Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objective:To investigate the correlation between hematopoietic cell kinase (HCK) and the expression level of the mitochondrial ribosomal protein L13 (MRPL13) and hematopoietic multimode ultrasound.Methods:204 female breast cancer patients treated by surgery in Quzhou people’s Hospital from Jan. 2017 to Sep. 2020 were selected as study subjects. Breast cancer tissues and adjacent normal tissues were extracted intraoperatively. Preoperative conventional ultrasound, shear wave elastography (SWE) and contrast-enhanced Ultrasonography (CEUS) were used to detect HCK and MRPL13 expression levels. Univariate analysis and binary Logistic regression were used to analyze the correlation between multi-mode ultrasonic features and HCK and MRPL13.Results:The positive expression ratios of HCK and MRPL 13 in breast cancer tissues were significantly higher than those in adjacent tissues ( χ2 was 5.625, 7.197; P was 0.018, 0.007) . In conventional ultrasound features, the proportions of HCK-positive breast cancer patients with irregular mass edges, microcalcifications, and grade II to III blood flow classification were significantly higher than those of HCK-negative patients ( χ2 was 7.437, 16.684, 23.262; P was 0.006, <0.001, <0.001) ; The proportion of MRPL13-positive breast cancer patients with a maximum diameter of ≥2 cm, irregular edges of the tumor, and grade II-III blood flow classification was significantly higher than that of MRPL13-negative patients ( χ2 was 4.676, 11.118, 8.389; P was 0.031, 0.001, 0.004) . For SWE signs, the proportion of HCK positive breast cancer patients with hard ring sign was significantly higher than that of HCK negative patients ( χ2=11.220, P=0.001) ; the proportion of MRPL13 positive breast cancer patients with hard ring sign and black hole sign was significantly higher than that of MRPL13. Those who were negative ( χ2 was 4.482, 8.775; P was 0.034, 0.003) . Among CEUS characteristics, the proportion of HCK-positive patients with high enhancement was significantly higher than that of HCK-negative patients ( χ2=7.356, P=0.007) ; the proportion of MRPL13-positive patients with high enhancement and late regression was significantly higher than that of MRPL13-negative patients ( χ2 was 9.165, 7.631; P was 0.002, 0.006) . The results of binary logistic analysis showed that there was microcalcification ( OR=4.619, 95% CI=2.657-8.119, P=0.009) , blood flow classification II to III ( OR=4.150, 95% CI=2.547-7.954, P=0.015) and high enhancement of CEUS ( OR=4.150, 95% CI=2.547-7.954, P=0.015) are independent risk factors for positive expression of HCK; blood flow grade II to grade III ( OR=4.213, 95% CI=3.145-8.557, P=0.012) , appearance of black hole sign ( OR=5.246, 95% CI=2.864-10.378, P<0.001) and high enhancement of CEUS ( OR=3.872, 95% CI=1.887~6.438, P=0.026) were the independent risk factors for the positive expression of MRPL13. Conclusion:The multimodal ultrasonographic features of breast cancer are helpful to predict the expression levels of HCK and MRPL13, so as to provide new imaging ideas for early diagnosis of breast cancer, the designation of treatment options and the preoperative non-invasive assessment of breast cancer prognosis.

Objective To optimize the exposure parameters and reduce the irradiation dose level in infants and young children during digital radiography (DR) chest radiography under the premise of satisfied image quality.Methods The thoracic thickness of 100 patients were measured.Determined the aluminum equivalent of the thoraxes of the infants and young children by comparing the grayscale value and the aluminum step wedge.Another 100 infants and young children of experimental exposure were performed with the aluminum step wedge as a phantom,under AEC control,kV was the only variant to explore the optimal exposure parameters with dose monitor simultaneously.At last,clinical validation was performed.Images quality was compared with x2 test.The radiation dose of two groups was compared with t test.Results The maximum,minimum,average thoracic thickness and their correspondent aluminum equivalent were 13.5 and 2.3 cm,8.0 and 1.4 cm,(10.6 ± 1.3) and 2.0 cm,respectively.The average thoracic thickness of experimental group was (10.1 ± 2.2) cm.The range of entrance surface dose was 0.068-0.056 mGy while the tube voltage range was 55-65 kV.The exposure index range was 0.60-0.74.The visual inspection of aluminum step wedge was from grades 8 to 11 with satisfying image quality at lower radiation.The infant chest X-ray photography exposure parameters formula have been optimized,that was kV =thoracic thickness (cm) × 2 + 38 (constant),mAs (0.8-1.0) with SID =100 cm,without filter grid.Compare to the conventional parameters,the image quality of new method had no significant differences (P ＞ 0.05).The actual average entrance surface dose was (0.048 ± 0.007) mGy,lower than AEC group (0.066 ± 0.008) mGy.The difference was statistically significant (t =16.781,P ＜ 0.001).Conclusions The optimized formula kV =thoracic thickness (cm) ×2 + 38(constant),mAs (0.8-1.0) with SID =100 cm was credible for lowering the radiation exposure with good image quality for clinical diagnosis.

Background:Both hormonal therapy (HT) and maintenance capecitabine monotherapy (MCT) have been shown to extend time to progression (TTP) in patients with metastatic breast cancer (MBC) after failure of taxanes and anthracycline?containing regimens. However, no clinical trials have directly compared the effcacy of MCT and HT after response to ifrst?line capecitabine?based combination chemotherapy (FCCT) in patients with hormone receptor (HR)?positive and human epidermal growth factor receptor 2 (HER2)?negative breast cancer. Methods:We retrospectively analyzed the charts of 138 HR?positive and HER2?negative MBC patients who were in non?progression status after FCCT and who were treated between 2003 and 2012 at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, in Beijing, China. The median number of ifrst?line chemotherapy cycles was 6 (range, 4–8); combined agents included taxanes, vinorelbine, or gemcitabine. Of these 138 patients, 79 received MCT, and 59 received HT. Single?agent capecitabine was administered at a dose of 1250mg/m2 twice daily for 14days, followed by a 7?day rest period, repeated every 3weeks. Of the 59 patients who received HT, 37 received aromatase inhibitors (AIs), 8 received selective estrogen receptor modulators (SERMs), and 14 received goserelin plus either AIs or SERMs. We then compared the MCT group and HT group in terms of treatment effcacy. Results:With a median follow?up of 43months, patients in the HT group had a much longer TTP than patients in the MCT group (13 vs. 8months,P=0.011). When TTP was adjusted for age, menopausal status, Karnofsky performance status score, disease?free survival, site of metastasis, number of metastatic sites, and response status after FCCT, extended TTP was still observed for patients in the HT group (hazard ratio: 0.63; 95% conifdence interval: 0.44–0.93;P=0.020). We also observed a trend of overall survival advantage for patients in the HT group vs. patients in the MCT group, but the difference was not signiifcant (43 vs. 37months,P=0.400). In addition, patients in the HT group gen?erally tolerated the treatment well, whereas patients in the MCT group experienced grades 3–4 adverse events, the most frequent of which were hand?foot syndrome (15.8%) and hematologic abnormalities (7.6%). Conclusion: For HR?positive and HER2?negative MBC patients, HT might be considered a treatment after response to FCCT but prior to MCT as a long?term administration.

Background:Acute myeloid leukemia (AML) with t(8;21) is a heterogeneous disease. Identifying AML patients with t(8;21) who have a poor prognosis despite achieving remission is important for determining the best subsequent therapy. This study aimed to evaluate the impact of Wilm tumor gene?1 (WT1) transcript levels and cellular homolog of the viral oncogenev?KIT receptor tyrosine kinase (C?KIT) mutations at diagnosis, andRUNX1?RUNX1T1 transcript levels after the second consolidation chemotherapy cycle on outcomes.
Methods:Eighty?eight AML patients with t(8;21) who received chemotherapy only or allogeneic hematopoietic stem cell transplantation (allo?HSCT) were included. Patients who achieved remission, received two or more cycles of consolidation chemotherapy, and had a positive measureable residual disease (MRD) test result (deifned as<3?log reduction inRUNX1?RUNX1T1 transcript levels compared to baseline) after 2–8 cycles of consolidation chemotherapy were recommended to receive allo?HSCT. Patients who had a negative MRD test result were recommended to receive further chemotherapy up to only 8 cycles.WT1 transcript levels andC?KIT mutations at diagnosis, andRUNX1?RUNX1T1 transcript levels after the second consolidation chemotherapy cycle were tested.
Results:Patients who had aC?KIT mutation had signiifcantly lowerWT1 transcript levels than patients who did not have aC?KIT mutation (6.7%±10.6% vs. 19.5%±19.9%,P<0.001). LowWT1 transcript levels (≤5.0%) but notC?KIT mutation at diagnosis, a positive MRD test result after the second cycle of consolidation chemotherapy, and receiv?ing only chemotherapy were independently associated with high cumulative incidence of relapse in all patients (hazard ratio [HR]=3.53, 2.30, and 11.49; 95% conifdence interval [CI] 1.64–7.62, 1.82–7.56, and 4.43–29.82;P=0.002, 0.034, and<0.001, respectively); these conditions were also independently associated with low leukemia?free survival (HR=3.71, 2.33, and 5.85; 95% CI 1.82–7.56, 1.17–4.64, and 2.75–12.44;P<0.001, 0.016, and<0.001, respectively) and overall survival (HR=3.50, 2.32, and 4.34; 95% CI 1.56–7.82, 1.09–4.97, and 1.98–9.53;P=0.002, 0.030, and<0.001, respectively) in all patients.
Conclusions: Testing forWT1 transcript levels at diagnosis in patients with AML and t(8;21) may predict outcomes in those who achieve remission. A randomized study is warranted to determine whether allo?HSCT can improve prog?nosis in these patients.

Objective To investigate whether serum level of low-density lipoprotein cholesterol can predict the expan?sion of hemorrhage growth in elderly male patients with acute hypertensive intracerebral hemorrhage. Methods Patients (n=108) who visited our hospital with from June 2012 until May 2014 spontaneous hypertensive intracerebral hemorrhage with?in 6 hours of onset which is confirmed by initial computed tomography (CT) were sent to repeated CT within 24 hours of on?set. All selected patients were divided into the LDL-C≥2.49 mmol/L group and LDL-C<2.49 mmol/L group. Clinical data of these 2 groups were compared and the relationships of hematoma growth and its risk factors were analyzed. Results Baseline blood pressure, the level of blood glucose, PT, APTT, FIB, PLT and hemorrhage volume did not differ significantly between the LDL-C≥2.49 mmol/L group and LDL-C<2.49 mmol/L group. The ratio of hemorrhage growth in LDL-C<2.49 mmol/L group was significantly higher than that in LDL-C≥2.49 mmol/L group (34.21%vs 11.43%). Multiple logistic regres?sion analysis showed that LDL-C<2.49 mmol/L was the only risk factor contribute to hemorrhage growth. Conclusion Pa?tients with LDL-C<2.49 mmol/L in acute intracerebral hemorrhage are of high risk of hemorrhage growth so early attention and appropriate procedure are needed to prevent or slow its growth.

Objective:To observe the effects of dentin proseeded with BMSCs or PDLCs incorporated with PDLCs sheets and calci-nated ceramic bovine bone(CBB)in the reconstruction of periodontal tissue.Methods:Root dentin slices were prepared and pre-seeded with BMSCs or PDLCs from beagle dog.After cultivated in osteoinduction medium(OST groups)orα-modified eagle's medi-um(MEM groups)for 3 weeks,the dentin slices observed by scanning electron microscope (SEM).Then the slices were wrapped successively with PDLCs sheets and CBB as new constructs(BMSCs or PDLCs/dentin/PDLCs sheets/CBB).The new constructs were transplanted into nude mice subcutaneously,8 week after transplantation,samples were havested and examined by HE staining.Re-sults:Enough cells and extracellular matrices were detected on the dentin slices by SEM in vitro.A little new immature cementum-like tissue without periodontal-like tissue on the surface of the new construcs was observed in OST groups.By contrast,in MEM groups,periodontal-like without immature cementum-like tissue formation was observed.Conclusion:Dentin proseeded with BMSCs or PDLCs incorporated with PDLCs sheets and CBB cultured by MEM can promote periodontal-like tissue regeneration.Cultured with osteooinduction medium can promote cementum-like tissue regeneration.

Objective To investigate the effect of high-flux hemodialysis on insulin resistance and microinflammatory state in elderly diabetic nephropathy (DN) patients with maintenance hemodialysis(MHD).Methods A total of 49 elderly DN patients with MHD and 10 healthy controls undergoing health examination survey were enrolled.Levels of homeostasis model assessment of insulin resistance index(HOMA-IR),interleukin-6(IL-6) and high sensitivity C-reactive protein(hs-CRP) were analyzed and compared between patients and the controls.Patients with MHD were randomly divided into two groups:high-flux hemodialysis(HFHD) group and low-flux hemodialysis (LFHD) group.Changes of the parameters including HOMA-IR,IL-6,hs CRP and urea excretion rate(kt/v) were observed before and after treatment for 12 months.Results Levels of IL-6,hs-CRP and HOMA-IR were significantly higher in DN patients with MHD than in the control group [(126.22±13.23)ng/L vs.(12.68±3.63)ng/L,(12.13±1.73)mg/L vs.(2.55±1.27) mg/L,(4.83 ±1.23) vs.(0.32 ± 0.15),respectively,all P＜ 0.01].The levels of IL-6 and Hs-CRP were positively correlated with HOMA-IR in elderly DN patients (R =0.656,0.729,R2 =0.43,0.532,both P＜0.01).Compared with before treatment,levels of fasting insulin(Fins),HOMA-IR and IL-6 were decreased in HFHD group after MHD for 12 months (all P＜ 0.05),while there were no differences in levels of Fins,HOMA-IR,IL-6 and hs-CRP in the LFHD group before and after MHD (all P＞0.05).The levels of Fins,HOMA-IR and IL-6 were significantly lower in the HFHD group than in the LFHD group after MHD for 12 months(all P＜0.05).Conclusions Insulin resistance and microinflammatory are common observed in elderly DN patients with MHD.High-flux hemodialysis may decrease the levels of IL-6 and hs-CRP,and ameliorate insulin resistance and microinflammatory state.

Objective To improve the understanding of pulmonary mucormycosis by analyzing the clinical manifestations,imaging features,diagnosis,treatment and prognosis of this disease.Methods The clinical data of eight patients diagnosed as pulmonary mucormycosis by histopathologic examination were retrospectively analyzed.Results Eight patients included six males and two females with age from 36 days to 66 years.Underlying conditions covered diabetes (n =4),renal transplantation (n =3),premature (n =1) and long-term corticosteroid treatment in two cases.Imaging manifestations revealed multiple irregular lumps or nodules in three cases,multiple cavities with thick wall in three cases,diffuse lung infiltrate in one case and lung opacities in one case.The diagnoses of seven patients were confirmed by percutaneous needle lung biopsy and the remaining one was diagnosed with fiberoptic bronchoscopy biopsy.Surgery combined with amphotericin B liposome(60 mg/d for three weeks)was applied to one patient who was cured with no recurrence after a 22 month follow-up.Three cases were given amphotericin B liposome (a newborn with 7mg/d for 62 days,the other two 60 mg/d for 31 days and 70 mg/d for 71 days respectively).All had achieved marked response with follow up from 8 to 29 months,but one patient relapsed and died of recurrent lung mucormycosis.The other three patients were treated with itraconazole 400-200 mg/d from 21 days to 1 year with duration of follow up from 1 month to 20 months.One patient was not evaluable due to missing.Two patients relapsed and one died.Conclusion Pulmonary mucormycosis is difficult to diagnose and treat with a high mortality.Percutaneous tranthoracic lung biopsy is a useful diagnostic method.Amphotericin B liposome or itraconazole may be active against mucus.Early control of causes is essential to improve the prognosis and reduce the recurrence in patients with pulmonary mucormycosis.

Objective To investigate the clinical features,radiology,diagnosis and treatment of postkidney-transplant pulmonary mucormycosis.Method Three cases of post-kidney-transplant pulmonary mucormycosis were successfully diagnosed by histopathologic examinations.The clinical features of the cases were analyzed.The patients consisted of 2 males and 1 female,aged 39 to 54 yearn All patients were subjected to renal transplantation due to uremia,one was complicated with with diabetes,and pulmonary mucormycosis occurred 6 months,2 years and 6 years after kidney transplant respectively.Fever,cough,bloody sputum and chest pain were the main clinical manifestations.Multiple irregular massive or diffuse infiltrates in the lungs were the early CT findings.In a shoot time,multiple thick-walled cavities occurred in the pulmonary lesions.Pleural effusion was found in one patient.The lung specimens of patients were obtained by CT-guided percutaneous biopsy.Result The first patiem was cured after one year therapy by hraconazole,but recurred after 8 months.The second patient had a marked effect after a 21-day therapy by Itraconazole,but died of disseminated mucor for excessive immunosuppressant against the renal transplantation rejection.The third patient also had a marked effect,and was still in follow up.Condusion The post-kidney-transplant pulmonary mucormycosis is difficult in diagnosis and treatment.CT-guided percutaneous biopsy is one of effective ways for diagnosis.Itraconazole appears to be effective in treatment of pulmonary mucormycosis.Early diagnosis and an appropriate immune ftmction are the keys to improve prognosis and reduce recurrence