Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

BACKGROUND:In recent years,methods for incorporating biominerals into bone tissue engineering scaffolds have been extensively studied,including solvent casting,freeze-drying,and 3D printing.However,the diverse types and complex compositions of biominerals lead to varying impacts on scaffold performance and differing requirements for fabrication processes,necessitating systematic research on their applicability.OBJECTIVE:To explore biomineral grinding and screening processes,and evaluate their solution rheological properties,hydrophilicity,mechanical properties,and biocompatibility when prepared as composite materials with polymer materials.METHODS:Five representative biominerals were selected,including turtle shell,eggshell,cuttlebone,deer antler,and pearl.These were ground into powders and screened,then mixed with polycaprolactone in specific proportions to prepare composite materials.The feasibility of applying biominerals in bone tissue engineering was explored by testing the elemental composition and particle size distribution of the powder,as well as the solution rheological properties,hydrophilicity,mechanical properties,and biocompatibility of the composite material.RESULTS AND CONCLUSION:(1)Most biomineral powders followed the rule that the longer the grinding time,the smaller the particle size.The desired particle size range could be obtained through methods such as sieving.Elemental mapping and Fourier Transform Infrared spectroscopy analyses indicated that the main inorganic mineral components of these five biominerals were calcium carbonate and calcium phosphate,containing the elements C,O,P,and Ca.(2)The method of dissolving polycaprolactone in 1,4-dioxane and adding biomineral powders to prepare scaffolds did not significantly alter the composite material composition and did not reduce biocompatibility.The addition of biomineral powders improved the hydrophilicity and 3D printability of polycaprolactone materials but decreased their mechanical properties.(3)These findings suggest that when applying biomineral powders to bone tissue engineering scaffolds,the proportion of powder added should be carefully chosen to balance hydrophilicity,printability,and mechanical properties.

BACKGROUND:In recent years,methods for incorporating biominerals into bone tissue engineering scaffolds have been extensively studied,including solvent casting,freeze-drying,and 3D printing.However,the diverse types and complex compositions of biominerals lead to varying impacts on scaffold performance and differing requirements for fabrication processes,necessitating systematic research on their applicability.OBJECTIVE:To explore biomineral grinding and screening processes,and evaluate their solution rheological properties,hydrophilicity,mechanical properties,and biocompatibility when prepared as composite materials with polymer materials.METHODS:Five representative biominerals were selected,including turtle shell,eggshell,cuttlebone,deer antler,and pearl.These were ground into powders and screened,then mixed with polycaprolactone in specific proportions to prepare composite materials.The feasibility of applying biominerals in bone tissue engineering was explored by testing the elemental composition and particle size distribution of the powder,as well as the solution rheological properties,hydrophilicity,mechanical properties,and biocompatibility of the composite material.RESULTS AND CONCLUSION:(1)Most biomineral powders followed the rule that the longer the grinding time,the smaller the particle size.The desired particle size range could be obtained through methods such as sieving.Elemental mapping and Fourier Transform Infrared spectroscopy analyses indicated that the main inorganic mineral components of these five biominerals were calcium carbonate and calcium phosphate,containing the elements C,O,P,and Ca.(2)The method of dissolving polycaprolactone in 1,4-dioxane and adding biomineral powders to prepare scaffolds did not significantly alter the composite material composition and did not reduce biocompatibility.The addition of biomineral powders improved the hydrophilicity and 3D printability of polycaprolactone materials but decreased their mechanical properties.(3)These findings suggest that when applying biomineral powders to bone tissue engineering scaffolds,the proportion of powder added should be carefully chosen to balance hydrophilicity,printability,and mechanical properties.

Objective To study the differences and mechanisms of damage to the reproductive organs of male rats by single and compound exposure to microwaves at 2.856 and 9.375 GHz.Methods A total of 40 male Wistar rats were randomly divided into sham group,S10 group,X10 group and SX5 group.Microwavesat 2.856 and 9.375 GHz were used to expose the rats for 6 min in the S10 and X10 groups with an average power density of 10 mW/cm2,respectively.The SX5 group was sequentiallyexposed to 2.856 and 9.375 GHz microwaves with an average power density of 5 mW/cm2 for 6 min.At 1 and 7 d after exposure,the sperm viability and serum sex hormones were detected by light microscopy and electron microscopy,and testicular tissue structure and oxidative stress and energy metabolism levels were examined.Results The sperm viability,testosterone(T),follicle stimulating hormone(FSH),and inhibin B(INHB)decreased in the S10 and X10 groups at 1 and 7 d after exposure(P＜0.01),and in the SX5 group at 7 d after exposure(P＜0.05).The LH decreased in all the exposure groups at 1 d after exposure(P＜0.01),and increased in the S10 and X10 groups at 7 d after exposure(P＜0.05).The spermatogenic epithelium of testicular tissue was lax,spermatogenic cells were edematous and vacuolated,chromatin condensed and shifted side by side,and the damage was significant in the S10 and X10 groups as compared with the SX5 group.The superoxide dismutase(SOD)activity in testis tissue decreased and malondialdehyde(MDA)content increased at 1 and 7 d after exposure in the S10 group(P＜0.01).In the X10 group,the SOD decreased at 1 d after exposure(P＜0.01).The lactate dehydrogenase(LDH)and succinate dehydrogenase(SDH)activity and adenosine triphosphate(ATP)content in testis tissue decreased at 1 and 7 d after exposure in the S10 and X10 groups(P＜0.05).In the SX5 group,the LDH and SDH decreased at 1 d after exposure(P＜0.05).Conclusion Single and combined exposure to S-band and X-band microwaves can cause damage to male reproductive organs.The S-band causes damage more significantly than that of X-band.Single-frequency microwave high-intensity exposure causes damage more significantly than that of multi-frequency microwave prolonged combined exposure.The damage is closely related to oxidative stress and energy metabolism.

Objective:To analyze the vaccination recommendations and follow-up for children with special health status.Methods:In this retrospective cohort study, 509 children who attended the Consultation Clinic of Vaccination for Special Health Children in Beijing Children′s Hospital from August 2020 to February 2023 were selected, the children were given vaccination planning advice after the assessment. The clinical data were collected, including the general situation, special health conditions, vaccination recommendations and implementation status, occurrence and outcomes of suspected adverse events following immunization (AEFI) after vaccination. The vaccination situation and safety in these children were evaluated.Results:Among the 509 children, the most common special health conditions were cardiovascular system diseases (103 cases), followed by neurological diseases (88 cases) and neonatal problems (82 cases). After comprehensive evaluation and multidisciplinary collaboration, 399 children (78.4%) were recommended to receive vaccination/catch-up vaccination according to the immunization program, 63 children (12.4%) were recommended to receive some vaccines but temporarily suspend others, and 47 children (9.2%) were recommended to temporarily suspend vaccination. A total of 449 children (88.2%) were actually vaccinated, AEFI occurred in 49 children and 45 cases were considered as general reactions.Conclusions:The majority of children with special health status can be vaccinated, and the overall compliance and safety are high. The individualized immunization evaluation model of multidisciplinary collaboration is conducive to the completion of the immunization program of children with special health status.

Objective To compare the efficacy of precut over a pancreatic duct stent(PPDS)and transpancreatic precut sphincterotomy(TPS)for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography(ERCP).Methods A retrospective analysis was conducted on the clinical data of all consecutive patients underwent ERCP by the same doctor in our hospital between April 2019 and March 2023.According to the selected method during difficult biliary cannulation when guidewire entered pancreatic duct unintendedly,the patients were divided into two groups,1)PPDS group:placing a pancreatic duct stent first,then using a needle knife to cut bile duct sphincter on the surface of the pancreatic duct stent,preserving pancreatic duct sphincter,and then selectively cannulate bile duct;2)TPS group:precut through pancreatic duct sphincter first,then a pancreatic duct stent was placed,and bile duct was selectively cannulated.The success rate of biliary cannulation and ERCP-related complication between the two groups were compared.Results Among 762 ERCP patients,84 patients were enrolled in this study,44 patients in PPDS group,and 40 patients in TPS group.In PPDS group,42 patients(95.4%,42/44)had successful biliary cannulation.No post-ERCP pancreatitis(PEP),bleeding,perforation occurred in PPDS group.In TPS group,39 patients(97.5%,39/40)had successful biliary cannulation.Four patients(10.0%,4/40)had PEP in PPDS group,no bleeding or perforation occurred.All patients were cured.The success rate of biliary cannulation between two groups had no significant difference(P>0.05),while the rate of PEP had significant difference(P<0.05).Conclusions Both PPDS and TPS are good choice for difficult biliary cannulation with high success rate of biliary cannulation.PPDS is more suitable for patients with high-risk factors for PEP,while TPS is a simple technique.

Objective To compare the efficacy of precut over a pancreatic duct stent(PPDS)and transpancreatic precut sphincterotomy(TPS)for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography(ERCP).Methods A retrospective analysis was conducted on the clinical data of all consecutive patients underwent ERCP by the same doctor in our hospital between April 2019 and March 2023.According to the selected method during difficult biliary cannulation when guidewire entered pancreatic duct unintendedly,the patients were divided into two groups,1)PPDS group:placing a pancreatic duct stent first,then using a needle knife to cut bile duct sphincter on the surface of the pancreatic duct stent,preserving pancreatic duct sphincter,and then selectively cannulate bile duct;2)TPS group:precut through pancreatic duct sphincter first,then a pancreatic duct stent was placed,and bile duct was selectively cannulated.The success rate of biliary cannulation and ERCP-related complication between the two groups were compared.Results Among 762 ERCP patients,84 patients were enrolled in this study,44 patients in PPDS group,and 40 patients in TPS group.In PPDS group,42 patients(95.4%,42/44)had successful biliary cannulation.No post-ERCP pancreatitis(PEP),bleeding,perforation occurred in PPDS group.In TPS group,39 patients(97.5%,39/40)had successful biliary cannulation.Four patients(10.0%,4/40)had PEP in PPDS group,no bleeding or perforation occurred.All patients were cured.The success rate of biliary cannulation between two groups had no significant difference(P>0.05),while the rate of PEP had significant difference(P<0.05).Conclusions Both PPDS and TPS are good choice for difficult biliary cannulation with high success rate of biliary cannulation.PPDS is more suitable for patients with high-risk factors for PEP,while TPS is a simple technique.

Objective:To understand the identification value of pointing gestures in children with autism spectrum disorder(ASD) and its relationship with functional development.Methods:From December 2020 to November 2021, 1 099 children from Children’s Health Care Center of Beijing Children’s Hospital were tested by pointing gestures test, including 942 ASD children and 157 typical developed children.And the data of children's neuropsychological development scale from 800 children aged 1.0-5.9 were collected.SPSS 20.0 was used for statistical analysis. Trend test was used to analyze the distribution of pointing gestures test sensitivity in autistic children, and ANOVA was used to analyze the relationship between pointing gestures test scores and functional development fields.Results:The sensitivity of pointing gestures was 83.5% in children aged 1.0-10.0 years, 76.3%-93.1% in children aged 1.0-4.9 years, and 93.1%-95.1% in children aged 1.0-2.9.With the increase of age, the sensitivity of pointing gestures in autistic children (linear-by-linear association =164.889, P<0.001) and the Yoden index had a decreasing trend. The positive predictive value (91.53%-100.00%) and negative predictive value (75.36%-91.84%) were found in the children aged 1.0-10.0 years.The sensitivity of pointing gestures test was 44.9% in children with mild autism aged 1.0-10.0 years and 46.5%-65.9% in children with mild autism aged from 1.0-3.9 years. The sensitivity of pointing gestures test was 81.5% in children with moderate autism aged from 1.0-10.0 years and 87.3%-97.8% in children with moderate autism aged 1.0-3.9 years. The sensitivity of the pointing gestures test was 97.2% in children with severe autism aged 1.0-10.0 years, and 100.0% in children with severe autism aged 1.0-3.9 years. The sensitivity of the pointing gestures in mild, moderate and severe autism children decreased with age (linear-by-linear association values were 16.725, 64.232, 66.732 respectively, all P<0.001). The children with severe autism mainly scored 2 points (80.3%, 419/522) on the pointing gestures test , and children with moderate autism mainly scored 1 point(64.2%, 170/265) on the pointing gestures test. There were significant differences in functional development among different pointing gestures test groups.Functional development score in the autism children with 0 score of pointing gestures test was significantly higher than those with 1 score and 2 scores of pointing gestures test (all P<0.05). Conclusion:Pointing gestures has good sensitivity in children with autism (especially 1.0-4.9 years of age), and may serve as an objectively observable screening method. The better children with autism score on the pointing gestures, the better their functional development.

Objective To assess the comparative efficacy of different methods for difficult biliary cannulation in endoscopic retrograde cholangio-pancreatography(ERCP)through a network meta-analysis.Methods Randomized controlled trials(RCTs)that compared the efficacy of different adjunctive methods(early or late needle-knife technique,pancreatic guidewire-assisted technique,pancreatic stent-assisted technique,transpancreatic sphincterotomy,persistent standard cannulation technique)for difficult biliary cannulation with each other were identified.The success rate of biliary cannulation and the incidence of post-ERCP pancreatitis(PEP)were the outcomes of interest.Pairwise and network meta-analysis and ranking according to surface under the cumulative ranking curve(SUCRA)for all methods were performed.Results Eighteen RCTs were identified according to selection criteria,and 2 033 patients were enrolled.The use of transpancreatic sphincterotomy over persistent standard cannulation technique(RR=1.34,95%CI:1.02-1.77)and over pancreatic guidewire-assisted technique(RR=1.26,95%CI:1.00-1.60)significantly increased the success rate of biliary cannulation.Based on SUCRA ranking,transpancreatic sphincterotomy followed by early needle-knife techniques were ranked highest in terms of increasing the success rate of biliary cannulation.Only early needle-knife technique significantly decreased PEP rate when compared with persistent standard cannulation technique(RR=0.53,95%CI:0.30-0.94),whereas both early needle-knife techniques and transpancreatic sphincterotomy led to lower PEP rates as compared with pancreatic guidewire-assisted technique(RR=0.41,95%CI:0.17-0.99;RR=0.49,95%CI:0.25-0.96;respectively).Based on SUCRA ranking,early needle-knife technique followed by transpancreatic sphincterotomy were ranked highest for decreasing the PEP rate of biliary cannulation.Conclusions Transpancreatic sphincterotomy increases the success rate of difficult biliary cannulation in ERCP;early needle-knife technique and transpancreatic sphincterotomy are superior to other interventions in decreasing PEP rates and should be considered as a choice of difficult biliary cannulation.