Introduction Canadian academic centres and children’s hospitals have had a longstanding interest in the improvement of drug therapy for children through research conducted across the four pillars of activity identifi...Introduction Canadian academic centres and children’s hospitals have had a longstanding interest in the improvement of drug therapy for children through research conducted across the four pillars of activity identified as being of展开更多
Importance:Pediatric medication is a challenging issue globally.Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are importan...Importance:Pediatric medication is a challenging issue globally.Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important.Objective:To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation.Methods:We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1,2013,to December 31,2022,on the Registration and Information Disclosure Platform for Drug Clinical Trials,the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises.Trials that included pediatric participants(under 18 years old)were retrieved,and their relevant characteristics were extracted and analyzed.Results:In total,895 pediatric clinical trials were collected,accounting for 5.1%of the total registered clinical trials initiated prior to January 1,2023.The overall average annual growth rate for the number of pediatric clinical trials was 12%(P<0.001).Phase III trials accounted for the highest proportion(49.1%,439).Of the 895 trials included,736(82.2%)were domestic trials,and 159(17.8%)were international multicenter trials.In terms of tested drugs,investigations of biological products accounted for the largest proportion of trials(67.4%,603).Among pediatric clinical trials,studies of vaccines accounted for the largest proportion of trials(41.0%,367),followed by trials for rare diseases(17.2%,154).Furthermore,geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China(35.7%,320)and Northeast China(0.8%,7),respectively.Interpretation:The growth trends for industry-sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013.Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children,expanding the scope of pediatric clinical trials,and improving the uneven geographical distribution of leading research centers.展开更多
Objective To observe the therapeutic effect of quick-impact Tuina method on treatment of pediatric muscular torticollis.Methods Pushing,kneading,and grasping manipulations combined with traction and flicking method we...Objective To observe the therapeutic effect of quick-impact Tuina method on treatment of pediatric muscular torticollis.Methods Pushing,kneading,and grasping manipulations combined with traction and flicking method were applied at sternocleidomastoid on the affected side for 38 cases of pediatric muscular torticollis.The treatment was given 1 time a day,10 times as a course.The therapeutic effect was evaluated after 3 courses of treatment.Results Thirty-four cases was evaluated as full recovery,3 cases as remarkable effectiveness,1 case as effectiveness,0 case as ineffectiveness,the total effective rate was 100.0%.Conclusion The combined method treating pediatric muscular torticollis regulated tendons and relieved blood stasis,improved muscular spasm,and dispersed mass,so as to enhance and restore the regular neck function with significant therapeutic effect.展开更多
文摘Introduction Canadian academic centres and children’s hospitals have had a longstanding interest in the improvement of drug therapy for children through research conducted across the four pillars of activity identified as being of
文摘Importance:Pediatric medication is a challenging issue globally.Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important.Objective:To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation.Methods:We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1,2013,to December 31,2022,on the Registration and Information Disclosure Platform for Drug Clinical Trials,the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises.Trials that included pediatric participants(under 18 years old)were retrieved,and their relevant characteristics were extracted and analyzed.Results:In total,895 pediatric clinical trials were collected,accounting for 5.1%of the total registered clinical trials initiated prior to January 1,2023.The overall average annual growth rate for the number of pediatric clinical trials was 12%(P<0.001).Phase III trials accounted for the highest proportion(49.1%,439).Of the 895 trials included,736(82.2%)were domestic trials,and 159(17.8%)were international multicenter trials.In terms of tested drugs,investigations of biological products accounted for the largest proportion of trials(67.4%,603).Among pediatric clinical trials,studies of vaccines accounted for the largest proportion of trials(41.0%,367),followed by trials for rare diseases(17.2%,154).Furthermore,geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China(35.7%,320)and Northeast China(0.8%,7),respectively.Interpretation:The growth trends for industry-sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013.Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children,expanding the scope of pediatric clinical trials,and improving the uneven geographical distribution of leading research centers.
文摘Objective To observe the therapeutic effect of quick-impact Tuina method on treatment of pediatric muscular torticollis.Methods Pushing,kneading,and grasping manipulations combined with traction and flicking method were applied at sternocleidomastoid on the affected side for 38 cases of pediatric muscular torticollis.The treatment was given 1 time a day,10 times as a course.The therapeutic effect was evaluated after 3 courses of treatment.Results Thirty-four cases was evaluated as full recovery,3 cases as remarkable effectiveness,1 case as effectiveness,0 case as ineffectiveness,the total effective rate was 100.0%.Conclusion The combined method treating pediatric muscular torticollis regulated tendons and relieved blood stasis,improved muscular spasm,and dispersed mass,so as to enhance and restore the regular neck function with significant therapeutic effect.
