Objective:To revise and enlarge the specification of pharmaceutical excipient sucrose palmitate.Methods:Reference to JP2018,USP-NF 2023,EP1 1.0,Chinese Pharmacopoeia 2020 edition of the four general rules and the first supplement of sucrose stearate pharmacopoeia standards and other relevant requirements for standard research.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient sucrose palmitate will be studied.At present,the quality standard of sucrose palmitate for pharmaceutical excipients has been disclosed.Conclusion:The established stand-ard will provide the quality guarantee for the application of sucrose palmitate in medicines.

Objective To explore the effect of sitagliptin and metformin combined with zoledronic acid in the treatment of type 2 diabetes mellitus(T2DM)complicated with osteoporosis(OP)on the levels of glucose and lipid metabolism and bone metabolism in patients.Methods Patients with T2DM combined with OP admitted to Nantong Second People's Hospital from January 2021 to January 2024 were selected as the research subjects and randomly divided into the combined group(sitagliptin and metformin combined with zoledronic acid)and the control group(zoledronic acid only).After 6 months of treatment,the clinical efficacy,glucose and lipid metabolism indicators[fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c),total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C)],bone metabolism indicators[osteoprotegerin(OPG),bone-specific alkaline phosphatase(BALP),osteocalcin(OC)]levels,changes in bone density,and incidence of adverse reactions were compared between the two groups before and after treatment.Results A total of 120 patients were included,with 60 patients in each group.After treatment,the total effective rate of the combination group was 93.33％,significantly higher than the control group's 73.33％(P＜0.05).The levels of FBG,2hPG,HbA1c,TC,TG,and LDL-C in two groups were significantly lower than those before treatment,while the levels of HDL-C,OPG,BALP,OC,and bone density in the femoral neck and lumbar spine were significantly higher than before treatment(P＜0.05);and all indicators of the combined group were better than those of the control group(P＜0.05).There was no statistically significant difference in the total incidence of adverse reactions between the two groups(P＞0.05).Conclusion Sitagliptin and metformin combined with zoledronic acid in the treatment of patients with T2DM complicated with OP is more effective in regulating their glycolipid metabolism and bone metabolism levels,increasing bone density,improving therapeutic effects,and it has better safety than zoledronic acid alone.

Objective To explore the effect of sitagliptin and metformin combined with zoledronic acid in the treatment of type 2 diabetes mellitus(T2DM)complicated with osteoporosis(OP)on the levels of glucose and lipid metabolism and bone metabolism in patients.Methods Patients with T2DM combined with OP admitted to Nantong Second People's Hospital from January 2021 to January 2024 were selected as the research subjects and randomly divided into the combined group(sitagliptin and metformin combined with zoledronic acid)and the control group(zoledronic acid only).After 6 months of treatment,the clinical efficacy,glucose and lipid metabolism indicators[fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),glycated hemoglobin(HbA1c),total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C)],bone metabolism indicators[osteoprotegerin(OPG),bone-specific alkaline phosphatase(BALP),osteocalcin(OC)]levels,changes in bone density,and incidence of adverse reactions were compared between the two groups before and after treatment.Results A total of 120 patients were included,with 60 patients in each group.After treatment,the total effective rate of the combination group was 93.33％,significantly higher than the control group's 73.33％(P＜0.05).The levels of FBG,2hPG,HbA1c,TC,TG,and LDL-C in two groups were significantly lower than those before treatment,while the levels of HDL-C,OPG,BALP,OC,and bone density in the femoral neck and lumbar spine were significantly higher than before treatment(P＜0.05);and all indicators of the combined group were better than those of the control group(P＜0.05).There was no statistically significant difference in the total incidence of adverse reactions between the two groups(P＞0.05).Conclusion Sitagliptin and metformin combined with zoledronic acid in the treatment of patients with T2DM complicated with OP is more effective in regulating their glycolipid metabolism and bone metabolism levels,increasing bone density,improving therapeutic effects,and it has better safety than zoledronic acid alone.

Objective:To revise and enlarge the specification of pharmaceutical excipient sucrose palmitate.Methods:Reference to JP2018,USP-NF 2023,EP1 1.0,Chinese Pharmacopoeia 2020 edition of the four general rules and the first supplement of sucrose stearate pharmacopoeia standards and other relevant requirements for standard research.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient sucrose palmitate will be studied.At present,the quality standard of sucrose palmitate for pharmaceutical excipients has been disclosed.Conclusion:The established stand-ard will provide the quality guarantee for the application of sucrose palmitate in medicines.

Background::Pulmonary embolism (PE) is a severe and acute cardiovascular syndrome with high mortality among patients with autoimmune inflammatory rheumatic diseases (AIIRDs). Accurate prediction and timely intervention play a pivotal role in enhancing survival rates. However, there is a notable scarcity of practical early prediction and risk assessment systems of PE in patients with AIIRD.Methods::In the training cohort, 60 AIIRD with PE cases and 180 age-, gender-, and disease-matched AIIRD non-PE cases were identified from 7254 AIIRD cases in Tongji Hospital from 2014 to 2022. Univariable logistic regression (LR) and least absolute shrinkage and selection operator (LASSO) were used to select the clinical features for further training with machine learning (ML) methods, including random forest (RF), support vector machines (SVM), neural network (NN), logistic regression (LR), gradient boosted decision tree (GBDT), classification and regression trees (CART), and C5.0 models. The performances of these models were subsequently validated using a multicenter validation cohort.Results::In the training cohort, 24 and 13 clinical features were selected by univariable LR and LASSO strategies, respectively. The five ML models (RF, SVM, NN, LR, and GBDT) showed promising performances, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.962-1.000 in the training cohort and 0.969-0.999 in the validation cohort. CART and C5.0 models achieved AUCs of 0.850 and 0.932, respectively, in the training cohort. Using D-dimer as a pre-screening index, the refined C5.0 model achieved an AUC exceeding 0.948 in the training cohort and an AUC above 0.925 in the validation cohort. These results markedly outperformed the use of D-dimer levels alone.Conclusion::ML-based models are proven to be precise for predicting the onset of PE in patients with AIIRD exhibiting clinical suspicion of PE.Trial Registration::Chictr.org.cn: ChiCTR2200059599.

Subclinical seizures (SCS) are paroxysmal electroencephalogram (EEG) events that do not accompany obvious subjective or objective behavioral changes. They are not uncommon in EEG monitoring, with an intracranial EEG detection rate of about 50%-60%, significantly higher than the scalp EEG detection rate of about 10%. SCS most frequently occur in patients with temporal lobe epilepsy. In terms of EEG characteristics, SCS often remain confined to the epileptogenic zone but can also spread outside of it. Their value in localizing the epileptogenic zone is comparable to that of clinical seizures (CS). Additionally, the concordance between SCS and CS localization is associated with favorable surgical outcomes, indicating the significant value of SCS in focal epilepsy. A systematic review of domestic and international research on SCS is provided in this paper, aiming to enhance understanding in this area.

Objective:To understand the current situation of mood disorders in patients with thoracic and lumbar osteoporotic fractures and to preliminarily explore its influencing factors.Methods:A cross-sectional survey method was used to select 212 patients with thoracic and lumbar osteoporotic fractures from Department of Orthopedics, West China Hospital, Sichuan University, from January 2018 to September 2020 as the research subjects. The general information questionnaire, Huaxi Emotional-distress Index, Pittsburgh Sleep Quality Index (PSQI) and pain Visual Analogue Scale (VAS) were used to investigate them.Results:The incidence of mood disorders in patients with thoracic and lumbar osteoporotic fractures was 10.38% (22/212). The results of multivariate regression analysis showed that age, days of injury, PSQI score and pain VAS score were the influencing factors of emotional disturbance in patients with thoracic and lumbar osteoporotic fractures ( t values were -3.72-7.66, all P<0.05). Conclusions:Patients with thoracic and lumbar osteoporotic fractures have mood disorders. Age, injury days, PSQI score and VAS score are related to the occurrence of mood disorders in patients with thoracic and lumbar osteoporotic fractures. More attention should be payed to the influencing factors of mood disorders in patients,and timely measures should be taken for individualized intervention.

Synchronous bilateral primary breast cancer refers to the simultaneous occurrence of primary cancers in both breasts. The overall morbidity is low. However, with the detection of occult breast cancer increasing recently, it shows an upward trend. The pathogenesis is not yet clear, old age, family history of primary breast cancer, sclerosing adenopathy of precancerous lesions and pathological characteristics of first cancer are currently recognized risk factors. Compared with unilateral breast cancer, prognosis for synchronous bilateral primary breast cancer is poor. Raise the risk awareness of high-risk women, check regularly to find non-palpable lesions as soon as possible. By taking various preventive treatments for patients with high-risk unilateral breast cancer, the incidence of breast cancer can be effectively reduced and the prognosis of patients can be improved. By reviewing the literature at home and abroad, it systematically expounds the risk factors, histopathological features, prognosis and preventive treatment of synchronous bilateral breast cancer.

Objective:To study the patterns of tocilizumab (TCZ) use, its efficacy and safety in patients with rheumatoid arthritis (RA) in routine clinical practice.Methods:A total of 407 patients with RA were enrolled from 23 centers and treated with TCZ within 8 weeks prior to the enrollment visit, and were followed for 6-month. The patterns of TCZ treatment at 6 months, the effectiveness and safety outcomes were recorded. Statistical analysis was performed using SAS version 9.4.Results:A total of 396 patients were included for analysis, in which 330 (83.3%) patients received TCZ combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and 16.7%(66/396) received TCZ monotherapy. At baseline, TCZ was initiated in 56.6%(224/396) and 9.6%(38/396) of patients after failure of DMARDs and other biological agents (bDMARDs) respectively. During the 6-month follow-up period, the mean frequency of TCZ administration was (3.7±1.6), the mean TCZ dosage was (7.4±1.2) mg/kg, and the mean interval between doses was (40±13) days. 120(25.8%) patients were on TCZ treatment at the end of the study. Improvements in disease activity, systemic symptoms and patient report outcomes were observed at the end of the study. 22.7%(90/396) patients experienced at least one treatment related adverse event, and 8 patients experienced at least one serious adverse event.Conclusion:This study demonstrates that TCZ treatment is effective in patients with RA when being treated for 6 months with an acceptable safety profile. The duration of TCZ treatment needs to be extended.

Objective:To analyze the viral nucleic acid and cytokines in 12 children with 2019-nCoV infection.Methods:Clinical and laboratory data of the children diagnosed with 2019-nCoV infection in Guangzhou Women and Children′s Medical Center from January to April 2020 were retrospectively analyzed. Throat and anal swabs were collected on alternate days for the detection of 2019-nCoV nucleic acid by fluorescence quantitative PCR. Flow cytometry was used to detect serum cytokines including IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-17F, IL-22, TNF-α and TNF-β during the early (both throat and anal swab tests were positive), the intermediate (throat swab test was negative, while anal swab test remained positive), and the convalescence (both throat and anal swab tests were negative) stages of infection.Results:A total of 12 children were enrolled in this study. The male-to-female ratio was 5∶1. The average age was (7.0±4.3) years. There were two asymptomatic, five mild and five common cases. No severe or critical cases were involved. Initially, throat and anal swab nucleic acid tests were simultaneously positive in nine children newly diagnosed in our hospital and the median time of viral shedding in throat swab was longer than that in throat swab [32 (4.5, 45.0) d vs 3 (2, 9) d, Z=11.0, P=0.010]. The median difference of viral shedding time between anal swab and pharyngeal swab was 25.5 (1.5, 42.8) d. The overall levels of serum cytokines IL-17A, IL -4 and IL-5 in different stages of the disease (early, intermediate and convalescence stage) were statistically different ( Z or F, P values were 8.33, 0.016; 5.36, 0.010 and 6.56, 0.004, respectively), and a significant increase was observed in the intermediate stage of infection. IL-17F, IL-2 and IL-22 were all increased during the infection, but there was no significant statistical difference among the three stages ( P>0.05). Conclusions:It was noted that intestinal viral shedding needed a longer time. Although the infectivity has not been determined, higher requirements have been put forward for disease prevention and control. Cytokines secreted by Th2 and Th17 cells were involved in the immune response in children with non-severe 2019-nCoV infection. Monitoring viral shedding and cytokine changes in pediatric patients would be conducive to disease assessment.