1.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
2.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
3.Chemical constituents from fruits of Morinda citrifolia and their inhibitory effects on proliferation of synoviocytes in vitro.
Zhang-Yang SHEN ; Ruo-Qing GUAN ; Meng-Ran DU ; Yuan BIAN ; Yu WANG ; Xin-Yuan SUO ; Shu-Hong XIONG ; Yan-Ping LIU ; Yan-Hui FU
China Journal of Chinese Materia Medica 2023;48(1):105-113
The chemical constituents from the fruits of Morinda citrifolia were systematically explored by chromatographic fractionation methods including silica gel, octadecylsilyl(ODS) gel, Sephadex LH-20 gel, and preparative high performance liquid chromatography(pre-HPLC). The chemical structures of all isolated compounds were identified on the basis of their physicochemical properties, spectroscopic analyses, as well as the comparisons of their physicochemical and spectroscopic data with the reported data in literature. As a result, 22 isolated compounds from the 90% ethanol extract of the fruits of M. citrifolia were identified, which were moricitritone(1), 2'-deoxythymidine(2), cyclo-(L-Pro-L-Tyr)(3), methyl-5-hydroxy-2-pyridinecarboxylate(4), methyl pyroglutamate(5), bisbenzopyran(6), epipinoresinol(7), 3, 3'-bisdemethyl pinoresinol(8), 3, 3'-bisdemethyltanegool(9), trimesic acid(10), crypticin B(11), kojic acid(12), vanillic acid(13), protocatechoic acid(14), 5-hydroxymethyl furfural(15), blumenol A(16), 1-O-(9Z, 12Z-octadecadienoyl) glycerol(17), mucic acid dimethylester(18), methyl 2-O-β-D-glucopyranosylbenzoate(19), 2-phenylethyl-O-β-D-glucoside(20), scopoletin(21), and quercetin(22). Among them, compound 1 was a new pyrone derivative, compounds 2, 4-7, 10-12, and 17 were isolated from the plants belonging to Morinda genus for the first time, and compound 18 was obtained from M. citrifolia for the first time. Moreover, on the basis of testing the activities of all isolated compounds on inhibiting the proliferation of synovial fibroblasts in vitro by MTS assay, the anti-rheumatoid arthritis activities of all isolated compounds were initially evaluated. The results showed that compounds 1-6, 9, 19, and 20 exhibited remarkable anti-rheumatoid arthritis activities, which displayed the inhibitory effects on the proliferation of MH7A synovial fibroblast cells with the IC_(50) values in the range of(3.69±0.08) to(168.96±0.98) μmol·L~(-1).
Fruit/chemistry*
;
Morinda/chemistry*
;
Synoviocytes
;
Cell Proliferation
;
Arthritis
4.Chemical constituents from Artocarpus incisus and their inhibitory effects on proliferation of synoviocytes in vitro.
Yu-Tong XIE ; Shu-Hong XIONG ; Yuan BIAN ; Yu WANG ; Ruo-Qing GUAN ; Xin-Yuan SUO ; Meng-Ran DU ; Yan-Ping LIU ; Yan-Hui FU
China Journal of Chinese Materia Medica 2022;47(17):4665-4673
The chemical constituents from the branches and leaves of Artocarpus incisus were isolated and purified via silica gel, ODS, and Sephadex LH-20 column chromatography as well as preparative HPLC. The chemical structures of all isolated compounds were identified in the light of their physicochemical properties, spectroscopic analyses, and comparisons of their physicochemical and spectroscopic data with the reported data in literature. As a result, 20 compounds were isolated and characterized from the 90% ethanol extract of the branches and leaves of A. incisus, which were identified as tephrosin(1), 6-hydroxy-6 a, 12 a-dehydrodeguelin(2), sarcolobin(3), lupiwighteone(4), 12-deoxo-12α-methoxyelliptone(5), 6 aα,12 aα-12 a-hydroxyelliptone(6), homopterocarpin(7), 3-hydroxy-8,9-dimethoxypterocarpan(8), pterocarpin(9), maackiain(10), medicarpin(11), calycosin(12), genistein(13), formononetin(14), 5-hydroxy-4',7-dimethoxy isoflavone(15), liquiritigenin(16), 4(15)-eudesmene-1β,7α-diol(17), ent-4(15)-eudesmene-1β,6α-diol(18), 1α-hydroxyisodauc-4-en-15-al(19), and guaianediol(20). Except compounds 13 and 16, all other compounds were isolated from the Artocarpus plants for the first time. Additionally, using MTS assay, compounds 1-20 were eva-luated for their anti-rheumatoid arthritis activities by measuring their anti-proliferative effects on synoviocytes in vitro. As a consequence, compounds 1-16 showed notable anti-rheumatoid arthritis activities, which displayed inhibitory effects on the proliferation of MH7 A synovial fibroblast cells, with the IC_(50) values in range of(9.86±0.09)-(218.07±1.96) μmol·L~(-1).
Arthritis
;
Artocarpus
;
Cell Proliferation
;
Ethanol
;
Genistein
;
Plant Extracts/pharmacology*
;
Silica Gel
;
Synoviocytes
5. A case of acute radiation injury of right finger caused by 192Ir external irradiation
Yuhan HOU ; Yulong LIU ; Youyou WANG ; Huahui BIAN ; Weibo CHEN ; Hong DAI ; Junchao FENG ; Ran CUI ; Ruihao WANG ; Yun DU ; Min WANG ; Zhen YAO
Chinese Journal of Radiological Medicine and Protection 2019;39(11):852-858
Objective:
To explore the treatment technique, occurrence and development patterns of such radiation injuries as in a major radiological accident in which a victim suffered mild bone marrow radiation sickness combined grade degree Ⅲ acute radiation induced skin injury, based on his dose estimation, clinical manifestations and disease treatments.
Methods:
History inquiry in detail, earlier physical dose estimation and biological dose estimation were conducted in conjunction with analyzing the chromosome aberration of peripheral blood lymphocytes. The physical dose was estimated by Monte Carlo method.The systematic laboratory and imaging examination was performed to evaluate the condition. The comprehensive analysis was conducted to determine the diagnosis and treatment plan.
Results:
At 3d after the exposure, "Ren" felt mild pain and discomfortable on the skin of the right index finger. The body of the right hand index finger was covered with blister at 21 d after exposure.The estimation of biological dose was 0.43 Gy (95%
6.Distribution of Avian Influenza A Viruses in Poultry-Related Environment and Its Association with Human Infection in Henan, 2016 to 2017
Xia Hong MA ; Lin Ruo WANG ; Fei Yi NIE ; Jia SU ; Xiao Dong LI ; Yi LI ; Hua Yan DU ; Yan Hai WEI ; Le Xing LI ; Zhe WANG ; Li Bian XU ; Yong Xue HUANG
Biomedical and Environmental Sciences 2019;32(11):797-803
Objective To survey avian influenza A viruses (AlVs) in the environment and explore the reasons for the surge in human H7N9 cases.Methods A total of 1,045 samples were collected from routine surveillance on poultry-related environments and 307 samples from human H7N9 cases-exposed environments in Henan from 2016 to 2017.The nucleic acids of influenza A (Flu A),H5,H7,and H9 subtypes were detected by real-time polymerase chain reaction.Results A total of 27 H7N9 cases were confirmed in Henan from 2016 to 2017,24 had a history of live poultry exposure,and 15 had H7N9 virus detected in the related live poultry markets (LPMs).About 96% (264/275) Flu A positive-environmental samples were from LPMs.H9 was the main AIV subtype (10.05%) from routine surveillance sites with only 1 H7-positive sample,whereas 21.17% samples were H7-positive in H7N9 cases-exposed environments.Samples from H7N9 cases-exposed LPMs (47.56%)had much higher AIVs positive rates than those from routine surveillance sites (12.34%).The H7+H9 combination of mixed infection was 78.18% (43/55) of H7-positive samples and 41.34% (43/104) of H9-positive samples.Conclusion The contamination status of AIVs in poultry-related environments is closely associated with the incidence of human infection caused by AlVs.Therefore,systematic surveillance of AlVs in LPMs in China is essential for the detection of novel reassortant viruses and their potential for interspecies transmission.
7. Practice of extracorporeal cardiopulmonary resuscitation in China after publication of the 2015 AHA guidelines for resuscitation: A multiinstitution survey
Lan-Fang DU ; Hong-Xia GE ; Qing-Bian MA ; Bao-Lan GE ; Jian-Zhong YANG ; Yu-Hong MI ; Yi-Xiong ZHANG
Asian Pacific Journal of Tropical Medicine 2019;12(14):12-16
Objective: To investigate the current practice of extracorporeal cardiopulmonary resuscitation (ECPR) for Chinese cardiac arrest patients after the publication of 2015 American Heart Association guidelines for cardiopulmonary resuscitation. Methods: A questionnaire was distributed to healthcare providers of emergency departments (EDs) and/or Intensive Care Units (ICUs) across 52 hospitals in China from August to November 2016. Data collection ended in February 2017. The questionnaire included three parts: (1) characteristics of the departments and the respondents; (2) knowledge about ECPR; (3) practice of ECPR in cardiac arrest patients (case volume, inclusion/exclusion criteria, ECPR procedure). The characteristics of the departments/hospitals were only answered by the head of the department. Results: A total of 1 952 (86.8%) respondents fulfilled the survey. Only 2.5% of the respondents from 3 of 52 hospitals performed ECPR. Among the three hospitals, the case number of ECPR were ≤5 per year and none of them had written ECPR procedures. Only one hospital had formal inclusion/exclusion criteria. The inclusion criteria included age between 18 to 60 years, suspected cardiogenic cardiac arrest, beginning of cardiopulmonary resuscitation <5 min after cardiac arrest and duration of cardiopulmonary resuscitation >10 min. The top three reasons for the nonuse of ECPR were unknown fields (31.2%), potential ECMO-related side effects (26.9%) and cost (18.7%). Conclusions: ECPR for cardiac arrest patients are not well understood by healthcare providers in the emergency department or ICUs and its application is still in the early stage in China. Educational training and other interventions are needed to promote the clinical practice.
8.Systematic Reviews/Meta-Analyses of Integrative Medicine in Chinese Need Regulation and Monitoring Urgently and Some Suggestions for Its Solutions.
Jia-Ying WANG ; Gui-Hua TIAN ; You-Ping LI ; Tai-Xiang WU ; Zhao-Xiang BIAN ; Liang DU ; Hong-Cai SHANG
Chinese journal of integrative medicine 2018;24(2):83-86
With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.
9.Research progress in small molecule drugs based on high-density lipoprotein for anti-atherosclerosis
Bei-bei MA ; Cong BIAN ; Bin HONG ; Yu DU ; Xiao-fang CHEN
Acta Pharmaceutica Sinica 2018;53(3):328-335
A large number of epidemiological data have shown that the high-density lipoprotein cholesterol level is negatively related to atherosclerotic cardiovascular disease, suggesting that high-density lipoprotein may have the effect of anti-atherosclerosis. It may play the role of anti-atherosclerosis, through the promotion of cholesterol reverse transport, anti-inflammatory, antioxidant, and against thrombosis and fibrinolysis and so on. Among them, reverse cholesterol transport which is mainly regulated by apolipoprotein A-I, ATP-binding cassette transporter 1, liver X receptor and cholesteryl ester transfer protein, may play a major role in the maintenance of cholesterol homeostasis and reversing the course of atherosclerosis. These regulatory factors may be potential targets in high density lipoprotein-based drug discovery. In this review, these key proteins are discussed for the current status of small molecule drugs against atherosclerosis.
10.Resistance to apoptosis should not be taken as a hallmark of cancer.
Rui-An WANG ; Zeng-Shan LI ; Qing-Guo YAN ; Xiu-Wu BIAN ; Yan-Qing DING ; Xiang DU ; Bao-Cun SUN ; Yun-Tian SUN ; Xiang-Hong ZHANG
Chinese Journal of Cancer 2014;33(2):47-50
In the research community, resistance to apoptosis is often considered a hallmark of cancer. However, pathologists who diagnose cancer via microscope often see the opposite. Indeed, increased apoptosis and mitosis are usually observed simultaneously in cancerous lesions. Studies have shown that increased apoptosis is associated with cancer aggressiveness and poor clinical outcome. Furthermore, overexpression of Bcl-2, an antiapoptotic protein, is linked with better survival of cancer patients. Conversely, Bax, CD95, Caspase-3, and other apoptosis-inducing proteins have been found to promote carcinogenesis. This notion of the role of apoptosis in cancer is not new; cancer cells were found to be short-lived 88 years ago. Given these observations, resistance to apoptosis should not be considered a hallmark of cancer.
Animals
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Apoptosis
;
physiology
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Biomarkers, Tumor
;
metabolism
;
Carcinogenesis
;
metabolism
;
Caspase 3
;
metabolism
;
Humans
;
Lymphoma, B-Cell
;
metabolism
;
pathology
;
Neoplasms
;
metabolism
;
pathology
;
Proto-Oncogene Proteins c-bcl-2
;
metabolism
;
Treatment Outcome
;
bcl-2-Associated X Protein
;
metabolism
;
fas Receptor
;
metabolism

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