1.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).
2.Application value of Hisense computer-assisted surgery system three-dimensional reconstru-tion in precision treatment of pediatric liver tumors
Rui LI ; Xiwei HAO ; Huanyu ZHANG ; Xin CHEN ; Chengzhan ZHU ; Zhong JIANG ; Jing ZHAO ; Yuhe DUAN ; Cong SHANG ; Jie MI ; Bin WEI ; Nan XIA ; Feifei WANG ; Fengjiao WANG ; Xia YANG ; Qian DONG
Chinese Journal of Digestive Surgery 2022;21(6):816-821
Objective:To investigate the application value of Hisense computer-assisted surgery system (CAS) three-dimensional reconstruction in the precision treatment of pediatric liver tumors.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 82 children with liver tumors who were admitted to Affiliated Hospital of Qingdao University from January 2013 to September 2021 were collected. There were 39 males and 43 females, aged 13(19)months. Children underwent upper abdominal dynamic enhanced computed tomography (CT) examination, and three-dimensional reconstruction was performed on CT images of arterial, equili-brium and venous phases with Hisense CAS. Surgical feasibility and scheme were evaluated and conducted based on the results of upper abdominal dynamic enhanced CT examination, and then revised according to three-dimensional reconstruction results of Hisense CAS. Observation indicators: (1) comparison of surgical scheme between two-dimensional enhanced CT images and three-dimensional reconstruction results of Hisense CAS; (2) intraoperative and postoperative situations; (3) follow-up. Follow-up was conducted by outpatient examination to detect postoperative compli-cations and residual liver compensation up to November 2021. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M(IQR) or M(range). Count data were described as absolute numbers or percentages. Results:(1) Comparison of surgical scheme between two-dimensional CT images and three-dimensional reconstruction results of Hisense CAS. ① Based on the two-dimensional CT images, 42 cases of 82 children could undergo one-stage resection and 40 children could not. However, based on the three-dimensional reconstruction results of Hisense CAS, 48 cases of 82 children could undergo one-stage resection and 34 children could not. There were 6 children with one-stage resection feasibility based on the three-dimensional reconstruction results of Hisense CAS rather than the two-dimensional CT images. For the 34 children undergoing chemotherapy firstly, 31 cases had surgical feasibility after chemotherapy based on the two-dimensional CT images and 3 cases could not undergo surgery because of unapparent tumor regression or tumor surrounding impor-tant vessels. However, the 34 children had surgical feasibility after chemotherapy based on the three-dimensional reconstruction results of Hisense CAS. The revision rate of surgical feasibility was 11.0%(9/82) for the 82 children. ② Based on the two-dimensional CT images, 15 cases of 82 children underwent liver left lobectomy, 21 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 13 cases underwent extended left hemihepatectomy, 23 cases underwent extended right hemihepatectomy, 3 cases underwent segmental hepatectomy. However, based on the three-dimensional reconstruction results of Hisense CAS, 20 cases of 82 children underwent liver left lobectomy, 29 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 7 cases underwent extended left hemihepatectomy, 14 cases underwent extended right hemihepatectomy, 5 cases underwent segmental hepatectomy. The revision rate of surgical scheme was 36.6%(30/82) for the 82 children. (2) Intraoperative and postoperative situations. The operation time, volume of intraoperative blood loss, duration of postoperative hospital stay of the 82 children were (182±18)minutes, 20(10)mL, (10.2±1.9)days, respectively. (3) Follow-up. All the 82 children were followed up for 10 (range, 2?18)months. There was no obvious complication occurred to the 82 children after surgery, and the residual liver can satisfy the liver compensation of body. All the children survived well.Conclusion:Three-dimensional reconstruction of Hisense CAS is conducive to judging the surgical feasibility and formulation of accurate surgical plan of children with liver tumors.
3. Analysis on oral medication rules of traditional Chinese medicine prescriptions for prevention of COVID-19
Dong-yang WU ; Xiao-tao HOU ; Zhong-shang XIA ; Er-wei HAO ; Jin-ling XIE ; Jing-yan LIANG ; Zheng-cai DU ; Jia-gang DENG ; Xiao-tao HOU ; Er-wei HAO ; Jin-ling XIE ; Zheng-cai DU ; Jia-gang DENG ; Er-wei HAO ; Jia-gang DENG ; Dong-yang WU ; Xiao-tao HOU ; Zhong-shang XIA ; Er-wei HAO ; Jin-ling XIE ; Zheng-cai DU ; Jia-gang DENG ; Qiu-ming LIANG
Chinese Herbal Medicines 2021;13(4):502-517
Objective: To analyze the medication rules of traditional Chinese medicine (TCM) preventive oral prescriptions for COVID-19. Methods: The preventive oral prescriptions for COVID-19 published by national and provincial health and wellness committees, administrations of TCM, medical institutions at all levels, medical masters and Chinese medicine experts were collected to establish a database, manual screening was carried out according to the inclusion and exclusion criteria, and frequency statistics, association rule analysis. The mutual information method, entropy hierarchical clustering and other methods were improved through Excel and the TCM inheritance auxiliary platform V2.5 to mine the rules and characteristics of medication. Results: The selected 157 prescriptions contained a total of 130 TCMs. The top five TCMs with the highest use frequency were Glycyrrhizae Radix et Rhizoma (86), Astragali Radix (80), Lonicerea Japonicae Flos (70), Atractylodis Macrocephalae Rhizoma (62), Saposhnikoviae Radix (60). In accordance with TCM efficacy classification, most of them were medicines for qi-tonifying (279), followed by medicines for clearing heat and drying dampness (163), dispelling pathogenic wind-cold (126), resolving dampness (111), as well as dispelling pathogenic wind-heat (99). The characteristics of four-natures of the selected medicines are as follows: most of them were cold (59), followed by warm (38) and mild (21). In terms of five-taste, most of them were sweet (26) and acrid-and-bitter (24), followed by sweet-and-bitter (20), bitter (20) and acrid (15). For the meridian attribution, the five-zang organs and six-fu organs were all involved, most of them attributed to lung meridian (80), followed by stomach meridian (57) and spleen meridian (40). Based on association rule analysis, 12 commonly used medicine combinations with two or three TCMs were found. The commonly used medicinal pairs included Astragali Radix and Saposhnikoviae Radix (51), Astragali Radix and Atractylodis Macrocephalae Rhizoma (46), Atractylodis Macrocephalae Rhizoma and Saposhnikoviae Radix (43), Astragali Radix and Atractylodis Macrocephalae Rhizoma and Saposhnikoviae Radix (38), Forsythiae Fructus and Astragali Radix (37), and so on. In addition, 14 core combinations of medicines were obtained by complex system entropy cluster analysis, on this basis, six new prescriptions were screened out based on unsupervised entropy hierarchical clustering analysis. According to The Catalogue of Edible Traditional Chinese Medicinal Materials, Traditional Chinese Medicinal Materials for Health Food, and New Resources of Food published by National Health Commission of the People's Republic of China, there are 35 species belonging to the group of edible traditional Chinese medicinal materials, 20 species belonging to the group of new resources of food, 31 species belonging to the group of traditional Chinese medicinal materials for health food, 19.11% of the preventive oral prescriptions for COVID-19 were composed of the medicines belonging to the above three groups. Besides, there are 11 toxic species, and 24.84% of the preventive oral prescriptions for COVID-19 contained toxic TCMs. Conclusion: We found that invigorating qi and resolving dampness were the main treatment used to prevent for COVID-19, combined with the methods for strengthening vital energy and eliminating pathogenic factors. Most of the preventive oral prescriptions for COVID-19 were treated in lung, spleen and stomach meridians. In the process of selecting prescriptions and using TCMs to prevent for COVID-19, the safety of preventive medicines was also emphasized. And the theory of “Preventive Treatment of Disease” was embodied in these preventive oral prescriptions for COVID-19. For the prescriptions containing toxic TCMs, special attention should be paid to their safety in clinical application.
4.Expert consensus on management of analgesia and sedation for patients with severe coronavirus disease 2019.
Xiang-Hong YANG ; Bo HU ; You SHANG ; Jiao LIU ; Ming ZHONG ; Xiu-Lling SHANG ; Zhi-Xiong WU ; Zhui YU ; Ren-Hua SUN ; Hong-Liang WANG ; Ming-Yan ZHAO ; Mei MENG ; Qiang-Hong XU ; Xia ZHENG ; De-Chang CHEN
Chinese Medical Journal 2020;133(18):2186-2188
5.A hypothesis on the Q-markers based on characteristics of opposite-effect of herbs: an example of Sanqi
Xiao-tao HOU ; Er-wei HAO ; Zheng-cai DU ; Zhong-shang XIA ; Jia-gang DENG ; Tie-jun ZHANG ; Chang-xiao LIU
Acta Pharmaceutica Sinica 2019;54(2):211-221
The quality definition of traditional Chinese medicine (TCM) is a hot area in modern research of TCM. In recent years, the characteristics of one herb with multiple effects have been widely accepted and studied. The typical opposite-effect of herbs is considered as a special part of one herb with multiple effects, and was summarized in this paper. Sanqi was used as an example of opposite-effect herbs for developing the strategies and approaches on the Q-markers. The traditional opposite-effect should be studied by modern pharmacological research methods. The correlation of the chemical components with the opposite effects should be established in order to verify the material basis and evaluate the mechanism including targets and pathways. The unique characteristics of chemical components should be analyzed and defined. Finally, the Q-markers of the opposite effect herb will be confirmed. This paper provides a useful reference for the precise quality control of herbal opposite-effects.
6.Design and implementation of field questionnaire survey system of taeniasis/cysticercosis
Huan-Zhang LI ; Jing-Bo XUE ; Men-Bao QIAN ; Xin-Zhong ZANG ; Shang XIA ; Qiang WANG ; Ying-Dan CHEN ; Shi-Zhu LI
Chinese Journal of Schistosomiasis Control 2018;30(2):211-214,225
A taeniasis/cysticercosis information management system was designed to achieve the dynamic monitoring of the epidemic situation of taeniasis/cysticercosis and improve the intelligence level of disease information management.The system in-cludes three layer structures(application layer,technical core layer,and data storage layer)and designs a datum transmission and remote communication system of traffic information tube in Browser/Server architecture.The system is believed to promote disease datum collection.Additionally,the system may provide the standardized data for convenience of datum analysis.
7.Effects of mild hypothermia on β-adrenergic signaling pathway in a cardiac arrest swine model
Fangfang ZHU ; Xianfei JI ; Xia ZHONG ; Haoran HU ; Lining LIANG ; Jibin CHEN ; Deya SHANG
Chinese Critical Care Medicine 2018;30(2):134-139
Objective To observe the effect of mild hypothermia on myocardial β-adrenergic receptor (β-AR) signal pathway after cardiopulmonary resuscitation (CPR) in pigs with cardiac arrest (CA) and explore the mechanism of myocardial protection. Methods Healthy male Landraces were collected for reproducing the CA-CPR model (after 8-minute untreated ventricular fibrillation, CPR was implemented). The animals were divided into two groups according to random number table (n = 8). In the mild hypothermia group, the blood temperature of the animals was induced to 33 ℃ and maintained for 6 hours within 20 minutes after return of spontaneous circulation (ROSC) by using a hypothermia therapeutic apparatus. In the control group, the body temperature of the animals was maintained at (38.0±0.5)℃ with cold and warm blankets. The heart rate (HR), mean arterial pressure (MAP), the maximum rate of increase or decrease in left rentricular pressure (+dp/dt max)were measured during the course of the experiment. The cardiac output (CO) was measured by heat dilution methods before CA (baseline), and 0.5, 1, 3, 6 hours after ROSC respectively, the venous blood was collected to detect the concentration of cTnI. Left ventricular ejection fraction (LVEF) was measured with cardiac ultrasound before CA and 6 hours after ROSC. Animals were sacrificed at 6 hours after ROSC and the myocardial tissue was harvested quickly, the mRNA expression of β1-AR in myocardium was detected by reverse transcription-polymerase chain reaction (RT-PCR), the contents of adenylate cyclase (AC) and cyclic adenosine monophosphate (cAMP) were detected by enzyme linked immunosorbent assay (ELISA), the protein content of G protein-coupled receptor kinase 2 (GRK2) was detected by Western Blot. Results After successful resuscitation, the HR of both groups were significantly higher than the baseline values, CO, ±dp/dt max were significantly decreased, MAP were not significantly changed, serum cTnI levels were significantly increased. Compared with the control group, HR at 0.5, 1, 3 hours after ROSC were significantly decreased in mild hypothermia group (bpm: 142.80±12.83 vs. 176.88±15.14, 115.80±11.48 vs. 147.88±18.53, 112.60±7.40 vs. 138.50±12.02, all 1 < 0.01), CO was significantly increased at 1 hours and 3 hours after ROSC (L/min: 3.97±0.40 vs. 3.02±0.32, 4.00±0.11 vs. 3.11±0.59, both 1 < 0.01), +dp/dt max at 3 hours and 6 hours was also significantly increased after ROSC [+dp/dt max (mmHg/s): 3 402.5±612.7 vs. 2 130.0±450.6, 3 857.5±510.4 vs. 2 562.5±633.9; -dp/dt max (mmHg/s): 2 935.0±753.2 vs. 1 732.5±513.6, 3 520.0±563.6 vs. 2 510.0±554.3, all 1 < 0.05], the cTnI was significantly decreased at 3 hours and 6 hours afher ROSC (μg/L: 1.39±0.40 vs. 3.24±0.78, 1.46±0.35 vs. 3.78±0.93, both 1 < 0.01). The left at 6 hours after ROSC in both groups was decreased as compared with that before CA. The LVEF in the mild hypothermia group was higher than that in the control group (0.52±0.04 vs. 0.40±0.05, 1 < 0.05). The mRNA expression of β1-AR, and concentrations of AC and cAMP in hypothermia group were significantly higher than those in control group [β1-AR mRNA (2-ΔΔCT): 1.18±0.39 vs. 0.55±0.17, AC (ng/L):197.0±10.5 vs. 162.0±6.3, cAMP (nmol/L): 1 310.58±48.82 vs. 891.25±64.95, all 1 < 0.05], GRK2 was lower than that in the control group (GRK2/GAPDH: 0.45±0.05 vs. 0.80±0.08, 1 < 0.05). Conclusion Mild hypothermia can reduce the degree of cardiac function injury after CPR, and its mechanism may be related to the reduction of impaired myocardial β-AR signaling after CPR.
8.Impact of Mycoplasma genitalium infection on the semen quality of infertile males.
Ze-Chen YAN ; Xue-Jun SHANG ; Wei LIU ; Xiu-Xia WAN ; Chang-Chun WAN ; Song XU ; Yong ZHONG ; Zhi-Qiang WENG
National Journal of Andrology 2018;24(4):317-321
ObjectiveTo explore Mycoplasma genitalium (MG) infection in the urogenital tract of infertile men and its influence on semen quality.
METHODSSemen samples were collected from 352 infertile males in the Center of Reproductive Medicine of Nanjing General Hospital from March to July 2015. MG infection was detected by real-time fluorescence simultaneous amplification and testing and semen analyses were conducted according to the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Ed) on the semen pH value, semen volume, total sperm count, sperm concentration, total sperm motility, percentages of progressively motile sperm (PMS) and immotile sperm (IMS), and sperm DNA fragmentation index (DFI). The data obtained were subjected to statistical analysis by t-test and non-parametric test (Wilcoxon test).
RESULTSMG infection was found in 3.4% (12/352) of the infertile patients. Compared with the MG-positive cases, the MG-negative ones showed a significantly higher semen volume ([2.85 ± 0.14] vs [3.84 ± 0.12] ml, P = 0.008) and percentage of PMS ([15.86±1.72] vs [60.95 ± 5.63] %, P = 0.032) but a lower DFI ([30.73 ±2.24] vs [20.71 ± 1.55]%, P = 0.014). However, no statistically significant differences were observed between the two groups in the semen pH value (7.38 ±0.02 vs 7.39 ± 0.01, P = 0.774), sperm concentration ([52.96 ± 15.78] vs [60.05 ± 4.29]×10⁶/ml, P = 0.683), sperm count ([154.15 ± 46.37] vs [221.56 ± 15.43]×106, P = 0.236), total sperm motility ([29.04 ± 3.11] vs [33.52 ± 1.51] %, P = 0.626), or percentage of IMS ([23.57 ± 0.99] vs [62.34 ± 1.69] %, P = 0.691).
CONCLUSIONSUrogenital MG infection is common in infertile males and potentially affects the semen quality, especially sperm vitality of the patient.
DNA Fragmentation ; Humans ; Infertility, Male ; microbiology ; physiopathology ; Male ; Male Urogenital Diseases ; microbiology ; Mycoplasma Infections ; complications ; Mycoplasma genitalium ; Semen ; Semen Analysis ; Sperm Count ; Sperm Motility ; Spermatozoa ; physiology
9. Research on rules of medication for diabetes mellitus based on analysis on 755 traditional Chinese medicine prescriptions
Chinese Traditional and Herbal Drugs 2018;49(3):739-744
To explore the rules of medication for diabetes and diabetic complications based on analysis on 755 traditional Chinese medicine (TCM) prescriptions. The information in 755 papers published from 1995 to 2016 was got including 755 herbal prescriptions, 367 herbs, 33 330 effective cases. Based on the above information, usage frequency of single herb, efficiency and the rules of formulating prescription for different types of diabetes were analyzed and compared using Microsoft Excel 2010 and Clementine 12.0 software. In the treatment of diabetes and its complications, the top four diabetes symptoms are about diabetes, diabetic neurological complications, diabetic nephropathy and diabetic cardiovascular complications, and accounting for 31.62%, 29.82%, 8.87%, and 6.47% of the total number of effective cases. Further analysis of the top four illnesses found that single herb commonly used in the treatment of diabetes was Astragali Radix, Dioscoreae Rhizoma, Rehmanniae Radix, Trichosanthis Radix, Ophiopogonis Radix, etc. The commonly used drugs categories were tonic herbs, heat-clearing herbs and blood activating herbs; The single medicine commonly used in the treatment of diabetic neurological complications was Astragali Radix, Angelicae Sinensis Radix, Chuanxiong Rhizoma, Radix Salviae Miltiorrhizae et Rhizoma, Cinnamomi Ramulus, etc. The commonly used drugs categories were tonic herbs, blood activating herbs and heat-clearing herbs; The single herb commonly used in the treatment of diabetic nephropathy was Astragali Radix, Dioscoreae Rhizoma, Salviae Miltiorrhizae Radix, Poria, Fructus Corni, etc., the commonly used drugs categories were tonic herbs, blood activating herbs and damp-clearing herbs. The single herb commonly used in the treatment of diabetic cardiovascular complications was Astragali Radix, Salviae Miltiorrhizae Radix, Angelicae Sinensis Radix, Carthami Flos, Chuanxiong Rhizoma, etc., the commonly used drugs categories were blood activating herbs, tonic herbs and heat-clearing herbs. The rules of medication of TCM for diabetes, diabetic neurological complications, diabetic nephropathy and diabetic cardiovascular complications showed similar characteristics, tonic herbs were used the most frequently, supplemented by blood activating herbs, heat-clearing herbs and damp-clearing herbs. However, the principle of formula is a little different for different types of diabetes and diabetic complications, specifically. The prescriptions for diabetes and diabetic neurological complications consist of tonic herbs as the principal, supplemented by blood activating herbs and heat-clearing herbs; The prescriptions for diabetic nephropathy are composed of tonic herbs as the principal, supplemented by blood activating herbs and damp-clearing herbs, as well as tonic herbs and blood activating herbs were equal components in the prescriptions for diabetic cardiovascular complications, supplemented by heat-clearing herbs.
10.Urgent need to improve the quality of case report in traditional Chinese medicine: Assessment on reporting quality of 3,417 cases.
Shu-Fei FU ; Wai KUN ; Xiao-Xi ZENG ; Li ZHANG ; Chung-Wah CHENG ; Lisa SONG ; Linda Li-Dan ZHONG ; Jia LIN ; Yong-Yan WANG ; Hong-Cai SHANG ; Zhao-Xia BIAN ; null
Chinese journal of integrative medicine 2016;22(6):473-480
OBJECTIVETo survey the reporting quality of traditional Chinese medicine (TCM) case reports published in recent years and understand the common problems. The assessment results would lay the foundation for the development of recommendations for case report in Chinese medicine.
METHODSThis survey determined the reporting quality of cases with Chinese herbal decoction, Chinese proprietary medicine, acupuncture, moxibustion and other traditional therapies published in 20 core medical journals of China by searching the China Academic Journals Full-text Database from 2006 to 2010. Fifty survey items in 16 domains were used to determine the reporting quality. One point was assigned to each item (Yes=1 point; No=0 point), and total score was 50 points. The domain of treatment was assessed independently, ranging from 2 to 9 items for different TCM interventions.
RESULTSThe total of 1,858 case reports, covering 3,417 cases were included to analyze from 13 out of 20 core medical journals of China. There were 74.8% of them did not identify the nature of study in title, while 73.9% did not comprise an abstract. Incomplete reporting was found in discussions/ comment, and only 38.9% had made recommendations or take-away messages. Figures and tables were infrequently used. Three cases cited the full names of patients, but without declaring that any consent was obtained. Over 90% reported the symptoms and signs of TCM, and characteristics on tongue and pulse, but less than 50% did mention other medical history and diagnostic rationale. More than 90% treatments of the included cases were herbal decoction, with clear reporting on the ingredients and dosages. However, the reporting rate of the dosages of each ingredient was just 48.4%. Almost none reported the quality control of crude herbs, manufacturers and lot numbers of herbal proprietary medicine. Besides, advices and precautions on diet, emotions and living were rare to be illustrated.
CONCLUSIONSystematic reporting recommendations are urged to develop for improving the contents and format of case reports in TCM.
Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; Periodicals as Topic ; Quality Assurance, Health Care ; Research Report ; standards

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