OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China,providing a reference for promoting enterprise R&D and production,as well as improving the supply guarantee mechanism for pediatric medicines.METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval,Pharnexcloud biomedical database,and National Medical Insurance Drug Directory,this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing.RESULTS As of June 30,2024,a total of 68 pediatric medicines had been approved through the priority review and approval process,covering 12 therapeutic areas,with oral dosage forms accounting for 64.71％.The median time from application to inclusion in priority review was 35.50 days,with an average of 41.69 days.The median time from inclusion in priority review to market approval was 1.24 years,with an average of 1.42 years.This included 12 domestic new medicines,21 domestic generic medicines,35 imported medicines,as well as 29 pediatric-specific medicines and 21 orphan medicines.Additionally,31 of these medicines had been included in the medical insurance catalog,representing a proportion of 45.59％.CONCLUSIONS Currently,a trend of differentiated competition is emerging between domestic and imported pediatric medicines.The therapeutic areas for pediatric medicines are continuously expanding,and the dosage forms are becoming more tailored to children's needs.However,there are still issues such as slow progress in new medicine development,insufficient stability in the medicine review and approval process,and a need to increase the proportion of medicines included in medical insurance.

AIM: To observe the effect of Su Bei Zhi Ke granules (SBZKG) on acute tracheobronchitis (Syndrome of Wind-cold Attacking Lung). METHODS: Mouse ear swelling experiment and mouse abdominal capillary permeability experiment was used to observe its anti-inflammatory effect. Cough test in mice induced by ammonia water, and phlegm test in rats were used to observe the expectorant and antitussive effects of phenol red test in mice. We used the mortality rate experiment of infected mice to observe its antibacterial and antiviral effects. RESULTS: Compared with the contral group, the large and medium dose groups of SBZKG both reduced mouse auricle swelling (P<0.05) and increased swelling inhibition rate, reducing mouse abdominal capillary permeability (P<0.05, P<0.01). SBZKG can increase the phenol red sputum output in the respiratory tract of mice (P<0.01), prolong the cough incubation period of mice, reduce the number of coughs in mice (P<0.05, P<0.01), and increase the sputum output in rats (P<0.05, P<0.01). SBZKG can reduce the mortality rate of mice infected with bacteria and viruses. CONCLUSION: SBZKG has certain anti-inflammatory, antitussive, expectorant, antibacterial and antiviral effects, and has certain therapeutic effects on acute tracheobronchitis.

Objective:To evaluate the changes of peripapillary retinal and choroid thickness of tail-suspension rats in simulated weightless.Methods:Sixty rats were divided into 2 groups: control group (15 rats) and tail-suspension group (45 rats). The rats in tail-suspension group were tested by -30° tail suspension to simulate the effect of weightlessness for establishing model. The peripapillary retinal thickness of the rats were measured before and after 4- and 8-week tail suspension by enhanced depth imaging-optical coherence tomography (EDI-OCT). The choroid thickness of the rats were measured before and after 4-, 8-, 10-, and 12-week tail-suspension by EDI-OCT.Results:There was a significant difference in the peripapillary retinal thickness among the groups with different suspension time ( F=30.89, P<0.001), and the thickness showed a downward trend with the extension of the tail suspension time. After 8 weeks of tail-suspension, there was a significant difference in the peripapillary retinal thickness between the tail-suspension group and the control group ( t=5.73, P<0.001). After 4, 8, 10, and 12 weeks of tail-suspension, there were significant differences in the choroidal thickness of the rats between the tail-suspension group and the control group ( t=6.32, 12.78, 9.69, 6.39, all P<0.001); there was a significant difference in the choroidal thickness of the rats with different suspension time ( F=51.08, P<0.001). With the time of the tail suspension, the choroidal thickness and its changes compared with before tail suspension showed an upward trend, and reached peak after 8 weeks and then slightly decreased. Conclusions:With the extension of tail-suspension time, the changes of peripapillary retinal thickness of the tail-suspension rats generally show a downward trend, and the changes of choroidal thickness generally increased, and decreased slightly after reaching peak.

Objective:To evaluate the changes of peripapillary retinal and choroid thickness of tail-suspension rats in simulated weightless.Methods:Sixty rats were divided into 2 groups: control group (15 rats) and tail-suspension group (45 rats). The rats in tail-suspension group were tested by -30° tail suspension to simulate the effect of weightlessness for establishing model. The peripapillary retinal thickness of the rats were measured before and after 4- and 8-week tail suspension by enhanced depth imaging-optical coherence tomography (EDI-OCT). The choroid thickness of the rats were measured before and after 4-, 8-, 10-, and 12-week tail-suspension by EDI-OCT.Results:There was a significant difference in the peripapillary retinal thickness among the groups with different suspension time ( F=30.89, P<0.001), and the thickness showed a downward trend with the extension of the tail suspension time. After 8 weeks of tail-suspension, there was a significant difference in the peripapillary retinal thickness between the tail-suspension group and the control group ( t=5.73, P<0.001). After 4, 8, 10, and 12 weeks of tail-suspension, there were significant differences in the choroidal thickness of the rats between the tail-suspension group and the control group ( t=6.32, 12.78, 9.69, 6.39, all P<0.001); there was a significant difference in the choroidal thickness of the rats with different suspension time ( F=51.08, P<0.001). With the time of the tail suspension, the choroidal thickness and its changes compared with before tail suspension showed an upward trend, and reached peak after 8 weeks and then slightly decreased. Conclusions:With the extension of tail-suspension time, the changes of peripapillary retinal thickness of the tail-suspension rats generally show a downward trend, and the changes of choroidal thickness generally increased, and decreased slightly after reaching peak.

Objective To investigate the effect of the treatment for Maisonneuve fracture with arthroscopicassistant plate-screw fixation ofsyndesmosis.Methods From January 2015 to December 2016,totally 22 patients with Maisonneuve fracture were treated in Shanghai Jiao Tong University Affiliated Six People's Hospital.Eleven patients in minimal invasive surgery (MIS)group were treated by the arthroscopic-assistant plate-screw fixation ofthe syndesmotic injury.Another 11 patients in the control group were performed a classic syndesmosis screw fixation.Plain radiographic examination was carried out during the follow-up.Functional evaluation was measured according to the American Orthopedic Foot Ankle Society (AOFAS) ankle hindfoot score and the Visual analogue scale(VAS).A t test was applied for the statistic analysis of post-operative outcome between the two groups at 6th and 12th month.Results The patients were followed for an average 18 months (range from 12 to 24 months)except one of MIS group.The X-ray demonstrated the solid bone union occurred on the 12th week in MIS group and 12.5th week in the control group.The implants of syndesmosis were removed at 12th week post-operatively.No cases of re-diastasis occurred during the follow-up.There was significant difference with in the groups.In the MIS group,the AOFAS ankle hindfoot score was (85.9 ±4.1) points at 6th month post-operatively,and increased to (90.8 ± 3.7) at 12th month (P ＜ 0.05).VAS score was (2.4 ± 1.2) at 6th month and (1.1 ± 0.7) at 12th month after the operation(P ＜0.05).In the control group,the AOFAS ankle hindfoot score was (81.1 ±4.7) points at 6th month after operation,and increased to (89.1 ± 3.4) at 12th month after operation (P ＜ 0.05).VAS score was (3.2 ± 1.3) at the 6th month and (1.0 ± 1.0) at the 12th month after operation (P ＜ 0.05).However,for the outcome comparison between the two groups,only the AOFAS ankle hindfoot score of 6th month post-operatively in MIS group was better than the control group (P ＜ 0.05),other results,had no significant difference.Nocomplications of implant failure,nonunion,malunion or post-traumatic arthritis were occurred during the followup.Conclusion The treatment of Maisonneuve fracture by arthroscopic-assistant plate-screw fixation proved to have an advantage of minimal invasion and accurate reduction and fixation,which is a safe and effective surgical method.

Objective To investigate the safety and effectiveness of left internal mammary artery (LIMA) angiography via right transradial approach with 5F universal coronary angiography catheter. Methods Left internal mammary artery (LIMA) angiography via right transradial approach with 5F universal coronary angiography catheter was performed following coronary angiography in 86 patients.The success rate of the procedure, the result of LIMA angiography, the time to LIMA, the volume of contrast, the incidence of complications and bypass vessels in patients who received coronary artery bypass grafting (CABG) were recorded and analysed. Results The success rate was 97.6%(84/86), and the result of LIMA angiography was satisfied; the time to LIMA was (6.5 ± 2.8) min, and the volume of contrast was (17.6 ± 11.1) ml;the incident of complications was 4.7%(4/86);56 patients received CABG. LIMA was harvested in all cases and left radial artery in 53 cases. Conclusions LIMA angiography via right transradial approach with 5F universal coronary angiography catheter is safe and effective, and it has significant sense to patients who will receive CABG.

Aim To explore the differences in hyper-trophic marker genes such as atrial natriuretic peptide ( ANP) , brain natriuretic peptide ( BNP) and β-myo-sin heavy chain (β-MHC) genes in different models of cardiac hypertrophy. Methods Respectively using re-nal abdominal aortic coarctation ( AAC) , arteriovenous fistula ( AVF) and isoproterenol ( ISO) methods to es-tablish C57BL/6 mouse model of cardiac hypertrophy. After modeling, each mouse ’ s body weight ( BW ) , heart weight ( HW) and left ventricular weight ( LVW) were weighed, and the heart weight ( HW/BW) and left ventricular index ( LVW/BW ) were calculated;myocardium by HE staining, pathological morphologi-cal changes were observed; myocardium by immuno-histochemistry, ANP, BNP and β-MHC protein ex-pression was observed;myocardium by Real-time PCR detection, ANP, BNP and β-MHC mRNA expression was observed. Results Compared with control group, HW/BW and LVW/BW were increased in three mod-els. Through the light microscope, each mouse model showed varying degrees of cardiac hypertrophy. ANP, BNP and β-MHC were increased in the protein and mRNA expression. Compared with AAC group, AVF and ISO groups’ myocardial tissue ANP, BNP and β-MHC expression were decreased in the protein and mRNA expression. Conclusions Three cardiac hy-pertrophy models are successful. Cardiac tissue ANP, BNP and β-MHC expression in AAC model exceeds AVF and ISO model.

OBJECTIVETo study the key points of treatment and amputation in patients with frostbite, so as to increase the successful rate of the treatment.

METHODSFive hundred and sixty-eight patients with frostbite admitted to our department from January 2005 to December 2014. (1) For the patients admitted to our department within one week after injury, the frostbite wounds were soaked in 42 °C herbal fluid (twice per day, 30 min for each time) and irradiated with infrared or red light (three times per day, 40 min for each time) from the day of admission to the 7th day after injury. Meanwhile, treatment for improvement of microcirculation, vasodilation, and anti-infection were also given. Then they received infrared or red light irradiation to the wound sites. For the patients admitted to our department longer than one week after frostbite, the frostbite wounds were irradiated with infrared or red light, and treated with antibiotics if inflammation was found around the wound. Among all the patients, 5 cases suffered from frozen stiff, and they were given fluid resuscitation as well as above-mentioned treatments after admission. (2) All patients were given wound treatment immediately after admission. The superficial partial-thickness wounds and deep partial-thickness wounds of 264 patients were given routine dressing change. The full-thickness wounds in 79 patients were treated with exposure therapy after routine dressing change first, and then granulation tissue of these wounds were grafted with autologous thigh split-thickness skin grafts. After debridement and exposure therapy, amputation was done in 225 patients 3 to 4 weeks after injury when the underlying bone was exposed. In 4 patients with exposure of calcaneus, the wounds were covered with reverse sural nerve nutrient vessels island flap. Mean healing time of superficial partial-thickness wound and deep partial-thickness wound, survival rate of skin graft in full-thickness wound, and survival rate of flap covering wound deep to bone at the heel were all recorded. The amputation rate of patients injured in December, January, February, and other months, that of patients admitted shorter than 1 day after frostbite, 1 to 3 days after frostbite, longer than 3 days and shorter than or equal to 5 days after frostbite, and longer than 5 days after frostbite, that of patients caused by drunkenness, mental disorders, improper protection, going astray, and trauma including traffic accident etc., and that of patients treated with rewarming under room temperature, rubbing with snow, wrapping with quilt, and soaking in warm water before admission were all recorded and analyzed. Parts of the data were processed with χ(2) test.

RESULTSAll patients were survived after treatment. Average wound healing time of superficial partial -thickness wound and deep partial-thickness wound was respectively 10 and 23 days. The survival rate of skin graft on full-thickness wound was about 95%. Survival rate of flap on wound deep to bone at the heel was 100%. Amputation rates of patients injured in December and January were respectively 47.46% (84/177), 42.56% (103/242), and both were significantly higher than those of patients injured in February and the other months [respectively 29.55% (26/88), 13.11% (8/61), with χ(2) values from 42.595 to 220.900, P values below 0.01]. Amputation rate of patients with admission time shorter than 1 day after frostbite was 32.06% (84/262), which was obviously lower than that of patients with admission time from 1 to 3 days after frostbite, longer than 3 days and less than or equal to 5 days after frostbite, or longer than 5 days after frostbite [respectively 40.48% (68/168), 49.02% (50/102), 52.78% (19/36), with χ(2) values from 107.284 to 165.350, P values below 0.01]. Amputation rates of patients with frostbite occurring after getting drunkenness, mental disorders, and trauma including traffic accident etc. were respectively 42.06% (106/252), 43.48% (60/138), and 53.12% (17/32), and they were all significantly higher than those of patients with frostbite caused by improper protection and going astray [respectively 27.45% (28/102), 22.73% (10/44), with χ(2) values from 187.260 to 209.738, P values below 0.01]. Amputation rates of patients undergoing treatment of rewarming under room temperature, rubbing with snow, wrapping with quilt before admission were respectively 44.29% (62/140), 48.28% (84/174), and 35.38% (46/130), and they were significantly higher than the amputation rate of patients who received the treatment of soaking in warm water [23.39% (29/124), with χ(2) values from 97.364 to 136.189, P values below 0.01].

CONCLUSIONSEarly diagnosis and treatment, properly rewarming at early stage, and correct wound treatment are the key points for reducing amputation rate of patients after frostbite. Attention should be paid to the occurrence of frostbite in December and January, and also to protection of high-risk groups (patients with mental disorders and drunker).

Amputation ; statistics & numerical data ; China ; Debridement ; Frostbite ; pathology ; therapy ; Granulation Tissue ; Humans ; Microcirculation ; Negative-Pressure Wound Therapy ; Skin ; blood supply ; Skin Transplantation ; methods ; Surgical Flaps ; Treatment Outcome ; Wound Healing

Objective To explore the relationship between 5-minute Apgar score and heart rate variability (HRV) in severely asphyxiated neonates. Methods A total of 103 severely asphyxiated neonates with 1-minute Apgar score of 0 to 3 points were selected. They were divided into Group A (>7 points, n=50) and Group B (≤7 points, n=53) based on 5-minute Apgar score. Meanwhile, 40 full-term neonates with 1-and 5-minute Apgar score greater than 7 points were selected as control group. 24-hour dynamic electrocardiogram was performed and HRV was analyzed on the third day after birth in three groups. Results PNN50, rMSSD, SDSD were decreased and SDNN, SDANN were increased in group B as compared with group A and control group (P<0.05). No signiifcant difference of HRV was observed between group A and control group (P>0.05). Conclusions Neonatal asphyxia can cause damage to autonomic nervous system. 5-minute Apgar score and HRV can be joint-ly used as a non-invasive index in autonomic nervous damage and its prognosis in asphyxiated newborns.

Objectives To evaluate the clinical value of heart rate variability (HRV) analysis in school-age healthy chil-dren with functional ST-T changes in electrocardiogram (ECG). Methods In 143 school-age children (50 cases of functional ST-T changes, 43 cases of myocarditis children with ST-T change, 50 cases of healthy controls without ST-T changes), HRV time domain value was measured in three groups with 24 dynamic electrocardiogram. Results Compared with healthy controls, PNN50, rMSSD and SDSD were decreased while the heart rate, SDNN and SDANN were increased in children with functional ST-T changes (P all<0.05). Meanwhile, compared with children with functional ST-T changes and healthy controls, the heart rate was increased while PNN50, rMSSD, SDSD, SDNN and SDANN were decreased in the myocarditis children with ST-T change (P<0.05). Conclusions The autonomic nervous system of school-age children is not stable. The functional ST-T changes are related with the imbalance between sympathetic and vagus nerve activities. HRV analysis has important diagnostic signifi-cance in the functional ST-T changes.