1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
2.Optimization of processing technology and investigation of hematopoiesis activity of red Notoginseng Radix et Rhizoma
Lang-Huan DUAN ; Qi-Hui LI ; Dong LÜ ; Yong WANG ; Xiu-Ming CUI
Chinese Traditional Patent Medicine 2024;46(1):48-54
AIM To optimize the processing technology of red Notoginseng Radix et Rhizoma and evaluate its blood tonifying activity.METHODS On the basis of a single factor experiment,with steaming temperature,steaming time,drying temperature,and drying time as influencing factors,the total contents of notoginsenoside R1,ginsenoside Rg1,Rb1,Rk3,Rh4,and 20(R)-ginsenoside Rg3 as evaluation indicators,Box-Behnken response surface method ology was used to optimize the processing technology.Upon the anemic mouse models jointly induced by 1-acetyl-2-phenylhydrazine(APH)and cyclophosphamide(CTX),the investigation of the blood tonifying activity of red Notoginseng Radix et Rhizoma was carried out in contrast to that of the steamed Notoginseng Radix et Rhizoma.RESULTS The optimal conditions,contributing saponin content of 8.326%and RSD of 0.087%,were determined as follows:steaming temperature of 130℃,steaming time of 4 hours,drying temperature of 60℃,and drying time of 48 h.The pharmacological activity revealed that the different processing techniques were responsible for the different blood enriching activity of notoginseng,with red Notoginseng Radix et Rhizoma displaying a better efficacy than that of steamed Notoginseng Radix et Rhizoma.CONCLUSION This stable and feasible method can be used to control the production of red Notoginseng Radix et Rhizoma.
3.Determination of Selenium in Organic Matrices Using Hydride Generation Atomic Fluorescence Spectrometry Combined with Online Oxygen Combustion
Yuan-Yuan MA ; Xiao-Hui HU ; Yong-Yu DING ; Xiang-Dong GAO ; Tai-Cheng DUAN
Chinese Journal of Analytical Chemistry 2024;52(10):1602-1608
An online sample decomposition and detection method for high-throughput determination of Se content in organic samples was established based on oxygen combustion combined with hydride generation atomic fluorescence spectrometry.The sole product of Se in oxygen combustion,SeO2,was quantitatively captured on the walls of the combustion flask in an open system.It was then eluted online and reacted in situ with 10%(V/V)HC1 carrier solution and 2%(m/V)NaBH4 reductant solution within the combustion flask.After optimization,for a maximum sample processing amount of 0.2 g,the sample analysis throughput was 20 sample/h.The detection limit(LOD,3SD)for Se reached 0.012 mg/kg,and the relative standard deviations for parallel determinations(RSDs,n=6)was 1.7%.The analytical results of certified reference materials,scallop(GBW10024)and chicken(GBW10018),were consistent with the certified values,and the analytical results of real samples were in good agreement with those obtained by traditional wet digestion.
4.Retrospective analysis of pediatric convulsion cases in the emergency department of a children's hospital in Beijing
Zhuyan DUAN ; Yanning QU ; Junting LIU ; Jun WANG ; Hui WANG ; Linying GUO ; Dong QU ; Xiaoxu REN
Chinese Pediatric Emergency Medicine 2024;31(10):777-782
Objective:To comprehensively analyze the clinical characteristics,classification of causes,treatment methods,and outcomes of pediatric convulsions in the emergency department,providing a scientific basis for the diagnosis and treatment of pediatric convulsions and optimizing emergency management for these cases.Methods:The clinical data of 18 217 children with convulsions in the emergency department of Capital Institute of Pediatrics' Children's Hospital from January 1,2016 to December 31,2020 were retrospectively analyzed.Results:A total of 18 217 children were admitted to the emergency department due to convulsions,accounting for 2.3% of all visits.Among them,58.7% cases were male and 41.3% cases were female,with an average age of (2.00±0.03) years.The main age was 1 to 3 years old (54.2%).Generalized convulsions were the primary type (82.3%),with focal seizures accounting for 17.7%.Most convulsions lasted less than 5 minutes (82.4%),and approximately 55.2% of the patients could self-resolve.Febrile convulsions were the primary cause (69.2%),followed by benign convulsions with mild gastroenteritis (11.7%) and epilepsy (10.5%).Regarding treatment,54.0% of the children recovered without medication.In the triage system of "three zones and four levels," the usage rate of anticonvulsants in the red zone was 93.1%,with 21.6% requiring combined treatment.After treatment,48.2% of the children returned home,92.2% showed improvement or recovery,and the mortality rate was extremely low at only 0.03%.Conclusion:Febrile convulsions are the main cause of pediatric convulsions in the emergency department,and an efficient triage system play an important role in improving treatment response.Different treatment zones and outcomes vary,providing important reference for optimizing emergency management.
5.Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine.
Yi-Lun QU ; Zhe-Yi DONG ; Hai-Mei CHENG ; Qian LIU ; Qian WANG ; Hong-Tao YANG ; Yong-Hui MAO ; Ji-Jun LI ; Hong-Fang LIU ; Yan-Qiu GENG ; Wen HUANG ; Wen-Hu LIU ; Hui-di XIE ; Fei PENG ; Shuang LI ; Shuang-Shuang JIANG ; Wei-Zhen LI ; Shu-Wei DUAN ; Zhe FENG ; Wei-Guang ZHANG ; Yu-Ning LIU ; Jin-Zhou TIAN ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2023;29(4):308-315
OBJECTIVE:
To investigate the factors related to renal impairment in patients with diabetic kidney disease (DKD) from the perspective of integrated Chinese and Western medicine.
METHODS:
Totally 492 patients with DKD in 8 Chinese hospitals from October 2017 to July 2019 were included. According to Kidney Disease Improving Global Outcomes (KDIGO) staging guidelines, patients were divided into a chronic kidney disease (CKD) 1-3 group and a CKD 4-5 group. Clinical data were collected, and logistic regression was used to analyze the factors related to different CKD stages in DKD patients.
RESULTS:
Demographically, male was a factor related to increased CKD staging in patients with DKD (OR=3.100, P=0.002). In clinical characteristics, course of diabetes >60 months (OR=3.562, P=0.010), anemia (OR=4.176, P<0.001), hyperuricemia (OR=3.352, P<0.001), massive albuminuria (OR=4.058, P=0.002), atherosclerosis (OR=2.153, P=0.007) and blood deficiency syndrome (OR=1.945, P=0.020) were factors related to increased CKD staging in patients with DKD.
CONCLUSIONS
Male, course of diabetes >60 months, anemia, hyperuricemia, massive proteinuria, atherosclerosis, and blood deficiency syndrome might indicate more severe degree of renal function damage in patients with DKD. (Registration No. NCT03865914).
Humans
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Male
;
Diabetes Mellitus, Type 2
;
Diabetic Nephropathies
;
Hyperuricemia
;
Kidney
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Proteinuria
;
Renal Insufficiency, Chronic/complications*
6.Interpretation of the essential updates in guidelines for the prevention and treatment of chronic hepatitis B (Version 2022).
Hong YOU ; Ya Meng SUN ; Meng Yang ZHANG ; Yue Min NAN ; Xiao Yuan XU ; Tai Sheng LI ; Gui Qiang WANG ; Jin Lin HOU ; Zhongping DUAN ; Lai WEI ; Fu Sheng WANG ; Ji Dong JIA ; Hui ZHUANG
Chinese Journal of Hepatology 2023;31(4):385-388
Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association update the guidelines for the prevention and treatment of chronic hepatitis B (version 2022) in 2022. The latest guidelines recommend more extensive screening and more active antiviral treating for hepatitis B virus infection. This article interprets the essential updates in the guidelines to help deepen understanding and better guide the clinical practice.
Humans
;
Hepatitis B, Chronic/drug therapy*
;
Hepatitis B/drug therapy*
;
Hepatitis B virus
;
Antiviral Agents/therapeutic use*
;
Gastroenterology
7.Ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China: a CR-HepB-based real-world study.
Xiao Qian XU ; Hao WANG ; Shan SHAN ; Hong YOU ; Yue Min NAN ; Xiao Yuan XU ; Zhong Ping DUAN ; Lai WEI ; Jin Lin HOU ; Hui ZHUANG ; Ji Dong JIA ; Yuan Yuan KONG
Chinese Journal of Hepatology 2023;31(7):698-704
Objective: To understand ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China. Methods: Patients with chronic HBV infection:demographic, virologic, hematologic, blood biochemistry, and antiviral treatment data were extracted from the China Registry of Hepatitis B (CR-HepB) database between 2012 and 2022 for descriptive statistics and change trend analysis. Multiple group comparisons were conducted using the Kruskal Wallis H test, while counting data was compared between groups using χ (2) test. Results: A total of 180 012 patients with chronic HBV infection were included, with a median age of 40 years old, and a male proportion accounting for 60.2%. The HBeAg positive rate was 43.3%. Over time, the median age of new patients each year increased from 39 to 47 years, while the HBeAg positive rate decreased from 51.3% to 32.8%. The initial diagnosis of patients was mainly CHB (71.4%), followed by hepatitis B cirrhosis (11.8%), inactive HBsAg carrier status (10.6%), and chronic HBV carrier status (6.2%). Among the newly registered patients every year from 2012 to 2022, the proportion of hepatitis B cirrhosis remained stable, but after 2019, the proportion of CHB increased and the proportion of other diagnoses decreased. The proportion of patients with cirrhosis increased with age in different age groups, with 3.5%, 19.3%, and 30.4% in the < 40, 40-69, and≥70 age groups, respectively. The proportion of women in patients with cirrhosis also increased with age, from 16.1% in those < 30 years old to 44.3% in those≥80 years old. From 2012 to 2022, the proportion of patients receiving first-line nucleos(t)ide analog antiviral treatment increased year by year, from 51.0% in 2012-2013 to 99.8% in 2022. Conclusion: The CR-HepB registration data reflect the changes in clinical characteristics and antiviral treatment patterns in patients with chronic HBV infection in China over the past ten years and can thus provide a reference to promote hepatitis B diagnosis and treatment practice, as well as scientific research.
Humans
;
Male
;
Female
;
Adult
;
Aged, 80 and over
;
Antiviral Agents/therapeutic use*
;
Hepatitis B, Chronic/epidemiology*
;
Hepatitis B e Antigens
;
Hepatitis B/drug therapy*
;
Hepatitis B Surface Antigens
;
Hepatitis A
;
Liver Cirrhosis/drug therapy*
;
China/epidemiology*
;
Registries
;
Hepatitis B virus/genetics*
;
DNA, Viral
8.Clinical characteristics of patients with rheumatic diseases and abnormal liver function
Chanyuan WU ; Mucong LI ; Xinwang DUAN ; Hongbin LI ; Yanhong WANG ; Qin LI ; Hui LUO ; Jian XU ; Lijun WU ; Yongfu WANG ; Cheng ZHAO ; Yongfei FANG ; Shudian LIN ; Dong XU ; Xinping TIAN ; Mengtao LI ; Xiaofeng ZENG
Chinese Journal of Internal Medicine 2023;62(9):1102-1113
Objective:To investigate the clinical characteristics of patients with rheumatic diseases and abnormal liver function, as well as determine the proportion and severity of liver function abnormalities.Methods:Cross-sectional study. Data were collected from patients registered in the Chinese Rheumatism Date Center from 2011 to 2021. The rheumatic diseases analyzed in this study were rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren syndrome (SS), ankylosing spondylitis (AS), and gout. Patient data, including demographic characteristics [ such as age, sex, body mass index,(BMI), and smoking history], liver function test results [including alanine aminotransferase (ALT), aspartate aminotransferase, alkaline phosphatase(ALP), and total bilirubin], and use of anti-rheumatic immune drugs and liver-protective drugs, were collected and compared between groups with normal and abnormal liver functions. In addition, the proportions of abnormal liver function were compared between sex and age groups.Results:A total of 116 308 patients were included in this study, including 49 659 with RA, 17 597 with SLE, 9 039 with SS, 11 321 with AS, and 28 692 with gout. The lowest proportion of liver function abnormalities was observed in patients with RA[11.02% (5 470/49 659)], followed by those with SS[17.97% (1 624/9 039)] and AS [18.22% (2 063/11 321) ], whereas patients with SLE [21.14% (3 720/17 597) ] and gout [28.73% (8 242/28 692)] exhibited the highest proportion of these abnormalities. Elevated ALT, mostly classified as grade 1, was the most commonly noted liver function abnormality, whereas elevated ALP was the least common. Some patients who took liver-protective drugs had normal liver function, with the lowest percentage observed in patients with gout [7.45% (36/483) ] and ranging from 21.7% to 30.34% in patients with RA, SLE, SS, and AS. The proportion of liver function abnormalities was higher in males than in females for all disease types [RA: 13.8%(1 368/9 906) vs. 10.3%(4 102/39 753); SLE: 33.6% (479/1 424) vs. 20.0% (3 241/16 173); SS: 25.4%(111/437) vs. 17.6%(1 513/8 602); AS: 20.1%(1 629/8 119) vs. 13.6% (434/3 202); and gout: 29.3% (8 033/27 394) vs. 16.1% (209/1 298)]. In RA, SLE, and AS, the proportions of liver function abnormalities were similar across all age groups. In SS, the proportion of liver function abnormalities increased with age [<40 years: 14.9%(294/1 979); 40-59 years: 18.1%(858/4 741); ≥60 years: 20.4%(472/2 319)], whereas a reversal of this trend was observed in gout [<40 years: 34.9%(4 294/12 320); 40-59 years: 25.5%(2 905/11 398);≥60 years: 21.0%(1 042/4 971)].Conclusions:The proportions of combined liver function abnormalities in patients with rheumatologic diseases were high, and the utilization rates of liver-protective drugs were low. It is necessary to pay more attention to monitoring patients′ liver function, timely administer liver-protective drugs, and optimize liver-protective regimens during the treatment of rheumatic diseases.
9.Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Trial.
Dong-Hai ZHENG ; Jia-Mei YANG ; Jian-Xiong WU ; Shu-Qun CHENG ; Shao-Geng ZHANG ; Dong WU ; Ai-Jun LI ; Xiao-Hui FU ; Xun LI ; Fu-Chen QI ; Wei-Hong DUAN ; Jun-Hui CHEN ; Zhi-Ying YANG ; Lu LIANG ; Jin-Xiong ZENG ; Wei-da ZHENG ; Meng-Chao WU
Chinese journal of integrative medicine 2023;29(1):3-9
OBJECTIVE:
To evaluate the efficacy and safety of Cidan Capsule combined with adjuvant transarterial chemoembolization (TACE) in patients with a high risk of early recurrence after curative resection of hepatocellular carcinoma (HCC).
METHODS:
A multicenter, randomized controlled trial was conducted in patients with high-risk recurrence factors after curative resection of HCC from 9 medical centers between July 2014 and July 2018. Totally 249 patients were randomly assigned to TACE with or without Cidan Capsule administration groups by stratified block in a 1:1 ratio. Postoperative adjuvant TACE was given 4-5 weeks after hepatic resection in both groups. Additionally, 125 patients in the TACE plus Cidan group were administrated Cidan Capsule (0.27 g/capsule, 5 capsules every time, 4 times a day) for 6 months with a 24-month follow-up. Primary endpoints included disease-free survival (DFS) and tumor recurrence rate (TRR). Secondary endpoint was overall survival (OS). Any drug-related adverse events (AEs) were observed and recorded.
RESULTS:
As the data cutoff in July 9th, 2018, the median DFS was not reached in the TACE plus Cidan group and 234.0 days in the TACE group (hazard ratio, 0.420, 95% confidence interval, 0.290-0.608; P<0.01). The 1- and 2-year TRR in the TACE plus Cidan and TACE groups were 31.5%, 37.1%, and 60.8%, 63.4%, respectively (P<0.01). Median OS was not reached in both groups. The 1- and 2-year OS rates in TACE plus Cidan and TACE groups were 98.4%, 98.4%, and 89.5%, 87.9%, respectively (P<0.05). The most common grade 3-4 AEs included fatigue, abdominal pain, lumbar pain, and nausea. One serious AE was reported in 1 patient in the TACE plus Cidan group, the death was due to retroperitoneal mass hemorrhage and hemorrhagic shock, and was not related to study drug.
CONCLUSIONS
Cidan Capsule in combination with TACE can reduce the incidence of early recurrence in HCC patients at high-risk of recurrence after radical hepatectomy and may be an appropriate option in postoperative anti-recurrence treatment. (Registration No. NCT02253511).
10.Analysis of dust hazard characteristics in 59 ferrous metal foundry enterprises in Ningbo City.
Peng Bo LENG ; Dong Hui DUAN ; Xiao Hai LI ; Guo Chuan MAO ; Ling Yan QU ; Dan Dan ZHANG ; Ai Hong WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(8):591-596
Objective: To analyze the post distribution of dust concentration in ferrous metal foundry enterprises and evaluate the occupational health risks, and provide basis for policies of the formulation of pneumoconiosis prevention and control. Methods: From August to September in 2020, the basic information, dust hazard information and occupational health management information of 59 ferrous metal casting enterprises were investigated, the dust concentration distribution was analyzed, and the risk assessment was carried out by using the quantitative assignment model. The dust concentration is tested by LSD method after logarithmic treatment. The 3 times time weighted average allowable exposure concentration of dust is taken as the peak concentration limit of dust; The time weighted average allowable exposure concentration of dust converted by exposure time is taken as the time weighted average exposure concentration limit of dust, and whether the time weighted average exposure concentration and peak concentration of dust at the same post exceed the limit is taken as the basis for exceeding the limit of dust post concentration to calculate the post exceeding the limit rate. Results: The dust hazards were mainly distributed in the posts of sand treatment, molding, sand falling, sand cleaning and cutting and grinding. Dust exposure time weighted average concentration was 0.44 (0.03, 5.11) mg/m(3), peak exposure concentration was 1.30 (0.18, 10.94) mg/m(3), and the over standard rate of Posts was 38.92% (79/203) . Weighted average exposure concentration of other dust (total dust) in the cutting and grinding post is 1.50 (0.15, 7.40) mg/m(3), peak exposure concentration is 0.90 (0.07, 12.48) mg/m(3), and the post exceedance rate is 4.88% (2/41) . Weighted average exposure concentration of silica dust (exhaling dust) in dust operation posts of investment casting enterprises is 0.43 (0.05, 6.35) mg/m(3), peak exposure concentration is 0.90 (0.12, 8.28) mg/m(3), and the post over standard rate is 35.77% (49/137) ; Weighted average exposure concentration of other dust (total dust) at the cutting and grinding post is 2.00 (11.00, 21.00) mg/m(3), and the post exceedance rate is 2.50% (2/80) . There was no significant difference in the concentration of respirable dust between sand casting and investment casting (P>0.05) . The concentration of respirable dust in sand casting was higher than that in sand treatment, molding and sand cleaning posts (P<0.05) . The concentration of silica dust in investment casting was higher than that in sand treatment and molding posts, and that in sand cleaning posts was higher than that in sand treatment posts (P<0.05) . 98.48% (454/461) of the dust operation posts have an occupational health risk value greater than or equal to 400, and 1.52% (7/461) of the dust operation posts have an occupational health risk value of 200~399. Conclusion: there is a high rate of exceeding the standard in the dust work posts in the ferrous metal foundry enterprises in Ningbo, and the workers have a high occupational health risk of pneumoconiosis or metal and its compound pneumoconiosis. Targeted measures should be taken to reduce the occupational health risk.
Air Pollutants, Occupational/analysis*
;
Dust/analysis*
;
Humans
;
Occupational Exposure/analysis*
;
Pneumoconiosis
;
Sand
;
Silicon Dioxide/analysis*

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