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 To evaluate and compare the performance of the Chronic Kidney Disease Epidemi-ology Collaboration(CKD-EPI)equation,the abbreviated Modification of Diet in Renal Disease(aMDRD)equa-tion,the Cockroft-Gault(C-G)formula,the Mayo Clinic Quadratic(MCQ)equation,and the Berlin Initiative Study 1(BIS1)equation in determining renal function among critically ill patients,and to identify the most appro-priate method for clinical application.Methods Critically ill patients admitted to the Intensive Care Units of the Department of Geriatric Medicine at the First Affiliated Hospital of Nanjing Medical University(Jiangsu Province Hospital)between June 2020 and June 2022 were included.Their renal function was assessed within 48 hours of admission using the 24-hour creatinine clearance rate(CrCl24h)as the reference standard,and compared with the CKD-EPI equation,aMDRD equation,C-G formula,MCQ equation,and BIS1 equation.The precision and accuracy of each equation in evaluating renal function in critically ill patients were analyzed.Results Total of 534 patients were included in the study.(1)The aMDRD equation exhibited the least bias(-3.91),yet the accuracy of the five estimated glomerular filtration rate(eGFR)equations was relatively low,ranging from 42.9%to 63.1%.(2)For renal function grading,the weighted κ agreement values between the CKD-EPI equation,aMDRD equation,C-G formula,MCQ equation,BIS1 equation,and CrCl24h were 0.464,0.555,0.403,0.405,and 0.159,respectively(all P<0.001).(3)Among patients with severe kidney function decline[CrCl24h≤60 mL/(min·1.73 m2)],the eGFR value derived from the C-G formula was the lowest,while that from the BIS1 equation was the highest.In patients with normal or moderately reduced renal function[60 mL/(min·1.73 m2)130 mL/(min·1.73 m2)],the eGFR value of the BIS1 equation was the lowest,and the aMDRD equation produced the highest eGFR value.(4)When renal function was severely decreased or augmented[CrCl24h>130 mL/(min·1.73 m2)],the accuracy of the CKD-EPI and MCQ equations declined.Conversely,as creatinine clearance increased,the accuracy of the aMDRD equation improved gradually.The C-G formula demonstrated an opposite trend compared to the aMDRD equation,and the BIS1 equation exhibited low accuracy across all groups.(5)The optimal critical values[mL/(min·m2)]for diagnosing augmented renal clearance(ARC)using the five eGFR equations were as follows:eGFRCKD-EPI:91.1,eGFRaMDRD:99.84,eGFRC-G:76.27,eGFRMCQ:100.87,eGFRBIS1:82.36.Conclusions The precision and accuracy of the five eGFR equations are relatively low,making them unsuitable for assessing renal function in critically ill patients.Collecting 24-hour urine to calculate creatinine clearance remains an essential method for evaluating renal function in this population.In the absence of early CrCl24h data upon ICU admission,the cut-off values of the eGFR equa-tions may serve as a tool for the early identification of ARC.Additionally,the aMDRD equation can provide a rough estimate of creatinine clearance in critically ill patients.

Medical professional spirit is an indispensable and important component in the modern medical system.It not only plays a key role in the harmonious development of doctor-patient relationships,but also is of great significance for the im-provement of medical quality and medical services.This article will start from the problems faced by the medical environment in the broader context,and take the cultivation of the"Guangdong Doctor"spirit,namely"cherishing life,respecting science,be-ing willing to contribute,and being united and enterprising",as an example to explore the importance of reshaping the medical professional spirit.Through specific measures such as strengthening professional spirit education,setting up role models,promo-ting the advanced,improving systems,strengthening supervision,and creating a good working environment,which aims to en-hance the professional quality and ethics of doctors,with the expectation of providing useful references for promoting harmonious doctor-patient relations and improving the quality of medical services.

Medical professional spirit is an indispensable and important component in the modern medical system.It not only plays a key role in the harmonious development of doctor-patient relationships,but also is of great significance for the im-provement of medical quality and medical services.This article will start from the problems faced by the medical environment in the broader context,and take the cultivation of the"Guangdong Doctor"spirit,namely"cherishing life,respecting science,be-ing willing to contribute,and being united and enterprising",as an example to explore the importance of reshaping the medical professional spirit.Through specific measures such as strengthening professional spirit education,setting up role models,promo-ting the advanced,improving systems,strengthening supervision,and creating a good working environment,which aims to en-hance the professional quality and ethics of doctors,with the expectation of providing useful references for promoting harmonious doctor-patient relations and improving the quality of medical services.

Background:Colorectal cancer(CRC)is a major cause of cancer death worldwide,and about 30%to 35%of CRC arises from the serrated pathway.Aims:To analyze the clinicopathological and histomorphological characteristics of colorectal superficially serrated adenoma(SuSA),and to investigate the malignant transformation potential of SuSA and further elucidate the role of RSPO2 and RSPO3 in its carcinogenic mechanism.Methods:A total of 169 serrated colorectal lesions confirmed pathologically and fulfilling the inclusion criteria were collected from Shanxi Bethune Hospital from February 2019 to May 2023.Among them,there were 84 cases of SuSA,23 sessile serrated lesions(SSL),32 traditional serrated adenomas(TSA),and 30 hyperplastic polyps(HP).Thirty-nine cases of tubular adenoma(TA),32 CRC,and 33 normal colorectal mucosal tissues were served as controls.The clinicopathological and histomorphological parameters were collected and recorded.Immunohistochemical staining was used to detect the protein expressions of RSPO2,RSPO3,p53,MLH1 and β-catenin.Results:Patients with SuSA were male predominance,with a mean age of 51.89 years.The average diameter of the lesions was 0.20 cm,predominantly located in the left colon and rectum,and frequently complicated with other polyps/adenomas.The histomorphological features of SuSA were as follows:the glandular necks and crypt bases exhibited straight tubular structure with low-grade dysplasia;the superficial layer demonstrated a serrated architecture,with or without dysplasia,and contained a variable number of goblet cells.Immunohistochemically,there were no statistically significant differences in RSPO2,RSPO3,and p53 expressions between SuSA and TSA(all P>0.05).A strong positive correlation was observed between RSPO2 and RSPO3 in colorectal lesions,excluding HP.Expressions of MLH1 and β-catenin showed no statistically significant differences between SuSA and other colorectal lesions(all P>0.05).Conclusions:SuSAs are more common in males,occur mostly in the left colon and rectum,and are often associated with other polyps/adenomas.They might be precursors of KRAS-mutated TSA and microsatellite stable CRC with high malignant potential.RSPO2 and RSPO3 might play an important role in the carcinogenesis of SuSA.

Background:Colorectal cancer(CRC)is a major cause of cancer death worldwide,and about 30%to 35%of CRC arises from the serrated pathway.Aims:To analyze the clinicopathological and histomorphological characteristics of colorectal superficially serrated adenoma(SuSA),and to investigate the malignant transformation potential of SuSA and further elucidate the role of RSPO2 and RSPO3 in its carcinogenic mechanism.Methods:A total of 169 serrated colorectal lesions confirmed pathologically and fulfilling the inclusion criteria were collected from Shanxi Bethune Hospital from February 2019 to May 2023.Among them,there were 84 cases of SuSA,23 sessile serrated lesions(SSL),32 traditional serrated adenomas(TSA),and 30 hyperplastic polyps(HP).Thirty-nine cases of tubular adenoma(TA),32 CRC,and 33 normal colorectal mucosal tissues were served as controls.The clinicopathological and histomorphological parameters were collected and recorded.Immunohistochemical staining was used to detect the protein expressions of RSPO2,RSPO3,p53,MLH1 and β-catenin.Results:Patients with SuSA were male predominance,with a mean age of 51.89 years.The average diameter of the lesions was 0.20 cm,predominantly located in the left colon and rectum,and frequently complicated with other polyps/adenomas.The histomorphological features of SuSA were as follows:the glandular necks and crypt bases exhibited straight tubular structure with low-grade dysplasia;the superficial layer demonstrated a serrated architecture,with or without dysplasia,and contained a variable number of goblet cells.Immunohistochemically,there were no statistically significant differences in RSPO2,RSPO3,and p53 expressions between SuSA and TSA(all P>0.05).A strong positive correlation was observed between RSPO2 and RSPO3 in colorectal lesions,excluding HP.Expressions of MLH1 and β-catenin showed no statistically significant differences between SuSA and other colorectal lesions(all P>0.05).Conclusions:SuSAs are more common in males,occur mostly in the left colon and rectum,and are often associated with other polyps/adenomas.They might be precursors of KRAS-mutated TSA and microsatellite stable CRC with high malignant potential.RSPO2 and RSPO3 might play an important role in the carcinogenesis of SuSA.

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 To evaluate and compare the performance of the Chronic Kidney Disease Epidemi-ology Collaboration(CKD-EPI)equation,the abbreviated Modification of Diet in Renal Disease(aMDRD)equa-tion,the Cockroft-Gault(C-G)formula,the Mayo Clinic Quadratic(MCQ)equation,and the Berlin Initiative Study 1(BIS1)equation in determining renal function among critically ill patients,and to identify the most appro-priate method for clinical application.Methods Critically ill patients admitted to the Intensive Care Units of the Department of Geriatric Medicine at the First Affiliated Hospital of Nanjing Medical University(Jiangsu Province Hospital)between June 2020 and June 2022 were included.Their renal function was assessed within 48 hours of admission using the 24-hour creatinine clearance rate(CrCl24h)as the reference standard,and compared with the CKD-EPI equation,aMDRD equation,C-G formula,MCQ equation,and BIS1 equation.The precision and accuracy of each equation in evaluating renal function in critically ill patients were analyzed.Results Total of 534 patients were included in the study.(1)The aMDRD equation exhibited the least bias(-3.91),yet the accuracy of the five estimated glomerular filtration rate(eGFR)equations was relatively low,ranging from 42.9%to 63.1%.(2)For renal function grading,the weighted κ agreement values between the CKD-EPI equation,aMDRD equation,C-G formula,MCQ equation,BIS1 equation,and CrCl24h were 0.464,0.555,0.403,0.405,and 0.159,respectively(all P<0.001).(3)Among patients with severe kidney function decline[CrCl24h≤60 mL/(min·1.73 m2)],the eGFR value derived from the C-G formula was the lowest,while that from the BIS1 equation was the highest.In patients with normal or moderately reduced renal function[60 mL/(min·1.73 m2)130 mL/(min·1.73 m2)],the eGFR value of the BIS1 equation was the lowest,and the aMDRD equation produced the highest eGFR value.(4)When renal function was severely decreased or augmented[CrCl24h>130 mL/(min·1.73 m2)],the accuracy of the CKD-EPI and MCQ equations declined.Conversely,as creatinine clearance increased,the accuracy of the aMDRD equation improved gradually.The C-G formula demonstrated an opposite trend compared to the aMDRD equation,and the BIS1 equation exhibited low accuracy across all groups.(5)The optimal critical values[mL/(min·m2)]for diagnosing augmented renal clearance(ARC)using the five eGFR equations were as follows:eGFRCKD-EPI:91.1,eGFRaMDRD:99.84,eGFRC-G:76.27,eGFRMCQ:100.87,eGFRBIS1:82.36.Conclusions The precision and accuracy of the five eGFR equations are relatively low,making them unsuitable for assessing renal function in critically ill patients.Collecting 24-hour urine to calculate creatinine clearance remains an essential method for evaluating renal function in this population.In the absence of early CrCl24h data upon ICU admission,the cut-off values of the eGFR equa-tions may serve as a tool for the early identification of ARC.Additionally,the aMDRD equation can provide a rough estimate of creatinine clearance in critically ill patients.

Objective:To investigate the effect of Shenfu injection on serum pepsinogen (PG) Ⅰ, PG Ⅱ and gastrin 17 (G17) in sepsis patients with acute gastrointestinal injury (AGI).Methods:From June 2021 to December 2022, a single-center randomized controlled clinical study was conducted to select patients with sepsis complicated with acute gastrointestinal injury (AGI) admitted to the ICU of the Affiliated Hospital of Xuzhou Medical University. Patients were randomly (random number) divided into Shenfu group and control group. All patients were given routine treatment of sepsis according to the guidelines, including treatment of primary disease, fluid resuscitation and supportive management. The Shenfu group was treated with Shenfu injection at the same time as routine treatment. The gastrointestinal injury indicators (PGⅠ, PGⅡ, G17 and AGI grades) before treatment and on the 3rd and 7th days of treatment, and duration of mechanical ventilation and length of ICU stay of the two groups were recorded and compared.Results:A total of 89 sepsis patients with AGI were enrolled, including 44 patients in the Shenfu group and 45 patients in the control group. Before treatment, there was no statistically significant difference in serum PGⅠ, PGⅡ, and G17 between the two groups of patients (all P>0.05). On the 3rd day of treatment, the serum PGⅠ levels in the Shenfu group were significantly lower than the control group [(156.46±62.90) μg/L vs. (183.03±45.44) μg/L, P<0.05]. There was no statistically significant difference in serum PGⅡ and G17 levels between the two groups (both P>0.05). On the 7th day of treatment, the serum levels of PG I, PG II, and G17 in the Shenfu group were significantly lower than those in the control group [(107.97±23.18) μg/L vs. (154.78±33.11) μg/L, (10.73±5.62) μg/L vs. (13.83±6.30) μg/L, (7.31±3.20) pmol/L vs. (9.29±3.92) pmol/L, all P<0.05]. The AGI grading, duration of mechanical ventilation, and length of ICU stay in Shenfu group were significantly reduced than those in the control group (all P<0.05). Conclusion:Shenfu injection can improve the serum gastric function, lower AGI grading, reduce mechanical ventilation time, and the length of ICU stay in sepsis patients with AGI.

Recurrent spontaneous abortion (RSA) is a common adverse pregnancy outcome in women of childbearing age and its etiology is complex and still not clear. The maternal-fetal interface microenvironment plays a key role in maintaining pregnancy. There are trophoblast cells, decidual stromal cells and immune cells in the maternal-fetal interface microenvironment. The abnormal number or function of these cells may induce changes in the microenvironment of maternal-fetal interface, such as spiral artery remodeling disorder and abnormal decidualization, which may lead to RSA. This review discusses the role and mechanism of these three main cells in RSA.