1.Rapid health technology assessment of insulin icodec for the treatment of type 2 diabetes mellitus
Jie LI ; Hong LI ; Guanji CHEN ; Xiaoyan CHANG ; Xiang YANG ; Zhitao JIANG
China Pharmacy 2025;36(22):2856-2861
OBJECTIVE To comprehensively evaluate the efficacy, safety and cost-effectiveness of insulin icodec in treating type 2 diabetes mellitus (T2DM), providing evidence-based guidance for new drug selection in hospital and clinical medication decision-making. METHODS PubMed, Cochrane Library, Embase, CNKI, Wanfang, VIP and foreign health technology assessment (HTA) websites were searched by using rapid health technology assessment from inception to 15 July 2025 for systematic reviews/meta-analyses, pharmacoeconomic studies, and HTA reports on insulin icodec in the treatment of T2DM. After data extraction and quality assessment, the findings of the included studies were analyzed descriptively. RESULTS Ten systematic reviews/meta-analyses and three pharmacoeconomic studies were included. Among them, 4 systematic reviews/meta-analyses were of high quality; the overall quality of the 3 pharmacoeconomic studies was relatively good. Regarding efficacy, insulin icodec was superior to once-daily basal insulin in reducing glycated hemoglobin (HbA1c) and in achieving the target of HbA1c<7% (P<0.05). No significant differences were observed between icodec insulin and comparators in lowering fasting plasma glucose (P>0.05). For safety, insulin icodec did not increase the incidence of any adverse events (AEs), serious AEs, clinically significant hypoglycemia (random glucose<3 mmol/L), injection-site reactions, or allergic reactions, compared with once-daily basal insulin overall (P> 0.05); however, insulin icodec was associated with a significant increase in body weight (P<0.05). Domestic economic evaluations indicated that insulin icodec was more cost-effective than insulin glargine and insulin degludec when its annual costs were in the range of 784.90-1 145.96 and 597.66-736.34 US dollars, respectively. CONCLUSIONS Insulin icodec demonstrates favorable efficacy and safety profiles in the treatment of T2DM; however, attention should be paid to the risk of weight gain. Under China’s healthcare system, insulin icodec demonstrates greater economic value only when the patient’s weekly required basal insulin dose falls within a specific range,and clinical practice requires individualization.
2.Romiplostim for the treatment of primary immune thrombocytopenia in adults:a rapid health technology assessment
Jie LI ; Jun XIE ; Yi HAN ; Ying MENG ; Liyuan GAO ; Xiaohui SHI ; Zhitao JIANG
Chinese Journal of Pharmacoepidemiology 2024;33(8):909-918
Objective To evaluate the efficacy,safety and economics of romiplostim for treating primary immune thrombocytopenia(ITP)by rapid health technology assessment,and to provide an evidence-based basis for policy makers and clinical practice.Methods PubMed,Cochrane Library,Embase,CNKI,WanFang Data and VIP databases and the official websites of health technology assessment agency were electronically searched to collect high-quality clinical evidence and pharmacoeconomics evaluation literature of romiplostim for the treatment of ITP from inception to January 18,2024.Two researchers independently screened the literature,extracted information,and accessed the quality of included the literature,the extracted results were categorized and evaluated.Results A total of 14 literature were included,in which 8 systematic reviews/Meta-analysis and 6 pharmacoeconomic studies.In terms of efficacy,treatment with romiplostim significantly elevated platelet response rate,sustained platelet response rate,and mean platelet count in patients with ITP compared with placebo(P<0.05).Romiplostim did not show a significant advantage in elevating patients'platelet response rate and sustained platelet response rate compared with other agents used to treat ITP(P>0.05).In terms of safety,the incidence of serious adverse events was statistically lower with romiplostim compared to placebo(P<0.05),while no significant differences were seen in the incidence of adverse events,bleeding events and thrombotic events(P>0.05).There were no significant differences in the incidence of adverse events,serious adverse events,bleeding events,or thrombotic events when comparing romiplostim to other drugs for the treatment of ITP(P>0.05).From an economic standpoint,most studies considered eltrombopag to be more economic advantages than romiplostim.Conclusion Romiplostim has good efficacy and safety in the treatment of ITP,and no advantage was shown in terms of economy.
3.Analysis on Nutritional Status of Vitamin D Among Adults of 6 Ethnic Minority Groups Native to Yunnan Province
Nan ZHANG ; Yanling YANG ; Qingqing WAN ; Jiang ZHAO ; Min PENG ; Xiao ZHU ; Zhitao LIU ; Qiang ZHANG
Journal of Kunming Medical University 2024;45(2):105-111
Objective To assess the nutritional status of vitamin D and associated factors among adults of six ethnic minority groups native to Yunnan Province,and provide evidence for policy making.Methods Between May 2019 and August 2020,a total of 690 adults were selected from Jinuo,Bulang,Jingpo,Deang,Achang and Pumi ethnic groups according to the sex and age composition in the 6th national census.A questionnaire survey and an anthropometric examination were conducted by trained health workers,and serum 25(OH)D levels were determined with high-performance liquid chromatography-tandem mass spectrometry.Results The median of serum 25(OH)D was 28.7(P25~P75∶24.3~33.8)ng/mL,and the prevalence of vitamin D sufficiency,insufficiency and deficiency were 44.2%、47.5%and 8.3%,respectively.There were significant differences in serum 25(OH)D levels among the six ethnic groups(χ2=139.29,P<0.01).Multivariate logistic regression showed that ethnic groups living in higher latitude areas(Pumi,Jingpo,Deang,and Achang),women,and those whose BMI≥24.0 were more likely to be vitamin D insufficient or deficient.Conclusion More than half of the ethnic adults suffer from vitamin D malnutrition which also varies across ethnicities.Further surveillance and interventions among key areas and populations are needed.
4.Research progress of effect of non-therapeutic thymectomy and thymectomy on overall health
Bincheng JIANG ; Ning XU ; Zhitao GU ; Wentao FANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(08):1122-1128
Thymectomy is the main treatment for thymoma and other thymic diseases. But the incidence of non-therapeutic thymectomy is high due to the difficulty in the differential diagnosis of anterior mediastinum lesions. Formerly, it was believed that the thymus gradually degraded and lost function with aging, and the preservation of the thymus was not valued. Recent studies have found that the removal of the thymus at all ages has adverse effects on overall health and leads to a significant increase in the risk of autoimmune diseases, malignancy, and all-cause mortality. Therefore, unnecessary thymectomy should be avoided. This article reviews the influence of thymectomy, including the changes of immunological indexes and clinical prognosis, and further discusses the current situation and avoidance methods of non-therapeutic thymectomy.
5.Efficacy and safety of glucokinase activators for type 2 diabetes mellitus therapy:a meta-analysis
Jie LI ; Xiaofei CHEN ; Zihan XU ; Xiaoyan LIU ; Yuechan ZHANG ; Yi HAN ; Wei ZHANG ; Zhitao JIANG
China Pharmacy 2023;34(1):102-106
OBJECTIVE To systematically evaluate the efficacy and safety of glucokinase activators in the treatment of type 2 diabetes mellitus. METHODS PubMed, Cochrane Library, Web of Science, Embase and CNKI databases were searched from the inception to March 2022. Randomized controlled trials about glucokinase activators versus placebo (or other oral hypoglycemic agents) in the treatment of type 2 diabetes were included, data were extracted and meta-analysis was analyzed using RevMan 5.4 software. RESULTS A total of 9 studies with 215 0 patients were included. In terms of hypoglycemic effect, compared with control group, glucokinase activators significantly reduced glycosylated hemoglobin (HbA1c) [MD=-0.40, 95%CI(-0.53, -0.26), P<0.000 01], fasting blood glucose[MD=-0.53, 95%CI(-0.85, -0.20), P=0.001] and 2 h postprandial blood glucose [MD=-2.28, 95%CI(-2.68, -1.88), P<0.000 01] in diabetic patients. In terms of safety, the incidence of hypoglycemia caused by glucokinase activators was higher than control group on the whole [RR=1.55, 95%CI(1.20,2.01), P= 0.000 8]. According to the subgroup analysis of organs activated by glucokinase activator, the incidence of hypoglycemia in the pancreas-liver dual activator group [RR=1.44, 95%CI(1.11,1.89), P=0.007] and liver-selective activator group [RR=2.26, 95%CI(1.02,5.03), P=0.05] was higher than that in the control group, the difference was statistically significant. CONCLUSIONS Glucokinase activators can effectively reduce HbA1c, fasting blood glucose and 2 h postprandial blood glucose in patients with type 2 diabetes, but the risk of hypoglycemia remains to be addressed.
6.Preventive effect of alkaline drinking water on hyperuricemia in mice
YU Shali ; LIN Chen ; JIANG Zhitao ; ZHU Chao ; ZHAO Xinyuan
Journal of Preventive Medicine 2021;33(8):772-776
Objective:
To observe the preventive effect of alkaline drinking water on hyperuricemia in mice.
Methods:
Sixty male SPF Kunming mice were randomly divided into six groups: pH 7.3, pH 8.0, pH 9.3 intervention groups, in which the mice were given water with pH values of 7.3±0.5, 8.0±0.5 and 9.3±0.6, respectively; the control group, model group and positive drug group ( with 2 g/L allopurinol ) were given double distilled water. Except for the control group, the mice in each group were given yeast by gavage (1.5 g/mL) for 13 days. On the 14th day, the mice were injected with 300 mg/kg potassium oxyzinate by intraperitoneal injection, and then fasted for 1 day. On the 16th day, serum uric acid, creatinine and urea nitrogen were detected, and renal tissues were stained to observe the morphology.The expression levels of neutrophil gelatinase-associated lipocalin ( NGAL ), tissue inhibitor of metalloproteinase 1( TIMP1 ), organic anion transporter 1 ( OAT1 ) and urate transporter 1 ( URAL-1 ) in renal tissues were determined bywestern blotting. The mRNA expression levels of URAL-1 and OAT1 were detected by real-time fluorescent quantita⁃tive polymerase chain reaction.
Results:
The level of serum uric acid was higher in the model group than in the control group and in the pH 9.3 intervention group (both P<0.05). The number and area of renal tubular lesions were less in the pH 9.3 intervention group than in the model group (all P<0.05). The relative expression levels of NGAL and
URAT-1 proteins were lower in the pH 9.3 intervention group than in the model group, and the relative expression level of OAT1 protein was higher in the pH 9.3 intervention group than in the model group ( all P<0.05). The relativeexpression level of URAT-1 mRNA was lower in the pH 9.3 intervention group than in the model group, and the rela⁃tive expression level of OAT1 mRNA was higher in the pH 9.3 intervention group than in the model group ( all P<0.05 ).
Conclusion
Alkaline drinking water with pH value of 9.3±0.6 can effectively prevent hyperuricemia and acute
kidney injury in mice.
7.The clinical effects of glycated hemoglobin, fasting blood glucose and serum C-peptide combined screening for gestational diabetes screening and its clinical significance
Haiyan JIANG ; Zhitao HU ; Qian LIU ; Min TIAN ; Shutao NIE
Chinese Journal of Postgraduates of Medicine 2020;43(4):375-378
Objective:To investigate the clinical effects of glycated hemoglobin, fasting blood glucose and serum C-peptide combined screening for gestational diabetes screening and its clinical significance.Methods:A total of 40 pregnant women with gestational diabetes mellitus (observation group) and 40 pregnant women (control group) in Peking University Medical Lu Zhong Hospital from January 2016 to September 2019 were enrolled. The changes of glycated hemoglobin, fasting blood glucose, and serum C-peptide were compared between the two groups, and the efficacy of combined screening for gestational diabetes was evaluated.Results:The glycated hemoglobin of the pregnant women in the observation group was significantly higher than that in the control group [(8.12 ± 1.14)% vs. (5.23 ± 0.15)%], the serum C-peptide of the pregnant women in the observation group was lower than that in the control group [(1.19 ± 0.28) nmol/L vs. (1.61 ± 0.22) nmol/L], and there were significant differences ( P<0.05). There was no significant difference in fasting blood glucose between the two groups ( P>0.05). When glycosylated hemoglobin, fasting blood glucose and serum C-peptide index was screened combinedly, the sensitivity, specificity, positive predictive value, negative predictive value and the areas under the receiver operation characteristic (ROC) curve were 98.65%, 86.50%, 88.42%, 95.45%, and 0.943, respectively. Compared with all other individual indicators, the difference was statistically significant ( P<0.05). Conclusions:The combined detection of glycosylated hemoglobin, fasting blood glucose and serum C-peptide can more accurately diagnose gestational diabetes mellitus at an early stage.
8.Simultaneous determination of four kinds of components in Gegen-Huangqin-Huanglian Decoction by UPLC-MS/MS
Xiaohui SHI ; Zhitao JIANG ; Wei ZHANG ; Lihua HUANG ; Yi HAN ; Hong CHEN ; Li QIAN
International Journal of Traditional Chinese Medicine 2020;42(9):895-899
Objective:To develop an UPLC-MS/MS method for the simultaneous determination of baicalin, berberine, glycyrrhizic acid and puerarin in Gegen-Huangqin-Huanglian Decoction. Methods:Isocratic elution was carried out with mobile phase consisting of acetonitrile - 4 mmol/L ammonium formate. The separation was performed on ACE Excel 3 C18 (2.1 mm × 100 mm, 3 μm), and the mass spectrometer was operated in the positive and negative ionization electrospray (ESI) mode using multiple monitoring (MRM) for analysis of four components. External standard method was used for fix quantity. The precursor to product ion transitions monitored for baicalin, berberine, glycyrrhizic acid and puerarin were m/z 447.0→271.0, 336.2→320.2, 821.4→350.9 and 415.2→294.9, respectively. Results:Baicalin, berberine, glycyrrhizic acid and puerarin were all analyzed exactly, the linear ranges were 0.002-0.080, 0.002-0.080, 0.001-0.040, 0.002-0.080 ng, respectively. The r were 0.998 3, 0.999 4, 0.997 9 and 0.999 5, respectively. The recoveries of four analytes ranged from 98.75% to 100.86% and the relative standard deviations were all below 0.74%. Conclusions:UPLC-MS/MS method is sensitive, accuate with rapid speed, which could be used for the determination of baicalin, berberine, glycyrrhizic acid and puerarin in Gegen-Huangqin-Huanglian Decoction.
9.Simultaneous determination of five compounds in Ganmaoning granules by UPLC-MS/MS
Chundi LIU ; Wei ZHANG ; Xiaohui SHI ; Xiaoyan LIU ; Yi HAN ; Lingyan LYU ; Zhitao JIANG
International Journal of Traditional Chinese Medicine 2019;41(1):62-66
Objective To establish a method for the simultaneous determination of adenosine, chlorogenic acid, caffeic acid, baicalin and wogonin in Ganmaoning granules. Methods The UPLC-MS/MS method was adopted. The separation was performed on ZOBAX SB C18 (2.1 mm×150 mm, 5μm) column with mobile phase consisted of methanol-2 mmol/L ammonium acetate aqueous solution (isocratic elution) at the flow rate of 0.2 ml/min. The column temperature was set at 35℃, and the injection volume was 2μl. The electrospray ionization source (ESI) was used. Multiple reaction monitoring (MRM) mode was adopted, using positive and negative ions scanning. The ion source temperature was 300℃, the drying gas temperature was 400℃, the drying gas flow was 20 L/min, the atomizing gas pressure was 55 psi, and the capillary voltage was 4000 V.Results The linear ranges of adenosine, chlorogenic acid, caffeic acid, baicalin and wogonin in Ganmaoling granules were 0.20-12.80 ng (r=0.9996), 1.00-64.00 ng (r=0.9998), 0.40-25.60 ng (r=0.9996), 4.00-256.00 ng (r=0.9992), 0.20-12.8 ng (r=0.9991), which showed the linear relationship was good. The limits of detection were 0.02, 0.10, 0.04, 0.40, 0.02 ng, respectively. The limits of quantitation were 0.04, 0.20, 0.08, 0.80, 0.04 ng, separately. TheRSDs of precision, reproducibility and stability (24 h) tests were no more than 3.5%. The recovery rates were 99.3%-100.75% (RSD=2.09%-3.17%).Conclusions The method established in this experiment is simple, rapid, sensitive and accurate. It can be used to simultaneously determine the contents of five components inGanmaoling granules, and can be used for quality control ofGanmaoninggranules.
10.Simultaneous determination of three compounds in penthorum Chinense pursh by HPLC
Zhen KANG ; Chundi LIU ; Xiaoyan LIU ; Zhitao JIANG ; Xingyue FENG ; Yongmei ZHANG
International Journal of Traditional Chinese Medicine 2019;41(8):863-866
Objective To establish a method for the simultaneous content determination ofquercetin,kaempferol and pinocembrin in Penthorum Chinense Pursh.Methods The HPLC analysis was carried out on Alltima C18 (250 mm × 4.6 mm,5 μm) with a mixture of methanol-0.2% phosphate (45:55) as the mobile phase.The determination wavelength was set at 270 nm with the flow rate of 1.0 ml/min.The column temperature was set at 30 ℃.Results The quercetin,kaempferol and pinocembrin showed good linearity in the range of 0.316-10.120 μg (r=0.999 9),0.012-0.397 μg (r=0.999 6) and 0.063-2.016 μg (r=0.999 8) respectively.The average recovery rates of quercetin,kaempferol and pinocembrin were 99.34% (RSD=1.51%),99.76% (RSD=l.96%) and 98.34% (RSD=1.56%) respectively.Conclusions The method is accurate and sensitive,which can be used for the content determination of quercetin,kaempferol and pinocembrin in Penthorum Chinense Pursh.


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