Objective:To evaluate the effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism.Methods:A multicenter, randomized, positive parallel controlled, non-inferiority clinical trial was conducted in ten hospitals in China from October 2017 to March 2019. A total of 188 subjects were enrolled according to the same inclusion and exclusion criteria in different institutes. The 188 subjects were randomly divided into the trial group or the control group according to 1∶1 by the central randomization system, with 94 cases in each group. Octoparms inferior vena cava filter was used in the trial group, and the Celect inferior vena cava filter in the control group. The primary effective index was clinical success rate,including the clinical success rate of filter placement and filter retrieval. The secondary index included the rate of manual success of the delivery sheath system,incidence of pulmonary embolism(within 6 months), incidence of filter fracture,migration (>20 mm),tilt(>15°) on insertion/retrieval,and the situation of inferior vena cava flow(within 6 months). Safety evaluation included the incidence of filter related complications and device-related adverse events immediately after surgery and during follow-up.Results:The success rate of implantation was 100% in 188 subjects. Filter retrieval was performed in 87 cases (92.55%) in the trial group and 91 cases (96.81%) in the control group. The clinical success rate of the trial group was 97.87%(92/94) and that of the control group 98.94%(93/94). There was no significant difference between the two groups (χ 2=0.77, P=0.380). The success rate of delivery sheath system was 96.81%(91/94) and 98.94%(93/94) in the trail group and the control group,respectively. There was no significant difference between the two groups( P=0.621). There was 1 case (1.22%) of new asymptomatic pulmonary embolism in the trial group after filter placement and 2 cases (2.44%) in the control group. There was no significant difference between the two groups ( P>0.05). No filter fracture or migration (>20 mm) occurred in either group. The tilting of filter (>15°) was found in 1 case (1.06%) in the test group and 1 case (1.06%) in the control group when the filter was placed. The tilting of filter (>15°) was found in 0 case in the test group and 2 cases (2.44%) in the control group when the filter was retrieved. There was no significant difference between the two groups ( P>0.05). Inferior vena cava thrombosis before filter retrieval was found in 5 cases (5.75%) in trial group and 3 cases (3.30%) in control group. There was no significant difference between the two groups ( P=0.489). There were no immediate serious complications during filter placement/removal in either group. No filter obstruction,migration,deformation,penetration and occlusion of inferior vena cava. The incidence of device-related adverse events was low in both group. There was no significant difference between the two groups ( P>0.05). Conclusion:The home-made umbrella-shaped Octoparms inferior vena cava filter is effective and safe in preventing pulmonary embolism, and is not worse than Celect filter.

Objective:To investigate the application of different imaging methods of 99Tc m-pyrophosphate (PYP) in the diagnosis and pathological classification of cardiac amyloidosis (CA). Methods:A total of 31 patients (22 males, 9 females, age 21-81(57.2±13.4) years) with suspected CA who underwent 99Tc m-PYP dual-phase scintigraphy (early-phase: 1 h, delay-phase: 2-3 h) and SPECT/CT (1 h) between December 2018 and December 2019 in Peking Union Medical College Hospital were retrospectively included. Taking clinical diagnosis as the standard, the results of visual score (≥2, positive) and semi-quantitative values (heart to contralateral lung (H/CL)≥1.5, positive) of 99Tc m-PYP uptake in dual-phase scintigraphy and SPECT/CT imaging were analyzed. One-way analysis of variance and Bonferroni test were used to analyze the data. Results:Among 31 patients with suspected CA, 15 were clinically diagnosed as CA (5 patients with transthyretin-related CA (ATTR-CA) and 10 patients with light chain CA (AL-CA)) and 16 were diagnosed as non-CA. All 5 patients with ATTR-CA had positive dual-phase scintigraphy and SPECT/CT imaging results. Three out of 10 patients with AL-CA had positive early-phase scintigraphy whereas negative delay-phase scintigraphy and SPECT/CT imaging results. Sixteen patients who were clinically diagnosed as non-CA had negative dual-phase scintigraphy and SPECT/CT imaging results. The sensitivity (5/5), specificity (10/10), positive predictive value (5/5), negative predictive value (10/10) and accuracy (15/15) of delay-phase scintigraphy and SPECT/CT imaging were the same. Among 31 patients, 16 patients carried transthyretin-related (TTR) gene mutation, and 4 of them who clinically diagnosed as variant ATTR (ATTRv) had positive image findings while 12 of them who not clinically diagnosed as CA had negative image findings. There were significant differences in H/CL between ATTR-CA group and AL-CA group in early-phase (2.11±0.24 vs 1.31±0.07) and delay-phase (2.02±0.19 vs 1.30±0.05; F values: 75.41 and 87.15, Bonferroni test, both P<0.01). Conclusions:99Tc m-PYP delay-phase scintigraphy and SPECT/CT have high diagnostic efficiencies in ATTR-CA, helping to determine the pathological classification of CA; while early-phase scintigraphy has false positive results. Moreover, 99Tc m-PYP imaging is helpful to detect CA in patients with TTR gene mutation.

A 3-week practice-oriented training course on chronic obstructive pulmonary disease (COPD) management was conducted in December 2020, 34 primary care physicians from township or community health service centers attended the course. The impact of the training course on the knowledge levels of COPD management was evaluated with a questionnaire survey, the questionnaire contained the knowledge of COPD and its management. The survey showed that before the training, the participants had low knowledge levels on the definition of COPD and its risk factors; 67.6% (23/34) were not aware of COPD-related guidelines and new developments, and 17.6%(6/34) had conducted COPD follow-up assessments, pulmonary rehabilitation, and health education; only 8.8% (3/34) had used the improved British Medical Research Council Dyspnea Index (mMRC) and the chronic obstructive pulmonary disease assessment test (CAT) for patient self-assessment; there was no pulmonary function instrument in their units, and only 3 doctors (8.8%) had previously participated in pulmonary function training and knew indications and contraindications of the pulmonary function test, and complete report interpretation; all participants were unable to use common inhalation devices and master inhalation techniques completely and correctly; 11.8% (4/34) had assessed patients′ handling inhalation devices and performing inhalation. After the training, the knowledge levels of COPD clinical features, lung function and inhalation technique were significantly improved, and the scores were significantly increased compared with those before the training ( P<0.001). The study shows that primary care physicians have insufficient knowledge and management skill of COPD. The practice-oriented training can significantly improve the knowledge and skills of primary care physician for COPD management in the community.

Artificial intelligence (AI) is an emerging science and technology that studies and develops theories, methods, technologies, and application systems for simulating and expanding human intelligence. AI has made great breakthroughs in the field of intelligent medicine, and has shown great potential in the diagnosis and treatment of diabetic retinopathy (DR), retinopathy of prematurity, and other fundus diseases. A number of clinical trials on the application of AI technologies to DR screening have been carried out in the domestic and overseas, which not only have a high accuracy rate, but also save doctors' reading time and reduce the burden of society, medical work and patients. However, due to the lack of evaluation system for DR intelligent diagnosis technology, the accuracy of AI system still lacks of big data verification. Secondly, most of the color fundus photographs are taken in the posterior 45°, which only show the most vulnerable areas, making some lesions undetectable. In addition, the current DR screening system has not yet been applied to the clinic, most of which are in the stage of prospective research and trials. There are still many obstacles from the environment to the hospital or the clinic. Doctors cannot use real patient data to evaluate the AI system, so it is not popular in clinical practice. In the future, DR screening algorithms and diagnostic models can be further improved and established to make DR AI screening more accurate.

Objective: To explore the significance of minimal residual disease (MRD) in predicting prognosis and guiding therapy of adults with Philadelphia-chromosome negative acute lymphoblastic leukemia (Ph^- ALL) in high-risk. Methods: Data of newly diagnosed adults with Ph^- ALL in high-risk who achieved CR were reviewed. Variables associated with outcome were identified by COX regression model and Landmark analysis. Results: A total of 177 patients, 99 (56%) cases male with a median age of 40 years (range, 16-65 years) were included in this study. Of them, 95 (54%) patients received allo-HSCT in CR₁. Multivariate analyses showed that MRD negativity after the first cycle of consolidation (HR=0.52, 95%CI 0.30-0.89, P=0.017) and achieving CR within 4 weeks (HR=0.43, 95%CI 0.24-0.79, P=0.006) were the factors significantly-associated with longer DFS, and allo-HSCT was associated with both longer DFS (HR=0.13, 95%CI 0.08-0.22, P<0.001) and OS (HR=0.24, 95%CI 0.15-0.41, P<0.001) . Landmark analysis was performed on 121 patients, of 85 patients achieving MRD negativity after the first cycle of consolidation, multivariate analyses showed that MRD negativity after the third cycle of consolidation was significantly-associated with longer DFS (HR=0.18, 95%CI 0.05-0.64, P=0.008) and OS (HR=0.14, 95%CI 0.04-0.50, P=0.003) . For the patients achieving MRD negativity after both the first and the third cycles of consolidation, the 3-year DFS rate in the allo-HSCT cohort had a higher trend compared with that in the chemotherapy cohort (75.2% vs 51.3%, P=0.082) , however, the 3-year OS rates in the 2 cohorts were similar (72.7% vs 68.7%, P=0.992) . In those with MRD positivity after the first and/or the third cycle of consolidation, 3-year DFS (64.8% vs 33.3%, P=0.006) and OS (77.0% vs 33.3%, P=0.028) rates in the allo-HSCT cohort were significantly higher than those in the chemotherapy cohort, and similar to those in the cohort achieving MRD negativity after both the first and the third cycles of consolidation and receiving allo-HSCT. Conclusions MRD negativity after the first cycle of consolidation was a predictor for better outcome in adults with Ph^- ALL in high-risk. The survival advantage of the allo-HSCT cohort was not pronounced compared with that in the chemotherapy cohort even in those with high-risk features but achieving MDR negativity after both the first and third cycles of consolidation. However, allo-HSCT could be a good option for the patients with MRD positivity after the first and/or the third cycle of consolidation.

Objective: To investigate the characteristic and prognostic significance of leukemia stem cells associated antigens expressions including CD34, CD38, CD123, CD96 and TIM-3 in t (8;21) AML. Methods: Bone marrow samples of 47 t (8;21) AML patients were collected at diagnosis from October 2015 to April 2018 in Peking University Peoples’ Hospital, then flow cytometry method was performed to detect the expression frequencies of CD34, CD38, CD123, CD96 and TIM-3 to analyze the relationship between leukemia stem cells associated antigens expressions and relapse. Results: Of 47 t (8;21) AML patients tested, the median percentages of CD34⁺CD38^-, CD34⁺ CD38^-CD123⁺, CD34⁺CD38^- CD96⁺ and CD34⁺ CD38^- TIM-3⁺ cells among nucleated cells were 2.37%, 0.24%, 0.27% and 0.06%, respectively. All the frequencies of CD34⁺CD38^-, CD34⁺CD38^-CD123⁺, CD34⁺CD38^-CD96⁺ and CD34⁺ CD38^-TIM-3⁺ cells had no impact on the achievement of CR after the first course of induction. All higher frequencies of CD34⁺CD38^-, CD34⁺CD38^-CD123⁺, CD34⁺CD38^-CD96⁺ cells were related to higher 2-year CIR rate. Whereas, the frequency of CD34⁺ CD38^- TIM-3⁺ cells had no impact on CIR rate. Both high frequency of CD34⁺ CD38^- cells and the high level of minimal residual diseases (patients with <3-log reduction in the RUNX1-RUNX1T1 transcript level after the second consolidation therapy) were independent poor prognostic factors of CIR[P=0.025, HR=6.9 (95%CI 1.3-37.4) ; P=0.031, HR=11.1 (95%CI 1.2-99.2) ]. Conclusion Different leukemia stem cells associated antigens had distinct prognostic significance in t (8;21) AML. High frequencies of CD34⁺ CD38^-, CD34⁺ CD38^- CD123⁺ and CD34⁺CD38^-CD96⁺ cells at diagnosis predicted relapse in patients with t (8;21) AML.

Objective: To explore and compare 4-color and 8-color fluorescence antibody panels for detecting minimal residual disease of multiple myeloma patients after therapy. Methods: One 8-color antibody panel was built including CD38 and CD138 for the identification of plasma cells (PCs) , membrane antigen CD45, CD19, CD56 and CD117, cytoplasmic Kappa (cκ) and Lambda (cλ) light chain antigen. Six tubes of 4-color panels were built, among them, membrane antigen CD45/CD19, CD56/CD117, CD19/CD56 and light chains were analyzed combined by CD38/CD138 for PCs gate in the tubes M1-3 and tube C-_κ/λ, respectively; CD19 or CD45 and cκ/cλ light chains were detected in the tube MC1-_CD38 for CD38/SSC identified PCs gate and tube MC2-_CD138 for CD138/SSC identified PCs gate separately. Twenty normal volunteer bone marrows and seventy-three specimens from multiple myeloma patients after complete remission were measured and analyzed. Results: MRD positive samples were discriminated in 82.19% of the specimen evaluated through either abnormal plasma cells (aPCs) or clonal plasma cells (cPCs) by 8-color antibody panel. Among of them, consistency was 89.04%. The median percentage of cPCs was 0.105%. The lowest sensitivity of experiment was 0.004%. Percentage of PCs identified by CD38/ SSC gate was higher than that by CD38/CD138 (P<0.001) and CD138/SSC gate (P=0.001) apparently. The lowest MRD positive rate was found in tube C (65.75%) , which lower than 8-color panel obviously (P=0.024) . The percentages of aPCs measured by tube M2-_56/117 were significantly lower than other tubes (P=0.014) . MRD positive rate determined by cPCs was higher than that by aPCs both in the tube MC1-_CD38 and tube MC2-_CD138, whose concordance rate were 68.49% and 79.45%, respectively. Compared with 8-color panel, tube MC2-_CD138 the best choice among six tubes of 4-color panels, which has the best sensitivity, accuracy and negative predicted value, higher positive predicted value and specificity. Tube M1-_45/19 was the second choice. Conclusions CD38/CD138 are the best markers for gating PCs. Membrane antigen and cκ/cλ detected simultaneously is a better method for MM MRD detection and 8-color antibody panel is an ideal approach. Two tubes of 4-color antibody combination, M1-_45/19 and MC2-_CD138 are recommended in the 4-color panels.

Intensity-modulated radiotherapy (IMRT) is gradually replacing conventional radiation therapy and has become the mainstream radical treatment for patients with nasopharyngeal carcinoma (NPC). IMRT can conform and increase radiation doses to tu-mor-associated regions as well as decrease exposure doses and volumes on normal organs and tissues to avoid damage on critical or-gans. Aside from system and setup errors, other factors, such as the gradual reduction of the primary NPC lesion and the decrease in vol-ume of involved neck lymph nodes as well as body weight loss and changes in the head and neck shape during IMRT, may cause devia-tions in the radiation doses and volume delivered to the NPC targets and the organs at risk. These factors may affect the accuracy of IMRT. Several researchers have attempted to correct such deviations during IMRT for NPC patients by using adaptive radiotherapy (ART). The results indicate that ART is feasible to a certain degree and can correct the deviations, including decrease in tumor volume, body weight loss, and changes in head and neck shape of NPC patients.

ObjectiveTo study the CT values of certain phantoms scanned by various CT scanners with dissimilar parameters.Methods The CT values of tissue equivalent inserts was measured in the TM164 and CIRS-062 phantom scanned by TOSHIBA AQUILIONTM,SIEMENS SOMATOMTMSENSATIONTM 64 and SIEMENS SOMATOMTM SENSATIONTM OPEN with different voltages,currents and slice thicknesses and then the corresponding CT-to-density curves was compared. Results There are no significant differences of CT values with various currents and slice thicknesses and also for low atom number materials scanned by different scanners with various tube voltages.The CT values of high atom number materials have obvious differences scanned with tube voltage,the maximum is about 400 HU.There are also significant differences between CT-density curves of two phantoms in the range from soft tissues to dense bone,the maximum is up to 500 HU.ConclusionsCT-density curves were highly affected by materials of phantoms,scanners and tube voltages.It is necessary to measure the curve with a comfortable phantom and certain scanner to assure the accuracy for dose calculation for treatment planning system.

Objective:To study the effect of Ginkgo biloba extract (EGb761) on metabolism of aflatoxin B_1(AFB_1) in Wistar rats. Methods:Seventy one Wistar rats were divided into three groups at random: group A (AFB_1 group), group B (AFB_1+EGb761 group), and group C (control group). The rats in groups A and B were given AFB_1(intraperitoneal injection, 100-200 μg/ kg body weight, 1-3 times/week). The rats in group B were fed the food containing EGb761 while the rats in groups A and C were given normal food. Blood samples were collected and liver biopsy was performed on the 14th, 28th and 42nd week. All the rats were sacrificed at the 64th week. The incidence of hepatoma was observed. The hepatic phase Ⅰ drug-metabolizing enzyme CYP450 and phase Ⅱ enzyme GST were detected by spectrometry. The serum AFB_1-lysine adduct was determined by high performance liquid chromatography (HPLC). The expression of 8-hydroxydeoxyguanosine(8-OHdG) was measured by immunohistochemistry. Results:The incidence of hepatocellular carcinoma (HCC) in group B was significantly lower than that in group A (26.92% vs 76.00%,P<0.001). No hepatocellular carcinoma developed in group C. EGb761 had no effects on the activities of CYP450 and GST in rat liver tissues. The level of AFB_1-lysine adduct reached the peak (4 356.01 pg/mg albumin) at the 14th week in group A. EGb761 significantly inhibited the formation of AFB_1-lysine adducts in serum by 13.07% at the 14th week (P＝0.033), and 73.63% at the 42nd week (P＝0.002). The expression of 8-OHdG protein in rat liver tissues in group B was significantly lower than that in group A at the 28th, 42nd, and 64th week (P<0.05). Conclusion:The main mechanism underlying the effect of EGb761 in blocking hepatogenesis induced by AFB_1 may not be fully related with its influence on the activity of liver phase Ⅰ and phase Ⅱ metabolizing enzymes. EGb761 inhibites the production of AFB_1-lysine addcuts, decreases the expression of 8-OHdG protein, and finally alleviates the DNA oxidative injury, which may be one of the mechanisms for the effects of EGb761 in inhibiting or delaying hepatogenesis induced by AFB_1.