Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.

Objective To analyze the risk factors and clinical outcomes of cognitive impairment in elderly patients with heart disease after surgery.Methods A total of 156 patients with heart valve diseases undergoing coronary artery bypass surgery admitted to the First Affiliated Hospital of H ainan Medical University from October 2021 to December 2023 were prospectively recruited.At 7 d postoperatively,Montreal cognitive assessment(MoCA)scale was used to assess their cogni-tive function,and based on MoCA score＜26 or not,they patients were divided into a cognitive impairment group(n=61)and a control group(n=95).The clinical features were compared be-tween the two groups,and the risk factors for cognitive impairment were analyzed.All patients were followed up for 1 year to compare the outcomes of the two groups.Results The cognitive impairment group had significantly advanced age,larger proportions of concomitant chronic respiratory diseases and sarcopenia,increased ratio of undergoing open heart surgery,and elevated incidence of intraoperative hypotension than the control group(P＜0.05,P＜0.01).Multivariate logistic regression analysis indicated that age,chronic respiratory diseases,sarcopenia,open heart surgery,and intraoperative hypotension were independent risk factors for postoperative cognitive impairment in elderly patients with heart diseases(OR=1.081,95％CI:1.007-1.161,P=0.030;OR=2.538,95％CI:1.062-6.066,P=0.036;OR=2.650,95％CI:1.174-5.985,P=0.019;OR=3.104,95％CI:1.391-6.929,P=0.006;OR=3.478,95％CI:1.298-9.322,P=0.0013).There was no statistical difference in preoperative MoCA scores between the two groups(27.90±1.40 vs 28.20±1.40,P=0.195).The MoCA score at 7 d and 6 and 12 months after surgery were obviously lower in the cognitive impairment group than the control group(22.90±1.27 vs 27.73±1.08,P=0.000;24.72±1.66 vs 27.73±1.23,P=0.000;25.48±1.73 vs 27.62±1.22,P=0.000).Age was identified as an independent factor affecting the outcome of cognitive function in the patients(OR=1.168,95％CI:1.035-1.318).Conclusion The incidence of postoperative cog-nitive impairment is relatively high in elderly patients with heart disease.So,relevant risk factors should be addressed to strengthen the prevention and management.

Under the new situation of establishing the new standard system for pharmaceutical packaging materials in the 2025 edition of the Chinese Pharmacopoeia and promulgating the appendix on pharmaceutical packaging ma-terials in the Good Manufacturing Practice for Drugs,it is urgently necessary to introduce relevant standards for quality agreements on pharmaceutical packaging materials.This article focuses on analyzing the development of group standards for pharmaceutical packaging materials under the new situation,the role and significance of quality agreements for pharmaceutical packaging materials,as well as the interpretation of key parts of the"Guidelines for the Management of Quality Agreements for Pharmaceutical Packaging Materials",in order to help enterprises quick-ly shift from the original"standard-only"approach to strengthening the quality management of the entire product life cycle through quality agreements.

Objective To analyze the risk factors and clinical outcomes of cognitive impairment in elderly patients with heart disease after surgery.Methods A total of 156 patients with heart valve diseases undergoing coronary artery bypass surgery admitted to the First Affiliated Hospital of H ainan Medical University from October 2021 to December 2023 were prospectively recruited.At 7 d postoperatively,Montreal cognitive assessment(MoCA)scale was used to assess their cogni-tive function,and based on MoCA score＜26 or not,they patients were divided into a cognitive impairment group(n=61)and a control group(n=95).The clinical features were compared be-tween the two groups,and the risk factors for cognitive impairment were analyzed.All patients were followed up for 1 year to compare the outcomes of the two groups.Results The cognitive impairment group had significantly advanced age,larger proportions of concomitant chronic respiratory diseases and sarcopenia,increased ratio of undergoing open heart surgery,and elevated incidence of intraoperative hypotension than the control group(P＜0.05,P＜0.01).Multivariate logistic regression analysis indicated that age,chronic respiratory diseases,sarcopenia,open heart surgery,and intraoperative hypotension were independent risk factors for postoperative cognitive impairment in elderly patients with heart diseases(OR=1.081,95％CI:1.007-1.161,P=0.030;OR=2.538,95％CI:1.062-6.066,P=0.036;OR=2.650,95％CI:1.174-5.985,P=0.019;OR=3.104,95％CI:1.391-6.929,P=0.006;OR=3.478,95％CI:1.298-9.322,P=0.0013).There was no statistical difference in preoperative MoCA scores between the two groups(27.90±1.40 vs 28.20±1.40,P=0.195).The MoCA score at 7 d and 6 and 12 months after surgery were obviously lower in the cognitive impairment group than the control group(22.90±1.27 vs 27.73±1.08,P=0.000;24.72±1.66 vs 27.73±1.23,P=0.000;25.48±1.73 vs 27.62±1.22,P=0.000).Age was identified as an independent factor affecting the outcome of cognitive function in the patients(OR=1.168,95％CI:1.035-1.318).Conclusion The incidence of postoperative cog-nitive impairment is relatively high in elderly patients with heart disease.So,relevant risk factors should be addressed to strengthen the prevention and management.

Objective:To explore the application effect of dyadic intervention scheme based on dyadic disease management theory and Information, Knowledge, Attitude, and Practice model in the discharge preparation of elderly stroke patients and family caregivers.Methods:The 92 pairs of elderly stroke patients and their caregivers hospitalized in the Department of Neurology in People′s Hospital of Zhengzhou University were conveniently selected. The non synchronous control method quasi experimental research was adopted. Totally 46 pairs of subjects who met the criteria for admission and discharge from May to July 2022 were set as the control group, and routine nursing was carried out; from August to October 2022, 46 pairs of subjects who met the criteria for admission and emission were set as the observation group to implement the dyadic intervention program. The scores of discharge readiness, self-efficacy and unplanned readmission rate of patients between the two groups were compared, and the scores of caregiver readiness, self-efficacy and caregiver stress between the two groups were compared.Results:Finally, 85 pairs of subjects completed the study, with 42 pairs in the control group and 43 pairs in the observation group. On discharge day, the total scores of discharge readiness and caregiver readiness in the observation group were (95.19 ± 4.47), (23.02 ± 2.20) points, respectively, which were higher than those in the control group (85.71 ± 5.31), (19.57 ± 1.65) points, with statistically significant differences ( t=8.91,8.16, both P<0.01); the self-efficacy levels of patients in the observation group at discharge and one month after discharge, as well as those of caregivers at discharge and one month after discharge were (73.86 ± 4.87), (75.91 ± 4.51), (75.67 ± 4.99), (79.21 ± 4.90) points, respectively, higher than those in the control group (71.62 ± 5.19), (73.33 ± 4.91), (73.48 ± 4.24), (75.48 ± 4.24) points, with statistically significant differences ( t values were from 2.05 to 3.75, all P<0.05); the pressure levels of caregivers in the observation group at discharge and one month after discharge were (7.51 ± 2.48), (6.28 ± 1.99) points, respectively, lower than those in the control group (8.76 ± 2.55), (7.45 ± 2.36) points, with statistically significant differences ( t=-2.29, -2.48, both P<0.05); the unplanned readmission rate of patients in the observation group one month after discharge was 7.0% (3/43), lower than the control group′s 23.8% (10/42), with statistically significant difference ( χ2=4.65, P<0.05). Conclusions:The implementation of dyadic intervention on elderly stroke patients and caregivers can make their discharge preparation process more adequate, thus reducing the caregiver′s care pressure, reducing the unplanned readmission rate of patients, and improving their health outcomes.

Objective:This study aims to explore the effect of propranolol combined with memory retrieval reconsolidation procedure on alcohol craving.Methods:A total of 54 patients with alcohol dependence who met the diagnostic criteria for alcohol dependence in DSM-Ⅳ were enrolled. The patients were randomly located into the alcohol retrieval-propranolol group (study group, n=28) and the alcohol retrieval-placebo group (control group, n=26) using the random number table. The study group used propranolol combined with a memory retrieval reconsolidation procedure, while the control group used a placebo combined with a memory retrieval reconsolidation procedure. The Visual Analog Scale (VAS) was used to evaluate the degree of alcohol craving induced by images such as wine bottle, pouring wine, and drinking (alcohol-related cue images, previous cue images) and neutral images (new cue) at stages of baseline measures, relevance learning, and memory test. The systolic blood pressure, diastolic blood pressure, and heart rate were applied to evaluate cue responsiveness. Repeated measures analysis of variance was used to compare the craving degree, systolic blood pressure, diastolic blood pressure, and heart rate between the two groups. The correlation between cue responsiveness and craving degree was analyzed. Results:Relevance learning stage: Compared with before learning, the levels of systolic blood pressure, diastolic blood pressure, and heart rate of the two groups increased in varying degrees after learning conditional stimulation-relevance learning+(CS+, namely neutral images paired learning with alcohol) ( F=52.79, 42.44, 49.53, P<0.05). Compared with the baseline measures, the VAS of neutral images in relevancy learning increased ( F=99.88, 68.69, both P<0.01). Memory test stage: (1) Compared with the control group, the VAS scores of cravings induced by wine bottles, pouring wine, drinking images, and neutral images were lower in the study group ( F=7.38, 13.27, 11.34, 4.62, P<0.05). Compared with the VAS scores of cravings induced by wine bottles, pouring wine, drinking images, and neutral images in the relevance learning stage, the VAS scores of the study group in the memory test stage were significantly lower ( F=43.89, 23.53, 15.93, 31.01, P<0.05). For the control group, VAS scores induced by pouring wine and drinking images were significantly increased ( F=13.40, 63.65, P<0.05). (2) After the memory test stage, compared with the control group, the levels of diastolic blood pressure and heart rate in the study group decreased ( F=20.99, 15.42, P<0.05). Compared with before the test, the levels of diastolic blood pressure and heart rate in the study group decreased after the test ( F=4.11, 8.05, P<0.05), while those in the control group increased ( F=81.86, 41.13, P<0.05). (3) The difference in diastolic blood pressure before and after the memory test stage was positively correlated with the difference in neutral VAS score between the memory test and association learning ( r=0.394, P=0.038). Heart rate difference before and after the memory test stage positively correlated with the VAS score difference between the memory test and associated learning drinking images ( r=0.389, P=0.041). Conclusion:Propranolol combined with memory retrieval reconsolidation procedure can reduce alcohol cravings induced by previous and new cues in patients with alcohol dependence.

Objective:This study aims to explore the effect of propranolol combined with memory retrieval reconsolidation procedure on alcohol craving.Methods:A total of 54 patients with alcohol dependence who met the diagnostic criteria for alcohol dependence in DSM-Ⅳ were enrolled. The patients were randomly located into the alcohol retrieval-propranolol group (study group, n=28) and the alcohol retrieval-placebo group (control group, n=26) using the random number table. The study group used propranolol combined with a memory retrieval reconsolidation procedure, while the control group used a placebo combined with a memory retrieval reconsolidation procedure. The Visual Analog Scale (VAS) was used to evaluate the degree of alcohol craving induced by images such as wine bottle, pouring wine, and drinking (alcohol-related cue images, previous cue images) and neutral images (new cue) at stages of baseline measures, relevance learning, and memory test. The systolic blood pressure, diastolic blood pressure, and heart rate were applied to evaluate cue responsiveness. Repeated measures analysis of variance was used to compare the craving degree, systolic blood pressure, diastolic blood pressure, and heart rate between the two groups. The correlation between cue responsiveness and craving degree was analyzed. Results:Relevance learning stage: Compared with before learning, the levels of systolic blood pressure, diastolic blood pressure, and heart rate of the two groups increased in varying degrees after learning conditional stimulation-relevance learning+(CS+, namely neutral images paired learning with alcohol) ( F=52.79, 42.44, 49.53, P<0.05). Compared with the baseline measures, the VAS of neutral images in relevancy learning increased ( F=99.88, 68.69, both P<0.01). Memory test stage: (1) Compared with the control group, the VAS scores of cravings induced by wine bottles, pouring wine, drinking images, and neutral images were lower in the study group ( F=7.38, 13.27, 11.34, 4.62, P<0.05). Compared with the VAS scores of cravings induced by wine bottles, pouring wine, drinking images, and neutral images in the relevance learning stage, the VAS scores of the study group in the memory test stage were significantly lower ( F=43.89, 23.53, 15.93, 31.01, P<0.05). For the control group, VAS scores induced by pouring wine and drinking images were significantly increased ( F=13.40, 63.65, P<0.05). (2) After the memory test stage, compared with the control group, the levels of diastolic blood pressure and heart rate in the study group decreased ( F=20.99, 15.42, P<0.05). Compared with before the test, the levels of diastolic blood pressure and heart rate in the study group decreased after the test ( F=4.11, 8.05, P<0.05), while those in the control group increased ( F=81.86, 41.13, P<0.05). (3) The difference in diastolic blood pressure before and after the memory test stage was positively correlated with the difference in neutral VAS score between the memory test and association learning ( r=0.394, P=0.038). Heart rate difference before and after the memory test stage positively correlated with the VAS score difference between the memory test and associated learning drinking images ( r=0.389, P=0.041). Conclusion:Propranolol combined with memory retrieval reconsolidation procedure can reduce alcohol cravings induced by previous and new cues in patients with alcohol dependence.

Objective To comparatively analyze the difference and characteristics of high mobility group box-1 protein(HMGB1) level with the levels in the patients with different severities of acute biliary tract infection (ABTI) to provide reference for its clinical diagnosis and treatment .Methods One hundred cases of ABTI in our hospital were divided into the mild group (48 cases) ,moder-ate group (29 cases) and severe group (23 cases) according to the severity of the disease .The HMGB1 detection results were com-pared among 3 groups and the differences in different disease types ,sex and age were analyzed .Results (1)The HMGB1 level had statistically significant difference among 3 groups (P<0 .05) ,moreover the mild group< moderate group< severe group ;(2)in the detection results ,the HMGB1 level in the mild group and moderate group had no statistical difference between males and fe-males(P>0 .05) ,but in the severe group ,the HMGB1 level in males was significantly higher than that in females (P<0 .05);(3) the HMGB1 level in the mild group had no statistical difference among difference age groups (P> 0 .05) ,while in the moderate group and severe group ,the HMGB1 level in the patients aged > 60 years old was significantly higher than that in the patients aged ≤60 years old(P<0 .05);(4) in the above 3 groups ,the HMGB1 level in the patients with acute cholecystitis was signifi-cantly higher than that in the patients with acute cholangitis (P<0 .05) .Conclusion The study results analysis indicates that the severe the ABTI disease condition ,the serum HMGB1 level is also accordingly and relatively increased ,in the patients with different severity degrees of ABTI ,the serum HMGB1 level has significant differences in age ,sex and disease type ,which prompts that the HMGB1 level can be used as the laboratory index for predicting and reflecting the ABTI severity and can be paid attention to .

OBJECTIVE:To promote the safe use of Heparin sodium injection for children. METHODS:According to litera-ture retrieve,questionnaire survey and field investigation,Health care failure mode and effect analysis method(HFMEA)was ad-opted to search for the failure modes of Heparin sodium injection for children,and preventive strategies were established and imple-mented based on these failure modes. Its effects were evaluated by comparing the error rate and risk priority number rating (RPN value)before and after the implementation. RESULTS:Totally 5 risk points of Heparin sodium injection requiring immediate inter-vention were obtained from RPN value,including wrong dose of Heparin sodium injection in prescribing,pharmacists'unclearness for the calculation method of the dose of Heparin sodium injection in dispensing,and nurses'no performing of double check sys-tem before infusion in administration,etc. After implementing related countermeasures,related error of Heparin sodium injection was decreased from 8 cases to 1 case,and error rate was declined from 3.76% to 0.51%(P<0.01). The RPN values of 5 failure modes were decreased from 112.08,91.56,115.78,94.52,99.23 to 28.02,23.91,27.71,23.63,20.55,respectively. CONCLU-SIONS:HFMEA can prospectively conduct systematical analysis for Heparin sodium injection for children. Implementing related countermeasures based on the current situation of our hospital can reduce the related error of Heparin sodium injection and promote the medication safety of children.

Objective To explore the dynamic change of high mobility group box-1(HMGB1) expression in sepsis shock patients and its relationship with prognosis.Methods A total of 98 patients with septic shock in ICU from March 2014 to March 2016 were collected as the research subjects and divided into the shock group (48 cases) and control group(50 cases) according to whether de-veloping shock at admission.The HMGB1 levels and APACHE Ⅱ scores change within 28 d after admission were compared be-tween the two groups ;the shock group was divided into the group A (HMGB1≤35 pg/mL ,30 cases) ,B(HMGB1>35 pg/mL ,18 cases) according to the HMGB1 level before treatment ,the two groups were observed for 3 months from the day admitted to hospi-tal.The APACHEⅡ score ,ScvO2 ,lactic acid concentration and lactic acid clearance rate after 7 d treatment ,ICU mechanical venti-lation use rate and survival rate within 3 months were compared between the two groups.Results The HMGB1 level and A-PACHEⅡ scores before admission had no statistical difference between the shock group and control group (P>0.05);the HMGB1 and APACHEⅡ scores on 7 ,14 ,21 ,28 d after admission in the shock group were significantly higher than those in the control group ,the difference was statistically significant(P<0.05);the APACHEⅡ score ,mean lactic acid clearance rate and ScvO2 after 7 d treatment in the group A were significantly higher than those in the group B ,the difference was statistically significant (P<0.05) ,the survival rate within 3 months after admission in the group A was also significantly higher than that in the group B ,the difference was statistically significant (P<0.05) ,while the lactic acid concentration and ICU mechanical ventilation use rate after 7 d treatment in the group A were significantly lower than those in the group B with statistical difference (P<0.05).Conclusion The HMGB1 level change has a strong correlation with the prognosis ,the higher the HMGB1 level ,the worse the prognosis of patients with septic shock ,HMGB1 can be used as an important indicator of monitoring disease condition changes in sepsis ,which is worthy of attention in clinical laboratory.