Objective:To investigate the efficacy and prognostic value of baseline 18F-FDG PET/CT metabolism parameters in patients with stage Ⅲ-Ⅳ lung adenocarcinoma before epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) monotherapy. Methods:From January 2012 to June 2020, 61 patients (19 males, 42 females; median age: 64 years) with stage Ⅲ-Ⅳ lung adenocarcinoma who underwent baseline 18F-FDG PET/CT imaging before EGFR-TKI monotherapy in 1 month in Beijing Hospital were retrospectively analyzed. The clinical data and metabolic parameters including SUV max, SUV max of lean body mass (SUL max), peak of SUV of lean body mass (SUL peak), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) of the hottest lesions on PET were analyzed. Patients were followed up to obtain the efficacy evaluation, progression-free survival (PFS) and overall survival (OS). ROC curve analysis was performed to obtain the optimal cut-off value of metabolic parameters to predict disease remission and prognosis. Kaplan-Meier method, log-rank test and Cox proportional risk regression model were used to analyze the prognostic factors. Results:After EGFR-TKI monotherapy, 42.9%(24/56) patients were in disease remission. The optimal cut-off values for predicting disease remission of SUL peak, SUV max, SUL max, MTV, and TLG were 5.9, 13.1, 11.1, 10.6 ml and 99.6 g, respectively. The remission rates of patients with SUV max>13.1, MTV>10.6 ml and TLG>99.6 g were significantly higher than those of patients with SUV max≤13.1(51.2%(21/41) vs 3/15; χ2=4.37, P=0.037), MTV≤10.6 ml (9/12 vs 36.6%(15/41); χ2=5.53, P=0.019) and TLG≤99.6 g (10/13 vs 35.0%(14/40); χ2=6.96, P=0.008). The follow-up period for survival was 0.05-6.80 years, and 10.3%(6/58) patients had no disease progression, and 44.3%(27/61) patients died. The optimal cut-off values of SUL peak, SUV max, SUL max, MTV, and TLG for PFS were 11.2, 17.0, 13.7, 2.7 ml and 14.8 g, and those for OS were 5.6, 14.3, 8.8, 2.8 ml and 37.3 g, respectively. Patients with never-smoking, SUV max≤17.0 and SUL peak≤11.2 had longer PFS ( χ2 values: 3.87-7.37, all P<0.05); never-smoking history (hazard ratio ( HR)=2.29, 95% CI: 1.08-4.87, P=0.031) and SUL peak≤11.2 ( HR=2.67, 95% CI: 1.35-5.27, P=0.005) were independent predictors for PFS. Patients with stage Ⅲ+ ⅣA, SUV max≤14.3, SUL peak≤5.6, SUL max≤8.8 and TLG≤37.3 g had longer OS ( χ2 values: 5.78-8.83, all P<0.05); stage Ⅲ+ ⅣA ( HR=2.81, 95% CI: 1.08-7.32, P=0.034) and SUL max≤8.8 ( HR=9.66, 95% CI: 1.25-74.91, P=0.030) were independent predictors for OS. Conclusions:Baseline 18F-FDG PET/CT imaging has good prospect in clinical application in patients with stage Ⅲ-Ⅳ lung adenocarcinoma before EGFR-TKI monotherapy. The higher baseline metabolic activity of tumor in the 18F-FDG PET/CT, the higher remission rate. Smoking history and SUL peak are independent predictors for PFS; SUL max and stage are independent predictors for OS.

Objective:To investigate the value of left ventricular systolic synchrony assessed by gated myocardial perfusion imaging(GMPI)in predicting major adverse cardiovascular events(MACE)in elderly patients with coronary heart disease(CHD).Methods:In this retrospective study, clinical data from elderly patients who had completed a two-day assessment of resting-loading GMPI between September 2012 and February 2014 in Beijing Hospital were collected, including the summed stress score(SSS)for total ischemic burden, measured by GMPI, left ventricular ejection fraction(LVEF), peak filling rate(PFR), phase band width(PBW), phase standard deviation(PSD)and phase entropy(PE).Follow-up of MACE was conducted.Independent risk factors for MACE were analyzed using a multifactorial Cox proportional hazards regression model, and the cumulative MACE incidence was analyzed using the Kaplan-Meier survival curve.Results:A total of 427 subjects were enrolled, including 200(46.8%)men, with a mean age of 74.1±6.5(60-92)years and 323(75.6%)aged ≥ 70 years.The median follow-up time was 54.7 months.At the end of follow-up, MACE occurred in 47 patients(11.0%).Compared with the group without MACE, the incidences of hypertension, hyperlipidemia, and hyperuricemia were significantly higher( χ2=5.20, 5.62, 3.86, all P<0.05), LVEF and PFR were significantly lower( t=-5.51, -5.23, both P<0.001), and SSS, PSD, PBW, and PE were significantly higher( Z=4.78, t=5.14, 5.78, 5.62, all P<0.001)in the MACE group.The results of Cox proportional hazards regression model analysis suggested that age ≥ 70(hazard ratio: 2.57, 95% CI: 1.08-6.13), abnormal perfusion(hazard ratio: 2.60, 95% CI: 1.31-5.15), increased PSD(hazard ratio: 3.72, 95% CI: 1.72-8.05)and increased PE(hazard ratio: 4.09, 95% CI: 1.94-8.63)were independent risk factors for the occurrence of MACE(all P<0.05).Further analysis on 323 patients ≥ 70 years indicated that abnormal perfusion(hazard ratio: 2.96, 95% CI: 1.40-6.26), increased PSD(hazard ratio: 3.51, 95% CI: 1.56-7.89), and increased PE(hazard ratio: 4.49, 95% CI: 2.08-9.71)were independent risk factors for MACE( P<0.05 for all). Conclusions:Parameters of GMPI systolic synchrony analysis can very well identify the population at high risk of MACE in elderly patients with CHD.

Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

The morbidity and mortality of lung cancer rank first in the world. Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) can significantly prolong survival of patients with advanced non-small cell lung cancer (NSCLC). 18F-FDG PET/CT can evaluate EGFR mutation status and EGFR-TKI efficacy. This article reviews the role of 18F-FDG PET/CT in predicting EFGR mutation, the efficacy and survival prognosis evaluation of EGFR-TKI therapy, as well as the development of latest EGFR-TKI PET imaging agents.

Animals ; SARS-CoV-2 ; Antibodies, Neutralizing ; Macaca mulatta ; COVID-19/prevention & control* ; Antibodies, Viral ; Vaccines

Objective:To study the value of ventilation/perfusion single-photon emission computed tomography(SPECT)in combination with a low-dose CT scan(SPECT/CT)in diagnosing pulmonary embolism(PE)in elderly patients.Methods:In this retrospective study, data were collected from 279 patients with suspected PE and undergone SPECT/CT between January 2015 and December 2019 at Beijing Hospital, with 163 aged ≥65(the elderly group)and 116 aged <65(the control group). Based on diagnosis confirmed during follow-up as the final diagnosis, the diagnostic efficacy of ventilation/perfusion SPECT/CT in the two age groups was examined.The diagnostic efficacy of ventilation/perfusion SPECT/CT and age-adjusted D-dimer in the elderly group was also compared.The diagnostic efficacy of ventilation/perfusion SPECT/CT and CT pulmonary angiography(CTPA)was compared in 43 elderly patients who had undergone both ventilation/perfusion SPECT/CT and CTPA.Results:The sensitivity, specificity and accuracy of ventilation/perfusion SPECT/CT in the elderly group were 96.10%(74/77), 91.86%(79/86)and 93.87%(153/163)in the elderly group and 96.43%(27/28), 94.31%(83/88)and 94.83%(110/116)in the control group, respectively, with no statistically significant difference between the two groups( χ2=0.000, 0.409, 0.116, P=1.000, 0.522, 0.733). The sensitivity, specificity and accuracy of age-adjusted D-dimer were 84.42%(65/77), 63.95%(55/86)and 73.62%(120/163), and were significantly different from those of ventilation/perfusion SPECT/CT(all P<0.05). Among 43 elderly patients undergone ventilation/perfusion SPECT/CT and CTPA, 1 was excluded because the diagnosis based on CTPA was uncertain.The diagnostic sensitivity, specificity and accuracy of ventilation/perfusion SPECT/CT were 96.55%(28/29), 92.31%(12/13)and 95.24%(40/42)and those of CTPA were 65.52%(19/29), 92.31%(12/13)and 73.81%(31/42). They had the same specificity, but there were significant differences in sensitivity and accuracy( P=0.012, 0.022). Conclusions:Ventilation/perfusion SPECT/CT has higher accuracy in the diagnosis of PE in elderly patients, compared with CTPA and age-adjusted D-dimer.

OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.

Objective: To determine whether noncontrast computed tomography (NCCT) models based on multivariable, radiomics features, and machine learning (ML) algorithms could further improve the discrimination of early hematoma expansion (HE) in patients with spontaneous intracerebral hemorrhage (sICH). Materials and Methods: We retrospectively reviewed 261 patients with sICH who underwent initial NCCT within 6 hours of ictus and follow-up CT within 24 hours after initial NCCT, between April 2011 and March 2019. The clinical characteristics, imaging signs and radiomics features extracted from the initial NCCT images were used to construct models to discriminate early HE. A clinical-radiologic model was constructed using a multivariate logistic regression (LR) analysis. Radiomics models, a radiomics-radiologic model, and a combined model were constructed in the training cohort (n = 182) and independently verified in the validation cohort (n = 79). Receiver operating characteristic analysis and the area under the curve (AUC) were used to evaluate the discriminative power. Results: The AUC of the clinical-radiologic model for discriminating early HE was 0.766. The AUCs of the radiomics model for discriminating early HE built using the LR algorithm in the training and validation cohorts were 0.926 and 0.850, respectively.The AUCs of the radiomics-radiologic model in the training and validation cohorts were 0.946 and 0.867, respectively. The AUCs of the combined model in the training and validation cohorts were 0.960 and 0.867, respectively. Conclusion NCCT models based on multivariable, radiomics features and ML algorithm could improve the discrimination of early HE. The combined model was the best recommended model to identify sICH patients at risk of early HE.

Objective:To compare the application of three different glomerular filtration rate(eGFR)-estimating equations in the elderly aged 60 years and over.Methods:The patients aged ≥ 60 years in our hospital from January 2012 to October 2017 were included as research subjects who underwent three GFR detection(as measured GFR i. e.mGFR)of serum creatinine(Scr), serum cystatin C(sCysC)and GFR by 99mTc-DTPA renal dynamic imaging.The advantages and disadvantages of each GFR-estimating(eGFR)equation in the elderly patients were compared.Results:A total of 122 patients were enrolled, including 90 males(73.8%), with a median age of 77 years.The median Scr and sCysC were 109 μmol/L and 1.39 mg/L, respectively, with their average of mGFR being(45.70±18.91)ml·min -1·1.73m -2.Overall, each eGFR-Scr equation over-estimated the GFR in varying degrees.In eGFR-Scr, full age spectrum equation(FAS)-Scr had the smallest bias(2.34)and the best accuracy(P30 75.4%), followed by Berlin Initiative Study(BIS)-Scr(P30 71.3%). In eGFR-CysC, the P30 of FAS-CysC and chronic kidney disease(CKD)-Epidemiology Collaboration(EPI)-CysC were 75.4% and 71.3%, respectively, and the accuracy of eGFR-CysC was comparable to that of BIS-Scr and FAS-Scr.In eGFR-combi, the bias of FAS-combi was the smallest(1.10), and the accuracy of FAS-combi, BIS-combi and CKD-EPI-combi was comparable, the P30 was 81.1%, 79.5% and 74.6%, respectively, and the P30 of FAS-combi and BIS-combi was higher than that of eGFR-Scr and eGFR-CysC.In the 60-80 age group, the accuracy of FAS-combi and BIS-combi was the best, P30 was 77.8% and 76.4% respectively, while, the accuracy of other equations were poor.In patients ≥ 80 years old, except for the modification of diet in renal disease(MDRD)equations and CKD-EPI-scr equation, the accuracy of other equations was acceptable, among which the accuracy of eGFR-combi equation was the best, and the P30 of FAS-combi, BIS-combi and CKD-EPI-combi were 86.0%, 84.0% and 80.0%, respectively. Conclusions:In elderly patients aged 60 years and over, the application of eGFR-combi equation is better than that of the respective eGFR-Scr and eGFR-CysC equations.The FAS equation has the best bias and accuracy, followed by the BIS equation.

Objective:To investigate the relationships between severe, diffuse decrease in global brain 18F-fluorodeoxxglucose(FDG)uptake, whole-body total lesion glycolysis(TLG)and short-term death in elderly patients with newly diagnosed stage Ⅳ cancer. Methods:Clinical and 18FFDG PET/CT data of 24 elderly patients newly diagnosed stage Ⅳ cancer showing marked diffuse decrease in global brain FDG uptake(the decreased brain uptake group)were retrospectively enrolled.Sixteen elderly patients with newly diagnosed stage Ⅳ cancer but without decreased global brain FDG uptake(the no decreased brain uptake group)and 25 healthy subjects were enrolled as the control groups.Correlations between brain FDG uptake and whole-body TLG were analyzed.We followed up the final outcomes of all patients and analyzed the short-term prognostic value of these manifestations. Results:The decreased brain uptake group included 17 patients with stage Ⅳ lymphoma and 7 patients with stage Ⅳ malignant tumor of other types[15 males, age: (73±9)years], while the no decreased brain uptake group included 8 patients with stage Ⅳ lymphoma and 8 patients with stage Ⅳ malignant tumor of other types[12 males, age: (65±5)years]and the healthy control group included 25 subjects[13 males, age: (65±6)years]. Patients were older in the decreased brain uptake group than in the no decreased brain uptake group( t=3.8, P=0.001). The global brain SUV means of the decreased brain uptake group and the no decreased brain uptake group were 4.9±1.8 and 10.9±2.0, respectively( t=-9.8, P=0.000). The global brain total glycolysis(TG)values of the two groups were 1786.5±1162.5 and 2868.4±1424.5, respectively( t=-2.6, P=0.012). The whole-body TLG values of the two groups were 6825.5±4776.9 and 2919.5±2031.7, respectively( t=3.6, P=0.001). Pearson correlation analysis showed that brain FDG uptake was adversely correlated with whole-body TLG.We followed up the survival outcomes of the two groups.The median follow-up lengths of the two groups were 6 months and 10 months, respectively( χ2=3.7, P=0.054). Fourteen(14/24)patients died in the decreased brain uptake group while 9(9/16)died in the no decreased brain uptake group( χ2=0.017, P=0.896). However, 8 cases died within 1 month post PET/CT scan in the decreased brain uptake group while none died in the no decreased brain uptake group( χ2=4.7, P=0.029). Conclusions:Severe, diffuse decrease in 18F-FDG PET/CT uptake in the whole cerebral cortex is more common in elderly patients with newly diagnosed stage Ⅳ cancer, whose total tumor load is significantly higher than that of cancer patients without decrease in whole cerebral cortex FDG uptake.This uptake reduction may indicate poor short-term outcome and the probability of short-term death may be high.