(Qsymia TM) were recently approved by FDA.Orlistat suppresses appetite inhibiting gastrointestinal lipase,being its adverse effects mostly gastrointestinal.Lorcaserin activates 5-HT2 C receptors,phentermine is a norepinephrine releasing drug,and topiramate is an anticonvulsivant drug with weight loss properties.展开更多
Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We co...Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We conducted a meta‐analysis to analyze the profile and incidence of AEs related to ADC use in the treatment of solid tumors and hematological malignancies.Methods:We searched the PubMed,Embase,and Cochrane Library databases for articles published from January 2001 to October 2022.The overall profile and incidence of all‐grade and grade≥3 treatment‐related AEs were the primary outcomes of the analysis.Results:A total of 138 trials involving 15,473 patients were included in this study.The overall incidence of any‐grade treatment‐related AEs was 100.0%(95%confidence interval[CI]:99.9%–100.0%;I2=89%)and the incidence of grade≥3 treatment‐related AEs was 6.2%(95%CI:3.0%–12.4%;I2=99%).Conclusions:This study provides a comprehensive overview of AEs related to ADCs used for cancer treatment.ADC use resulted in a high incidence of any‐grade AEs but a low incidence of grade≥3 AEs.The AE profiles and incidence differed according to cancer type,ADC type,and ADC components.展开更多
Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists...Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the U.S. Food and Drug Administration’s designation of these two drugs as “breakthrough therapy”. The objective of the present article is to demonstrate that the evidence on which the FDA and then the TGA relied is irretrievably flawed and should be dismissed. Method: Expert review of psychedelic therapy clinical trials and specifically of the methodology and measures used. Results: The present review demonstrates that the studies the U.S. FDA and the Australian TGA relied on to approve these two psychedelic drugs for therapy are irretrievably flawed. All future trials will follow the same procedure and are therefore bound to be flawed as well. Conclusions: Psychedelic drug studies have so far provided no trustworthy evidence of their effectiveness for treating mental disorders and are not likely to produce this evidence in the future. Psychedelic drug therapy is in any event impractical because of its specialized training requirements and very high treatment costs. It is also dangerous because false publicity about its effectiveness will almost certainly lead to unsupervised self-dosing with drugs that not only are illegal but have an unacceptably high addiction rate.展开更多
基金Project of Xi’an Science and Technology Plan(23YXYJ0163)Education and Teaching Reform Research Project of Xi’an Medical University in 2023(S202311840061)+1 种基金First Affiliated Hospital of Xi’an Medical University of China(XYYFY-2023-01)2021 Xi’an Medical University University-Level Science and Technology Innovation Team(2021TD14)。
文摘To understand the current situation of institutional registration in Shaanxi Province after the implementation ofregistration system management in drug clinical trial institutions.Relevant information was collected on the“Announcement on the Accreditation of Drug Clinical Trial Institutions”issued by the National Medical Products Administration from 2005 to August 2022,the record management information system of drug and medical device clinical trial institutions,and the drug clinical trial registration and information publicity platform.A retrospective analysis was carried out in terms of institutional development,regional distribution,registered majors,principal investigators,and the number of drug clinical trials.After the implementation of institution registration,the number of drug clinical trial institutions in Shaanxi Province increased by 47.4%,884 principal investigators were registered,the number of registered majors expanded from 58 qualified to 117,and the professional scope increased by 50.4%.The policy of institution registration is conducive to promoting the rational use of medical resources and the development of drug clinical trial institutions and improving the healthy development of the pharmaceutical industry in Shaanxi Province.
文摘Oxidative stress disturbs the balance between the production of reactive oxygen species(ROS)and the detoxification biological process.It plays an important role in the development and progression of many chronic diseases.Upon exposure to oxidative stress or the inducers of ROS,the cellular nucleus undergoes some biological processes via different signaling pathways,such as stress adaption through the forkhead box O signaling pathway,inflammatory response through the IκB kinase/nuclear factor-κB signaling pathway,hypoxic response via the hypoxia-inducible factor/prolyl hydroxylase domain proteins pathway,DNA repair or apoptosis through the p53 signaling pathway,and antioxidant response through the Kelch-like ECH-associated protein 1/nuclear factor E2-related factor 2 signaling pathway.These processes are involved in many diseases.Therefore,oxidative stress has gained more attraction as a targeting process for disease treatment.Meanwhile,anti-oxidative stress agents have been widely explored in pre-clinical trials.However,only limited clinical trials are performed to evaluate the efficacy of anti-oxidative stress agents or antioxidants in diseases.In this letter,we further discuss the current clinical trials related to anti-oxidative stress treatment in different diseases.More pre-clinical studies and clinical trials are expected to use anti-oxidative stress strategies as disease treatment or dietary supplementation to improve disease treatment outcomes.
基金This study was supported by the Fundamental Research Funds for the Central Universities(No.5003516009).
文摘This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.
文摘<strong>Objective</strong><span style="font-family:;" "=""><span style="font-family:Verdana;"><strong>:</strong> To explore the establishment and roles of study nurses in IBD drug clinical trials. </span><b><span style="font-family:Verdana;">Methods</span></b><span style="font-family:Verdana;">: The management experience of this department’s study nurses in IBD drug clinical trials was retrospectively analyzed. </span><b><span style="font-family:Verdana;">Results</span></b><span style="font-family:Verdana;">: The study nurses played very important roles at all links during the preliminary preparation of IBD drug clinical trials, the whole-process management after project initiation, and the later work of project conclusion. </span><b><span style="font-family:Verdana;">Conclusions</span></b><span style="font-family:Verdana;">: As direct participants in drug clinical trials, study nurses play a very important role in ensuring standardization of the trial process, safeguarding patient’s rights and safety, and assisting investigators in carrying out study works smoothly.</span></span>
文摘Objective To provide a basis for future regulation reform of drug clinical trials in China in the context of the continuous deepening of drug regulation reform. Methods Literature review and regulation study were conducted to analyze the course and development trend of drug clinical trial regulation in China. Results and Conclusion It is found that the regulation system and the standardization for clinical trials in China are gradually improving, but there is still a gap compared with developed countries. In the future, the regulation authorities still need to further improve relevant regulations, clarify regulation responsibilities, and to improve the drug clinical trial review system to ensure the quality of clinical trials and the safety and effectiveness of listed drugs.
文摘Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care.Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized.Results and Conclusion There has been an upsurge in clinical drug trials in China.Hospital pharmacists play increasingly important roles in all aspects of clinical trials,such as stakeholder liaisons,protocol developers,ethics committee members,research team members,study drug managers,and subject intervention agents.Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team.Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals.Pharmacists should be the designers,researchers,managers and supervisors of clinical drug trials.We expect that all clinical trial projects will include hospital pharmacists in their research teams soon.
文摘Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main goals are to determine safety and effectiveness of the intervention. If preclinical studies show that the therapy is safe and effective, clinical trials are started. Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, and V clinical studies. Understanding the basis of clinical trial phases will help researchers plan and implement clinical study protocols and, by doing so, improve the number of therapies coming to market for patients.
文摘<strong>Objective:</strong> The study was conducted to understand the situation of patients with inflammatory bowel disease (IBD) to participant clinical trials and to analyze the factors affecting the clinical trial participation of patients with IBD. A clinical experiment guidance will be proved by this study to maximized the benefits to patients and to help the clinical trial to conduct successfully. <strong>Method: </strong>An anonymous questionnaire was designed and was administrated to the patients with IBD who were randomly delivered in the inpatient or outpatient departments. The survey result was analyzed. <strong>Result:</strong> Total 372 available questionnaires were returned. Among these patients, 26.3% patients with IBD indicated willingness to participate, 57.3% indicated a situation dependence, and 41.04% indicated unwillingness. Among the potential factors that may influence the patient’s willingness to participate the clinical, trusted physician’s recommendation, no proved drugs to use and accessing to free medication to release financial burden were statistically significant. <strong>Conclusion:</strong> The overall willingness of IBD patients to participate in drug clinical trials is not high. Among the patients who are willing to participate in clinical trials, the main reasons for their participation are that they trust doctors’ recommendation, can get free medication and examination, and can reduce the economic burden. Efficacy and safety were the main influencing factors in patients who were case-dependent and unwilling to participate in clinical trials.
文摘Objective:To evaluate the efficacy and safety of leuprolide acetate in the treatment of endometriosis. Methods:The patients with endometriosis were randomly divided into leuprolide(n = 75) and control(n=74) groups.They were treated with either sustained-release injection of leuprolide acetate or Enatntone injection(control) for 3 times totally.After treatment,the ovarian mass volume was measured under B ultrasound.The changes in hormone levels of estrodial(E_2),FSH and LH,the pelvic signs,the scores of the patient's subjective symptoms during menstruation and non-menstrual days were observed. Results:The rate of changes in ovarian mass volume had no statistically significant difference between the two groups(P=0.495-0.965).The average reduction of ovarian mass volume was 47.91%in leuprolide group,and 53.51%in the control group 12 weeks after first medication.The distinct improvement rate and improvement rate of total symptom scores during menstruation and non-menstrual days had no significant difference between the two groups.The hormone levels of E_2,FSH and LH were not significantly different between the two groups.The differences in the incidence of adverse reactions were not significant between the two groups. Conclusion:Leuprolide acetate produced by Livzon China is effective and safe in the treatment of endometriosis.
文摘The hypothesis in drug clinical trials is that the drug is better than a placebo in patients suffering from a disease. The unstated assumption is that the drug cures the disease or is a powerful treatment for the disease. This is an incorrect assumption. Drugs do not cure or treat diseases. The body heals itself; drugs promote this ability of the body to heal itself. Placebos are assumed to be inactive; however, placebos can also promote the ability of the body to heal itself. Placebos are actually treatments that can stimulate endogenous healing mechanisms. The possible place of placebos in health management is controversial. Clinical trial design should be altered. The hypothesis of clinical trials should be that the drug speeds up or improves the healing of the patient, putting patient healing as the first objective. Placebos should not be used as controls but could be tested as drugs in their own right. The control in clinical trials should be no treatment. Alternatively, new drugs could be compared to existing drugs in clinical trials.
文摘Obesity is a chronic disease which requires treatment.As lifestyle interventions alone hardly ever result in long-term weight loss,pharmacotherapy is an important adjunct to lifestyle measures to improve the induction and maintenance of weight loss.Owing to the limited options currently available for the pharmacological treatment of obesity,it is imperative to develop new safe compounds.This study aims to review the current medications approved by European Medicines Agency and United States Food and Drug Administration(FDA)for the treatment of obesity,focusing essentially on their benefits and risks,as well as on the new drugs which are presently under clinical trials.Moreover,it lists the anti-obesity agents that have been recently withdrawn from the market.A revision of the scientific literature was carried out,through a search on Pubmed for papers published from January 2010 to January2013.Orlistat(Xenical) is currently the only long-term pharmacotherapy for obesity available in the European market,as rimonabant and sibutramine were with-drawn in 2008 and 2010,respectively,due to serious psychiatric and cardiovascular adverse effects.Lorcaserin(BelviqTM) and the association of phentermine and topiramate(Qsymia TM) were recently approved by FDA.Orlistat suppresses appetite inhibiting gastrointestinal lipase,being its adverse effects mostly gastrointestinal.Lorcaserin activates 5-HT2 C receptors,phentermine is a norepinephrine releasing drug,and topiramate is an anticonvulsivant drug with weight loss properties.
基金the Thousand Talents of Program of High-end Innovation of Qinghai Province in China(for Dr.Jiuda Zhao).
文摘Background:The wide use of antibody‐drug conjugates(ADCs)is transforming the cancer‐treatment landscape.Understanding the treatment‐related adverse events(AEs)of ADCs is crucial for their clinical application.We conducted a meta‐analysis to analyze the profile and incidence of AEs related to ADC use in the treatment of solid tumors and hematological malignancies.Methods:We searched the PubMed,Embase,and Cochrane Library databases for articles published from January 2001 to October 2022.The overall profile and incidence of all‐grade and grade≥3 treatment‐related AEs were the primary outcomes of the analysis.Results:A total of 138 trials involving 15,473 patients were included in this study.The overall incidence of any‐grade treatment‐related AEs was 100.0%(95%confidence interval[CI]:99.9%–100.0%;I2=89%)and the incidence of grade≥3 treatment‐related AEs was 6.2%(95%CI:3.0%–12.4%;I2=99%).Conclusions:This study provides a comprehensive overview of AEs related to ADCs used for cancer treatment.ADC use resulted in a high incidence of any‐grade AEs but a low incidence of grade≥3 AEs.The AE profiles and incidence differed according to cancer type,ADC type,and ADC components.
文摘Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the U.S. Food and Drug Administration’s designation of these two drugs as “breakthrough therapy”. The objective of the present article is to demonstrate that the evidence on which the FDA and then the TGA relied is irretrievably flawed and should be dismissed. Method: Expert review of psychedelic therapy clinical trials and specifically of the methodology and measures used. Results: The present review demonstrates that the studies the U.S. FDA and the Australian TGA relied on to approve these two psychedelic drugs for therapy are irretrievably flawed. All future trials will follow the same procedure and are therefore bound to be flawed as well. Conclusions: Psychedelic drug studies have so far provided no trustworthy evidence of their effectiveness for treating mental disorders and are not likely to produce this evidence in the future. Psychedelic drug therapy is in any event impractical because of its specialized training requirements and very high treatment costs. It is also dangerous because false publicity about its effectiveness will almost certainly lead to unsupervised self-dosing with drugs that not only are illegal but have an unacceptably high addiction rate.