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 goal-directed fluid therapy(GDFT)combined with ultrasound-guided erector spinae plane block(ESPB)on perioperative stress response and postoperative recovery in patients undergoing robot-assisted pedicle screw fixation surgery.Methods Eighty patients scheduled for elec-tive surgery were randomly divided into two groups:control(general anesthesia+conventional fluid management,n=40)and intervention(general anesthesia+GDFT+ESPB,n=40).Heart rate(HR),mean arterial pressure(MAP),serum cortisol(Cor),norepinephrine(NE),blood glucose(GLU)levels,and resting VAS scores were measured and compared between the two groups preoperatively(T?),at screw placement(T?),at end of surgery(T?),30 minutes after extubation(T?),at 24 hours(T?),and 48 hours(T?)postoperatively.Intraoperative fluid volume,remifentanil consumption,postoperative rescue analgesia frequency,time to first ambulation,length of stay,and complications(agitation,nausea and vomiting,respiratory depression)were recorded.Results There were no differences in baseline(T?)indicators between the two groups(P>0.05).The intervention group exhibited significantly lower levels of HR,MAP,Cor,NE,and GLU at T?,T?,and T? compared with the control group(P<0.05),with Cor,NE,and GLU reduced by>30%at T?(P<0.05).Intraoperative fluid volume and remi-fentanil dosage were significantly reduced(both P<0.05).VAS scores and the number of rescue analgesia requests were lower at T?,T?,and T?(P<0.01).Time to first ambulation time and postoperative hospital stay were shortened(both P<0.01).The incidence of agitation,nausea/vomiting and overall complications was lower in the interven-tion group(P<0.05),whereas respiratory depression rates did not differ(P>0.05).Conclusion GDFT plus ESPB can effectively suppress perioperative stress response in robot-assisted spinal surgery,significantly reduce intraoperative opioid dosage and fluid volume,optimize postoperative analgesia,enhance recovery,and lower complication risk.This combination provides an effective ERAS strategy for improving surgical safety and recovery quality.

Objective:To understand the current status of family resilience in children with autism and explore its influencing factors, providing a basis for developing intervention measures to improve family resilience in these families.Methods:Convenience sampling was used to select children with autism and their caregivers who underwent rehabilitation training at the Department of Child Developmental Behavior, Third Affiliated Hospital of Zhengzhou University from March to September 2023. A cross-sectional survey was conducted using a general information questionnaire, the Chinese version of the Family Resilience Assessment Scale, the Chinese version of the Parenting Burnout Scale, and the Caregiver Stress Scale.Results:A total of 280 questionnaires were distributed, and 271 valid questionnaires were collected. Among the 271 children with autism, 210 were male and 61 were female, with the majority aged 3-5 years old (169 cases). Among the 271 caregivers, 21 were male and 250 were female, with the majority aged 30-39 years old (149 cases). The total score of the Chinese version of the Family Resilience Assessment Scale was (70.59 ± 14.08) points, with scores of (49.96 ± 10.23) points for family communication and problem-solving, (7.13 ± 1.62) points for social resource utilization, and (13.52 ± 3.31) points for maintaining a positive attitude. Multiple linear regression analysis showed that the child′s age, disease duration, reimbursement method, parenting burnout, and caregiver stress were influencing factors of family resilience in children with autism ( t values were -10.40-3.48, all P<0.05). Conclusions:The level of family resilience in children with autism needs improvement. Higher levels of parenting burnout and caregiver stress are associated with lower levels of family resilience. Future interventions should be developed based on these influencing factors to promote the physical and mental health of children with autism and their caregivers.

Objective:To screen the risk factors for non-complete procedural success of transvenous lead extraction(TLE),and to establish a prediction model based on the results and evaluate its predictive efficacy.Methods:A total of 1 029 patients who underwent TLE in Peking University People's Hospital from January 2014 to December 2020 were enrolled and divided into training set(n=720)and validation set(n=309)using the random number method.There were no statistically significant differences among the variables in the training set and the validation set.The training set was divided into the complete procedural success(CPS)group(n=664)and the non-CPS group(n=56).Univariate analysis was employed to screen the relevant indicators of non-CPS,followed by binary logistic regression analysis to identify the independent risk factors of non-CPS.Subsequently,a predictive model and nomogram were constructed.The receiver operating characteristic(ROC)curve analysis was applied to evaluate the ability of the model to distinguish non-CPS from TLE patients in the training set and validation set.The Hosmer-Lemeshow goodness-of-fit test was used to assess the consistency between the predicted risk and the actual risk of the model.Results:Univariate analysis showed that the relevant variables with P<0.1 including the age at the first implantation of the lead,the number of leads extracted,the oldest dwell time of lead extracted,the presence of abandoned leads,non-manual traction for lead extracted,the number of extracted leads>3,bilateral lead implantation,and the indications for TLE.The binary logistic regression analysis revealed that the presence of abandoned leads(OR=2.252,95%CI:1.111-4.564,P=0.024),the oldest dwell time of the extracted leads(OR=1.009,95%CI:1.005-1.012,P<0.001),and the number of extracted leads>3(OR=3.177,95%CI:1.306-7.733,P=0.011)were independent risk factors for non-CPS of TLE.ROC curve analysis revealed that the area under the ROC curve(AUC)of the training set was 0.80(95%CI:0.75-0.85,P<0.001).The AUC of the validation set was 0.81(95%CI:0.72-0.90,P<0.001).The Hosmer-Lemeshow goodness-of-fit test indicated that the P values of both the training set(P=0.089)and the validation set(P=0.136)were greater than 0.05.Conclusions:The presence of abandoned leads,the oldest dwell time of lead extracted,and the number of extracted leads>3 are independent risk factors for non-CPS in patients undergoing TLE.The nomogram model based on the above factors has satisfactory predictive ability.

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 goal-directed fluid therapy(GDFT)combined with ultrasound-guided erector spinae plane block(ESPB)on perioperative stress response and postoperative recovery in patients undergoing robot-assisted pedicle screw fixation surgery.Methods Eighty patients scheduled for elec-tive surgery were randomly divided into two groups:control(general anesthesia+conventional fluid management,n=40)and intervention(general anesthesia+GDFT+ESPB,n=40).Heart rate(HR),mean arterial pressure(MAP),serum cortisol(Cor),norepinephrine(NE),blood glucose(GLU)levels,and resting VAS scores were measured and compared between the two groups preoperatively(T?),at screw placement(T?),at end of surgery(T?),30 minutes after extubation(T?),at 24 hours(T?),and 48 hours(T?)postoperatively.Intraoperative fluid volume,remifentanil consumption,postoperative rescue analgesia frequency,time to first ambulation,length of stay,and complications(agitation,nausea and vomiting,respiratory depression)were recorded.Results There were no differences in baseline(T?)indicators between the two groups(P>0.05).The intervention group exhibited significantly lower levels of HR,MAP,Cor,NE,and GLU at T?,T?,and T? compared with the control group(P<0.05),with Cor,NE,and GLU reduced by>30%at T?(P<0.05).Intraoperative fluid volume and remi-fentanil dosage were significantly reduced(both P<0.05).VAS scores and the number of rescue analgesia requests were lower at T?,T?,and T?(P<0.01).Time to first ambulation time and postoperative hospital stay were shortened(both P<0.01).The incidence of agitation,nausea/vomiting and overall complications was lower in the interven-tion group(P<0.05),whereas respiratory depression rates did not differ(P>0.05).Conclusion GDFT plus ESPB can effectively suppress perioperative stress response in robot-assisted spinal surgery,significantly reduce intraoperative opioid dosage and fluid volume,optimize postoperative analgesia,enhance recovery,and lower complication risk.This combination provides an effective ERAS strategy for improving surgical safety and recovery quality.

Purpose To analyze the MRI features and clinical diagnostic value of fetal ovarian cysts.Materials and Methods A retrospective analysis was performed on 70 pregnant women who were suspected of fetal ovarian cysts by ultrasound and underwent MRI examination and completed follow-up data in Women's Hospital School of Medicine Zhejiang University from January 2019 to November 2021.All pregnant women underwent fetal MRI examination within one week after ultrasound,and the diagnostic value was evaluated by comparing with the diagnostic results after delivery.Results Seventy neonates were clearly diagnosed,and 78 lesions were diagnosed as ovarian cysts in 70 patients,including 51 simple ovarian cysts and 27 complex ovarian cysts.Ultrasound and MRI were in excellent agreement in the diagnosis of simple and complex ovarian cysts(Kappa=0.852,P<0.001).Ultrasound and MRI diagnosis of fetal ovarian complex cysts were 22 and 27 lesions,the accuracy rate was 81.5%and 100%,respectively.65 ovarian cysts subsided,the overall regression rate was 83.3%.Conclusion MRI is perior to ultrasound in the diagnosis of the origin and nature of lesions,which is of great significance of antenatal and postnatal management and clinical evaluation of prognosis.

Objective:To explore the diagnosis and treatment of the flying personnel with asymptomatic primary hyperparathyroidism (aPHPT) and the principles of aeromedical assessments.Methods:The clinical data of a helicopter navigator with aPHPT was retrospectively analyzed, and the related literature was reviewed.Results:A helicopter navigator was diagnosed with hyperplasie parathyroide or parathyroid adenoma in November 2020. In March 2021, the patient had his parathyroid adenoma explored and excised. Postoperatively, levels of parathyroid hormone (PTH) and serum calcium were mildly elevated, but without typical clinical manifestations of primary hyperparathyroidism, so temporary grounding was warranted. In June 2023, the patient returned to the hospital for re-examination, where PTH and serum calcium remained elevated. Parathyroid static imaging showed a focal concentration in the right lower parathyroid region, which was consistent with the manifestation of parathyroid adenoma so that the patient was diagnosed with aPHPT, resulting in temporary grounding. In June 2024, the patient was admitted to the Department of Endocrinology, Air Force Medical Center for aeromedical assessment, where PTH and serum calcium showed mild elevation, without such complications as urinary calculi or osteoporosis. The patient was diagnosed with aPHPT with no indication for surgery. Dynamic follow-up and monitoring of parathyroid-related indicators were recommended. The patient was determined as eligible for flight via aeromedical assessment and has flown safely for 200 h so far.Conclusions:For flying personnl with aPHPT, it is crucial to identify potential risks of disease progression and find out whether parathyroidectomy can improve clinical symptoms and surgical outcomes. The aeromedical assessment of aPHPT flying personnel should involve comprehensive assessments of conditions and dynamic monitoring of biochemical indicators, and be individualized according to the type of aircraft and flight duties.

Objective:To screen the risk factors for non-complete procedural success of transvenous lead extraction(TLE),and to establish a prediction model based on the results and evaluate its predictive efficacy.Methods:A total of 1 029 patients who underwent TLE in Peking University People's Hospital from January 2014 to December 2020 were enrolled and divided into training set(n=720)and validation set(n=309)using the random number method.There were no statistically significant differences among the variables in the training set and the validation set.The training set was divided into the complete procedural success(CPS)group(n=664)and the non-CPS group(n=56).Univariate analysis was employed to screen the relevant indicators of non-CPS,followed by binary logistic regression analysis to identify the independent risk factors of non-CPS.Subsequently,a predictive model and nomogram were constructed.The receiver operating characteristic(ROC)curve analysis was applied to evaluate the ability of the model to distinguish non-CPS from TLE patients in the training set and validation set.The Hosmer-Lemeshow goodness-of-fit test was used to assess the consistency between the predicted risk and the actual risk of the model.Results:Univariate analysis showed that the relevant variables with P<0.1 including the age at the first implantation of the lead,the number of leads extracted,the oldest dwell time of lead extracted,the presence of abandoned leads,non-manual traction for lead extracted,the number of extracted leads>3,bilateral lead implantation,and the indications for TLE.The binary logistic regression analysis revealed that the presence of abandoned leads(OR=2.252,95%CI:1.111-4.564,P=0.024),the oldest dwell time of the extracted leads(OR=1.009,95%CI:1.005-1.012,P<0.001),and the number of extracted leads>3(OR=3.177,95%CI:1.306-7.733,P=0.011)were independent risk factors for non-CPS of TLE.ROC curve analysis revealed that the area under the ROC curve(AUC)of the training set was 0.80(95%CI:0.75-0.85,P<0.001).The AUC of the validation set was 0.81(95%CI:0.72-0.90,P<0.001).The Hosmer-Lemeshow goodness-of-fit test indicated that the P values of both the training set(P=0.089)and the validation set(P=0.136)were greater than 0.05.Conclusions:The presence of abandoned leads,the oldest dwell time of lead extracted,and the number of extracted leads>3 are independent risk factors for non-CPS in patients undergoing TLE.The nomogram model based on the above factors has satisfactory predictive ability.

The historical development of endogenous wind （内风） is traced with time as the thread， based on the progression of factors such as syndromes， causes of disease， and pathogenesis. It is believed that the concept of wind syndrome originated in The Inner Canon of Yellow Emperor （《黄帝内经》）， encompassing both exogenous wind （外风） and endogenous wind syndrome. Over time， exogenous wind syndrome gradually evolved into mild syndromes and severe syndromes， while endogenous wind syndrome emerged from severe syndromes of exogenous wind. Endogenous wind syndrome has both syndrome and pathogenic attributes， and its theoretical system has gradually become more refined. Based on the theories of ancient and modern medical practitioners， and combining the holistic perspectives with Xiang （象） thinking， it is proposed that endogenous wind has both physiological and pathological distinctions. The physiological endogenous wind refers to the liver's moderate dispersing and regulating function， which helps to distribute qi （气）， blood， and body fluids， while pathological endogenous wind arises from abnormal liver dispersal. Therefore， in clinical practice， different treatment methods， such as tonifying， unblocking， and warming， can be applied according to the differentiation of deficiency and excess in the pathogenesis.