AIM: To evaluate the visual function and optical quality in adults aged 80y and older following the bilateral implantation of zonal refractive multifocal intraocular lens(IOL, LS-313 MF30).METHODS: A single-center, non-randomized, prospective clinical trial was conducted, involving cataract patients aged 80 y and older. Patients received bilateral implantation of the LS-313 MF30 or CT Asphina 409MP, based on personal preference. Postoperative assessments included uncorrected and corrected visual acuity at distance, intermediate, and near ranges, as well as defocus curve. Subjective evaluations were performed using the visual function(VF-14)questionnaire, spectacle independence rates, and patient satisfaction surveys. Photic phenomena such as glare, halos, and starbursts were also analyzed.RESULTS: The MF30 group(16 eyes from 8 participants, 85.38±2.56 y)exhibited superior uncorrected and corrected intermediate and near visual acuity compared to the 409MP group(26 eyes from 13 participants, 85.77±2.20 y), while distance visual acuity was comparable between groups. The defocus curve of the MF30 group revealed two peaks at 0.00 D and -3.00 D, indicating a broader depth of focus. Patients in the MF30 group reported higher rates of spectacle independence and greater satisfaction. While photic phenomena such as glare(28.6% vs 18.5%, P=0.584), starburst(9.5% vs 3.7%, P=0.567)and halos(23.8% vs 11.11%, P=0.438)were more prevalent in the MF30 group, they were generally mild and did not significantly impact daily activities.CONCLUSION: Zonal refractive multifocal IOLs provide elderly patients with improved distance and near vision, greater spectacle independence, and greater satisfaction. Although photic phenomena were slightly more frequent with MF30, they are generally reported as non-disruptive and do not affect their daily life compared to monofocal IOLs.

Objective The causal relationship between endometriosis(EMs)and 15 trace elements including copper,calcium,carotene,folic acid,iron,magnesium,potassium,selenium,vitamin A,vitamin B12,vitamin B6,vitamin C,vitamin D,vitamin E and zinc was analyzed by double sample Mendelian randomization(MR).Methods Multiple trace elements were used as exposure factors,and the incidence risk of EMs was used as the outcome factor for two-sample MR analysis.The data were sourced from the publicly available integrative epidemiology unit open Genome-Wide Association Studies database and Finnish Genome Research Project database.Five Mendelian randomization analysis methods were employed to investigate the causal relationship between EMs and trace elements.Additionally,sensitivity analysis was carried out to evaluate the influence of heterogeneity and horizontal pleiotropy on the results of the MR analysis.Results The impact of trace elements on various types of EMs varies.The results of the inverse variance weighted(IVW)method indicated that trace element calcium(OR=1.465,95％CI:1.094-1.962)and vitamin B6(OR=1.580,95％CI:1.146-2.178)might be risk factors for ovarian EMs.Vitamin B6(OR=0.203,95％CI:0.044-0.939)may be a protective factor for tubal EMs.The above research results were not affected by heterogeneity and horizontal pleiotropy(P＞0.05).This study did not find a causal relationship between other trace elements and EMs.Conclusion The trace elements calcium and vitamin B6 predicted by genetics may play a regulatory role in the development of EMs.

Objective To study the therapeutic effects of Yigan Fupi decoction(YGFP)on irritable bowel syndrome(IBS)and its mechanism of action in repairing the intestinal barrier and reducing IBS sensitivity through the PKA/PKC-CREB pathway.Methods Baby rats separated from their mother were randomly divided into a model control(M)and a YGFP group,while baby rats without maternal separation were used as a normal control(N)group.The YGFP group was given YGFP for 4 weeks.Abdominal withdrawal reflux was used to evaluate intestinal sensitivity.Liquid chromatography tandem mass spectrometry and ELISA were used to detect bile acid metabolite concentrations and serum levels of interleukin(IL)-6 and CXCL1,respectively.HE staining was used to observe pathological changes in the colon,and Western Blot and immunohistochemistry were used to analyze the relative protein expression levels of PKA,PKC,CREB,5HT2AR,5-HT7R,ZO-1,and Claudin 1.Results Compared with the normal control group,the M group showed a significantly decreased visceral pain threshold,significantly increased levels of total bile acid metabolites,IL-6,and CXCL1,significantly increased relative expression of PKA,PKC,CREB,5HT2AR,and 5-HT7R,and significantly decreased relative expression of ZO-1 and Claudin 1.Compared with the M group,the YGFP group showed a significantly increased visceral pain threshold,significantly reduced levels of total bile acid metabolites,IL-6,and CXCL1,significantly reduced relative expression of PKA,PKC,CREB,5HT2AR,and 5-HT7R,and increased relative expression of ZO-1 and Claudin 1.Conclusions YGFP effectively improved IBS through a mechanism that may involve repair of the intestinal barrier and reduced sensitivity through the PKA/PKC-CREB pathway.

Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

Objective The causal relationship between endometriosis(EMs)and 15 trace elements including copper,calcium,carotene,folic acid,iron,magnesium,potassium,selenium,vitamin A,vitamin B12,vitamin B6,vitamin C,vitamin D,vitamin E and zinc was analyzed by double sample Mendelian randomization(MR).Methods Multiple trace elements were used as exposure factors,and the incidence risk of EMs was used as the outcome factor for two-sample MR analysis.The data were sourced from the publicly available integrative epidemiology unit open Genome-Wide Association Studies database and Finnish Genome Research Project database.Five Mendelian randomization analysis methods were employed to investigate the causal relationship between EMs and trace elements.Additionally,sensitivity analysis was carried out to evaluate the influence of heterogeneity and horizontal pleiotropy on the results of the MR analysis.Results The impact of trace elements on various types of EMs varies.The results of the inverse variance weighted(IVW)method indicated that trace element calcium(OR=1.465,95％CI:1.094-1.962)and vitamin B6(OR=1.580,95％CI:1.146-2.178)might be risk factors for ovarian EMs.Vitamin B6(OR=0.203,95％CI:0.044-0.939)may be a protective factor for tubal EMs.The above research results were not affected by heterogeneity and horizontal pleiotropy(P＞0.05).This study did not find a causal relationship between other trace elements and EMs.Conclusion The trace elements calcium and vitamin B6 predicted by genetics may play a regulatory role in the development of EMs.

Objective To study the therapeutic effects of Yigan Fupi decoction(YGFP)on irritable bowel syndrome(IBS)and its mechanism of action in repairing the intestinal barrier and reducing IBS sensitivity through the PKA/PKC-CREB pathway.Methods Baby rats separated from their mother were randomly divided into a model control(M)and a YGFP group,while baby rats without maternal separation were used as a normal control(N)group.The YGFP group was given YGFP for 4 weeks.Abdominal withdrawal reflux was used to evaluate intestinal sensitivity.Liquid chromatography tandem mass spectrometry and ELISA were used to detect bile acid metabolite concentrations and serum levels of interleukin(IL)-6 and CXCL1,respectively.HE staining was used to observe pathological changes in the colon,and Western Blot and immunohistochemistry were used to analyze the relative protein expression levels of PKA,PKC,CREB,5HT2AR,5-HT7R,ZO-1,and Claudin 1.Results Compared with the normal control group,the M group showed a significantly decreased visceral pain threshold,significantly increased levels of total bile acid metabolites,IL-6,and CXCL1,significantly increased relative expression of PKA,PKC,CREB,5HT2AR,and 5-HT7R,and significantly decreased relative expression of ZO-1 and Claudin 1.Compared with the M group,the YGFP group showed a significantly increased visceral pain threshold,significantly reduced levels of total bile acid metabolites,IL-6,and CXCL1,significantly reduced relative expression of PKA,PKC,CREB,5HT2AR,and 5-HT7R,and increased relative expression of ZO-1 and Claudin 1.Conclusions YGFP effectively improved IBS through a mechanism that may involve repair of the intestinal barrier and reduced sensitivity through the PKA/PKC-CREB pathway.

Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.