Objective To investigate the causal relationship between immune cells and various molecular subtypes of breast cancer (BC) by using two-sample Mendelian randomization (MR). Methods This study employed a two-sample MR analysis, with 731 immune cell types from the GWAS catalog as the exposure factors and four BC molecular subtypes (HR+/HER2−, HR+/HER2+, HR−/HER2+, and HR−/HER2−) from the BCAC Consortium as the outcome variables. For causal inference, inverse variance weighting (IVW) was employed as the primary analytical method, alongside multiple consistency validation approaches, including MR-Egger, weighted median, weighted mode, simple mode, and Bayesian weighted Mendelian randomization. Reverse MR and sensitivity analyses were employed to effectively evaluate and exclude potential biases and interference from reverse causality. Results Significant causal associations were identified for specific immune cell phenotypes across subtypes. In HR+ BC, the HER2+ subtype was associated with seven immunophenotypes (five protective and two risk increasing), whereas the HER2− subtype was associated with eight immunophenotypes (four protective and four risk increasing). In HR− BC, the HER2+ subtype was associated with five immunophenotypes (one protective and four risk increasing), and the HER2− subtype (triple-negative BC) was associated with seven immunophenotypes (six protective and one risk-increasing). CD28+CD45RA−CD8+ T cells and naive CD8+ T cells have a bidirectional causal relationship with HR+/HER2+ breast cancer, Whereas the expression of CD8 on CD39+CD8+ cells also has a bidirectional relationship with HR+/HER2− breast cancer. Furthermore, CD4−CD8− NKT cells exhibited opposing effect directions in HER2+ versus HER2− subtypes. Conclusion From a genetic perspective, this study confirms the existence of subtype-specific causal associations between immune cell phenotypes and distinct molecular subtypes of BC, revealing heterogeneity in immune regulation.

Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective To explore the application value of iterative model reconstruction(IMR)technique in low-dose lumbar CT scanning.Methods A total of 48 patients who underwent lumbar CT plain scan were selected and divided into regular-dose group(group A)and ultra-low dose group(group B).The group A underwent imaging with 120 kV tube voltage,automatic tube current modulation technology,and iDose 4 reconstruction.The group B was scanned with a tube voltage of 100 kV and a tube current of 80 mAs,and the images of B1 and B2 groups were reconstructed by iDose 4 and IMR,respectively.The standard deviation(SD)value(the SD value represents the noise of the measured tissue),signal-to-noise ratio(SNR),and contrast-to-noise ratio(CNR)of cancellous bone,intervertebral disc,dural sac,and psoas muscle were measured and calculated at the L3-L4 vertebral body level.Two diagnosticians rated the image quality.Sample t-test and ANOVA were used to compare the measurement results and subjective scores.Results The comparison of SD for intervertebral disc,dural sac,and psoas muscle showed group B2＜group A＜group B1,while the subjective score comparison indicated group A＞group B2＞group B1.The SNR for intervertebral disc and psoas muscle demonstrated group B2＞group A＞group B1.There was no significant difference in bone quality score between group A and group B1(P＞0.05),but there was a significantly different between the bone quality scores of group B2 and those obtained with iDose 4 reconstruction(group A and group B1)(P＜0.05).The effective dose(ED)of group B was reduced by approximately 70.28％compared with group A.Conclusion IMR can significantly reduce SD,improves SNR and CNR,resulting in high-quality images.Compared to iDose 4 technique,IMR has more advantages in soft tissue display,while iDose 4 technique is superior in observing fine bone structures.The combined application of iDose 4 and IMR technique ensures high-quality images for diagnosis,while significantly reducing the radiation dose to patients.

Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

Objective Taking the medicinal excipient pectin as an example,based on the ICH Q3C risk assessment and management concept,this paper explores the control standards for residual solvents in pectin in the variety text of the Chinese Pharmacopoeia.Methods Pectin products from different processes and manufacturers were analyzed,the types of solvent residues in pectin were identified,and the solvent residues of products from different manufacturers were analyzed by gas chromatography.Results According to the product process,there was a risk of residual methanol(class 2),ethanol and isopropanol(class 3)in pectin products.In 18 batches of samples,the residual amount of methanol was measured in the range of 0.05％-0.17％,the residual amount of ethanol was in the range of 0.01％-0.38％,isopropanol was not detected,and the total amount of residual solvents was in the range of 0.07％-0.55％.Conclusions It is suggested that the residual solvent inspection item may not be listed separately in the main text of the pectin standard of the Chinese Pharmacopoeia.It is recommended that the manufacturer is required to indicate the name and limit of residual solvents under the labeling item of the standard.

Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

Objective To explore the application value of iterative model reconstruction(IMR)technique in low-dose lumbar CT scanning.Methods A total of 48 patients who underwent lumbar CT plain scan were selected and divided into regular-dose group(group A)and ultra-low dose group(group B).The group A underwent imaging with 120 kV tube voltage,automatic tube current modulation technology,and iDose 4 reconstruction.The group B was scanned with a tube voltage of 100 kV and a tube current of 80 mAs,and the images of B1 and B2 groups were reconstructed by iDose 4 and IMR,respectively.The standard deviation(SD)value(the SD value represents the noise of the measured tissue),signal-to-noise ratio(SNR),and contrast-to-noise ratio(CNR)of cancellous bone,intervertebral disc,dural sac,and psoas muscle were measured and calculated at the L3-L4 vertebral body level.Two diagnosticians rated the image quality.Sample t-test and ANOVA were used to compare the measurement results and subjective scores.Results The comparison of SD for intervertebral disc,dural sac,and psoas muscle showed group B2＜group A＜group B1,while the subjective score comparison indicated group A＞group B2＞group B1.The SNR for intervertebral disc and psoas muscle demonstrated group B2＞group A＞group B1.There was no significant difference in bone quality score between group A and group B1(P＞0.05),but there was a significantly different between the bone quality scores of group B2 and those obtained with iDose 4 reconstruction(group A and group B1)(P＜0.05).The effective dose(ED)of group B was reduced by approximately 70.28％compared with group A.Conclusion IMR can significantly reduce SD,improves SNR and CNR,resulting in high-quality images.Compared to iDose 4 technique,IMR has more advantages in soft tissue display,while iDose 4 technique is superior in observing fine bone structures.The combined application of iDose 4 and IMR technique ensures high-quality images for diagnosis,while significantly reducing the radiation dose to patients.

The field of artificial intelligence is rapidly evolving, and there has been an interest in its use to predict the risk of lymph node metastasis in T1 colorectal cancer. Accurately predicting lymph node invasion may result in fewer patients undergoing unnecessary surgeries; conversely, inadequate assessments will result in suboptimal oncological outcomes. This narrative review aims to summarize the current literature on deep learning for predicting the probability of lymph node metastasis in T1 colorectal cancer, highlighting areas of potential application and barriers that may limit its generalizability and clinical utility.