This study aimed to explore key quality control factors that affected the prognosis of intensive care unit (ICU) patients in Chinese mainland over six years (2015-2020). The data for this study were from 31 provincial and municipal hospitals (3425 hospital ICUs) and included 2 110 685 ICU patients, for a total of 27 607 376 ICU hospitalization days. We found that 15 initially established quality control indicators were good predictors of patient prognosis, including percentage of ICU patients out of all inpatients (%), percentage of ICU bed occupancy of total inpatient bed occupancy (%), percentage of all ICU inpatients with an APACHE II score ⩾15 (%), three-hour (surviving sepsis campaign) SSC bundle compliance (%), six-hour SSC bundle compliance (%), rate of microbe detection before antibiotics (%), percentage of drug deep venous thrombosis (DVT) prophylaxis (%), percentage of unplanned endotracheal extubations (%), percentage of patients reintubated within 48 hours (%), unplanned transfers to the ICU (%), 48-h ICU readmission rate (%), ventilator associated pneumonia (VAP) (per 1000 ventilator days), catheter related blood stream infection (CRBSI) (per 1000 catheter days), catheter-associated urinary tract infections (CAUTI) (per 1000 catheter days), in-hospital mortality (%). When exploratory factor analysis was applied, the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation: nosocomial infection management (21.35%), compliance with the Surviving Sepsis Campaign guidelines (17.97%), ICU resources (17.46%), airway management (15.53%), prevention of deep-vein thrombosis (14.07%), and severity of patient condition (13.61%). Based on the different weights of the core elements associated with the 15 indicators, we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management + 17.97%xcompliance with SSC guidelines + 17.46%×ICU resources + 15.53%×airway management + 14.07%×DVT prevention + 13.61%×severity of patient condition. This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system.
Humans ; China/epidemiology* ; Cross Infection/epidemiology* ; Intensive Care Units/statistics & numerical data* ; Quality Control ; Quality Indicators, Health Care/statistics & numerical data* ; Sepsis/therapy* ; East Asian People/statistics & numerical data*

OBJECTIVE: To investigate the safety and the short-term efficacy of venetoclax combined with azacitidine followed by cladribine (VAC regimen) in children with refractory/ relapsed acute myeloid leukemia (AML). METHODS: The clinical data, treatment outcomes, complications, and blood product consumption of 6 children with refractory/relapsed AML treated with VAC regimen in the Children's Hospital of Soochow University from August 2021 to December 2021 were retrospectively analyzed. RESULTS: Among the 6 children, there were 1 male and 5 females. 5 cases were refractory AML, and 1 case was relapsed AML, which recurred again 16 months after allogeneic hematopoietic stem cell transplantation. 4 children were accompanied by chromosomes or genes that predicted poor prognosis, such as RUNX1, FLT3-ITD, KMT2A exon 2-exon 8 dup, MLL-AF6, 7q-, KMT2A exon 2-exon 10 dup, etc. After received VAC regimen, 4 cases achieved CR+CRi, 1 case achieved PR (only MRD did not relieve, MRD was 0.59%), and 1 case was NR (but the proportion of bone marrow blasts decreased). All 6 patients had grade Ⅳ neutropenia, and 4 patients had grade Ⅳ thrombocytopenia. During the period of neutropenia, none of the 6 children developed symptoms of infection such as fever, cough, and diarrhea. No treatment-related death occurred. CONCLUSION Venetoclax combined with azacitidine followed by cladribine provides a new treatment option for patients with relapsed/refractory AML who have poor efficacy in early induction remission theragy, showing good efficacy and safety.
Child ; Female ; Humans ; Male ; Azacitidine/therapeutic use* ; Cladribine/therapeutic use* ; Retrospective Studies ; Leukemia, Myeloid, Acute/genetics* ; Neutropenia ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use*

Histone lysine-specific demethylase 1(LSD1) has become a promising molecular target for lung cancer therapy. Upon the screening platform for LSD1 activity, some Chinese herbal extracts were screened for LSD1 activity inhibition, and the underlying mechanism was preliminarily investigated at both molecular and cellular levels. The results of LSD1 inhibition showed that Puerariae Lobatae Radix extract can effectively reduce LSD1 expression to elevate the expression of H3 K4 me2 and H3 K9 me2 substrates in H1975 and H1299 cells. Furthermore, Puerariae Lobatae Radix was evaluated for its anti-lung cancer activity. It had a potent inhibitory ability against the proliferation and colony formation of both H1975 and H1299 cells. Flow cytometry and DAPI staining assays indicated that Puerariae Lobatae Radix can induce the apoptosis of lung cancer cells. In addition, it can significantly suppress the migration and reverse the epithelial-mesenchymal transition(EMT) process of lung cancer cells by activating E-cadherin and suppressing the expression of N-cadherin, slug and vimentin. To sum up, Puerariae Lobatae Radix displayed a robust inhibitory activity against lung cancer, and the mechanism may be related to the down-regulation of LSD1 expression to induce the cell apoptosis and suppress the cell migration and EMT process. These findings will provide new insights into the action of Puerariae Lobatae Radix as an anti-lung cancer agent and offer new ideas for the study on the anti-cancer action of Chinese medicine based on the epigenetic modification.
Pueraria/chemistry* ; Histone Demethylases/analysis* ; Plant Roots/chemistry* ; Epithelial-Mesenchymal Transition ; Neoplasms

BACKGROUND: Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment. METHODS: This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR. RESULTS: A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities. CONCLUSION: Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult ; Antineoplastic Combined Chemotherapy Protocols ; Bendamustine Hydrochloride/therapeutic use* ; China ; Humans ; Lymphoma, Non-Hodgkin/drug therapy* ; Neoplasm Recurrence, Local/drug therapy* ; Prospective Studies ; Rituximab/therapeutic use*

The 2017 China (Lianyungang) International Medical Technology Conference was held in Lianyungang,Jiangsu Province during November 15-17,2017.During this conference,the Division for Traditional Chinese Medicine and Natural Products Pharmacology of Chinese Pharmacological Society (CNPHARS) and Jiangsu Kanion Pharmaceutical Co. Ltd.jointly held the Forum on R&D and Interna-tionalization of New Drugs and Health Products of Traditional Chinese Medicine.The forum was co-chaired by Professor ZHANG Yong-xiang, President of CNPHARS, Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Chair of the Natural Product Section of Inter-national Union of Basic&Clinical Pharmacology(IUPHAR), Professor DU Guan-hua,former President of CNPHARS and Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Dr.XIAO Wei,Chairman of the Board of Jiangsu Kanion Pharmaceutical Co. Ltd. And Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS. More than 70 scholars attended the forum, including four foreign experts [Michael SPEDDING, Secretary-General of IUPHAR; Professor Valérie B. SCHINI-KERTH, Vice-Chair of the Natural Product Section of IUPHAR; Professor Cherry WAINWRGHT, Director of Centre for Natural Product Drugs of Robert Gordon University; Professor InKyeom KIM, Director of the Korean Society of Pharmacology], members of the Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS and leading researchers at Jiangsu Kanion Pharmaceutical Co.,Ltd.GU Jin-hui,Director of the Division of National Science and Technology Major Project for Drug Innovation,Department of Health Science,Technology and Education,National Health and Family Planning Commission of the People's Republic of China was also invited to attend the forum. Representatives discussed the R&D and internationalization of new drugs and health products of traditional Chinese medicine.The summary of views and advice of some experts was published here for the purpose of promoting domestic and overseas academic exchange, and playing an active role in improving the level of R&D and internationalization of new drugs and health products of traditional Chinese medicine in China.

Renal transplant (RT) recipients have a high risk of developing cardiovascular diseases.However,the effects of renal transplantation on the development of arteriosclerosis have been controversial.The carotid intima-media thickness (CIMT) and diameter (CD) are important indicators of vascular remodeling and arteriosclerosis.In this study,31 patients with hemodialysis (HD),31 RT recipients and 84 age-and gender-matched control subjects were enrolled.Their CIMT and CD were measured by ultrasonic radiofrequency tracking,and the linear regression models and Z test were used to identify the progression of arteriosclerosis and the risk factors.Compared with HD group,RT group had significantly lower CIMT and CD.CIMT was found to be associated with age,body weight,resistance index and diastolic velocity,while CD was associated significantly with age,body weight,pulsatility index,end diastolic velocity and diastolic blood pressure (DBP),respectively.The correlation curves between CIMT and age showed the slopes of curves were decreased successively in control,RT and HD groups,and the curves between CD and age showed the slopes were decreased in order of RT ＞ control ＞ HD groups.It was concluded that CIMT and CD were significantly correlated with age in RT and moderately with age in HD patients.RT could reduce the progress of arteriosclerosis in patients with end-stage renal disease.

We assessed the role of diabetes mellitus (DM) on treatment effects in drug-susceptible initial pulmonary tuberculosis (PTB) patients. A prospective study was conducted in eight provinces of China from October 2008 to December 2010. We enrolled 1,313 confirmed drug-susceptible initial PTB patients, and all subjects received the treatment regimen (2H3R3E3Z3/4H3R3) as recommended by the national guidelines. Of the 1,313 PTB patients, 157 (11.9%) had DM; these patients had more sputum smear-positive rates at the end of the second month [adjusted odds ratios (aOR) 2.829, 95% confidence intervals (CI) 1.783-4.490], and higher treatment failure (aOR 2.120, 95% CI 1.565-3.477) and death rates (aOR 1.536, 95% CI 1.011-2.628). DM was a contributing factor for culture-positive rates at the end of the second month and treatment failure and death of PTB patients, thus playing an unfavorable role in treatment effects of PTB.
Antitubercular Agents ; therapeutic use ; China ; epidemiology ; Diabetes Mellitus ; epidemiology ; therapy ; Female ; Humans ; Male ; Mycobacterium tuberculosis ; drug effects ; Tuberculosis, Pulmonary ; complications ; drug therapy ; epidemiology ; microbiology

Objective·To investigate the relationship between quantitative indices of carotid plaques from contrast-enhanced ultrasound and leukocytes, and explore the value in the patients with acute large artery atherosclerotic stroke (LAAS). Methods·A total of 62 patients with LAAS and 48 matched control subjects hospitalized in Shanghai General Hospital, Shanghai Jiao Tong University from June 2016 to June 2017 were enrolled. Obvious carotid plaques were examined by contrast-enhanced ultrasound. The parameters of time-intensity curve i.e. peak (PTIC) and mean (MTIC), and the parameters of fitting curve i.e. peak (PFC), sharpness (SFC), and under the curve area (AUCFC) were obtained. These parameters were compared between the groups using two samples t tests. The correlations between the parameters and leukocyte counts were analyzed by Pearson correlation analysis. Results·① In LAAS group, the total leukocyte and neutrophil counts were higher than those of the control group, while the lymphocyte count was lower than that of the control group (P<0.05). ② The PTIC, MTIC, PFC, SFC and AUCFC were significantly larger in LAAS group than those in the control group, respectively (P<0.05).③ PTIC, MTIC and PFC were negatively correlated with lymphocytes, respectively (r=-0.291, -0.263 and -0.270, P<0.05). SFC and AUCFC were positively correlated with neutrophils, respectively (r=0.261 and 0.298, P<0.05). Conclusion·Quantitative indices of carotid plaques from contrast-enhanced ultrasound are associated with circulating leukocytes, and the association helps assess the vulnerability of the plaques.

The objective of this prospective study of the risks of treatment failure in patients with drug-susceptible pulmonary tuberculosis (PTB) was to provide reference data to help develop a disease control strategy. Participants were recruited in eight provinces of China from October 2008 to December 2010. A total of 1447 patients with drug-susceptible PTB and older than 15 years of age were enrolled. Demographic characteristics, bacteriological test results, and patient outcome, i.e., cure or treatment failure were recorded and compared using the chi-square or Fisher's exact tests. Multivariate logistic regression was used to identify factors associated with risk of treatment failure. Of the 1447 patients who were enrolled, 1349 patients (93.2%) were successfully treated and 98 (6.8%) failed treatment. Failure was significantly associated with age 365 years [odds ratio (OR)=2.522, 95% confidence interval (CI): (1.097-5.801)], retreatment [OR=2.365, 95% CI: (1.276-4.381)], missed medicine [OR=1.836, 95% CI: (1.020-3.306)], treatment not observed [OR=1.879 95% CI: (1.105-3.195)], and positive culture result after the first [OR=1.971, 95% CI: (1.080-3.597)] and second month [OR=4.659, 95% CI: (2.590-8.382)]. The risk factors associated with treatment failure were age 365 years, retreatment, missed medication, treatment not observed, and positive culture at the end of month 1 or month 2. These risk factors should be monitored during treatment and interventions carried out to reduce or prevent treatment failure and optimize treatment success.
Adolescent ; Adult ; Aged ; Antitubercular Agents ; therapeutic use ; China ; epidemiology ; Female ; Humans ; Male ; Middle Aged ; Mycobacterium tuberculosis ; drug effects ; physiology ; Prospective Studies ; Retreatment ; Risk Factors ; Treatment Failure ; Tuberculosis, Multidrug-Resistant ; drug therapy ; epidemiology ; microbiology ; Tuberculosis, Pulmonary ; drug therapy ; epidemiology ; microbiology ; Young Adult

Differences in arterial stiffness between the two sides of the carotid arteries were investigated using ultrasonic radiofrequency in 88 patients with type 2 diabetes and 70 controls. The compliance coefficient (CC), pulse wave velocity (PWV), intima-media thickness (CIMT) and diameter (CCAD) of the common carotid arteries (CCAs) were measured. The ratio of the left to right CCAs was calculated to provide four indexes: CC ratio, PWV ratio, CIMT ratio and CCAD ratio. In the diabetes group, the PWV on the left side was significantly higher than that on the right side, while the CC on the left side was significantly lower than that on the right side. The bilateral CIMT was thicker and CCAD was wider, the left PWV traveled faster, and the right CC was higher in the diabetes group than in the control group. The PWV ratio between the two groups was significantly different and correlated positively with duration of diabetes and systolic blood pressure (SBP). The differences between the two sides of CCAs in patients with diabetes suggested that disease duration and SBP were important risk factors for arterial stiffness. Identifying the difference could potentially lead to the much earlier diagnosis of arteriosclerosis.
Adult ; Aged ; Blood Pressure ; Carotid Artery, Common ; diagnostic imaging ; physiopathology ; Carotid Intima-Media Thickness ; Case-Control Studies ; Diabetes Mellitus, Type 2 ; diagnostic imaging ; physiopathology ; Echocardiography ; instrumentation ; methods ; Female ; Humans ; Male ; Middle Aged ; Pulse Wave Analysis ; Risk Factors ; Ultrasonics ; Vascular Stiffness