Folic acid-O-carboxymethyl chitosan ultrasmall superparamagnetic iron oxide nanoparticles (FA-OCMCS-USPIO-NPs) are a novel molecular targeting MR contrast agent. This paper reperts the pharmacokinetics and magnetic resonance response characteristics of FA-OCMCS-USPIO-NPs in normal rats and mice, and discussed its distributing regularity in animals, providing basis for tumor targeting imaging. O-phenanthroline method was used to determine iron content in rats' plasma and mice's organs following high and low doses of nanoparticles injected through tail vein, and the blood concentration-time curve was drawn, the calculated t1/2 of two groups were greater than 7 h. The results of tissue distribution showed that only a small part of nanoparticles were swallowed by the liver and spleen, while none in the heart, lung and kidney. At the same times, the phagocytosis of nanoparticles did not change with the dose. The results of MRI showed that renal excretion occurred 4 hours after injection, and signal to noise ratio (SNR) of liver and kidney returned to normal levels 24 hours after injection. There were no nanoparticles in the lungs. So a part of nanoparticles escaped from phagocytosis of liver and spleen, and it owned lower toxicity and longer half-life. indicated its use for tumor-targeting imaging. All of these indicated its use for tumor-targeting imaging.

OBJECTIVETo optimize a compound prescription for treatment of liver fibrosis with an improved therapeutic effect and low toxicity.

METHODSIn rat models of liver fibrosis induced by thioacetamide (TAA), the optimized prescription was screened based on a uniform design with 2-factor 5-level table using Uniform Design 3.0 software and tested using liver content of Hyp as the screening index. To verify the efficacy of the optimized prescription, the rat models of liver fibrosis were randomized into normal control group, model group, colchicine group and optimized prescription group, and the changes of hepatic Hyp content, serum HA, ALT, AST, and ALB levels, and the pathology liver fibrosis were observed after corresponding treatments.

RESULTSThe optimized prescription, which contained 70 mg/kg glycyrrhizin and 70 mg/kg matrine, showed a significant therapeutic effect against liver fibrosis in rats (Plt;0.05), and the effect was equivalent to that of colchicine (P>0.05).

CONCLUSIONUniform design is a valuable method in prescription optimization. The optimized compound prescription of matrine and glycyrrhizin has a significant effect in inhibiting liver fibrosis.

Alkaloids ; administration & dosage ; Animals ; Drug Therapy, Combination ; Female ; Glycyrrhizic Acid ; administration & dosage ; Liver Cirrhosis ; chemically induced ; drug therapy ; Male ; Phytotherapy ; Quinolizines ; administration & dosage ; Rats ; Rats, Sprague-Dawley ; Thioacetamide

To investigate the knowledge regarding clinical research among children at 8-18 years of age. The survey results will form the basis for developing public education program for this population. Methods The survey was conducted among children at 8-18 years of age using WeChat and spot investigation between January 2016 and January 2017. According to different developmental stages, the survey population was divided into four groups: age 8-10, 11-13, 14-15 and 16-18 years. The level of knowledge regarding clinical research was analyzed. Results Totally 1 329 questionnaires were issued and 1 233 effective questionnaires were returned with a recovery rate of 92.8%. The overall awareness rate regarding clinical research was 32.8% (405/1 233). It revealed that 282 (22.9%) individuals thought that clinical research was to treat people like experimental rats. When asked"who have the final decision on research participation", the percentages of those who chose oneself, parents or guardian and doctor were 44.6% (550/1 233), 74.2% (915/1 233) and 36.8% (454/1 233) respectively. When asked "If you want to participate a study, but your parents or guardian do not agree, what would you do?", 33.9% (418/1 233) of individuals will "give up". As to "If you do not want to participate a study, but your parents or guardian think you should, what would you do? ", 51.3% (632/1 233) chose"listen to parents" and 28.8% (355/1 233) chose"refuse the suggestions of parents or guardian". As to "what are your greatest concerns of participating an investigation?", 68.1% (840/1 233) chose"worry about added pain or discomfort". But 58.0%(715/1 233) thought if"doctors and nurses take good care of me"their "concerns will reduce" or "feel better to participate in the research? ". 55.6% (686/1 233) and 49.3% (608/1 233) individuals responded that they will"participate in an research? "when they"know that other people also participate the research" and when they"know the details regarding what will happen after the enrollment". Conclusions The knowledge level of clinical research among children aged 8-18 years were not high. It is very necessary to promote the public education of clinical research for this population and also very necessary to address their concern regarding the research.

Objective:To understand the distribution characteristics of pulse oxygen saturation (SpO 2) in the high altitude areas. Methods:From September 2016 to December 2017, all healthy and full-term live births in the First Hospital of Lanzhou University and Dunhuang, Jiuquan, Jingning and Lintao branches were selected as the research objects.Critical congenital heart disease or pulmonary diseases were excluded in advance.SpO 2 in different parts of newborns within 12 hours of birth was measured.Statistical comparisons of SpO 2 in different parts of male and female neonates in the same area and SpO 2 in different parts of different regions were made.The number of SpO 2 and the distribution of percentile difference between the lower limbs and the right upper limb of newborns at different altitude areas were obtained. Results:There were no significant difference between male and female infants in SpO 2 value at any lo-wer extremity and right upper extremity and the difference value in the same area (all P>0.05). There were significant differences in the median ( M) values of SpO 2 and the M value of the difference between the two values of any lower limb and right upper limb at different altitudes (all P<0.05). The results showed that the M value of SpO 2 of the right upper limb ( M=96%) in Lanzhou (1 520 m above sea level) was lower than that in Dunhuang (1 138 m above sea level, M=97%) and Jiuquan (1 481 m above sea level, M=97%), and the M value of the difference between the two values ( M=2%) was higher than that in Dunhuang and Jiuquan ( M=1%) ( P<0.05). The M of SpO 2 of any lower limb ( M=96%) and right upper limb ( M=96%) in Jingning areas (1 668 m above sea level) were lower than that in Dunhuang and Jiuquan area (all P<0.05). The median value of SpO 2 of any lower limb ( M=96%) and right upper limb ( M=96%) in Lintao area (1 883 m above sea level) was lower than that in Dunhuang and Jiuquan areas, and the M value of the difference between the two values ( M=2%) was higher than that in Dunhuang and Jiuquan (all P< 0.05). When the altitude was lower than 1 500 m, the M value of SpO 2 was 97%, P3- P97 was 93%-100%; the M value of the difference between any lower limb and right upper limb was 1, and P3- P97 was 0-4.When the altitude was higher than 1 500 m, the M value of SpO 2 was 95%-96%, P3- P97 was 89%-100%; the M value of SpO 2 of an lower limb and right upper limb was 1%-2%, and P3- P97 was 0-9%. Conclusions:The SpO 2 number and percentage distribution of the difference between any lower limb and right upper limb of newborns at different altitudes are different.

Objective:To evaluate the current status of the registered pediatric drug or vaccine clinical trials in China for the purpose of providing a reference for the development of pediatric clinical trials in China.Methods:We collected the data about registered pediatric clinical trials that were conducted from September 6, 2013(Mandatory registration start date) to September 6, 2019 (Cut-off date) at Chinadrugtrials.org.cn platform. The survey items included trial name and number, drug classification, sponsor′s information, current trial status, completion status, etc. The clinical trials were categorized by drug group (includes chemical medicine, traditional Chinese medicine and natural medicine, biological products) and by vaccine group.Results:During the six years 349 pediatric clinical trials were registered on the platform, including 162 pediatric drug trials and 187 vaccine trials. The numbers of chemical drugs and biological products registered in 2018 were 23 and 11, respectively, the highest in the history. The number of pediatric clinical trials of traditional Chinese medicine and natural medicine was 11 in 2014, but from 2015 to 2018 only 2 to 4 trials were registered each year. The overall completion rates of the registered drug and vaccine clinical trials were 22.8% (37/162) and 41.7%(78/187), respectively. Only 42 international multicenter pediatric clinical trial projects were registered on the platform. The numbers of drug and vaccine phase Ⅰ clinical trials were 4 and 46, respectively. Thirty-six pediatric endocrine system agent clinical trials were carried out, with the largest number of all the drug categories registered on the platform.Conclusions:In recent years the number of registered pediatric drug and vaccine clinical trials increased in China. However, the number is still very limited. It is urgent to further promote the development of pediatric clinical trials.

By collecting 475 protocol violation reports of pediatric clinical trials accepted by the ethics committee of a grade A tertiary hospital from January 2016 to December 2022, and conducting classification statistics of the responsible body, types of violation, and natures of violation, this paper analyzed and discussed the specific reasons and response measures for protocol violation. The results showed that the most common types of protocol violation included missed medication and incorrect medication dosage for pediatric research participants, missed laboratory inspection, over-windowed follow-up, and non-compliance with inclusion/exclusion criteria. And the responsibility bodies were pediatric research participants and/or their guardians, followed by the researchers. Besides, the sponsor, clinical trial coordinator, and other factors also contributed to protocol violation. Establishing awareness of responsible body, emphasizing subject management, building sound quality control system, and strengthening ethical supervision are the main countermeasures to prevent and reduce protocol violation in pediatric clinical trials, which helps to protect the safety and rights of pediatric research participants and promote standardized research in pediatric clinical trials.

Objective: To investigate the knowledge regarding clinical research among children at 8-18 years of age. The survey results will form the basis for developing public education program for this population. Methods: The survey was conducted among children at 8-18 years of age using WeChat and spot investigation between January 2016 and January 2017. According to different developmental stages, the survey population was divided into four groups: age 8-10, 11-13, 14-15 and 16-18 years. The level of knowledge regarding clinical research was analyzed. Results: Totally 1 329 questionnaires were issued and 1 233 effective questionnaires were returned with a recovery rate of 92.8%. The overall awareness rate regarding clinical research was 32.8% (405/1 233) . It revealed that 282 (22.9%) individuals thought that clinical research was to treat people like experimental rats. When asked "who have the final decision on research participation", the percentages of those who chose oneself, parents or guardian and doctor were 44.6% (550/1 233), 74.2% (915/1 233) and 36.8% (454/1 233) respectively. When asked "If you want to participate a study, but your parents or guardian do not agree, what would you do?", 33.9% (418/1 233) of individuals will "give up". As to "If you do not want to participate a study, but your parents or guardian think you should, what would you do?", 51.3% (632/1 233) chose "listen to parents" and 28.8% (355/1 233) chose "refuse the suggestions of parents or guardian". As to "what are your greatest concerns of participating an investigation?" , 68.1% (840/1 233) chose "worry about added pain or discomfort". but 58.0% (715/1 233) thought if "doctors and nurses take good care of me" their "concerns will reduce" or "feel better to participate in the research?". 55.6% (686/1 233) and 49.3% (608/1 233) individuals responded that they will "participate in an research?" when they "know that other people also participate the research" and when they "know the details regarding what will happen after the enrollment". Conclusions The knowledge level of clinical research among children aged 8-18 years were not high. It is very necessary to promote the public education of clinical research for this population and also very necessary to address their concern regarding the research.

【Objective:】 To analyze and explore the key points of the ethical review of real-world research in pediatric population, and to provide reference for ethical review of real-world research in pediatric population. 【Methods:】 According to the characteristics of real-world research and pediatric clinical trials, the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research. 【Results:】 The ethics committee should pay particular attention to the review of informed consent, privacy protection, risk benefit assessment, cost and compensation, and should also take into account the research design, data governance, research conflicts of interest, research registration and publication, etc., and conduct scientific and reasonable ethical review of real-world research in pediatric population. 【Conclusion:】 Clinical trials in pediatric population should have stricter and scientific ethical review, which can not only protect the interests of vulnerable groups of minors, but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research, so as to better protect children and promote their health.