1.A contrastive analysis on clinical features of latent autoimmune diabetes in adults and type 2 diabetes mellitus in the elderly
Bo LIANG ; Liangyi LI ; Jiayu LIN ; Ruhai LIN ; Huiyao CAI ; Xiahong LIN ; Xisheng LI
Chinese Journal of Geriatrics 2014;33(8):877-880
Objective To explore the differences in clinical features between the latent autoimmune diabetes in adults (LADA) and type 2 diabetes mellitus (T2DM) in the elderly.Methods Clinical features of 41 cases with LADA and 49 cases with T2DM were retrospectively analyzed and compared.Results (1) Body mass index (BMI),fasting and postprandial levels of cpeptide,triglyceride (TG) and serum albumin were lower in LADA patients than in T2DM patients.(2) The levels of fasting and postprandial blood glucose were higher in LADA patients than in T2DM patients.(3) There were no statistically significant differences in the disease course,blood pressure (BP),and the functions of liver and kidney between LADA and T2DM patients.Conclusions As compared with T2DM patients,LADA patients have higher blood glucose level,lower BMI and TG level,and poorer function of islet B cell.But there is no significant difference in the chronic complications between two groups.
2.Prevalence survey of hyperuricemia and its association with hypertriglyceridemia and hypertension in elderly people in Quanzhou of Fujian province
Liangyi LI ; Huibin HUANG ; Bo LIANG ; Xiaoyu CHEN ; Huiyao CAI ; Xisheng LI
Chinese Journal of Geriatrics 2013;(3):338-340
Objective To investigate the morbidity rate of hyperuricemia and its association with hypertriglyceridemia and hypertension in elderly people in Fujian Quanzhou.Methods A crosssectional population survey for hyperuricemia was performed in Fujian Quanzhou.Questionnaire and physical examination were conducted in 1358 subjects.The levels of serum UA and lipid-profile as well as blood pressure were measured.Results In the same aged group,the level of blood uric acid was significantly higher in male (371.7±83.6) μmol/L than in female (294.8±66.5) μmol/L (t=15.8,P<0.01).Blood uric acid concentration was gradually increased with aging in the group at age 40-70 years,but was gradually decreased with aging in female group aged over 70 years (F=12.1,P<0.01).The total morbidity rate of hyperuricemia was 18.6%.The incidence of hypertriglyceridemia or hypertension in female with hyperuricemia was higher than those with normouricemia (22.1% vs.10.5%,59.1% vs.26.2%,x2=16.3,65.0,all P<0.01).The incidence of hypertension in male with hyperuricemia was higher than those with normouricemia (54.6% vs.42.8%,x2=4.0,P<0.05).Conclusions The morbidity rate of hyperuricemia in elderly people is higher in south China coast than other region of China.The incidence of hypertriglyceridemia and hypertension in people with hyperuricemia is significantly higher than those with normouricemia.
3.A multicenter study of effect of pidotimod on the immune function in children with respiratory tract infection
Yanyuan YANG ; Hua ZHANG ; Zhanling LI ; Xiuhui XU ; Huiyao ZHONG ; Ruhua CHEN
Chinese Journal of Biochemical Pharmaceutics 2014;37(7):132-134,137
Objective To explore the clinical curative effect of pidotimod on patients with respiratory tract infection and effect on immune function. Methods 120 children with recurrent respiratory tract infection in the Third Hospital of Qinhuangdao,the Third Staff Hospital of Baogang Group,the Third Hospital of Wulanchabu were selected,and were divided into two groups according to random number table.60 cases in control group were treated with routine treatment of anti-infection,relieving cough,eliminating phlegm,antipyretic;60 cases in experimental group were treated with pidotimod on the basis of routine treatment,oral with boiled water,0.4g per times,2 times a day,with a course of 60 days.Clinical curative effect after treatment and serum immunoglobulin (IgG,IgA,IgM)levels,T lymphocyte subsets (CD3+,CD4+,CD8+)levels and NK cells relative activities before and after treatment were compared between two groups.Results After treatment,the total effective rate of experimental group (95.00%)was significantly higher than that of control group (81.67%),and the difference was statistically significant (P<0.05);the immune indexes before treatment had no significant difference,and levels of serum immunoglobulin and T lymphocyte subsets were improved,and levels of serum immunoglobulin (IgG,IgA,IgM)and T lymphocyte subsets (CD3+,CD4+,CD8+)of experimental group were more higher than those of control group,and the difference was statistically significant (P<0.05 );relative activity of NK cells in both groups improved after treatment,but relative activity of NK cells in experimental group was significantly higher than that in control group,and the difference was statistically significant (P<0.05 );adverse reactions according minor rashes and anemia were observed in two groups,and there was no significant differece in the incidence of adverse reactions,and ADR was tolerable after symptomatic treatment.Conclusion Pidotimod could significantly improve the clinical curative effect of patients with respiratory tract infections and effectively improve the immune function of patients with recurrent respiratory tract infections with high security,which has a clinical significance.
4.Myocardial perfusion evaluation by using Double FLASH coronary artery CT angiography based on Patlak Plots
Yueqi MEN ; Zhang ZHANG ; Mengshan WU ; Lihong NAN ; Ruijun LI ; Huiyao LI ; Fan YANG ; Fengtan LI ; Dong LI
Chinese Journal of Radiology 2021;55(6):638-643
Objective:To explore the feasibility of using Double FLASH coronary CTA (CCTA) to evaluate myocardial blood perfusion based on the original Patlak Plots.Methods:A total of 50 subjects with non-ischemic heart disease were prospectively included in the study who received dynamic myocardial CT perfusion (CTP) and Double FLASH CTA scans in General Hospital of Tianjin Medical University from January 2018 to January 2020 due to coronary heart disease or suspected coronary heart disease. The age of the enrolled patients was at least 18 years old and there was no moderate or above stenosis on CTA. The dynamic CTP images were analyzed by using CTP analysis software on FRONTIER platform to calculate the CTP derived MBF (MBF CTP). While the CTA derived MBF (MBF CTA) was calculated from the CT attenuation values of both aorta and myocardium segments on two scanning time set of Double FLASH CTA which were measured by two independent radiologists. Pearson correlation and Bland-Altman analysis were used to compare the results of MBF CTP and MBF CTA. Results:There was a strong linear correlation between MBF CTP and MBF CTA measurements. In the mid anteroseptal level: MBF CTA=0.936MBF CTP-11.999, r2=0.600, P<0.01. In the mid anterolateral level: MBF CTA=1.010MBF CTP-9.206, r2=0.448, P<0.01. In the apex: MBF CTA=0.822MBF CTP+16.904, r2=0.375, P<0.01. Bland-Altman analysis also showed there were no significant differences between MBF CTP and MBF CTA measurements. Compared with dynamic CTP scan, Double FLASH CTA mode significantly reduced the radiation dose [(4.33±1.89) mSv vs. (1.38±0.19) mSv, t=4.378, P=0.030]. Conclusions:This study validated the feasibility and accuracy of the MBF CTA measurement based on the theory of Patlak Plots only using Double FLASH CTA images. This method might have the potential to expand the clinical application of one-stop CTP examination for simultaneously evaluating coronary artery and myocardial ischemia in the clinic.
5.Screening of biomarkers in exhaled breath of mice exposed to benzene
Wei YOU ; Huiyao LI ; Lizhu YE ; Xiumei XING ; Yongmei XIAO ; Wen CHEN ; Liping CHEN
Chinese Journal of Preventive Medicine 2021;55(5):672-678
Objective:To screen the biomarkers in the exhaled breath of mice exposed to benzene by using exhaled breath online analysis system.Methods:Thirty 8-week-old male C57BL/6 mice were randomly divided into six groups (0, 3, 32, 324, 648, and 1 296 mg/m 3) and treated with benzene vapour for 28 days. At the end of the exposure, the peripheral blood cell counts and blood glutathione (GSH) were detected. The content of malondialdehyde (MDA) in HL60 cells treated by mice plasma was examined. Exhaled breath data from mice were collected by Secondary electrospray ionization source high resolution mass spectrometry (SESI-HRMS). Targeted analysis underlying benzene metabolites and oxidative stress metabolites was performed to screen the biomarkers in exhaled breath. Results:After benzene exposure, the number of peripheral blood cells was decreased in different degrees, particularly in the white blood cells (WBC) number. The WBC in 32 and 324 mg/m 3 groups was declined by 27.76% and 52.87%, respectively compared to that in control group ( P<0.05). Meanwhile, compared with the control group, the GSH content of peripheral blood cells from 324 mg/m 3 group decreased by 13.16% ( P<0.05). In addition, MDA content was increased by 18.11% in HL60 cells treated with plasma from 324 mg/m 3 group mice ( P<0.05). The phenol, hydroquinone/catechol, benzenetriol and trans, trans-Muconic acid ( t,t-MA) in the exhaled gas of mice could be used as biomarkers for benzene exposure ( R 2>0.8, P<0.001). The peak intensity of five small molecular metabolites related to oxidative stress (ω-carboxylic fatty acid C 5H 10O 3, ω-carboxylic fatty acid C 6H 12O 3, glutamate, cysteine and MDA) increased with the increase of benzene concentration ( P<0.05), which was negatively correlated with WBC decline ( P<0.001), suggesting that these molecules mignt be used as biomarkers of benzene-induced toxicity. Conclusions:Phenol, hydroquinone/catechol, benzenetriol and trans, trans-Muconic acid ( t,t-MA) in exhaled breath of mice could be used as biomarkers for benzene exposure; ω-carboxylic fatty acid C 5H 10O 3, ω-carboxylic fatty acid C 6H 12O 3, glutamate, cysteine and MDA might be used as markers of benzene-induced toxicity.
6.Screening of biomarkers in exhaled breath of mice exposed to benzene
Wei YOU ; Huiyao LI ; Lizhu YE ; Xiumei XING ; Yongmei XIAO ; Wen CHEN ; Liping CHEN
Chinese Journal of Preventive Medicine 2021;55(5):672-678
Objective:To screen the biomarkers in the exhaled breath of mice exposed to benzene by using exhaled breath online analysis system.Methods:Thirty 8-week-old male C57BL/6 mice were randomly divided into six groups (0, 3, 32, 324, 648, and 1 296 mg/m 3) and treated with benzene vapour for 28 days. At the end of the exposure, the peripheral blood cell counts and blood glutathione (GSH) were detected. The content of malondialdehyde (MDA) in HL60 cells treated by mice plasma was examined. Exhaled breath data from mice were collected by Secondary electrospray ionization source high resolution mass spectrometry (SESI-HRMS). Targeted analysis underlying benzene metabolites and oxidative stress metabolites was performed to screen the biomarkers in exhaled breath. Results:After benzene exposure, the number of peripheral blood cells was decreased in different degrees, particularly in the white blood cells (WBC) number. The WBC in 32 and 324 mg/m 3 groups was declined by 27.76% and 52.87%, respectively compared to that in control group ( P<0.05). Meanwhile, compared with the control group, the GSH content of peripheral blood cells from 324 mg/m 3 group decreased by 13.16% ( P<0.05). In addition, MDA content was increased by 18.11% in HL60 cells treated with plasma from 324 mg/m 3 group mice ( P<0.05). The phenol, hydroquinone/catechol, benzenetriol and trans, trans-Muconic acid ( t,t-MA) in the exhaled gas of mice could be used as biomarkers for benzene exposure ( R 2>0.8, P<0.001). The peak intensity of five small molecular metabolites related to oxidative stress (ω-carboxylic fatty acid C 5H 10O 3, ω-carboxylic fatty acid C 6H 12O 3, glutamate, cysteine and MDA) increased with the increase of benzene concentration ( P<0.05), which was negatively correlated with WBC decline ( P<0.001), suggesting that these molecules mignt be used as biomarkers of benzene-induced toxicity. Conclusions:Phenol, hydroquinone/catechol, benzenetriol and trans, trans-Muconic acid ( t,t-MA) in exhaled breath of mice could be used as biomarkers for benzene exposure; ω-carboxylic fatty acid C 5H 10O 3, ω-carboxylic fatty acid C 6H 12O 3, glutamate, cysteine and MDA might be used as markers of benzene-induced toxicity.
7.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
8.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
9.An investigation of recognition and needs of policies of science and technology achievement transformation a-mong the medical personnel in 21 tertiary hospitals in Shanghai
Xiaojie HAN ; Yingying WANG ; Huiyao CHEN ; Xiaoxin YE ; Yuanyuan LI ; Xiaofeng XU ; Lu WEI ; Na LI ; Yun LIN ; Yuhong NIU ; Rong ZHOU ; Yang HONG
Chinese Journal of Medical Science Research Management 2019;32(4):277-280
Objective To understand the cognition ,attitudes and needs of the science and technology achievement trans-formation policies among the medical personnel of 21 tertiary hospitals in Shanghai .Methods Convenient sampling method was used .The self-designed questionnaires were used to survey 420 personals in 21 tertiary hospitals in Shanghai ,and 411 valid questionnaires were responded with a valid rate of 97 .86% .Results The cognition of science and technology achievement transformation policies of the respondents was low ,and the degree of cognition was related to the professional titles ( P<0 .05) .While the recognition degree of some policies was high ;40 .47% agreed that enterprises could be the decision-maker during the transformation process ;85 .99% agreed that it is OK to hire the Technology intermediary service agencies to evalu-ate the achievements value ,confirmed that need such agencies to provide the services of information collection and screening . Conclusions More Policy publicity should be enhanced among the medical personnel ,communications about their needs and suggestions on the science and technology achievement transformation should be carried out to further update related policies , as well as improve the transformation of science and technology achievements in health system .
10.Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines
LI JIANG ; SU KAI ; LI FANG ; TANG WEI ; HUANG YAO ; WANG LE ; HUANG HUIYAO ; SHI JUFANG ; DAI MIN
Chinese Journal of Lung Cancer 2016;19(10):692-699
Background and objective Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evalu-ate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future.Methods Electronic searches were done in English and Chinese databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer offcial websites. Articles were screened according to the predeifned inclusion and exclusion criteria by two researchers. hTe quality of guidelines was assessed by AGREE II.Results At last, a total of 11 guidelines with methodology were included. hTe guidelines were is-sued mainly by USA (81%). Canada and China developed one, respectively. As for quality, the average score in the “Scale and objective” of all guidelines was 80, the average score in the “Participants” was 52, the average score in the “rigorism” was 50, the average score in the “clarity” was 76, the average score in the “application” was 43 and the average score in the “independence”was 59. hTe highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level.Conclusion hTe number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidence-based methodology was accepted globally in the guideline development.