1.Simultaneous Determination of 30 Compounds Illegally Added in Chinese Patent Medicine for Promoting Blood Circulation and Removing Blood Stasis Medicine by UHPLC-MS/MS
Linlin ZHANG ; Zheng LI ; Huan YANG ; Cheng ZHENG ; Dengfeng TANG ; Bilian CHEN
Chinese Journal of Modern Applied Pharmacy 2024;41(3):359-365
OBJECTIVE
To establish an ultra-performance liquid chromatography-tandem mass spectrometry method for the simultaneous determination of 30 compounds(including antianginal drugs, anticoagulant, anti-platelet aggregators and anti-inflammatory analgesics) illegally added in Chinese patent medicine for promoting blood circulation and removing blood stasis.
METHODS
The sample was extracted by ultrasonication with 60% methanol. The analysis was performed on Phenomenex Kinetex C18 column (2.1 mm×100 mm, 2.6 μm) with gradient elution using 0.1% formic acid solution and acetonitrile as the mobile phase at the flow rate of 0.3 mL·min–1, and the column temperature was 40 ℃. Mass spectrometry was collected using electrospray ionization (ESI), simultaneous scanning of positive and negative ions, and multiple reaction monitoring mode.
RESULTS
The linearity of the 30 compounds was good in the mass range examined, with the correlation coefficients all >0.999. The limits of detection of each compound ranged from 1.3 to 238.4 ng·g–1 and the average recoveries ranged from 63.7% to 108.2% with the RSDs of 1.0% to 6.7%. The method was used to test 90 batches of Shujin Huoxue tablets. Paracetamol was detected in 3 batches, while the rest of the compounds were not detected. The amount of paracetamol detected ranged from 0.16 to 0.93 μg per tablet, which was much lower than the minimum daily dose of the corresponding drug, excluding intentional addition. The probable explanation was the residues caused by incomplete cleaning validation of the enterprise’s collinear production.
CONCLUSION
This method is rapid, accurate, highly sensitive, and highly selective, and can be used for qualitative screening and quantitative determination of 30 chemical compounds illegally added in Chinese patent medicine for promoting blood circulation and removing blood stasis.
2.Investigation of an outbreak of sapovirus infection in a middle school in Chaozhou City , Guangdong Province in 2022
CHEN Xiaobin ; CHEN Shaoxiong ; LI Dengfeng
China Tropical Medicine 2024;24(5):603-
Abstract: Objective To comprehend the gastroenteritis outbreak triggered by sapovirus (SaV) in a middle school located in Chaozhou City in 2022, ultimately providing a scholarly reference for the implementation of preventive and control measures against contagious diarrhea within educational institutions. Methods Descriptive epidemiological methods were employed to analyze the epidemiological characteristics of the outbreak. A 1∶3 case-control study was conducted to identify potential correlation factors. Anal swab specimens from students and kitchen workers, food samples from the cafeteria, and environmental swab samples were collected for nucleic acid PCR testing of Sapovirus, Norovirus, Staphylococcus aureus, five types of enterotoxigenic Escherichia coli, Salmonella, and Bacillus cereus. One SaV-positive nucleic acid sample was randomly selected for VP1 capsid protein sequencing. Results A total of 148 sapovirus cases and 6 asymptomatic infections were reported in this outbreak. The predominant clinical manifestations were vomiting (83.1%), nausea (38.5%), and vertigo (24.3%), with no fever symptoms reported. The peak incidence was recorded on March 20, showing a propagative and point source exposure pattern. Cases were distributed across 83.3% of the classes in the school, with the highest incidence rate of 32.69% in Class 311. The case-control study revealed that having lunch on campus on March 18 was a significant correlation factor for the disease (OR=4.17, 95%CI: 1.58-11.00). A total of 43 students and 23 kitchen workers anal swab specimens, 7 food samples, and 9 cafeteria environmental swab samples were collected. Of these, 20 students and 6 kitchen workers anal swab specimens tested positive for SaV nucleic acid, while the remaining samples returned negative results. Gene sequencing indicated the presence of the GI.6 genotype. Hygiene investigation exposed improper food handling practices among some kitchen workers. Conclusions This outbreak was caused by a GI.6 genotype SaV infection, with exposure in the cafeteria on March 18 being the primary contributing factor for the outbreak and subsequent spread.
3.Safety and immunogenicity of freeze-dried rabies vaccine (Vero-cells) for human use in healthy people aged 9-65 years.
Li Li HUANG ; Zhi Qiang XIE ; Wei ZHANG ; Ke ZHANG ; Yan Xia WANG ; Ze Qian WANG ; Xiao Jing WU ; Dong Mei LIU
Chinese Journal of Preventive Medicine 2023;57(2):222-228
Objective: To assess the safety and immunogenicity of freeze-dried rabies vaccine (Vero-cells) for human use on different immunization procedures in healthy people aged 9-65 years. Methods: A randomized, blind, positive-controlled clinical study was conducted in March 2015. The eligible residents aged 9-65 were recruited in Dengfeng city and Biyang County, Henan Province. A total of 1 956 subjects were enrolled. The subjects were randomly (1∶1∶1) assigned to 5-dose control group, 4-dose trial group and 5-dose trial group, with 652 subjects in each group. The subjects of 5-dose control group were immunized with control vaccine on days 0, 3, 7, 14 and 28. The subjects of 4-dose trial group were immunized with trial vaccine on days 0, 7 and 21 (2-1-1 phases) and the subjects of 5-dose trial group were immunized with trial vaccine on days 0, 3, 7, 14 and 28. A combination of regular follow-up and active reporting was used to observe local and systemic adverse reactions till 30 days after the first and full immunization, and the incidence rate of adverse reactions in three groups was analyzed and compared. The venous blood was collected before the first immunization, 7 days after the first immunization, 14 days after the first immunization and 14 days after the full immunization. The neutralizing antibody of rabies virus was detected by rapid fluorescent focus inhibition test (RFFIT), and the seropositive conversion rate and geometric mean concentration (GMC) of antibody were calculated. Results: The adverse reaction rates in 5-dose control group, 4-dose trial group and 5-dose trial group were 41.87% (273/652), 35.43% (231/652) and 34.97% (228/652), respectively. The adverse reaction rates of 4-dose trial group and 5-dose trial group were lower than those of the 5-dose control group (P<0.05). The local reactions were mainly pain, itching, swelling and redness in injection site, while the systemic reactions were mainly fever, fatigue, headache and muscle pain. The severity of adverse reactions was mainly mild (level 1), accounting for 85.33% (518/607), 89.02% (373/419) and 88.96% (427/480) of the total number of adverse reactions in each group. At 14 days after the first immunization and 14 days after the full immunization, the antibody positive conversion rates of three groups were all 100%. At 7 days, 14 days after the first immunization and 14 days after the full immunization, the GMCs of three groups were 0.60, 0.72, 0.59 IU/ml, 20.42, 23.99, 24.38 IU/ml and 22.95, 23.52, 24.72 IU/ml, respectively, with no significant difference (P>0.05). Conclusion: The freeze-dried rabies vaccine (Vero-cells) for human use has good safety and immunogenicity when inoculated according to 5-dose and 4-dose immunization procedures.
Humans
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Rabies Vaccines
;
Antibodies, Viral
;
Antibodies, Neutralizing
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Rabies virus
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Vaccination
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Rabies/prevention & control*
4.Therapeutic Effect of Modified Baqia Baweitang on Diabetic Foot Due to Dampness-heat Toxicity
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(23):114-121
ObjectiveTo observe the clinical effect of modified Baqia Baweitang on diabetic foot due to dampness-heat toxicity. MethodOne hundred and four patients were randomized into control and observation groups (52 cases). The control group was treated with epalrestat combined with Compound Huangbai Liquid, and the observation group with modified Baqia Baweitang on the basis of the therapy in the control group. The resting pain, intermittent claudication, foot cold feeling, traditional Chinese medicine (TCM) symptoms, ulcer area, ulcer surface pH, ulcer depth, and percutaneous oxygen partial pressure were measured before and after treatment. The blood glucose and lipid levels [fasting blood glucose (FPG), 2 h postprandial blood glucose (2 h PG), triglyceride (TG), and total cholesterol (TC)], hemorheological indexes (peak blood flow, blood flow, vascular diameter, and pulse index), motor and sensory nerve conduction velocity, and inflammatory cytokines [tumor necrosis factor-α (TNF-α), interleukin (IL)-6, IL-13, and C-reactive protein (CRP)] in the serum and skin lesions were determined. The clinical efficacy and safety were compared between the two groups. ResultThe total response rate in the observation group was 96.2% (50/52), which was higher than that (80.8%, 42/52) in the control group (χ2=6.029, P<0.05). The treatment in both groups decreased the resting pain, intermittent claudication, foot cold feeling, TCM symptom scores, ulcer area, ulcer surface pH, and ulcer depth (P<0.05) and increased the percutaneous oxygen partial pressure (P<0.05). Furthermore, the treatment lowered the levels of FPG, 2 h PG, TG, TC, blood flow peak, TNF-α, IL-6, IL-18, and CRP (P<0.05) and increased the blood flow, vascular diameter, pulse index, and the motor and sensory nerve conduction velocity (P<0.05). Moreover, the changes in the above indexes were more significant in the observation group than in the control group (P<0.05).The incidence of adverse reactions was 21.2% (11/52) in the control group and 23.1% (12/52) in the observation group, with no statistical significance. ConclusionModified Baqia Baweitang can promote wound healing, improve the dorsal artery hemorheology of feet, accelerate nerve conduction, and reduce inflammation in the patients with diabetic foot due to dampness-heat toxicity.
5.Application of KARL iterative algorithm combined with low-dose CT scanning in young and middle-aged patients with femoral neck fractures
Jinping FANG ; Dongdong LI ; Dengfeng ZHENG ; Feibin LIU
Chinese Journal of Postgraduates of Medicine 2023;46(10):939-943
Objective:To investigate the application value of KARL iterative algorithm combined with low-dose CT scanning in young and middle-aged patients with femoral neck fractures.Methods:The clinical data of 132 young and middle-aged patients with femoral neck fractures diagnosed by clinical and CT scan in Taizhou Bo′ai Hospital from August 2019 to May 2022 were collected. There were 68 cases in the conventional dose group reconstructed by projection, and 64 cases in the low dose group reconstructed by KARL iterative algorithm. The subjective image quality score, the excellent and good rates and CT value, signal to noise ratio (SNR) were compared between the two groups. The effective dose (ED), CT dose index (CTDIvol), dose-length product (DLP) were compared between the two groups.Results:There were no significant differences in subjective image quality score, the excellent and good rates between the two groups ( P>0.05). There were no significant differences in CT values and SNR of the trabecular dense area at the central level of the femoral head, the iliopsoas muscle at the same level, and the anterior abdominal wall or buttocks subcutaneous fat at the same level between the two groups ( P>0.05). The levels of CTDIvol, DLP and ED in he low-dose group were lower than those in the conventional dose group: (3.35 ± 1.05) mGy vs. (12.90 ± 2.92) mGy, (66.33 ± 20.26) mGy/cm vs. (253.12 ± 58.57) mGy/cm, (0.99 ± 0.30) mSv vs. (3.79 ± 0.88) mSv, there were statistical differences ( P<0.05). Conclusions:Based on KARL iterative algorithm combined with low-dose CT scanning has no significant effect on the clinical diagnosis and classification of femoral neck fractures, the scanning image has a high objective evaluation value, and can effectively reduce the radiation dose received by patients, which is useful for clinical preoperative diagnosis and surgical planning.
6.Research on the present situation of detection strategies for infectious markers related to transfusion transimission in China
Wei TAN ; Shengyan YING ; Ning CHENG ; Yujun LI ; Xiaoli CHEN ; Fang WANG ; Yang ZHANG ; Xiaojie LIU ; Lin BAO ; Yong DUAN ; Chen MA ; Chunlan LIU ; Dengfeng WANG ; Zhijun ZHEN ; Li LI ; Jian ZHANG ; Ranran LU ; Peng WANG ; Mingxia LI ; Xinli JIN ; Xiaobo CAI ; Mei YU ; Jianling ZHONG ; Lili ZHU ; Jianping LI
Chinese Journal of Experimental and Clinical Virology 2023;37(4):383-388
Objective:To analyze the detection strategy and basic detection situation of markers of infectious diseases transmitted by transfusion in blood testing laboratories of blood stations in China.Methods:Based on the data of practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021, the data on the testing strategies and the basic detection information of the markers for the transmission of infectious diseases through transfusion in the member laboratories of the practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021 were collected, and the situation of the selection for testing markers, testing strategy and the testing method and other relevant aspects were sorted out and analyzed by charts.Results:The selection of the testing markers was consistent, but HTLV testing item was added in some member laboratories. The detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously was adopted in 47 member blood stations; 3) NAT method was dominated by mini pool-NAT in member laboratories. The number of members adopting mini-pools of 8 (MP8)-NAT decreased from 17 in 2017 to 14 in 2021, while the number of members adopting mini-pools of 6 (MP6)-NAT increased from 13 in 2017 to 22 in 2021; Roche NAT system accounted for the largest proportion.Conclusions:In order to ensure blood safety and avoid missing detection, the blood stations still adopt the detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously; Meanwhile, in order to increase the NAT positive rate, the proportion of mini pool-NAT mainly decreased year by year despite its dominating role, while the proportion of individual donation-NAT increased year by year; NAT method is transiting from mini-pools of 8 (MP8) to mini-pools of 6 (MP6); The proportion of imported NAT system used in NAT laboratory is relatively large.
7.Effects of demand-oriented system training in the training of advanced nurses in the Chest Pain Center Cardiac Catheterization Laboratory
Yuhui LI ; Zeya SHI ; Jinhua ZHOU ; Wenyao XIE ; Dengfeng YU ; Yu ZHANG
Chinese Journal of Modern Nursing 2022;28(7):963-967
Objective:To explore the effect of the demand-oriented system training in the training of advanced nurses in the Chest Pain Center Cardiac Catheterization Laboratory.Methods:From January 2018 to December 2020, convenience sampling was used to select nurses who were trained in the Chest Pain Center Cardiac Catheterization Laboratory of Hunan Provincial People's Hospital as the research subject. The nurses who engaged in advanced studies from January 2018 to June 2019 were set as the control group ( n=57) , and the nurses who engaged in advanced studies from July 2019 to December 2020 were set as the observation group ( n=60) . The control group conducted traditional training, and the observation group carried out demand-oriented system training on the basis of the control group. The theoretical and operational assessment scores, comprehensive ability and satisfaction were compared between the two groups of nurses before and after advanced studies. Results:After the intervention, the nurses in the observation group had higher scores in theoretical and operational assessment, clinical skill and management in comprehensive ability and the satisfaction score than those in the control group, and the differences were statistically significant ( P<0.05) . Conclusions:The effect of the demand-oriented system training in the advanced nurses in the Chest Pain Center Cardiac Catheterization Laboratory is better than the traditional training, and it is worthy of clinical promotion.
8.HIV-, HBV- and HCV- NAT yield in individual donations: a multi-center analysis in Henan province from 2017 to 2019
Yan ZHANG ; Jianhua FANG ; Wenchao GE ; Yifang WANG ; Qi JIANG ; Shanhua CHEN ; Dan CHEN ; Jia WU ; Nan CHEN ; Yu MENG ; Huiyun HAN ; Dengfeng WANG ; Xiaozhen ZHANG ; Yue ZHANG ; Fengyong MA ; Bin JIA ; Weijie LI ; Sili SUN ; Fei ZHAO ; Yongqing ZHOU ; Suneng ZHANG
Chinese Journal of Blood Transfusion 2021;34(1):68-72
【Objective】 To analyze the HIV-, HCV- and HBV- NAT yield rate in different areas of Henan province, so as to provide the basis for disease prevention and control as well as the establishment of a unified quality control standard for nucleic acid testing(NAT) in the Henan province. 【Methods】 The number and prevalence of NAT yielding samples with isolated infectious virus, namely HIV, HCV and HBV, in 18 blood stations in Henan province from 2017~2019, as well as the trends were analyzed. The NAT quality of each laboratory and each testing system was analyzed according to the ratio of reactive individual donation(ID) results to reactive minipools(MP). 【Results】 The HBV, HCV and HIV ID-NAT yield numbers in 3 501 251 blood donations were HBV 2 606(74/100 000), HCV 21 (0.63/100 000), and HIV 34(1.00/100 000). The HBV ID-NAT yield rate showed an upward trend in the whole province from 2017 to 2019, while the prevalence of HIV and HCV ID-NAT yield didn′t differ significantly during three years. 5 kinds of NAT detection systems were applied in 18 blood centers. among which Ⅰ, Ⅱ, Ⅳ and Ⅴ were triplex detection systems. 2661 ID-reactive samples were implicated in 5 595 MP-reactive samples, with a resolution rate of 47.56%. The resolution rate of triplex NAT system Ⅰ, Ⅱ, Ⅳ and Ⅳ was 39.63%~47.95%, 40.43%~54.36%, 51.61% and 70.00%~45.45%, respectively. An upward trend in triplex NAT resolution rate was observed in 8 laboratories, i. e.B, D, E, F, I, K, L and Q, and an descending trend in A and C. The NAT system Ⅲ, a ID-NAT system, was used only by laboratory C, presenting a NAT-yield rate of 0.19% (282/145 474) and resolution rate of 46.45% (131/282). 【Conclusion】 The majority of NAT-yield of one infectious virus in Henan province is HBV, presenting annual increasing trend. The quality management of NAT laboratories should be strengthened as the divergence was seen in the performance of different NAT laboratories.
9.Single-ELISA reactive rate of four blood screening items in 18 blood station laboratories: Henan, 2019
Yan ZHANG ; Mingjun CHEN ; Hongna ZHAO ; Yonglei LV ; Jianhua FANG ; Qi JIANG ; Shanhua CHEN ; Dan CHEN ; Jia WU ; Nan CHEN ; Yu MENG ; Huiyun HAN ; Dengfeng WANG ; Xiaozhen ZHANG ; Yue ZHANG ; Fengyong MA ; Bin JIA ; Junjie LI ; Sili SUN ; Fei ZHAO ; Yongqing ZHOU ; Suneng ZHANG
Chinese Journal of Blood Transfusion 2021;34(8):878-882
【Objective】 To analyze the cause of single-ELISA reactive of four blood screening items in 18 blood stations in Henan, so as to provide the basis for improving the quality of blood screening. 【Methods】 The single-ELISA reactive rate of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP of 18 blood station laboratories in Henan throughout 2019 was calculated, and the causes were analyzed according to different ELISA reagent combinations and gray area settings in each laboratory. 【Results】 The overall single-ELISA reactive rates of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP were 1.740(2 154/1 237 789), 0.564‰(698/1 237 789), 1.421‰(1 759/1 237 789) and 1.561‰(1 932/1 237 789), respectively, showing significant differences by detection items (P <0.05). Person correlation analysis showed that the single-ELISA reactive rate was independent of the gray area settings.but dependent on laboratories and reagent combinations. The single-ELISA reactive rate of HBsAg, anti-HCV, HIV Ag/Ab and anti-TP in D laboratory was the highest and higher than that in other labs using the same reagent.The laboratories with high HBsAg single-ELISA reactive rate were mostly those using a combination of imported reagents and domestic reagents, including the top 6 laboratories. The laboratories with high anti-HCV single-ELISA reactive rate were mostly those using certain domestic reagents. No obvious rules was noticed by single-ELISA reactive for anti-HIV. Laboratories with high anti-TP single-ELISA reactive rate were mostly those using combination 4. 【Conclusion】 The HBsAg single-ELISA reactive rate was the highest in the four blood screening items of blood station laboratories in Henan. The single-ELISA reactive rate is related to the laboratory itself and the reagent manufacturer, suggesting that laboratory quality control should be strengthened and proper reagent combination should be selected to reduce the waste of blood.
10.Distribution characteristics of blood pressure in Hainan centenarians
Jing LI ; Shengshu WANG ; Shanshan YANG ; Penggang TAI ; Fuyin KOU ; Yali ZHAO ; Wangping JIA ; Wenzhe CAO ; Ke HAN ; Fuxin LUAN ; Dengfeng ZHOU ; Sibing ZHANG ; Liang LIU ; Qiao ZHU ; Chaoxue NING ; Miao LIU ; Yao HE
Chinese Journal of Epidemiology 2021;42(1):73-79
Objective:To explore the blood pressure levels and the influencing factors of hypertension among Hainan centenarians, and provide basic data for the further blood pressure related studies of the centenarian population.Methods:The baseline data were from China Hainan Centenarian Cohort Study (CHCCS). This cross-sectional data, based on the community population, was a complete sample study of centenarians, including questionnaire survey, physical examination and physiological index detection. A total of 1 002 centenarians were recruited to describe the blood pressure level. According to the guidelines for the prevention and treatment of hypertension in Chinese adults in 2018, the prevalence of hypertension was analyzed.Results:The median levels of systolic blood pressure, diastolic pressure and pulse pressure were 152.0, 76.0 and 76.5 mmHg, respectively. Blood pressure level was higher in females than in males. The prevalence of hypertension was 71.9%, mainly in isolated systolic hypertension with the prevalence of 60.1%. The results of multivariate analysis showed that the risk of hypertension in women was higher than that in men ( OR=1.624, 95% CI: 1.155-2.283), and the risk of hypertension in the northern ( OR=0.625, 95% CI: 0.434-0.901) and central areas ( OR=0.586, 95% CI: 0.346-0.993) was lower than that of the Eastern. Conclusion:The prevalence of hypertension, mainly in isolated systolic hypertension, showing gender and regional distribution differences.


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