OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics （ 2026 edition ） in response to the challenges faced by such clinics in China， including uneven development， large discrepancies in service specifications， insufficient patient awareness， and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association， the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association， and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association， a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research， current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections： definition and connotation of pharmacist-managed clinics， establishment requirements， implementation and management， post competency， and practical research. Firstly， the definition and connotation included three operational forms of pharmacist-managed clinics （independent mode， physician-pharmacist joint mode， and online pharmacist-managed clinic mode） and classified service modes （specialty-specific， drug-specific， and disease-specific pharmacist-managed clinics）. The establishment requirements were further refined， covering system construction （pharmaceutical service management system， quality control and assessment mechanism）， personnel qualifications （professional credentials， continuing education and professional training， etc）， service recipients， as well as service venues and facilities. Subsequently， the implementation and management of pharmacist-managed clinics were proposed， involving service procedures， intervention measures， documentation and records， patient education and follow-up， humanistic care， as well as risk management and quality control. Finally， post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics， as well as the suggestions on teaching methods； practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment， management， teaching， and research， fill the guideline gap in this field， and can promote the high-quality development of pharmacist-managed clinics.

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 To provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment. METHODS The design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

AIM:To systematically evaluate the clinical interchangeability of adalimumab biosimi-lars in terms of efficacy,safety,and immunogenici-ty,and to provide evidence-based reference for clinical interchangeability.METHODS:Randomized Controlled Trials(RCTs)on the interchangeability of adalimumab biosimilars were systematically searched in PubMed,Embase,Cochrane Library,CNKI,WANFANG and SinoMed from inceptions to October 2023.Data were extracted from the litera-ture that met the inclusion criteria,risk of bias was assessed using the Cochrane Handbook for System-atic Reviews of Interventions 5.0 bias risk assess-ment tool.Meta-analysis was performed using Rev-man 5.4 software.The certainty of evidence was graded using the GRADE tool recommended by the Cochrane Collaboration.This study was conducted according to the PRISMA guideline.RESULTS:Eigh-teen studies were included,with 7 focusing on pso-riasis and 11 on rheumatoid arthritis.Regarding ef-ficacy,for psoriasis,there were no statistical differ-ences in PASI 75 response rates and sPGA scores of ≤1 after 1-4 switches between biosimilars and the reference drug(P＞0.05,moderate-quality evi-dence).For rheumatoid arthritis,there were no sta-tistical differences in ACR 20/50/70 response rates after 1-3 switches(P＞0.05,moderate-quality evi-dence).Regarding safety,there were no statistical differences in the risk of adverse events after single or multiple switches for both diseases(P＞0.05,moderate-quality evidence).Regarding immunoge-nicity,there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches(P＞0.05,moderate-quality evi-dence).High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches be-tween adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy,safety and immunogenicity for psoriasis and rheu-matoid arthritis patients.

Objectives To describe the Epstein Barr virus (EBV) infection of children in Hefei, analyze its epidemiological characteristics, and explore the factors affecting EBV infection. Methods The children as the outpatient in the department of our hospital were recruited as the research subjects from June 2018 to June 2021. Epidemiological data of the research subjects were collected from medical records and the laboratory tests were performed to detect the related serological indicators of EBV. The distribution characteristics of different serological antibodies of EBV were described. According to the types of serological antibodies, all research subjects were divided into three states: primary infection, previous infection and non-infection. Logistics regression was used to analyze the factors affecting the infection status. Results There were 480 children in this study. The mean age and body mass index of all research subjects were 8.7±1.5 years and 20.78±3.2kg/m2, respectively. There were 276 boys(57.50%) and 204 girls(42.50%). 67 children(12.92%) were positive for VCA-IgM antibody. 326 children(67.92%) were positive for VCA-IgG antibody. 290 children(60.42%) were positive for NA-IgG antibody and 25 children(5.21%) were positive for EA-IgG antibody. There was no significant distribution difference of serological antibodies in gender, season of onset, disease duration, fever, angina and enlargement of lymph nodes. However, there were significant distribution differences of serological antibodies among different body mass index(χ²=50.207, P<0.001) and age(χ²=48.295, P<0.001). According to the types of serological antibodies, all research subjects were divided into three states. There were 78(16.25%) children with primary infection, 335(69.79%) with previous infection and 67(13.96%) with non-infection. Only age was the main factor affecting infection status by Logistic regression analysis(P_{primary infection vs. non-infection}<0.001, OR_{primary infection vs. non-infection}=0.580; P_{previous infection vs. non-infection}=0.038, OR_{previous infection vs. non-infection}=2.347). Conclusion The previous infection by EBV is the mainly infection type in children aged 6 to 12 year. The positive VCA-IgG antibody accounts for the most in previous infection. Age is the important influencing factor on EB infection. The younger the age, the higher the probability of primary infection. Besides, the positive VCA-IgM antibody is the main pattern of primary infection in children.

【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.

Objective:To explore the therapeutic characteristics of population with gout achieving treat-to-target (T2T) indicators through real-world research and evaluate their safety.Methods:A total of 3 287 patients diagnosed with gout by rheumatologists in 21 first-class tertiary hospitals in 10 provinces, municipalities, and autonomous regions in China from January 2015 to December 2021 were included in this polycentric cross-sectional study. The database included patients′ general information, disease characteristics, and clinical application of traditional Chinese and Western medicine treatment measures. SPSS and Excel software were used for data analysis. Frequency analysis, cluster analysis, and factor analysis were used to summarize the characteristics and rules of treatment measures for patients with gout who achieved the target after treatment. The occurrence of adverse events (AE) was recorded during treatment.Results:After treatment, 691 visits (7%) achieved the serum urate (SUA) target, and the most frequent use of urate-lowering therapy (ULT) was febuxostat, followed by benzbromarone. The most common treatment options were following: GroupⅠ: traditional Chinese medicine (TCM) decoction-TCM external treatment-physical exercise-proprietary Chinese medicine; GroupⅡ: ferulic acid-nonsteroidal anti-inflammatory drugs (NSAIDs); Group Ⅲ: allopurinol-sodium bicarbonate-benzbromarone; Group Ⅳ: glucocorticoid-colchicine; Group Ⅴ: febuxostat. A total of 5 898 visits (60%) chieved manifestations of joint pain VAS scores target, and the most frequently used drug to control joint symptoms was NSAIDs. The frequency of use of drugs to control joint symptoms were 2 118 times (usage rate reached 35.9%), while the frequency of ULT were 2 504 times (usage rate reached 42.5%), which was higher than the joint symptom control drug. The most common treatment options were following: Group Ⅰ: proprietary Chinese medicine-TCM decoction-TCM external treatment-physical exercise; Group Ⅱ: NSAIDs-colchicine hormones; Group Ⅲ: allopurinol, Group Ⅳ: benzbromarone; Group Ⅴ: febuxostat. A total of 59 adverse events occurred during treatment.Conclusion:The proportions of gout patients who reach target serum urate level & good control of joint symptoms are both very low, and ULT and anti-inflammatory prescription patterns are very different from international guidelines, so it is necessary to strengthen the standardized management of gout patients. At the same time, life intervention measures account for a certain proportion of the treatment plans for the T2T population, and further exploration is needed.

Objective To investigate the efficacy of entecavir (ETV) versus tenofovir disoproxil fumarate (TDF) and the treatment measures for poor response in previously untreated chronic hepatitis B (CHB) patients with high viral load. Methods A total of 165 CHB patients who received antiviral therapy and met the inclusion criteria in Department of Infectious Diseases, The First Affiliated Hospital of Guangxi Medical University, from June 2016 to July 2021 were enrolled. The patients enrolled had a baseline HBV DNA level of > 6lg copies/ml and were previously untreated CHB patients who had used ETV or TDF for 48 weeks, and quantitative real-time PCR was used to measure HBV DNA. Virologic response rate was calculated after 48 weeks of treatment; a logistic regression analysis was used to investigate the influencing factors for the response of HBV DNA < 500 copies/mL and HBV DNA < 100 copies /mL at 48 weeks; a stratified analysis was performed to compare the virologic response rate of HBV DNA < 500 copies /ml and HBV DNA < 100 copies/ml after 48 weeks between the patients with different ages, sexes, baseline HBV DNA levels, baseline alanine aminotransferase (ALT) levels, types of first-line medication, and HBeAg statuses. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups, and the binary logistic regression model was used for multivariate analysis. Results After 48 weeks of treatment, 85.5% (141/165) of the patients achieved an HBV DNA load of < 500 copies/mL, and 66.1% (109/165) of the patients achieved an HBV DNA load of < 100 copies /mL, with no significant difference in treatment outcome between the ETV group and the TDF group. The multivariate logistic regression analysis showed that sex( OR =2.793, 95% CI : 1.197-6.517), baseline HBV DNA( OR =0.369, 95% CI : 0.142-0.959), baseline ALT( OR =4.556, 95% CI : 1.770-11.732), and baseline HBeAg( OR =0.120, 95% CI : 0.033-0.429) were influencing factors for complete virologic response(all P < 0.05). For the patients with normal ALT (≤40 U/L) at baseline, 75.6% (34/45) achieved an HBV DNA load of < 500 copies/mL after 48 weeks of treatment, and 53.3% (24/45) achieved an HBV DNA load of < 100 copies/mL, with no significant difference in treatment outcome between the ETV group and the TDF group. For the patients with abnormal ALT (> 40 U/L) at baseline, 89.2% (107/120) achieved an HBV DNA load of < 500 copies/mL after 48 weeks of treatment, and the proportion of such patients in the TDF group was significantly higher than that in the ETV group (96.1% vs 84.1%, χ 2 =4.386, P =0.036); 70.8% (85/120) achieved an HBV DNA load of < 100 copies/mL, the proportion of such patients was no significant difference between the TDF group and the ETV group (78.4% vs 65.2%). The response of HBV DNA < 100 copies/ml of the normal baseline ALT group and the abnormal baseline ALT group, there were no significant differences between the patients aged≤30 years and aged > 30 years (77.8% vs 47.2%, 85.2% vs 66.7%). For the patients who did not achieve complete virologic response (HBV DNA ≥100 copies/mL) after 48 weeks of treatment, 87.9% (29/33) achieved complete virologic response after the original treatment regimen was prolonged for 48 weeks, and 100% (9/9) of the patients achieved complete virologic response after switching to or adding the first-line nucleos(t)ide analogues (NUCs) without cross-resistance sites with the original regimen for another 48 weeks. Conclusion The patients aged > 30 years should receive antiviral therapy as early as possible, regardless of viral load and ALT level, especially those with a family history of liver cirrhosis or hepatocellular carcinoma; the patients aged ≤30 years who have a normal ALT level and a high viral load should consider initiating antiviral therapy after providing informed consent. For the patients with poor response after 48 weeks of treatment, first-line NUCs without cross-resistance sites with the original regimen should be switched to or added in time.

Objective:To analyze the correlation between blood routine-derived inflammation indicators and respiratory function in patients with pneumoconiosis.Methods:In January 2021, 492 male pneumoconiosis patients hospitalized in Hefei Institute of Occupational Disease Control and Prevention from 2012 to 2020 were randomly selected as the case group, 492 dust exposed non pneumoconiosis workers who underwent occupational health examination at the same time were taken as the control group. The occupational history and clinical examination data of the two groups of subjects were collected, the correlation between blood routine-derived inflammatory indexes and pulmonary function and blood gas analysis was analyzed retrospectively.Results:Compared with the control group, the lymphocyte monocyte ratio (LMR) in the case group was decreased, and the neutrophil lymphocyte ratio (NLR) was increased, and the difference was statistically significant ( P<0.05) . There were significant differences in forced vital capacity as a percentage of the predicted value (FVC) , forced expiratory volume in the first second as a percentage of the predicted value (FEV 1%) , one second rate (FEV 1/FVC) , partial pressure of oxygen (PaO 2) , partial pressure of carbon dioxide (PaCO 2) , and pH among pneumoconiosis patients at different stages ( P<0.05) . FVC%, FEV 1%, FEV 1/FVC, and PaO 2 decreased with the increase of the stage, the trend test was statistically significant (tau-b=-0.24, -0.34, -0.37, -0.17, P<0.05) , PaCO 2 and pH increased with the increase of the stage, and the trend test was statistically significant (tau-b=0.10, 0.08, P<0.05) . There were statistically significant differences in LYM, LMR, NLR, platelet lymphocyte ratio (PLR) in patients with pneumoconiosis at different stages ( P<0.05) , and LYM and LMR decreased with the increase of stage, trend test showed that there was statistically significant (tau-b=-0.11, -0.13, P<0.05) . There were significant differences in FVC%, FEV 1%, FEV 1/FVC, PaO 2, pH, LMR, NLR, PLR among patients with different types of pneumoconiosis ( P<0.05) . LMR in pneumoconiosis patients was significantly positively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=0.342, 0.324, 0.203, 0.207, P<0.05) , NLR was significantly negatively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=-0.193, -0.202, -0.164, -0.177, P<0.05) , PLR was significantly negatively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=-0.194, -0.193, -0.106, -0.113, P<0.05) . Multiple linear regression analysis showed that LMR in pneumoconiosis patients was positively related with FVC%, FEV 1% and PaO 2 ( P<0.05) . Conclusion:LMR in patients with pneumoconiosis has a certain correlation with lung function and blood gas analysis, LMR is expected to become a sensitive indicator for evaluating pneumoconiosis.

Objective:To analyze the correlation between blood routine-derived inflammation indicators and respiratory function in patients with pneumoconiosis.Methods:In January 2021, 492 male pneumoconiosis patients hospitalized in Hefei Institute of Occupational Disease Control and Prevention from 2012 to 2020 were randomly selected as the case group, 492 dust exposed non pneumoconiosis workers who underwent occupational health examination at the same time were taken as the control group. The occupational history and clinical examination data of the two groups of subjects were collected, the correlation between blood routine-derived inflammatory indexes and pulmonary function and blood gas analysis was analyzed retrospectively.Results:Compared with the control group, the lymphocyte monocyte ratio (LMR) in the case group was decreased, and the neutrophil lymphocyte ratio (NLR) was increased, and the difference was statistically significant ( P<0.05) . There were significant differences in forced vital capacity as a percentage of the predicted value (FVC) , forced expiratory volume in the first second as a percentage of the predicted value (FEV 1%) , one second rate (FEV 1/FVC) , partial pressure of oxygen (PaO 2) , partial pressure of carbon dioxide (PaCO 2) , and pH among pneumoconiosis patients at different stages ( P<0.05) . FVC%, FEV 1%, FEV 1/FVC, and PaO 2 decreased with the increase of the stage, the trend test was statistically significant (tau-b=-0.24, -0.34, -0.37, -0.17, P<0.05) , PaCO 2 and pH increased with the increase of the stage, and the trend test was statistically significant (tau-b=0.10, 0.08, P<0.05) . There were statistically significant differences in LYM, LMR, NLR, platelet lymphocyte ratio (PLR) in patients with pneumoconiosis at different stages ( P<0.05) , and LYM and LMR decreased with the increase of stage, trend test showed that there was statistically significant (tau-b=-0.11, -0.13, P<0.05) . There were significant differences in FVC%, FEV 1%, FEV 1/FVC, PaO 2, pH, LMR, NLR, PLR among patients with different types of pneumoconiosis ( P<0.05) . LMR in pneumoconiosis patients was significantly positively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=0.342, 0.324, 0.203, 0.207, P<0.05) , NLR was significantly negatively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=-0.193, -0.202, -0.164, -0.177, P<0.05) , PLR was significantly negatively correlated with FVC%, FEV 1%, FEV 1/FVC and PaO 2 ( rs=-0.194, -0.193, -0.106, -0.113, P<0.05) . Multiple linear regression analysis showed that LMR in pneumoconiosis patients was positively related with FVC%, FEV 1% and PaO 2 ( P<0.05) . Conclusion:LMR in patients with pneumoconiosis has a certain correlation with lung function and blood gas analysis, LMR is expected to become a sensitive indicator for evaluating pneumoconiosis.