Objective: To compare quality control (relative purity and specific activity) and process control [plasminogen (Pg) antigen recovery and potency recovery] indexes of samples before and after adding the Q chromatography step to the full chromatography process of human Pg, thereby determining whether the addition of this step could improve Pg recovery by affinity chromatography. Methods: A Q chromatography step was added before the Pg affinity chromatography in the original Pg chromatography process. The loading solution, flow through solution and eluate of Q chromatography and Pg affinity chromatography were collected. The potency of coagulation factor Ⅱ (FⅡ), Ⅶ (FⅦ), Ⅷ (FⅧ), Ⅸ (FⅨ), and Ⅹ(FⅩ) were detected by the coagulation method, the total protein content was detected by the BCA method, and the Pg potency was detected by the chromogenic substrate method. The content of specific plasma proteins was detected by immunoturbidimetry, the potency recovery of coagulation factors was calculated, and the flow direction of coagulation factors was analyzed. The recovery of different plasma protein antigens were calculated, and the distribution of impurity proteins was analyzed. The relative purity and specific activity of Pg, antigen content, and potency recovery in the target fractions were calculated and compared with the original process indicators, so as to determine the effect of adding Q chromatography on the original process. Furthermore, the reproducibility after process modification was assessed. Results: 100% of FⅡ, FⅩ, and FⅨ, 87.81% of FⅧ, and 40.44% of FⅦ in filtered plasma were removed by Q chromatography. The residual FⅦ (53.26%) and FⅧ (13.30%) in Q flow-through fraction were completely removed by Pg affinity chromatography. In both the original process (without Q-chromatography) and the modified process (with Q-chromatography), non-target plasma proteins mainly existed in the flow-through fraction of Pg affinity chromatography. The antigen recovery of IgM, ceruloplasmin (CER), and fibronectin (FNC) in Q-chromatography flow-through fraction were reduced. In contrast, antigen recovery of other plasma proteins [IgG, IgA, Pg, albumin (AlB), alpha-1-antitrypsin (AAT), and fibrinogen (Fg)] were all >90%, which were consistent with the protein composition and proportion in the original affinity chromatography loading solution. Compared with the recovery rate of Pg antigen in the original process (74.4%), the total recovery of Pg antigen in the modified process was significantly increased (89.97%). Compared with the recovery of IgG (97.48%) and Fg (95.32%) in the Pg affinity flows-through fraction of the original process, the modified process resulted in a slight reduction in the recovery of IgG (94.60%), while the recovery of Fg was not affected (95.05%). The potency recovery rate, specific activity, and relative purity of Pg after Q chromatography were 99.3%, 0.016 U/mg, and 0.15%. These values were the same as those of Pg affinity chromatography loading solution by the original process, indicating that introduction of Q chromatography did not affect subsequent Pg affinity chromatography. Compared with the recovery of Pg antigen in three batches of the original process (66.49±1.02)%, the recovery of Pg antigen in the affinity chromatography eluent of the modified process [five batches; (77.43±4.43)%] was significantly improved. Furthermore, the potency recovery was (86.80±4.28)%, the relative purity was (81.99±1.25)%, the specific activity was (8.679±1.073)U/mg, and the process was reproducible. Conclusion: The addition of Q chromatography could improve the recovery of Pg affinity chromatography in the full chromatography process.

OBJECTIVE T o analyze the current situation and characteristics of hospital-associated infection in a psy-chiatric hospital,providing references for formulation of control measures for hospital-associated infection.METHODS A retrospective analysis was conducted on hospital-associated infection data from Shanghai Mental Health Center between Jan.1,2019,and Oct.31,2024.The infection rates and infection sites across different years,patient populations,and departments were analyzed.RESULTS A total of 47 051 inpatients were investiga-ted,with 1 798 cases of hospital-associated infections,resulting in an infection rate of 3.82％.The highest inci-dence rate was observed in 2020(4.13％).The top three departments with the highest incidence rates were the in-fectious disease department(12.13％),geriatric psychiatry(7.67％),and the Traditional Chinese Medicine De-partment department(4.90％).The primary infection sites were the lower respiratory tract(57.06％),urinary tract(18.24％),skin and soft tissue(14.29％).The incidence rate was higher in males(5.32％)than in females(2.72％)(P＜0.001).Statistically significant differences were found in the incidence rates among different age groups(P＜0.001),with the highest rate observed in patients aged over 90 years(17.11％).The lowest infection rate was found in patients hospitalized for less than 60 days(0.69％),while the highest was in those hospitalized for more than 1 000 days(49.94％).CONCLUSIONS The patients in psychiatric hospitals are susceptible to infec-tions in the respiratory tract,urinary tract,skin and soft tissue.Targeted prevention and control measures can be implemented based on high-risk factors such as age,length of stay,and gender to reduce the occurrence of in-fections.

OBJECTIVE T o analyze the current situation and characteristics of hospital-associated infection in a psy-chiatric hospital,providing references for formulation of control measures for hospital-associated infection.METHODS A retrospective analysis was conducted on hospital-associated infection data from Shanghai Mental Health Center between Jan.1,2019,and Oct.31,2024.The infection rates and infection sites across different years,patient populations,and departments were analyzed.RESULTS A total of 47 051 inpatients were investiga-ted,with 1 798 cases of hospital-associated infections,resulting in an infection rate of 3.82％.The highest inci-dence rate was observed in 2020(4.13％).The top three departments with the highest incidence rates were the in-fectious disease department(12.13％),geriatric psychiatry(7.67％),and the Traditional Chinese Medicine De-partment department(4.90％).The primary infection sites were the lower respiratory tract(57.06％),urinary tract(18.24％),skin and soft tissue(14.29％).The incidence rate was higher in males(5.32％)than in females(2.72％)(P＜0.001).Statistically significant differences were found in the incidence rates among different age groups(P＜0.001),with the highest rate observed in patients aged over 90 years(17.11％).The lowest infection rate was found in patients hospitalized for less than 60 days(0.69％),while the highest was in those hospitalized for more than 1 000 days(49.94％).CONCLUSIONS The patients in psychiatric hospitals are susceptible to infec-tions in the respiratory tract,urinary tract,skin and soft tissue.Targeted prevention and control measures can be implemented based on high-risk factors such as age,length of stay,and gender to reduce the occurrence of in-fections.

Objective Network Meta-analysis was used to compare and estimate the therapeutic effect and safety of oral Chinese patent drugs in treatment of diabetic peripheral neuropathy(DPN).Methods PubMed,Cochrane Library,EMbase,Web of Science,China National Knowledge Infrastructure(CNKI),Chinese Citation Database(CCD),China Science Periodical Database(CSPD)and SinoMed was retrieved to collect randomized controlled trials(RCTs),which were related to oral Chinese patent drugs in treatment of DPN.Cochrane Handbook 5.3 was used to assess the quality of the studies,and Stata 15 and ADDIS 1.16.5 were utilized to analyse data.Results 48 RCTs were included,including 4200 patients,involving 11 kinds of Chinese patent drugs.In terms of improving clinical total effective rate,the top three interventions were mecobalamin combined with Tangmaikang granules,Jinlida granules and Naoxintong capsules.The top three interventions for improving toronto clinical scoring system(TCSS)were mecobalamin combined with Mailuoning peroral liquids,Mudan granules and Xuefuzhuyu capsules.In the aspect of improving sensory conduction velocity(SCV)of median nerve,the top three interventions were mecobalamin combined with Tongxinluo capsules,Xuesaitong soft capsules and Fufangxueshuantong capsules.The top three interventions for improving SCV of peroneal nerve were mecobalamin combined with Xuefuzhuyu capsules,Jinlida granules and Mailuoning peroral liquids.In terms of improving motor conduction velocity(MCV)of median nerve,the top three interventions were mecobalamin combined with Tongxinluo capsules,Yindanxinnaotong soft capsules and Tangmaikang granules.The top three interventions for improving MCV of peroneal nerve were mecobalamin combined with Xuesaitong soft capsules,Yindanxinnaotong soft capsules and Tongxinluo capsules.In the terms of improving blood glucose,several studies reported that Tangmaikang granules and Tongmaijiangtang capsules combined with mecobalamin could improve the level of glycated hemoglobin(HbA1c),which was superior to mecobalamin alone.Compared with mecobalamin alone,mecobalamin combined with Chinese patent drugs did not increase the occurrence of adverse reactions.Conclusion Mecobalamin combined with Chinese patent drugs can improve the therapeutic effect,TCSS scores and nerve conduction velocity,and the safety is satisfactory,which can provide some reference for clinical medication.

Objective Network Meta-analysis was used to compare and estimate the therapeutic effect and safety of oral Chinese patent drugs in treatment of diabetic peripheral neuropathy(DPN).Methods PubMed,Cochrane Library,EMbase,Web of Science,China National Knowledge Infrastructure(CNKI),Chinese Citation Database(CCD),China Science Periodical Database(CSPD)and SinoMed was retrieved to collect randomized controlled trials(RCTs),which were related to oral Chinese patent drugs in treatment of DPN.Cochrane Handbook 5.3 was used to assess the quality of the studies,and Stata 15 and ADDIS 1.16.5 were utilized to analyse data.Results 48 RCTs were included,including 4200 patients,involving 11 kinds of Chinese patent drugs.In terms of improving clinical total effective rate,the top three interventions were mecobalamin combined with Tangmaikang granules,Jinlida granules and Naoxintong capsules.The top three interventions for improving toronto clinical scoring system(TCSS)were mecobalamin combined with Mailuoning peroral liquids,Mudan granules and Xuefuzhuyu capsules.In the aspect of improving sensory conduction velocity(SCV)of median nerve,the top three interventions were mecobalamin combined with Tongxinluo capsules,Xuesaitong soft capsules and Fufangxueshuantong capsules.The top three interventions for improving SCV of peroneal nerve were mecobalamin combined with Xuefuzhuyu capsules,Jinlida granules and Mailuoning peroral liquids.In terms of improving motor conduction velocity(MCV)of median nerve,the top three interventions were mecobalamin combined with Tongxinluo capsules,Yindanxinnaotong soft capsules and Tangmaikang granules.The top three interventions for improving MCV of peroneal nerve were mecobalamin combined with Xuesaitong soft capsules,Yindanxinnaotong soft capsules and Tongxinluo capsules.In the terms of improving blood glucose,several studies reported that Tangmaikang granules and Tongmaijiangtang capsules combined with mecobalamin could improve the level of glycated hemoglobin(HbA1c),which was superior to mecobalamin alone.Compared with mecobalamin alone,mecobalamin combined with Chinese patent drugs did not increase the occurrence of adverse reactions.Conclusion Mecobalamin combined with Chinese patent drugs can improve the therapeutic effect,TCSS scores and nerve conduction velocity,and the safety is satisfactory,which can provide some reference for clinical medication.

【Objective】 To determine the ELISA kit for screening convalescence plasma with high potency of SARS-CoV-2 IgG by comparing and analyzing the plasma detection results of convalescent plasma collected in different periods via ELISA kits from two manufacturers and the results of mixed plasma with different potency via pseudovirus neutralization experiments. 【Methods】 Two ELISA kits from different manufacturers(named A, B) were used to detect the plasma of 269 convalescent patients collected from Feb.2020~Jan.2022. The correlation and concordance rate of the two results were analyzed to determine the kit preliminarily. According to the titers of diluted series of standard of the preliminary selected kit, 5 mixed plasma samples (G4-G128) with different potency were prepared. The correlation of ELISA IgG results of product A/B, as well as the pseudovirus neutralization test of the original strain, Omicron mutant BA.1 and BA.2 strains were analyzed. Combined with the outside-well dilution mode of the strongly positive samples, the kit for high potency of SARS-CoV-2 IgG screening was determined. 【Results】 When the internal control reference B2 was used as the standard, the detection sensitivity of product A and B was 1∶32 vs 1∶8; the detection sensitivity of product A was 4 times that of product B. The correlation Pearson r between the results given by two kits was 0.944 1(P<0.000 1). Product B with low sensitivity was primarily selected as an alternative kit. The ELISA IgG results of samples from mixed plasma showed that the order of correlation r between product A and B was 0.988. The correlation r between product A and neutralization antibody potency of the three viruses was original strain (0.978)>BA.2(0.970)>BA.1(0.799); the order of correlation r between ELISA IgG results of product B and neutralization antibody potency of the three viruses was original strain(0.994)>BA.2(0.968)>BA.1(0.804). If twice-diluted B2 was taken as the excellent standard, 55.4% of product B met the criterion, while 47.2% of product A met.For positive plasma with high IgG potency, the product B kit required a lower dilution of the sample, which was more convenient to operate. 【Conclusion】 Both of the ELISA IgG kit from product A and B can be used to screen IgG antibodies of SARS-CoV-2, while product B is more suitable for screening positive plasma with high IgG potency.