Objective To evaluate the effects of metabolic factors on the quality of 18F-fluorode oxyglucose (18F-FDG) myocardial metabolic imaging in coronary artery disease (CAD) patients with type 2 diabetes mellitus (T2DM). Methods Seventy CAD patients aged 60 years or over with T2DM were studied with myocardial 18 F-FDG dual isotope simultaneous acquisition (DISA) single photon emission computed tomography (SPECT). Fasting plasma glucose, total triglyceride (TG),total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-eholesterol(LDL-C), insulin, C peptide and glyeosylated hemoglobia (HbAlc) were detected. Insulin resistance and islet β cell function were calculated by using the Homeostasis Model Assessment (HOMA) equation. Results Compared with the bad image quality group (36 cases), patients in the excellent image quality group (34 cases) were younger [with average age of (62.2±8.5) years vs. (67.6±8.3) years, P<0.01] and slimmer [with BMI of (24.7±2.6)kg/m2 vs. (26.1±2.5)kg/m2, P<0.05]. The levels of fasting insulin and C peptide were lower in the excellent image quality group than those in the bad image quality group [with fasting insulin level of 8.3 (5.1～12.4) mIu/L vs. 12.7,(6.1～17.9)mIu/L and C-peptide level of 0.6(0.5～0.9)nmol/L vs. 0.9(0.6～1.2)nmol/L, respectively,both P<0.05]. The HOMA insulin resistant index was reduced in the excellent image group [2.7(1.6～4.0) vs. 4.1(1.7～6.5), P<0.05]. Logistic regression analysis showed that obesity and age≥65 years were independent risk factors for image quality, with OR value of 3.73 (95% CI: 1.12～12.45,P=0.022)and 3.75 (95%CI:0.96～14.6,P=0.058)after adjustment of other metabolic factors. Conclusions Insulin resistance is the main factor that influences the quality of 18F-FDG myocardial metabolic imaging in patients with T2DM. In addition, age≥65 years and obesity are also risk factors for image quality.

Objective:To investigate the application value of renal depth correction by the integrated CT in glomerular filtration rate (GFR) determination by 99Tc m-diethylene triamine pentoacetic acid (DTPA) renal dynamic imaging for patients with hydronephrosis. Methods:A total of 338 patients (191 males, 147 females, age (49.6±14.5) years) in Beijing Tsinghua Changgung Hospital from April 2016 to June 2019 with different degrees of hydronephrosis were respectively analyzed. Patients were divided into groups of normal-mild, normal-moderate, normal-heavy, mild-mild, mild-moderate, mild-heavy, moderate-moderate, moderate-heavy and heavy-heavy according to the degree of bilateral hydronephrosis. The renal depth was measured by the integrated CT method and the routine method, and the absolute value of bilateral renal depth difference in normal-mild, normal-moderate and normal-heavy groups was calculated by the 2 methods. Based on the renal depth measured by the 2 methods, the single renal GFR was measured by 99Tc m-DTPA dynamic renal imaging Gates method and compared between the 2 methods. Total GFR measured by the 2 methods were compared with estimated GFR (eGFR). One-way analysis of variance analysis, paired t test, and Pearson correlation analysis were used. Results:For the integrated CT measurements, the absolute value of bilateral renal depth difference in normal-mild, normal-moderate and normal-heavy groups were significantly different ((0.39±0.24), (1.16±0.65) and (1.00±0.90) cm; F=15.241, P<0.05). The renal depth and the single renal GFR measured by the integrated CT method were higher than those measured by the routine method ( t values: 16.06-19.78, 14.27-17.23, all P<0.05) in the kidneys with normal, mild, moderate and heavy hydronephrosis. There were significant differences between the total GFR measured by the routine method and eGFR in all groups ( t values: from -8.178 to 5.879, all P<0.05); however, in the integrated CT method, except that the total GFRs in moderate-heavy group and heavy-heavy group were overestimated ( t values: 3.035 and 11.247, both P<0.05), there were no significant differences between the total GFR ((111.57±17.37), (103.71±15.22), (79.79±12.62), (100.33±18.49), (100.28±15.43), (84.09±20.72) and (74.14±14.57) ml·min -1·1.73 m -2) and eGFR ((109.16±12.81), (103.20±13.26), (78.60±14.12), (100.98±15.20), (99.89±14.05), (84.61±20.24) and (73.44±14.57) ml·min -1·1.73 m -2) in normal-mild, normal-moderate, normal-heavy, mild-mild, mild-moderate, mild-heavy and moderate-moderate groups ( t values: from -0.301 to 1.948, all P>0.05). The total GFR measured by the 2 methods were significantly correlated with eGFR in 338 patients with hydronephrosis ( r values: 0.888 and 0.928, both P<0.01). Conclusion:Compared with the routine method, except for the moderate-heavy group and heavy-heavy group, renal depth correction by the integrated CT may have greater clinical significance in GFR measurement by renal dynamic imaging for patients with hydronephrosis.

Objective To evaluate the therapeutic effects of stem cell transplantation in heart failure patients with old myocardial infarction (OMI) by MRI.nethods Hcart failure patients [NYHA 2.7±0.7,male=18,mean age (59.5±10.1) Y] with OMI were randomly divided into 2 groups (group A:CABG+stem cell transplantation,group B:CABG;n=10 each).Left ventricular (LV) function was measured by MRI,viable myoeardium was detected by 18F-FDG myocardial metabolism imaging and late contrast-enhanced at baseline and 6 months post intervention.Results LVEF and LVEDV at baseline for group A were (20.71±6.09)% and (172.73±32.74) ml,and for group B were (27.59±2.31)% and (155.13±28.36)ml,respectively (P＞0.05).The LVEF was equally improved in group A and B (mean 8.63% vs.10.37%,P＞0.05) while ALVEDV was significant higher in group A than that in group B [(9.91±39.50)ml vs.(-22.34±31.35)ml.P＜0.05].Ventricular wall thickening ratio at 6 months post intervention was significantly higher in group A than that in group B[(11.40 ±11.53)% vs.(2.27±7.20)%,P＜0.05].Late contrast-enhanced M RI results correlated with 18F-FDG myocardial metabolism imaging SPECT well in assessment of myocardial viability (kappa value:0.446,P＜0.001;sensitivity:68.3% and specificity:92.5%).Conclusions Stem cell therapy on top of CABG aggravated LV remodeling in heart failure patients with old myocardial infarction.The specificity of MRI Is similar to 18F-FDG SPECT while the sensitivity is inferior to 18F-FDG SPECT on detecting viable myocardium.

Objective:To assess the safety of sitagliptin added to metformin on cardiovascular adverse events in real world patients with type 2 diabetes mellitus(T2DM).Methods:Real world data from Yinzhou Regional Health Care Database were used to select T2DM patients with diagnosis and treatment records in the platform from January 1,2017 to December 31,2022.According to drug prescription records,the patients were divided into metformin plus sitagliptin group(combination group)and metformin monotherapy group(monotherapy group).A series of retrospective cohorts were constructed according to the index date.Finally,full retrospective cohorts were constructed according to propensity score model,including baseline covariates that might be related to outcomes,to match the subjects in the combination group and monotherapy group for the purpose of increasing the comparability of baseline characteristics.The participants were followed up from the index date until the first occurrence of the following events:Diagnosis of outcomes,death,or the end of the study period(December 31,2022).Cox proportional risk model was used to estimate the hazard ratio(HR)and 95％confidence interval(CI)of sitagliptin added to metformin on 3-point major adverse cardiovascular events(3P-MACE)combination outcome and secondary cardiovascular outcomes.Results:Before propensity score matching,the proportion of the pa-tients in combination group using insulin,α glucosidase inhibitors,sodium-glucose transporter 2 inhibi-tors(SGLT-2I)and glienides at baseline was higher than that in monotherapy group,and the baseline fasting blood glucose(FBG)and hemoglobin A1c(HbA1c)levels in combination group were higher than those in monotherapy group.After propensity score matching,5 416 subjects were included in the combination group and the monotherapy group,and baseline characteristics were effectively balanced be-tween the groups.The incidence densities of 3P-MACE were 6.41/100 person years and 6.35/100 per-son years,respectively.Sitagliptin added to metformin did not increase or decrease the risk of 3P-MACE compared with the metformin monotherapy(HR=1.00,95％CI:0.91-1.10).In secondary outcomes analysis,the incidence of cardiovascular death was lower in the combination group than in the monothera-py group(HR=0.59,95％CI:0.41-0.85),and no association was found between sitagliptin and the risk of myocardial infarction and stroke(HR=1.12,95％CI:0.89-1.41;HR=0.99,95％CI:0.91-1.12).Conclusion:In T2DM patients in Yinzhou district of Ningbo,compared with metformin alone,sitagliptin added to metformin may reduce the risk of cardiovascular death,and do not increase the inci-dence of overall cardiovascular events.The results of this study can provide real-world evidence for post-marketing cardiovascular safety evaluation of sitagliptin.

Objective:Differences between randomized controlled trial (RCT) results and real world study (RWS) results may not represent a true efficacy-effectiveness gap because efficacy-effectiveness gap estimates may be biased when RWS and RCT differ significantly in study design or when there is bias in RWS result estimation. Secondly, when there is an efficacy- effectiveness gap, it should not treat every patient the same way but assess the real-world factors influencing the intervention's effectiveness and identify the subgroup likely to achieve the desired effect.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:Ten articles were included to discuss how to use the RCT research protocol as a template to develop the corresponding RWS research protocol. Moreover, based on correctly estimating the efficacy-effectiveness gap, evaluate the intervention effect in the patient subgroup to confirm the subgroup that can achieve the expected benefit-risk ratio to bridge the efficacy-effectiveness gap.Conclusion:Using real-world data to simulate key features of randomized controlled clinical trial study design can improve the authenticity and effectiveness of study results and bridge the efficacy-effectiveness gap.

Objective:Randomized controlled trials (RCT) usually have strict implementation criteria. The included subjects' characteristics of the conditions for the intervention implementation are quite different from the actual clinical environment, resulting in discrepancies between the risk-benefit of interventions in actual clinical use and the risk-benefit shown in RCT. Therefore, some methods are needed to enhance the extrapolation of RCT results to evaluate the real effects of drugs in real people and clinical practice settings.Methods:Six databases (PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP) were searched up to 31 st December 2022 with detailed search strategies. A scoping review method was used to integrate and qualitatively describe the included literature inductively. Results:A total of 12 articles were included. Three methods in the included literature focused on: ①improving the design of traditional RCT to increase population representation; ②combining RCT Data with real-world data (RWD) for analysis;③calibrating RCT results according to real-world patient characteristics.Conclusions:Improving the design of RCT to enhance the population representation can improve the extrapolation of the results of RCT. Combining RCT data with RWD can give full play to the advantages of data from different sources; the results of the RCT were calibrated against real-world population characteristics so that the effects of interventions in real-world patient populations can be predicted.

Humans ; Incretins/therapeutic use* ; Diabetes Mellitus, Type 2/drug therapy* ; Hypoglycemic Agents/therapeutic use* ; Risk Assessment