Objective:To evaluate the clinical efficacy of endoclip papillaplasty (ECPP) for preventing recurrent choledocholithiasis after endoscopic retrograde cholangiopancreatography (ERCP).Methods:A retrospective analysis was conducted on 1 941 patients who underwent ERCP for choledocholithiasis in Henan Provincial People's Hospital from January 2019 to December 2023. A total of 250 patients who received ECPP were assigned to the ECPP group, while 251 matched controls were selected via 1∶1 year-stratified sampling into the control group. After follow-up, 209 ECPP cases and 190 controls were ultimately included in the analysis. Stone removal success rate, incidence of perioperative complications, and postoperative choledocholithiasis recurrence were compared between the two groups. Univariate and multivariate logistic regression were used to determine the risk factors for choledocholithiasis recurrence after ERCP.Results:Both groups achieved 100.0% stone removal success rate. There was no significant difference in the incidence of intraoperative perforation [0.5% (1/209) VS 1.1% (2/190), χ2=0.01, P=0.934], postoperative hyperamylasemia [21.5% (45/209) VS 17.4% (33/190), χ2=1.10, P=0.295] or post-ERCP pancreatitis [3.8% (8/209) VS 8.1% (9/190), χ2=0.20, P=0.653] between the ECPP group and the control group. The ECPP group showed significantly lower bleeding rate [5.1% (11/209) VS 12.3% (23/190), χ2=5.98, P=0.014] and choledocholithiasis recurrence rate [10.5% (22/209) VS 18.9% (36/190), χ2=5.68, P=0.017] compared with the control group. The multivariate logistic regression identified dilated common bile duct diameter ( OR=1.881, 95% CI: 1.101-3.213, P=0.021) as an independent risk factor for choledocholithiasis recurrence, while being female ( OR=0.482, 95% CI: 0.266-0.875, P=0.016) and ECPP ( OR=0.497, 95% CI:0.278-0.887, P=0.018) were protective factors. Conclusion:ECPP effectively reduces choledocholithiasis recurrence rate and bleeding risk after ERCP. ECPP and being female serve as protective factors for choledocholithiasis recurrence, while dilated bile duct diameter is an independent risk factor.

Objective To investigate the effects of different cultivation method and harvest periods on chromatic characteristics and the primary bioactive components of Dendrobium officinale.Methods Fifteen batches of three-year-old Dendrobium officinale were categorized into five cultivation groups:DP-ZP,YB-ZP,HS-ZP,SP-ZP,and ZJ-ZP,with three batches per group.Thirty-six batches of Dendrobium officinale samples were categorized into twelve harvest groups according to different harvest periods and growth years:the T1 to T6 groups were three-year-old samples,and the F1 to F6 groups were four-year-old samples.Chromaticity values of Dendrobium officinale under different cultivation methods and harvest periods were measured using colorimetry.Polysaccharide content under different cultivation method and harvest periods was quantified via ultraviolet spectrophotometry.Mannose,glucose,flavonoids,and phenolic acids(rutin,quercetin,naringenin,and syringic acid)were analyzed in each group under different cultivation methods and harvest periods using HPLC.The total amount of mannose and glucose,the peak area ratio of mannose to glucose,and the total amount of flavonoids and phenolic acids were calculated.The entropy weight-TOPSIS method was applied to assign objective weights to indicators,followed by the calculation of relative closeness(C)for comprehensive quality assessment of medicinal materials.Results Under different cultivation methods,compared with the DP-ZP group,the b? value of the ZJ-ZP and YB-ZP groups decreased,whereas that of the SP-ZP group increased.The L? value and polysaccharide,syringic acid,naringenin,and quercetin contents decreased,whereas the a? value increased in the YB-ZP,SP-ZP,HS-ZP,and ZJ-ZP groups.The mannose contents decreased in the HS-ZP and SP-ZP groups and increased in the ZJ-ZP group(P<0.05).The glucose content in the ZJ-ZP and SP-ZP groups decreased,the peak area ratio of mannose to glucose increased(P<0.05).Compared with the SP-ZP group,the mannose and glucose contents and the total amount of mannose and glucose were significantly increased,and the peak area ratio of mannose to glucose was decreased in the DP-ZP,YB-ZP,HS-ZP,and ZJ-ZP groups(P<0.01).Compared with the ZJ-ZP group,the rutin contents and the total amount of flavonoids and phenolic acids were decreased in the SP-ZP,HS-ZP,DP-ZP,and YB-ZP groups(P<0.05).Compared with the T3 group,the L? value of the T1,T2,T5,and T6 groups decreased,whereas the b? value increased.The a? value and the peak area ratio of mannose to glucose increased in the T1,T2,and T4 to T6 groups,whereas the polysaccharide and glucose contents and the total amount of mannose and glucose decreased(P<0.05).Compared with the T5 group,the mannose content in the T1 to T4 and T6 groups decreased,whereas the rutin content increased in the T1 to T4 groups(P<0.05).Compared with the T6 group,the syringic acid and quercetin contents increased in the T1 to T5 groups,and the total amount of flavonoids and phenolic acids increased in the T1 to T4 group(P<0.05).Compared with the F1 group,the syringic acid content in the F2 to F6 group increased,the quercetin content decreased(P<0.01).Compared with the F2 group,the glucose and rutin content and the total amount of flavonoids and phenolic acids decreased in the F1 and F3 to F6 groups(P<0.01).Compared with the F3 group,the L? value decreased,the b? value increased,mannose content and the total amount of mannose and glucose decreased in the F1,F2,and F4 to F6 groups.Polysaccharide content in the F1 and F4 to F6 groups decreased(P<0.05).Compared with the F6 group,the peak area ratio of mannose to glucose was significantly decreased in the F1 to F4 groups(P<0.01).Entropy weight-TOPSIS analysis showed that the C of chromatic characteristics and primary bioactive components in DP-ZP(C=0.661 1)and F5(C=0.538 9)groups were the highest.Conclusion Dendrobium officinale cultivated under greenhouse conditions and four-year-old Dendrobium officinale harvested in February exhibit optimal overall quality.These findings provide an experimental basis for the selection of cultivation method and the optimal harvest period of high-quality Dendrobium officinale.

OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

BACKGROUND: The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections. METHODS: This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups. RESULTS: A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% (158/179) in Group A, 89.6% (120/134) in Group B, 89.1% (123/138) in Group C, and 87.7% (192/219) in Group D. The per-protocol (PP) eradication rates were 92.9% (156/168) in Group A, 94.5% (120/127) in Group B, 94.5% (121/128) in Group C, and 93.6% (190/203) in Group D. There was no statistically significant difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups. CONCLUSION: The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs. REGISTRATION ClinicalTrials.gov , NCT05173493.
Humans ; Helicobacter Infections/drug therapy* ; Helicobacter pylori/pathogenicity* ; Male ; Female ; Prospective Studies ; Middle Aged ; Anti-Bacterial Agents/adverse effects* ; Adult ; Aged ; Treatment Outcome ; Proton Pump Inhibitors/therapeutic use*

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective To investigate the effects of different cultivation method and harvest periods on chromatic characteristics and the primary bioactive components of Dendrobium officinale.Methods Fifteen batches of three-year-old Dendrobium officinale were categorized into five cultivation groups:DP-ZP,YB-ZP,HS-ZP,SP-ZP,and ZJ-ZP,with three batches per group.Thirty-six batches of Dendrobium officinale samples were categorized into twelve harvest groups according to different harvest periods and growth years:the T1 to T6 groups were three-year-old samples,and the F1 to F6 groups were four-year-old samples.Chromaticity values of Dendrobium officinale under different cultivation methods and harvest periods were measured using colorimetry.Polysaccharide content under different cultivation method and harvest periods was quantified via ultraviolet spectrophotometry.Mannose,glucose,flavonoids,and phenolic acids(rutin,quercetin,naringenin,and syringic acid)were analyzed in each group under different cultivation methods and harvest periods using HPLC.The total amount of mannose and glucose,the peak area ratio of mannose to glucose,and the total amount of flavonoids and phenolic acids were calculated.The entropy weight-TOPSIS method was applied to assign objective weights to indicators,followed by the calculation of relative closeness(C)for comprehensive quality assessment of medicinal materials.Results Under different cultivation methods,compared with the DP-ZP group,the b? value of the ZJ-ZP and YB-ZP groups decreased,whereas that of the SP-ZP group increased.The L? value and polysaccharide,syringic acid,naringenin,and quercetin contents decreased,whereas the a? value increased in the YB-ZP,SP-ZP,HS-ZP,and ZJ-ZP groups.The mannose contents decreased in the HS-ZP and SP-ZP groups and increased in the ZJ-ZP group(P<0.05).The glucose content in the ZJ-ZP and SP-ZP groups decreased,the peak area ratio of mannose to glucose increased(P<0.05).Compared with the SP-ZP group,the mannose and glucose contents and the total amount of mannose and glucose were significantly increased,and the peak area ratio of mannose to glucose was decreased in the DP-ZP,YB-ZP,HS-ZP,and ZJ-ZP groups(P<0.01).Compared with the ZJ-ZP group,the rutin contents and the total amount of flavonoids and phenolic acids were decreased in the SP-ZP,HS-ZP,DP-ZP,and YB-ZP groups(P<0.05).Compared with the T3 group,the L? value of the T1,T2,T5,and T6 groups decreased,whereas the b? value increased.The a? value and the peak area ratio of mannose to glucose increased in the T1,T2,and T4 to T6 groups,whereas the polysaccharide and glucose contents and the total amount of mannose and glucose decreased(P<0.05).Compared with the T5 group,the mannose content in the T1 to T4 and T6 groups decreased,whereas the rutin content increased in the T1 to T4 groups(P<0.05).Compared with the T6 group,the syringic acid and quercetin contents increased in the T1 to T5 groups,and the total amount of flavonoids and phenolic acids increased in the T1 to T4 group(P<0.05).Compared with the F1 group,the syringic acid content in the F2 to F6 group increased,the quercetin content decreased(P<0.01).Compared with the F2 group,the glucose and rutin content and the total amount of flavonoids and phenolic acids decreased in the F1 and F3 to F6 groups(P<0.01).Compared with the F3 group,the L? value decreased,the b? value increased,mannose content and the total amount of mannose and glucose decreased in the F1,F2,and F4 to F6 groups.Polysaccharide content in the F1 and F4 to F6 groups decreased(P<0.05).Compared with the F6 group,the peak area ratio of mannose to glucose was significantly decreased in the F1 to F4 groups(P<0.01).Entropy weight-TOPSIS analysis showed that the C of chromatic characteristics and primary bioactive components in DP-ZP(C=0.661 1)and F5(C=0.538 9)groups were the highest.Conclusion Dendrobium officinale cultivated under greenhouse conditions and four-year-old Dendrobium officinale harvested in February exhibit optimal overall quality.These findings provide an experimental basis for the selection of cultivation method and the optimal harvest period of high-quality Dendrobium officinale.

Objective:To evaluate the clinical efficacy of endoclip papillaplasty (ECPP) for preventing recurrent choledocholithiasis after endoscopic retrograde cholangiopancreatography (ERCP).Methods:A retrospective analysis was conducted on 1 941 patients who underwent ERCP for choledocholithiasis in Henan Provincial People's Hospital from January 2019 to December 2023. A total of 250 patients who received ECPP were assigned to the ECPP group, while 251 matched controls were selected via 1∶1 year-stratified sampling into the control group. After follow-up, 209 ECPP cases and 190 controls were ultimately included in the analysis. Stone removal success rate, incidence of perioperative complications, and postoperative choledocholithiasis recurrence were compared between the two groups. Univariate and multivariate logistic regression were used to determine the risk factors for choledocholithiasis recurrence after ERCP.Results:Both groups achieved 100.0% stone removal success rate. There was no significant difference in the incidence of intraoperative perforation [0.5% (1/209) VS 1.1% (2/190), χ2=0.01, P=0.934], postoperative hyperamylasemia [21.5% (45/209) VS 17.4% (33/190), χ2=1.10, P=0.295] or post-ERCP pancreatitis [3.8% (8/209) VS 8.1% (9/190), χ2=0.20, P=0.653] between the ECPP group and the control group. The ECPP group showed significantly lower bleeding rate [5.1% (11/209) VS 12.3% (23/190), χ2=5.98, P=0.014] and choledocholithiasis recurrence rate [10.5% (22/209) VS 18.9% (36/190), χ2=5.68, P=0.017] compared with the control group. The multivariate logistic regression identified dilated common bile duct diameter ( OR=1.881, 95% CI: 1.101-3.213, P=0.021) as an independent risk factor for choledocholithiasis recurrence, while being female ( OR=0.482, 95% CI: 0.266-0.875, P=0.016) and ECPP ( OR=0.497, 95% CI:0.278-0.887, P=0.018) were protective factors. Conclusion:ECPP effectively reduces choledocholithiasis recurrence rate and bleeding risk after ERCP. ECPP and being female serve as protective factors for choledocholithiasis recurrence, while dilated bile duct diameter is an independent risk factor.

Objective To observe the correlations of pontine biological indicators on fetal brain median sagittal MRI with gestational week.Methods Data of head MRI of 226 normal fetuses without obvious abnormalities of central nervous system(normal group)and 17 fetuses with abnormalities(abnormal group)at gestational age of 23 to 38 weeks were retrospectively analyzed.Pontine biological indicators based on median sagittal MRI were obtained,including pons anteroposterior diameter(PAD),total pons area(TPA),pontine basal anteroposterior length(AP),pontine basal cranio-caudal length(CC),basis pontis area(BPA)and pontine angle of midbrain(MAP).According to the gestational week,the fetuses of normal group were divided into 8 subgroups.The distributing ranges of pontine biological indicators at different gestational weeks were analyzed,and the correlations of pontine biological indicators with gestational week in normal group were explored,and the developmental status of fetal pons in abnormal group were assessed.Results In normal group,PAD,TPA,AP,CC and BPA all showed linear positive correlation(r=0.887,0.914,0.787,0.866,0.865,all P＜0.001),while MAP was not significantly correlated with gestational week(P＞0.05).Among 17 fetuses in abnormal group,abnormal PAD or TPA was found each in 8 fetuses,abnormal AP was observed in 14,abnormal CC was noticed in 3 and abnormal BPA was found in 11 fetuses.Conclusion Fetal pontine biological indicators such as PAD,TPA,AP,CC and BPA on median sagittal MRI were positively correlated with gestational week,hence being able to be used for evaluating fetal pontine development.

Objective To explore the genetic characteristics of fetuses with congenital heart diseases(CHD)diagnosed by prenatal ultrasound.Methods Data of 613 singletons with prenatal ultrasonic diagnosed CHD were retrospectively analyzed.The cardiac structural abnormalities were classified into 8 types.Whole-exome sequencing(WES)was performed for 40 fetuses since chromosomal karyotyping analysis and/or chromosomal microarray analysis(CMA)showed benign copy number variations(CNV)or variants of uncertain significance(VUS).Results Among 613 fetuses,479 fetuses underwent both chromosomal karyotyping analysis and CMA,genomic abnormalities were detected in 60 fetuses(60/479,12.53％).Among 134 fetuses underwent only CMA,genomic abnormalities were found in 4 fetuses(4/134,2.99％).According to results of chromosomal karyotyping analysis and/or CMA,abnormalities were noticed in 40 fetuses(40/568,7.04％)among 568 fetuses with isolated CHD,while in 15 fetuses(15/45,33.33％)among 45 fetuses with non-isolated CHD,respectively.Abnormality detection rate of chromosomal karyotyping analysis and/or CMA in fetuses with complex CHD(10/41,24.39％)was higher than that in fetuses with non-complex CHD(54/572,9.44％).Among complex CHD fetuses,abnormality detection rate was the highest in fetuses with conotruncal defect(CTD)combined with malformation of venous system(4/13,30.77％),while among fetuses with non-complex CHD,situs inversus viscerum had the highest detection rate(1/4,25.00％).Among 40 fetuses chromosomal karyotyping analysis and/or CMA showed benign CNV or VUS,WES indicated pathogenic CNV/likely pathogenic CNV(P/LP)in 3 fetuses,VUS in 3 fetuses and benign CNV in 34 fetuses.Conclusion Fetuses with CHD,especially extracardiac malformations had possibilities of genomic abnormalities.Fetuses with CTD combined with malformation of venous system had higher possibilities of genomic abnormalities.Compared with CMA alone,chromosomal karyotyping analysis combined with CMA was helpful for detecting genomic abnormalities.