1.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
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.
2.Can adalimumab biosimilars be clinically interchanged:evidence based on a systematic review and Meta-analysis
Yang HU ; Zaiwei SONG ; Yuan GAO ; Yiwen RAN ; Dan JIANG ; Rongsheng ZHAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(7):722-734
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.
3.Determination of the ELISA kits for screening convalescence plasma with high potency of SARS-CoV-2 IgG
Zhijun ZHOU ; Lu FENG ; Shenglan YUE ; Yan PENG ; Bin GAO ; Deiming JI ; Juan LI ; Kejin CHEN ; Lianzhen LIN ; Cesheng LI ; Yong HU ; Taojing LI
Chinese Journal of Blood Transfusion 2023;36(3):199-203
【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 B
4.Epidemiological characteristics of Epstein-Barr virus infection in children
Qiwu ZHANG ; Deqiang HU ; Rongsheng WEI
Journal of Public Health and Preventive Medicine 2023;34(3):110-113
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(Pprimary infection vs. non-infection<0.001, ORprimary infection vs. non-infection=0.580; Pprevious infection vs. non-infection=0.038, ORprevious 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.
5.Analysis of the real situation of medication in the population with gout achieving T2T indicators: a multicentre real-world study
Weiqin GAO ; Xuezhong GONG ; Yuanyuan ZHANG ; Xingchen DU ; Ping JIANG ; Fengyuan GUAN ; Ying LU ; Xiao SU ; Hongze JIANG ; Hongbin LI ; Yongfei FANG ; Hengli ZHAO ; Jiangyun PENG ; Mingli GAO ; Li SU ; Fang HE ; Qingwen TAO ; Chunrong HU ; Peng LI ; Zeguang LI ; Yuelan ZHU ; Ying GU ; Ming ZHANG ; Rongsheng WANG ; Ting JIANG ; Xiaolin YANG ; Qi ZHU ; Quan JIANG ; Jianyong ZHANG ; Xiaolei FAN ; Yu XUE ; Dongyi HE
Chinese Journal of Rheumatology 2023;27(6):361-367
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.
6.Efficacy of entecavir versus tenofovir disoproxil fumarate in treatment of chronic hepatitis B patients with high viral load
Huikun ZHOU ; Jianning JIANG ; Minghua SU ; Rongming WANG ; Bobin HU ; Deli DENG ; Huilan WEI ; Xianshuai LIANG ; Wenming HE ; Rongsheng GUO
Journal of Clinical Hepatology 2022;38(3):532-536
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.
7.Correlation analysis between blood routine-derived inflammatory markers and respiratory function in pneumoconiosis patients
Xinxin HU ; Shengping LIU ; Rongsheng ZHOU ; Maoneng HU ; Jing WEN ; Tong SHEN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(7):508-514
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.
8.Correlation analysis between blood routine-derived inflammatory markers and respiratory function in pneumoconiosis patients
Xinxin HU ; Shengping LIU ; Rongsheng ZHOU ; Maoneng HU ; Jing WEN ; Tong SHEN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(7):508-514
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.
9.Comparing the clinical characteristics and prognosis of seropositive and seronegative rheumatoid arthritis patients in China: a real-world study
Yehua JIN ; Ting JIANG ; Xiaolei FAN ; Rongsheng WANG ; Yuanyuan ZHANG ; Peng CHENG ; Yingying QIN ; Mengjie HONG ; Mengru GUO ; Qingqing CHENG ; Zhaoyi LIU ; Runrun ZHANG ; Cen CHANG ; Lingxia XU ; Linshuai XU ; Ying GU ; Chunrong HU ; Xiao SU ; Luan XUE ; Yongfei FANG ; Li SU ; Mingli GAO ; Jiangyun PENG ; Qianghua WEI ; Jie SHEN ; Qi ZHU ; Hongxia LIU ; Dongyi HE
Chinese Journal of Rheumatology 2021;25(5):307-315
Objective:In general, patients with seropositive rheumatoid arthritis (RA) are considered to show an aggressive disease course. However, the relationship between the two subgroups in disease severity is controversial. Our study is aimed to compare the clinical characteristics and prognosis of double-seropositive and seronegative RA in China through a real-world large scale study.Methods:RA patients who met the 1987 American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European Anti-Rheumatism Alliance RA classification criteria, and who attended the 10 hospitals across the country from September 2015 to January 2020, were enrolled. According to the serological status, patients were divided into 4 subgroups [rheumatoid factor (RF)(-) anti-cyclic citrullinated peptide (CCP) antibody (-), RF(+), RF(+) anti-CCP antibody(+), anti-CCP antibody(+)] and compared the disease characteristics and treatment response. One-way analysis of variance was used for measurement data that conformed to normal distribution, Kruskal-Wallis H test was used for measurement data that did not conform to normal distribution; paired t test was used for comparison before and after treatment within the group if the data was normally distributed else paired rank sum test was used; χ2 test was used for count data. Results:① A total of 2 461 patients were included, including 1 813 RF(+) anti-CCP antibody(+) patients (73.67%), 129 RF(+) patients (5.24%), 245 RF(-) anti-CCP antibody(-) patients (9.96%), 74 anti-CCP antibody(+) patients (11.13%). ② Regardless of the CCP status, RF(+) patients had an early age of onset [RF(-) anti-CCP antibody(-) (51±14) years old, anti-CCP antibody(+) (50±15) years old, RF(+) anti-CCP antibody(+) (48±14) years old, RF(+)(48±13) years old, F=3.003, P=0.029], longer disease duration [RF(-) anti-CCP antibody(-) 50 (20, 126) months, anti-CCP antibody(+) 60(24, 150) months, RF(+) anti-CCP antibody(+) 89(35, 179) months, RF(+) 83(25, 160) months, H=22.001, P<0.01], more joint swelling counts (SJC) [RF(-) anti-CCP antibody(-) 2(0, 6), Anti-CCP antibody(+) 2(0, 5), RF(+) anti-CCP antibody(+) 2(0, 7), RF(+) 2(0, 6), H=8.939, P=0.03] and tender joint counts (TJC) [RF(-) anti-CCP antibody(-) 3(0, 8), anti-CCP antibody(+) 2(0, 6), RF(+) anti-CCP antibody(+) 3(1, 9), RF(+) 2(0, 8), H=11.341, P=0.01] and the morning stiff time was longer [RF(-) anti-CCP antibody(-) 30(0, 60) min, anti-CCP antibody(+) 20(0, 60) min, RF(+) anti-CCP antibody(+) 30(10, 60) min, RF(+) 30(10, 60) min, H=13.32, P<0.01]; ESR [RF(-) anti-CCP antibody(-) 17(9, 38) mm/1 h, anti-CCP antibody(+) 20(10, 35) mm/1 h, RF(+) anti-CCP antibody(+) 26(14, 45) mm/1 h, RF(+) 28(14, 50) mm/1 h, H=37.084, P<0.01] and CRP [RF(-) anti-CCP antibody(-) 2.3 (0.8, 15.9) mm/L, Anti-CCP antibody(+) 2.7(0.7, 12.1) mm/L, RF(+) anti-CCP antibody(+) 5.2(1.3, 17.2) mm/L, RF (+) 5.2(0.9, 16.2) mm/L, H=22.141, P<0.01] of the RF(+)patients were significantly higher than RF(-) patients, and RF(+) patients had higher disease severity(DAS28-ESR) [RF(-) anti-CCP antibody(-) (4.0±1.8), anti-CCP antibody(+) (3.8±1.6), RF(+) anti-CCP antibody(+) (4.3±1.8), RF(+) (4.1±1.7), F=7.269, P<0.01]. ③ The RF(+) anti-CCP antibody(+) patients were divided into 4 subgroups, and it was found that RF-H anti-CCP antibody-L patients had higher disease severity [RF-H anti-CCP antibody-H 4.3(2.9, 5.6), RF-L anti-CCP antibody-L 4.5(3.0, 5.7), RF-H anti-CCP antibody-L 4.9(3.1, 6.2), RF-L anti-CCP antibody-H 2.8(1.8, 3.9), H=20.374, P<0.01]. ④ After 3-month follow up, the clinical characteristics of the four groups were improved, but there was no significant difference in the improvement of the four groups, indicating that the RF and anti-CCP antibody status did not affect the remission within 3 months. Conclusion:Among RA patients, the disease activity of RA patients is closely related to RF and the RF(+) patients have more severe disease than RF(-) patients. Patients with higher RF titer also have more severe disease than that of patients with low RF titer. After 3 months of medication treatment, the antibody status does not affect the disease remission rate.
10.Isolation, identification and heavy metals biosorption of a lead and cadmium-tolerant strain.
Jiancai WANG ; Xinghua LIU ; Huaizhong WANG ; Hongmei HU ; Lili PANG ; Baohua HUANG ; Rongsheng ZHU
Chinese Journal of Biotechnology 2020;36(8):1600-1609
Adding biological passivation agent during composting is one of the most effective ways to reduce the toxicity of heavy metals in contaminated livestock manure. To further improve biological passivation, we obtained a strain with high-heavy metal compounds tolerance to passivate heavy-metal contaminated manure and to characterize heavy-metal biosorption. High-tolerance microorganisms for lead and cadmium were isolated and screened from swine manure composting samples. The strain was identified by its morphology and molecular biology. After the influence of different pH, temperature and salt concentrations on growth of the strain were investigated, the optimal growth conditions were obtained for further analysis of its biosorption characteristics of lead and cadmium. The bacterium with tolerance to lead and cadmium termed SC19 was obtained, whose lead resistance was 600 mg/L and cadmium resistance was 120 mg/L. The isolate was further identified as Cedecea sp., and then its optimum pH was 7.0, temperature was 37 °C, and salt concentration was 0.5%. Lead removal was highest after 30 min of adsorption by the SC19 strain cultured for the stationary phase 36 h, and the maximum removal rate and biosorption capacity of lead were 60.7% and 329.13 mg/g, respectively. Meanwhile, cadmium removal was highest after 30 min of adsorption by the strain cultured for the logarithmic phase 8 h, and the maximum removal rate and biosorption capacity of cadmium were 51.0% and 126.19 mg/g, respectively. Fourier Transform InfraRed (FT-IR) results revealed that the biosorption process mainly happened on the surface of SC19 cell and many active groups on the cell surface could chelate the Pb²⁺ and Cd²⁺. By comprehensive comparison, it was showed that strain SC19 shared a certain capacity of Pb²⁺ and Cd²⁺ biosorption, and the bacterium provided precious microbial germplasm resources for biological passivation of heavy metal contaminated manure.


Result Analysis
Print
Save
E-mail