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.Tocilizumab therapy for immune checkpoint inhibitor associated myocarditis: a case report.
Si Jin WU ; Xiao Hang LIU ; Wei WU ; Min QIAN ; Ling LI ; Li ZHANG ; Hua Xia YANG ; Mei GUAN ; Jian CAO ; Yi Ning WANG ; Gui Ren RUAN ; Na NIU ; Ying Xian LIU
Chinese Journal of Cardiology 2022;50(4):397-400
3.Clinical application of free/total PSA ratio in the diagnosis of prostate cancer in men over 50 years of age with total PSA levels of 2.0-25.0 ng ml-1 in Western China.
Xue-Dan GAO ; Qiang MIAO ; Jun-Long ZHANG ; Jian-Zhao ZHAI ; Xue-Mei GUI ; Yi-Han CAI ; Qian NIU ; Bei CAI
Asian Journal of Andrology 2022;24(2):195-200
The goal of this study was to investigate the clinical application of free/total prostate-specific antigen (F/T PSA) ratio, considering the new broad serum total PSA (T-PSA) "gray zone" of 2.0-25.0 ng ml-1 in differential diagnosis of prostate cancer (PCa) and benign prostate diseases (BPD) in men over 50 years in Western China. A total of 1655 patients were included, 528 with PCa and 1127 with BPD. Serum T-PSA, free PSA (F-PSA), and F/T PSA ratio were analyzed. Receiver operating characteristic curves were used to assess the efficiency of PSA and F/T PSA ratio. There were 47.4% of cancer patients with T-PSA of 2.0-25.0 ng ml-1. When T-PSA was 2.0-4.0 ng ml-1, 4.0-10.0 ng ml-1, and 10.0-25.0 ng ml-1, the area under the curve (AUC) of F/T PSA ratio was 0.749, 0.769, and 0.761, respectively. The best AUC of F/T PSA ratio was 0.811 when T-PSA was 2.0-25.0 ng ml-1, with a specificity of 0.732, a sensitivity of 0.788, and an optimal cutoff value of 15.5%. The AUC of F/T PSA ratio in different age groups (50-59 years, 60-69 years, 70-79 years, and ≥80 years) was 0.767, 0.806, 0.815, and 0.833, respectively, and the best sensitivity (0.857) and specificity (0.802) were observed in patients over 80 years. The T-PSA trend was in accordance with the Gleason score, tumor node metastasis (TNM) stage, and American Joint Committee on Cancer prognosis group. Therefore, the F/T PSA ratio can facilitate the differential diagnosis of PCa and BPD in the broad T-PSA "gray zone". Serum T-PSA can be a Gleason score and prognostic indicator.
Area Under Curve
;
Humans
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Male
;
Middle Aged
;
Prostate-Specific Antigen
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Prostatic Neoplasms/pathology*
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ROC Curve
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Sensitivity and Specificity
4.Research progress on chemical constituents,pharmacological activities,and quality control of Patrinia villosa.
Yu FAN ; Dong-Mei SHA ; Ma-Li-Niu SHA ; Jian-Long LAN ; Lai-Yue-Bu HAI ; Bie-Jun-Zhang QU ; Xin-Jia YAN ; Yuan LIU
China Journal of Chinese Materia Medica 2022;47(22):6005-6019
Patrinia villosa, regarding its functions in clearing heat and detoxification and eliminating carbuncles and pus, is widely used as a traditional medicinal herb that contains rich nutrition and substances such as various amino acids, vitamins, and soluble su-gar, and it is also an edible wild herb in Chinese folk tradition for 2 000 years. In 1973, Japanese scholars firstly separated three iridoids from Japanese P. villosa, and by 2021, chemical components such as flavonoids, iridoids, organic acids, triterpenoids, phenylpropanoids, and steroids have been found, which have multiple pharmacological effects, including antioxidant, antitumor, anti-diarrhea, antibacterial, sedative, and liver protection capabilities. Studies indicate that flavonoids, saponins, phenylpropanoids, and triterpenoids in P. villosa are vital substances for its pharmacological activities. However, the quality of this medicinal material cannot be controlled due to the unclear records in ancient books in the past dynasties and different drug use habits in different places, and thus its circulation is chaotic. At present, researchers have used flavonoids, organic acids, phenylpropanoids, triterpenoid saponins, and other compounds to conduct studies in this regard. Therefore, on the basis of the existing literature resources, we comprehensively summarize the chemical constituents, pharmacological activities, and quality control of P. villosa to further provide a reference for the safety and effectiveness of clinical drug use and lay a foundation for the follow-up experimental research.
Patrinia/chemistry*
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Flavonoids/pharmacology*
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Saponins
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Triterpenes/pharmacology*
;
Iridoids
;
Quality Control
5.Heterotopic ossification after arthroscopy for hip impingement syndrome.
Guan-Ying GAO ; Xin ZHANG ; Ling-Hui DAI ; Hong-Jie HUANG ; Rui-Qi WU ; Xiao-Dong JU ; Yu MEI ; Xing-Yue NIU ; Jian-Quan WANG ; Yan XU
Chinese Medical Journal 2019;132(7):827-833
BACKGROUND:
Heterotopic ossification (HO) is a known complication of hip arthroscopy. We investigated incidence of HO after hip arthroscopy and determined whether revision for HO improved outcome.
METHODS:
A retrospective study was conducted on 242 patients (140 men and 102 women, mean age: 36.2 ± 9.5 years) who underwent hip arthroscopy for femoroacetabular impingement (FAI) between January 2016 and January 2018. The average follow-up period was 22.88 ± 11.74 months (range: 11-34 months). Thirteen (5.37%) cases of HO (six men and seven women, five left hips and eight right hips; mean age: 37.5 ± 4.7 years) were observed. Among them, four cases with HO with obvious pain symptoms and persistent non-remission underwent revision surgery to remove HO. Monthly follow-up was conducted. Visual analog scale (VAS), modified Harris Hip Score (mHHS), and non-Arthritis Hip Score (NAHS) were evaluated and compared between HO and non-HO patients. Independent sample t test, Mann-Whitney U test and the Chi-square test were used for inter-group comparisons. HO degree was evaluated using Brooker classification. Symptoms and function were evaluated before and after revision.
RESULTS:
A total of 242 patients were involved in this study. Thirteen cases (5.4%) had imaging evidence of HO. Nine (9/13) were classified as Brooker stage I, three (3/13) Brooker stage II, and one (1/13) Brooker stage III. HO was detected by ultrasonography as early as 3 weeks after operation. After primary surgery, the mHHS of the HO group and non-HO group increased by 13.00 (8.50, 25.50) and 24.00 (14.00, 34.50) points (Z = -1.80, P = 0.08), NAHS increased by 18.00 (9.50, 31.50) and 26.00 (13.50, 36.00) points (Z = -1.34, P = 0.18), and VAS decreased by 3.00 (2.00, 4.00) and 4.00 (3.00, 4.50) points (Z = -1.55, P = 0.12). Average follow-up time after revision was 9.00 ± 2.94 months; mHHS increased by 34.75 points (t = -55.23, P < 0.01) and NAHS by 28.75 points (t = -6.03, P < 0.01), and VAS decreased by 4 points (t = 9.80, P < 0.01). HO and non-HO patients were similar for demographic and surgical data, and clinical and functional scores.
CONCLUSION
HO incidence after arthroscopic treatment of FAI is similar to that found in previous studies. Most HO have no effect on clinical symptoms. Patients who undergo revision HO resection show improvement in pain and joint function.
Adult
;
Arthroscopy
;
adverse effects
;
Female
;
Femoracetabular Impingement
;
surgery
;
Hip Joint
;
pathology
;
surgery
;
Humans
;
Male
;
Middle Aged
;
Ossification, Heterotopic
;
diagnosis
;
etiology
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Retrospective Studies
;
Treatment Outcome
6.Prevalence and influencing factors of peritoneal calcification in patients with long peritoneal dialysis duration
Qingyu NIU ; Huiping ZHAO ; Bei WU ; Jian WU ; Li ZUO ; Mei WANG
Chinese Journal of Nephrology 2018;34(4):241-248
Objective To investigate the prevalence and related factors of peritoneal calcification in peritoneal dialysis(PD)patients with long dialysis duration,and to explore the relationship between peritoneal calcification and vascular calcification.Methods This cross-section study enrolled PD patients who had received PD for more than 4 years in Peking University People's Hospital.Peritoneal calcification and abdominal aortic calcification were reviewed by CT scan.Demographic data,clinical characteristics,laboratory data including calcium phosphorus metabolism indexes(Ca,P,ALP and iPTH)and PD adequacy were collected.The influencing factors of peritoneal calcification were analyzed by Logistic regression analysis.The correlation between peritoneal calcification and abdominal aortic calcification were tested by Spearman correlation analysis.SPSS 19.0 was used for statistical analysis.Results(1)Seventy-nine PD patients were enrolled:32 males(40.5%);mean age was(58.7±13.1)years and average PD duration was 77.25(58.00,88.00)months.The major primary diseases were glomerulonephritis(46.8%)and diabetic nephropathy(30.4%).(2)6 patients(7.6%)had CT-detectable peritoneal calcification.77(97.5%)patients were found with various degrees of peritoneal thickening.The prevalence of peritoneal calcification was 7.6%in patients with PD duration more than 4 years,10.3%in patients with PD duration more than 6 years,18.8%in patients with PD duration more than 8 years and 40.0%in patients with PD duration more than 10 years,showing an increasing trend.Compared with non-peritoneal calcification group,the patients in peritoneal calcification group received higher doses of Vitamin D(P < 0.001)and lower triglyceride levels(P=0.041).The patients were divided into two groups according to whether dialysis duration was longer than 9 years,and the proportion of patients with long PD duration in peritoneal calcification group was higher(P=0.013).Logistic regression analysis showed that PD duration,calcium and phosphorus metabolism indexes were not independent risk factors of peritoneal calcification.High vitamin D dose was an independent risk factor for peritoneal calcification(B=2.667,OR=14.394,95%CI 1.655-125.165,P=0.016).(3)74 patients were found with abdominal aortic calcification in different degrees,and the prevalence rate of abdominal aortic calcification was 93.7%.Spearman correlation analysis showed that there was no correlation between peritoneal calcification and vascular calcification(r=0.70,P=0.542).Conclusions The prevalence of peritoneal calcification in long PD duration patients is low.Peritoneal calcification may be associated with high Vitamin D dose and long PD duration.
7.External Quality Analysis of Quality Indicators on Specimen Acceptability
Yuan-Yuan YE ; Wei WANG ; Hai-Jian ZHAO ; Feng-Feng KANG ; Wei-Xing LI ; Zhi-Ming LU ; Wei-Min ZOU ; Yu-Qi JIN ; Wen-Fang HUANG ; Bin XU ; Fa-Lin CHEN ; Qing-Tao WANG ; Hua NIU ; Bin-Guo MA ; Jian-Hong ZHAO ; Xiang-Yang ZHOU ; Zuo-Jun SHEN ; Wei-Ping ZHU ; Yue-Feng L(U) ; Liang-Jun LIU ; Lin ZHANG ; Li-Qiang WEI ; Xiao-Mei GUI ; Yan-Qiu HAN ; Jian XU ; Lian-Hua WEI ; Pu LIAO ; Xiang-Ren A ; Hua-Liang WANG ; Zhao-Xia ZHANG ; Hao-Yu WU ; Sheng-Miao FU ; Wen-Hua PU ; Lin PENG ; Zhi-Guo WANG
Journal of Modern Laboratory Medicine 2018;33(2):134-138,142
Objective To analyze the status of quality indicators(QI) on specimen acceptability and establish preliminary qual ity specification.Methods Web based External Quality Assessment system was used to collect data of laboratories partici pated in "Medical quality control indicators in clinical laboratory" from 2015 to 2017,including once in 2015 and 2017 and twice in 2016.Rate and sigma scales were used to evaluate incorrect sample type,incorrect sample container,incorrect fill level and anticoagulant sample clotted.The 25th percentile (P25) and 75th percentile (P75) of the distribution of each QI were employed to establish the high,medium and low specification.Results 5 346,7 593,5 950 and 6 874 laboratories sub mitted the survey results respectively.The P50 of biochemistry (except incorrect fill level),immunology and microbiology reach to 6σ.The P50 of clinical laboratory is 4 to 6σ except for incorrect sample container.There is no significant change of the continuous survey results.Based on results in 2017 to establish the quality specification,the P25 and P75 of the four QIs is 0 and 0.084 4 %,0 and 0.047 6 %,0 and 0.114 2 %,0 and 0.078 4 %,respectively.Conclusion According to the results of the survey,most laboratories had a faire performance in biochemistry,immunology and microbiology,and clinical laboratory needs to be strengthened.Laboratories should strengthen the laboratory information system construction to ensure the actual and reliable data collection,and make a long time monitoring to achieve a better quality.
8. Effects of different light on the ethology and melatonin secretion in depressive rats
Shu-Zhe ZHOU ; Wei-Min DANG ; Guo-Yi ZHANG ; Tian-Hang ZHOU ; Jian LIN ; Tian-Mei SI ; Ji-Tao LI ; Zhong-Kai HE ; Can-Tao ZHONG ; Sheng WANG ; Li ZHAO ; Yong-Zhi WANG ; Wei WEI ; Zhen-Lie HUANG ; Kuo ZHANG ; Zhi-Zhong CHEN ; Yi LIU ; Yang LIU ; Rong-Sheng ZHAO ; Hai-Ming SUN ; Si-Heng LI ; Rong-Feng NIU ; Yu-Zhen TONG ; Yan-Tao MA ; Xin YU
China Occupational Medicine 2016;43(01):8-14
OBJECTIVE: To observe the impact of energy saving light,incandescent light and circadian light on the ethology of depressive rats and explore its possible mechanism on affecting the secretion of melatonin. METHODS: Thirty rats aged 6weeks were randomly selected from 40 specific pathogen free health female SD rats after they adapted to the living environment,depressive rat models were established in the rats by bilateral ovariectomy combined with isolated living and chronic unpredictable mild stress stimulation at the age of 11-14 weeks. Then these 30 ovariectomized rats were randomly divided into 3 intervention groups,including an energy saving light group,an incandescent light group and a circadian light group,with 10 rats in each group. The rats in these 3 groups were given specific experimental light intervention for 3 weeks respectively at the age of 17 weeks. The other 10 rats were raised in conventional environment as the control group. Their body weights were measured at the age of 17,19,20 and 21 weeks. The ethology tests were carried out by sucrose preference test and the open-field test at the age of 7,14 and 20 weeks respectively. The melatonin levels in peripheral blood of 7 time points from 19: 30 to 8: 30 were measured in the rats at age of 21 weeks. One rat in each group at every time point was randomly selected for examination. RESULTS: At the age of 17 weeks before light-intervention,the body weights of rats in 4 groups showed no significant difference( P > 0. 05). After light-intervention,at the age of 17-20 weeks,the body weights of rats in 3 intervention groups were gradually increased with the increase of age( P < 0. 05).There was no significant difference between body weights of rats at the age of 21 weeks and those at the age of 20 weeks in each group( P > 0. 05). At age of 7 weeks,no significant differences were found in sucrose consumption and standing scores among these 4 groups( P > 0. 05). After the depressive models were established,at the age of 14 weeks before light-intervention,in rats of these 3 intervention groups,the sucrose consumption and standing scores were lower than those of the control group( P < 0. 05),and there was no significant difference found in the above 2 indexes among these 3intervention groups( P > 0. 05). At the age of 20 weeks after light-intervention,the sucrose consumption and standing scores were not significantly different from each other among the 4 groups( P > 0. 05). The peak levels of melatonin in the peripheral blood of rats in these 3 intervention groups were higher than that in the control group. The peak levels onsets of melatonin in peripheral blood of rats in the circadian light group and the energy saving light group were earlier or 2 hours delayed compared to that of control group,while it was similar between the incandescent light group and control group.CONCLUSION: The circadian light,the energy saving light and the incandescent light are similarly effective in improving the behaviors of depressive rats. The circadian light can delay the onset of peak level of melatonin in peripheral blood.
9.A new phenylpropanoid glycoside compound isolated from Karelinia caspia
Jiang-bo HE ; Yan-fen NIU ; Jian TAO ; Jing JIA ; Bo WANG ; Xue-mei ZHANG ; Fang HE ; Hua-jie ZHU
Acta Pharmaceutica Sinica 2016;51(4):613-
To study the constituents of Karelinia caspia (Pall.) Less, three phenylpropanoid derivatives and other compounds were isolated by silica gel, RP-18 chromatographic methods. Compound 1 was a new phenylpropanoid glycoside named as kareline A. Their structures were determined by spectroscopic analysis, including 1D- and 2D-NMR and mass spectrometry.
10.Association between APOC3 promoter region polymorphisms and non-alcoholic fatty liver disease.
Tonghong NIU ; Man JIANG ; Haogang LIU ; Xiangjun JIANG ; Zhonghua LIN ; Mei ZHANG ; Jian WANG ; Ning GENG ; Yongning XIN ; Shiying XUAN
Chinese Journal of Hepatology 2014;22(5):374-379
OBJECTIVETo investigate the association between two polymorphisms of the APOC3 gene (T-455C and C-482T) and hereditary risk of non-alcoholic fatty liver disease (NAFLD).
METHODSA total of 287 patients with NAFLD and 310 control subjects were genotyped by PCR and direct sequencing. Serum lipid profiles were also detected by standard biochemical
METHODSOne-hundred-and-eighty of the study participants were used to measure the APOC3 content by enzyme-linked immunosorbent assay. Inter-group differences and associations were assessed statistically using Chi square and t tests and logistic and linear regression analyses.
RESULTSThe frequencies of neither the genotypes or alleles were significantly different between the NAFLD cases and the controls. Compared with the most common genotypes-455TT or-482CC, none of the variants showed a significant increase in risk of NAFLD or for the clinical and biochemical parameters. The adjusted odds ratios (with 95% confidence intervals) of NAFLD were 1.25 (0.79-1.96) and 1.20 (0.76-1.89) for carriers of the APOC3-455C and-482 T variants respectively (P more than 0.05).
CONCLUSIONThe T-455C and C-482T polymorphisms of the APOC3 gene are not associated with risk of NAFLD, pathogenic changes in lipid profiles, or insulin resistance in Han Chinese.
Adult ; Aged ; Alleles ; Apolipoprotein C-III ; genetics ; Case-Control Studies ; Female ; Gene Frequency ; Genotype ; Humans ; Insulin Resistance ; Lipids ; blood ; Male ; Middle Aged ; Non-alcoholic Fatty Liver Disease ; genetics ; metabolism ; Polymorphism, Single Nucleotide ; Promoter Regions, Genetic ; Young Adult

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