1.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
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.
2.Clinical and diffusion imaging study of brain damage in patients with neurosyphilis
Yuwen XIE ; Ruiyun ZHAO ; Pingping WANG
Journal of Practical Radiology 2025;41(7):1104-1108
Objective To investigate the clinical and diffusion imaging of brain damage in patients with neurosyphilis.Methods Eighty patients with neurosyphilis with brain damage were retrospectively selected as the study group,and were divided into mild group(n=38)and moderate to severe group(n=42)according to imaging results.Another 80 healthy subjects in the same period were selected as the control group.The values of apparent diffusion coefficient(ADC)and fractional anisotropy(FA)were compared among the three groups.Pearson test was used to analyze the correlation between ADC and FA values in various brain regions and cognitive function in patients with neurosyphilis brain damage.Results ADC values in parieto-occipital lobe,frontal lobe,basal gan-glia and hemioval center in moderate to severe group were significantly higher than those in mild group and control group,and FA values were significantly lower than those in mild group and control group(P<0.05).The results of Pearson analysis showed that the ADC and FA values of parieto-occipital lobe,frontal lobe and hemioval center were significantly correlated with Wechsler adult intel-ligence scale-revised of China(WAIS-RC)knowledge,WAIS-RC arithmetic,verbal fluency test(VFT),Montreal cognitive assess-ment(MoCA),forward digit span test(FDST),trail making test A(TMT-A)and trail making test B(TMT-B)scores(P<0.05).Conclusion The ADC and FA values of parieto-occipital lobe,frontal lobe,basal ganglia and hemioval center are closely related to the severity of brain damage,which is helpful for clinical diagnosis.
3.Clinical and diffusion imaging study of brain damage in patients with neurosyphilis
Yuwen XIE ; Ruiyun ZHAO ; Pingping WANG
Journal of Practical Radiology 2025;41(7):1104-1108
Objective To investigate the clinical and diffusion imaging of brain damage in patients with neurosyphilis.Methods Eighty patients with neurosyphilis with brain damage were retrospectively selected as the study group,and were divided into mild group(n=38)and moderate to severe group(n=42)according to imaging results.Another 80 healthy subjects in the same period were selected as the control group.The values of apparent diffusion coefficient(ADC)and fractional anisotropy(FA)were compared among the three groups.Pearson test was used to analyze the correlation between ADC and FA values in various brain regions and cognitive function in patients with neurosyphilis brain damage.Results ADC values in parieto-occipital lobe,frontal lobe,basal gan-glia and hemioval center in moderate to severe group were significantly higher than those in mild group and control group,and FA values were significantly lower than those in mild group and control group(P<0.05).The results of Pearson analysis showed that the ADC and FA values of parieto-occipital lobe,frontal lobe and hemioval center were significantly correlated with Wechsler adult intel-ligence scale-revised of China(WAIS-RC)knowledge,WAIS-RC arithmetic,verbal fluency test(VFT),Montreal cognitive assess-ment(MoCA),forward digit span test(FDST),trail making test A(TMT-A)and trail making test B(TMT-B)scores(P<0.05).Conclusion The ADC and FA values of parieto-occipital lobe,frontal lobe,basal ganglia and hemioval center are closely related to the severity of brain damage,which is helpful for clinical diagnosis.
4.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
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.
5.Research progress on decision aids for diagnosis and treatment of colorectal cancer
Huina YAN ; Ruiyun LIU ; Jiaxun WANG ; Min ZHAO ; Anqi ZHANG
Chinese Journal of Modern Nursing 2024;30(28):3795-3799
This article reviews the demand, development process, aid types, effects, and existing problems of decision aids for colorectal cancer. The aim is to provide reference for the development of convenient and efficient decision aids for colorectal cancer diagnosis and treatment in China, and to improve the quality of treatment decisions for colorectal cancer patients.
6.Differences and mechanisms of reproductive damage in male rats caused by single and combined exposures to S-band and X-band microwaves
Yanyang LI ; Yueyue PANG ; Li ZHAO ; Haoyu WANG ; Junqi MEN ; Binwei YAO ; Ruiyun PENG
Military Medical Sciences 2024;48(8):565-571
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.
7.The recognition significance of pointing gestures in children with autism spectrum disorder and its relationship with functional development
Yang MA ; Nina XIONG ; Ming ZHAO ; Wenjing JI ; Ruiyun SHEN ; Yanjie CHEN ; Shijie LI ; Hongmei HUANG ; Zhuang WEI ; Wanxia ZHANG ; Aimin LIANG
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(11):981-986
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.
8.The correlation of developing capability of autistic children with social and linguistic parenting behaviors
Nina XIONG ; Ming ZHAO ; Wanxia ZHANG ; Ruiyun SHEN ; Shijie LI ; Yang MA ; Wenjing JI ; Zhuang WEI ; Juan DU ; Aimin LIANG
Chinese Journal of Behavioral Medicine and Brain Science 2021;30(6):533-539
Objective:To investigate the correlation between social and linguistic parenting behaviors and developing capability of children with autism.Methods:From August 2020 to December 2020, the social and linguistic parenting behaviors of 302 parents of children diagnosed with autism were investigated in the outpatient department of the hospital.Meanwhile, the data of Gesell scale for children, the social life competence scale for infant and junior middle school students, the autism behavior checklist and the Cancy autism behavior scale were collected.SPSS 20.0 software was used for statistical analysis.Independent sample t test and analysis of variance were used to compare the social and linguistic parenting behaviors of different parents.Pearson correlation analysis was used to analyze the correlation between the social and linguistic parenting behaviors of parents and children's developmental ability and symptom severity. Results:There were no statistically significant differences in children's social and language development parenting behavior between father and mother ( t=1.033, P=0.303; t=-0.312, P=0.756). There were no statistically significant differences in children's social and linguistic parenting behaviors between fathers of different age groups ( F=1.425, P=0.244; F=1.127, P=0.345). Among mothers of different age groups, the social parenting behaviors of <30 years old and 30-34 years old groups were significantly better than those of 35-39 years old group ( F=3.374, P=0.019; LSD: P=0.010, P=0.006). Among fathers, the social parenting behavior( F=4.346, P=0.008; LSD: P=0.020, P=0.001) and social + linguistic parenting behavior in the graduate group and college group were significantly better than those in the high school/vocational group( F=3.965, P=0.012; LSD: P=0.020, P=0.002). Among mothers, the social parenting behavior ( F=2.812, P=0.040; LSD: P=0.008, P=0.023, P=0.009), linguistic parenting behavior ( F=3.769, P=0.011; LSD: P=0.010, P=0.025, P=0.001), social + linguistic parenting behavior ( F=3.654, P=0.013; LSD: P=0.005, P=0.015, P=0.002) in graduate and above groups were significantly better than those in college group, high school/vocational group, junior high school and below groups.The scores of social parenting behavior(40.72±6.80), linguistic parenting behavior(27.20±5.22), and social + linguistic parenting behavior(67.92±11.10) were significantly correlated with children’s fine motor(61.75±16.41)( r=0.193, P=0.001; r=0.153, P=0.009; r=0.190, P=0.001), cognition(68.28±16.83)( r=0.231, P=0.000; r=0.186, P=0.001; r=0.229, P=0.000), language(53.01±18.55) ( r=0.262, P=0.000; r=0.305, P=0.000; r=0.304, P=0.000) and social self-care(61.44±17.85) ( r=0.264, P=0.000; r=0.238, P=0.000; r=0.274, P=0.000). The scores of linguistic parenting behavior and social + linguistic parenting behavior were correlated with children's social life ability (8.65±0.89) ( r=0.142, P=0.046; r=0.140, P=0.049). There was no significant correlation between social parenting behavior, linguistic parenting behavior, social + linguistic parenting behavior and the scores of ABC scale (50.53±21.39) ( r=-0.089, P=0.336; r=-0.115, P=0.215; r=-0.107, P=0.250) and CABS scale (13.96±4.54) ( r=-0.050, P=0.490; r=-0.059, P=0.411; r=-0.058, P=0.421). Conclusions:The social and linguistic parenting behaviors are related to their age and educational level, and are significantly correlated to developing capability of children with autism, but have nothing to do with the severity of children's symptoms.
9.Investigation on the health status of children in an organization in the urban area of Beijing
Nina XIONG ; Yue QIAN ; Ying WANG ; Juan DU ; Wenjing JI ; Ming ZHAO ; Ruiyun SHEN ; Aimin LIANG
Chinese Journal of Health Management 2020;14(6):560-564
Objective:To understand the health status of children in an organization in the urban area of Beijing.Methods:From October to November 2019, 558 children aged from 0 to 13 of employees in an organization in Beijing received physical examination, including height, weight, ophthalmology and otorhinolaryngology, heart and lung examination, etc.Statistical analysis was conducted on the items related to physical status and with higher detection rate. Body mass index (BMI)≥P 85(P is the percentile compared to the standardized growth curve) was defined as overweight and BMI≥P 95 as obese. The rate and composition ratio were used to describe the relevant data of each item in children′s physical examination. The differences between different age groups and gender groups were compared with the chi-square test. Results:The items with high detection rate were overweight, obesity, rhinitis, caries, phimosis, etc. The ratio of children′s weight and height ≤P 10 were 3.4% and 2.7%, ≥P 97 were 12.0% and 7.0%respectively; the rates of overweight (BMI≥P 85) and obesity (BMI≥P 95) in children were 13.8% and 13.3% respectively, the ratio of weight ≥P 97, height ≥P 97 and BMI≥P 95all increased with age in all children and in boys (all P<0.05), the ratio of BMI≤P 5 increased with age ( P<0.05), and the ratio of body weight ≥P 75 decreased with age in boys ( P<0.05); the ratio of weight ≥P 75 in boys was significantly higher than that in girls ( P<0.05). The prevalence of rhinitis in children was 39.8%, among which the prevalence of allergic rhinitis was 14.9%.The prevalence of allergic rhinitis in the 3.0-5.9 age group of all children was significantly higher than that in 0.0-0.9 age group and 6.0-9.9 age group (both P<0.05), the prevalence of total rhinitis in the 3.0-5.9 age group of girls was significantly higher than that in 0.0-0.9 age group, 1.0-2.9 age group and 10.0-13.9 age group (all P<0.05). The prevalence of dental caries in children (excluding the group of 0.0-0.9 years old) was 26.0%, the prevalence of dental caries in the 3.0-5.9 age group of all children was significantly higher than that in 1.0-2.9 age group and 10.0-13.9 age group (both P<0.05), the prevalence of dental caries in 3.0-5.9 age group and 6.0-9.9 age group of boys and girls were both significantly higher than that in 1.0-2.9 age group (all P<0.05). The prevalence of phimosis in boyswas 31.5%, the phimosis rates were significantly higher in the 1.0-2.9 age group and 3.0-5.9 age group than that in 6.0-9.9 age group and 10.0-13.9 age group (all P<0.05). No statistical differences were found in the prevalence of allergic rhinitis and dental caries between obese and non-obese children ( P>0.05). Conclusion:The severity of overweight and obesity in children is beyond our expectation, the allergenicity problem is becoming more and more prominent, the prevention and treatment of dental caries needs to be improved urgently, and the phimosis problem in boys needs to be paid attention to.
10.Metabonomic analysis of plasma biochemical changes in pyrexia rats after treatment with Gegenqinlian decoction, aspirin and itraconazole by UHPLC-FT-ICR-MS
Ting LIU ; Ruiyun LI ; Yue CUI ; Zhiguo YU ; Yunli ZHAO
Journal of Pharmaceutical Analysis 2020;10(6):581-587
A metabonomic approach involving an ultrahigh-performance liquid chromatography combined with Fourier transform ion cyclotron resonance mass spectrometry (UHPLC-FT-ICR-MS) was used to investi-gate the changes in the endogenous metabolites in the plasma of rats with yeast-induced pyrexia treated with Gegenqinlian decoction (GQLD), aspirin and itraconazole. The differences in the small molecule profiles of treatment using traditional Chinese medicine, etiological treatment and symptomatic treat-ment were elucidated. Thirty-six plasma metabolites were identified or putatively identified, and the effects of the three medicines on the thirty-six metabolites were studied. Their metabolic pathways indicated that GQLD, aspirin and itraconazole ameliorated the rats with yeast-induced pyrexia pre-dominantly by regulating the metabolisms of phospholipid, sphingolipid, fatty acid oxidation, fatty acid amides, amino acid and glycerolipid in vivo. The pharmacodynamics and metabonomic results showed that the three medicines exhibited the therapeutic effects on pyrexia by regulating the perturbations of multiple metabolisms. The study provided a scientific basis for an in-depth understanding of the ther-apeutic effects of GQLD, aspirin and itraconazole on rats with yeast-induced pyrexia.

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