1.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
2.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
3.The impact of undergraduate nursing students on the transition shock and risk perception of nursing profession: a correlational analysis
Xunqi ZHANG ; Lili GONG ; Xinhai MENG ; Lihua ZHOU
Chinese Journal of Practical Nursing 2024;40(15):1127-1132
Objective:To understand the current status of transition shock and risk perception of nursing profession among undergraduate nursing students, and to explore the correlation between transition shock and risk perception of nursing profession.Methods:In May 2023, convenience sampling was employed to survey 140 undergraduate nursing students from the School of Nursing, Anhui Medical University as the research subjects. A cross-sectional survey was conducted using a general information questionnaire, Nurse Risk Perception Questionnaire and Transition Shock Scale.Results:The final valid questionnaire was 133 copies. Among 133 internship nursing students, there were 23 males and 110 females. The total score of risk perception of nursing profession among undergraduate nursing students was (90.77 ± 16.48), while the total score for transition shock was (47.22 ± 7.14). A significant positive correlation was found between risk perception of nursing profession and transition shock ( r=0.589, P<0.01). Transition shock was identified as a factor influencing risk perception of nursing profession among undergraduate nursing students ( t=8.47, P<0.01). Conclusions:The risk perception of nursing profession and transition shock among undergraduate nursing students were at a moderate level and positively correlated. Nursing managers should take proactive measures to alleviate the challenges faced by interns during the transition process, diminish their apprehension towards the nursing profession risk, and improve the quality of clinical internships.
4.Establishment and application of fluorescence PCR method for genotyping of Mycoplasma pneumoniae based on specimen nucleic acid
Yiwei ZHANG ; Liyong LIU ; Lihua HE ; Fanliang MENG ; Ruixue GU ; Jie GONG ; Shaoli LI ; Fei ZHAO
Chinese Journal of Microbiology and Immunology 2024;44(8):653-659
Objective:To establish a nucleic acid detection and genotyping method for Mycoplasma pneumoniae ( Mp) based on nucleic acid in clinical samples. Methods:Through genomic comparison, the specific target sequences of Genotype 1 and Genotype 2 Mp strains were selected to design synthetic primers and probes, and a PCR detection and classification method for Mp dual fluorescent probe was established, and the specificity, accuracy, detection limit and repeatability of the method were evaluated. The established fluorescence PCR method was used to detect the nucleic acid of clinical specimens and compared with the reported fluorescent PCR methods. Results:The nucleic acid of 18 pathogens, including other species of Mycoplasma and common respiratory bacteria and viruses, which were closely related to the Mp species, were detected, and the results showed that there was no cross-reactivity. The accuracy of detection and typing of 90 Mp nucleic acid was 100%. The detection limits of Genotype 1 and Genotype 2 Mp samples were 1.0 copy/μl, and the experimental coefficient of variation of repeatability within groups and between groups was less than 2.5%. In the detection of 88 nucleic acid of clinical specimens, the Kappa value was 0.675 and the P value was 0.267 compared with the reported real-time PCR method, showing a high degree of agreement. Conclusions:The method for detecting and genotyping Mp in this study has high sensitivity, specificity, and accuracy, which can be applied to the monitoring and prevention and control of Mp in the disease control system of provinces and cities at all levels in China. This method promotes the improvement of the Mp prevention and control system in China, strengthens the surveillance ability, and is of great significance for the early warning and prediction of Mp.
5.Clinical and imaging features of phosphaturic mesenchymal tumors.
Cheng CHANG ; Aihong YU ; Yuhua YOU ; Xiaoxin PENG ; Xiaoguang CHENG ; Xintong LI ; Wei LIANG ; Lihua GONG ; Wei DENG
Chinese Medical Journal 2023;136(3):351-353
7.Research on fungal culturomics based on different universal media
ZHANG Shu ; ZHOU Mengshi ; LI Rui ; GENG Yuanyuan ; ZHAO Fei ; HE Lihua ; GONG Jie
China Tropical Medicine 2023;23(8):783-
Abstract: Objective To screen out a more universally applicable culture medium for the isolation and culturing of pathogenic fungi through comparing the performance of various universal fungal culture media, to optimize the fungal culturomics technique, and to better apply it to the culturomics research of pathogenic fungi. Methods Multiple common fungal culture media Sabouraud dextrose agar (SDA), potato dextrose agar (PDA), modified Dixon (mDixon), modified LeemingNotman agar (MLNA), etc., and a new pan-fungal medium (PF) were used to culture 40 strains of common pathogenic fungi to determine the growth states of strains under different conditions. Based on that, PF, SDA, PDA, mDixon and MLNA, a total of 5 culture media, were used to isolate and culture a simulated sample (suspension of Candida albicans and Aspergillus fumigatus), 10 human samples (4 fecal samples and 6 vaginal secretion samples) and 3 environmental samples. Results The positive growth rates of 40 strains of pathogenic fungi in the 7 media were as follows: PDA 95.0% (38/40), SDA 95.0% (38/40), BHI 95.0% (38/40), YPD 90.0% (36/40), mDixon 95.0% (38/40), MLNA 87.5% (35/40), PF 100.0% (40/40). For the simulated samples, PF could effectively promote the self-limited growth of filamentous fungi, performing better in isolation and culture. For the human samples and environmental samples, PF showed the same versatility as SDA and PDA. Conclusions In the isolation and culturing of pathogenic fungi, PF medium can effectively isolate and culture most fungal species. Meanwhile, PF can make the fast-growing fungi show self-limited growth and clear edges, and not easy to cross-contamination, which indicates it is conducive to the isolation and identification of single colonies. PF medium outperforms other common media in isolating strains from unknown samples in culturomics, which illustrates PF medium can be effectively used for the study of
fungal culturomics.
8.Usage of printing equipment in college teachers' offices and influencing factors of released particulate matter
Yu PENG ; Chao GONG ; Shirui ZHU ; Qian ZHAO ; Lihua HE ; Canqing YU ; Lailai YAN ; Yu XU ; Yun WANG
Journal of Environmental and Occupational Medicine 2021;38(11):1219-1223
Background Printing and copying equipment is likely to release a large amount of particulate matter, thereby endangering human health. However, there is insufficient research on the level of particulate matter released by printers in offices and its influencing factors. Objective This study is designed to investigate the usage of printing equipment in college teachers' offices and the level of indoor particulate matter during printing, and to explore the influence of printer location and indoor ventilation on the particulate matter pollution level released during printer operation. Methods From 9:00 to 16:00 on January 4 to 6, 2021, 20 faculty offices in a university in Beijing were selected by convenient sampling to measure the indoor particulate matter level during printing, and to investigate the printing equipment usage of 31 users in the offices. Besides, experiments were designed to explore the influence of position and distance from a printer, ventilation, and the distance between a printer and a nearby window during ventilation on the number concentration of particulate matter released by the printers. Results Except one printer being placed on the ground, the other 30 printers were placed on office desks (0.71±0.16) m above the ground. Among them, 65% of the printers (n=20) were less than 1 m away from the users horizontally, and 74% of the users (n=23) accessed the printers 1-5 times a week, printing (7.03±4.07) pages per time. The peak mass concentrations in users' offices during printing of PM10, PM2.5, and PM1 were (21.96±12.96), (7.92±5.54), and (5.77±5.00) μg·m−3, respectively, and the peak number concentration of PM0.25−0.28 was (40941±36926) P·L−1. The experiments showed that when the particle sizer was located in the front, side, and back of the printers, the peak values of PM0.25−0.28 number concentration during printing were (24257±551), (12588±1354), and (11192±249) P·L−1, respectively, and the difference among them was statistically significant (F=214.9, P<0.01); when the particle sizer was placed 0.1, 0.2, and 0.3 m away from the printers, the peak values of PM0.25−0.28 number concentration during printing were (24257±551), (19847±1426), and (16480±878) P·L−1, respectively, and the difference among them was statistically significant (F=44.66, P<0.01); when the experiment room was ventilated or not, the peak values of PM0.25−0.28 number concentration during printing were (18595±488) and (24257±551) P·L−1, respectively, and the difference between them was statistically significant (F=192.6, P<0.01); when the distance between the printer and the window was 1, 2, 3 m, the peak values of PM0.25-0.28 number concentration during printing were (16780±823), (18347±348), and (18595±488) P·L−1, respectively, and the difference among them was statistically significant (F=8.407, P<0.05). Conclusion The overall printer workload is small and the concentration of particulate matter in the faculty offices is low when the printers are working. Printer position, distance, ventilation, and the distance from a nearby window under ventilation conditions are factors affecting the concentration of particulate matter released by the printers.
9.DNA sequencing of H3F3A mutations in H3.3 immunohistochemistry-negative giant cell tumors of bone
Lihua GONG ; Wen ZHANG ; Xiaoqi SUN ; Ming ZHANG ; Yi DING
Chinese Journal of Pathology 2021;50(3):190-193
Objective:To investigate the subtypes of H3F3A DNA mutation in H3.3 immunohistochemistry (IHC) negative giant cell tumors of bone (GCTB).Methods:IHC expression of G34W mutated protein was evaluated in 181 cases GCTB. In H3.3 IHC negative cases, Sanger DNA sequencing analysis was used to detect the subtypes H3F3A mutations.Results:Overall, 164 (90.61%) cases of GCTB showed nuclear expression of H3.3, and 17 cases were negative. These 17 H3.3 negative cases were subjected to Sanger DNA sequencing analysis; results showed that eight presented rare mutation subtypes occurring at glycine 34 to leucine (G34L, 3/181, 1.66%), glycine 34 to valine (G34V, 3/181, 1.66%) and glycine 34 to arginine (G34R, 2/181, 1.10%), and the other nine cases were wild type (glycine 34, 9/181, 4.97%). Sanger DNA sequencing analysis confirmed the absence of G34W mutation in the H3.3 negative cases. Combining IHC and DNA sequencing analysis increased the detection rate of H3F3A mutation in the GCTB to 95.03%.Conclusions:H3.3 IHC could detect H3F3A G34W mutation in GCTB, but not for other rare mutation and wild types loci.
10. Comparison of two epidemic patterns of COVID-19 and evaluation of prevention and control effectiveness: an analysis based on Guangzhou and Wenzhou
Guanhao HE ; Zuhua RONG ; Jianxiong HU ; Tao LIU ; Jianpeng XIAO ; Lingchuan GUO ; Weilin ZENG ; Zhihua ZHU ; Dexin GONG ; Lihua YIN ; Donghua WAN ; Junle WU ; Min KANG ; Tie SONG ; Jianfeng HE ; Wenjun MA
Chinese Journal of Epidemiology 2020;41(0):E035-E035
Objective To compare the epidemiological characteristics of COVID-19 in Guangzhou and Wenzhou, and evaluate the effectiveness of their prevention and control measures. Methods Data of COVID-19 cases reported in Guangzhou and Wenzhou as of 29 February, 2020 were collected. The incidence curves of COVID-19 in two cities were constructed. The real time reproduction number ( R t ) of COVID-19 in two cities was calculated respectively. Results A total of 346 and 465 confirmed COVID-19 cases were analysed in Guangzhou and Wenzhou, respectively. In two cities, most cases were aged 30-59 years (Guangzhou: 54.9%; Wenzhou: 70.3%). The incidence curve peaked on 27 January, 2020 in Guangzhou and on 26 January, 2020 in Wenzhou, then began to decline in both cities. The peaks of imported COVID-19 cases from Hubei occurred earlier than the peak of COVID-19 incidences in two cities, and the peak of imported cases from Hubei occurred earlier in Wenzhou than in Guangzhou. In early epidemic phase, imported cases were predominant in both cities, then the number of local cases increased and gradually took the dominance in Wenzhou. In Guangzhou, the imported cases was still predominant. Despite the different epidemic pattern, the R t and the number of COVID-19 cases declined after strict prevention and control measures were taken in Guangzhou and in Wenzhou. Conclusion The time and scale specific differences of imported COVID-19 resulted in different epidemic patterns in two cities, but the spread of the disease were effectively controlled after taking strict prevention and control measures.

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