ObjectiveTo investigate the efficacy and safety of cinobufagin tablets combined with thalidomide/dexamethasone （TD） regimen in the treatment of newly diagnosed multiple myeloma （NDMM） with phlegm and stasis obstruction. MethodsThe clinical data of 50 patients with NDMM of phlegm and stasis obstruction who were hospitalized at the Jiangsu Province Hospital of Chinese Medicine from June 1st， 2015 to July 31th， 2019 were retrospectively analyzed， and they were divided into a control group （bortezomib/dexamethasone-containing regimen， 27 cases） and an observation group （cinobufagin tablets combined with TD regimen， 23 cases）. The clinical efficacy and safety were compared between the two groups after two or three courses of treatment. The primary outcomes were clinical remission rate including overall response rate and deep remission rate， one-year and two-year overall survival rate， and adverse effects. The secondary outcomes were the proportion of plasma cells in bone marrow， hemoglobin， β2-microglobulin， lactate dehydrogenase， serum creatinine， blood urea nitrogen， bone pain score， and KPS functional status score （KPS score） before and after treatment. ResultsIn terms of clinical efficacy， there was no statistically significant difference （P＞0.05） in the overall response rate ［the observation group 69.57%（16/23） vs the control group 70.37% （19/27）］ and deep remission rate ［the observation group 56.52% （13/23） vs the control group 55.56% （15/27）］ between groups after the treatment. The one-year overall survival rates of the observation group and the control group were 90.9% and 92.4%， and the two-year overall survival rates were 81.8% and 80.9% respectively， with no statistically significant differences between groups （P＞0.05）. During the treatment， no renal function injury occurred in both groups. The incidence of peripheral nerve injury in the observation group was 8.70%， which was lower than 48.15% in the control group （P＜0.01）. After the treatment， the proportion of myeloma plasma cells， β2-microglobulin， serum creatinine level， and bone pain score decreased， while the hemoglobin level and KPS score increased in both groups （P＜0.05 or P＜0.01）. Compared between groups after treatment， the bone pain score of the observation group was lower than that of the control group， while the KPS score was higher than that of the control group （P＜0.05）. ConclusionThe clinical efficacy of cinobufagin tablets combined with TD in the treatment of NDMM is equivalent to bortezomib/dexamethasone-containing regimen， but the former is more helpful in relieving the pain and improving the quality of life， and has better safety.

Objective To develop a method for the determination of ketamine analogues in hair samples by liquid chromatography quadrupole linear ion trap mass spectrometry(QTRAP LC-MS/MS).Methods 20 mg of washed and dried hair was added to 1 mL extracting solution and then prepared using an ultrasonic extraction with frozen pulverization method.After centrifugation and purification with membrane,the supernatant was separated in a ACQUITY UPLC? HSS T3 column with gradient elution,finally tested with multiple reaction monitoring for the detection of 10 ketamine analogues.The above method was applied for quantitative analysis of ethylfluamine,F-norketamine and tiletamine in 20 positive samples.Results When the concentration ranged from 0.01 to 2.00 ng/mg,there was good linearity for 10 ketamine analogues with the correlation coefficients over 0.99.The recoveries ranged from 89.1％to 106.1％,and the matrix effects were between 88.3％and 106.0％.Among the 20 positive samples,the contents of ethylfluamine,F-norketamine and tiletamine in hair ranged between 0.02～8.35 ng/mg,0.01～0.94 ng/mg and 0.02～10.93 ng/mg,respectively.Their mean values were 1.59 ng/mg,0.28 ng/mg and 2.69 ng/mg.Their medians were 0.40 ng/mg,0.19 ng/mg and 2.11 ng/mg.Conclusion The established method was simple,efficient,reliable and suitable for the determination of ketamine analogues in hair.The data provided reference for the drug control and forensic science practice.

Objective To investigate the clinical effect of digital subtraction angiography(DSA)-guided foam sclerotherapy on lower limb varicose veins.Methods The relevant data of patients with lower limb varicose veins treated by DSA-guided foam sclerotherapy were analyzed retrospectively.At the same time,the safety and efficacy were compared before and after operation according to clinical etiology anatomy pathophysiology(CEAP)and clinical symptoms.Results Among the 278 affected limbs treated,2(0.72％)had neurological complications during treatment,8(2.88％)had chest tightness or cough during treatment,7(2.52％)had thrombophlebitis after treatment,and 28(10.07％)had hyperpigmentation after treatment.No serious complications such as skin necrosis,deep vein thrombosis(DVT)or pulmonary embolism(PE)occurred.There were 48 cases of grade C1 and 201 cases of grade C2 before treat-ment,while 244 cases of grade C0 and 26 cases of grade C1 after treatment,and the differences were statistically significant(P＜0.05).Conclusion DSA-guided foam sclerotherapy on lower limb varicose veins is a safe and effective minimally invasive treatment with high technical success rate.

BACKGROUND: Sarcopenia is an age-related progressive skeletal muscle disorder involving the loss of muscle mass or strength and physiological function. Efficient and precise AI algorithms may play a significant role in the diagnosis of sarcopenia. In this study, we aimed to develop a machine learning model for sarcopenia diagnosis using clinical characteristics and laboratory indicators of aging cohorts. METHODS: We developed models of sarcopenia using the baseline data from the West China Health and Aging Trend (WCHAT) study. For external validation, we used the Xiamen Aging Trend (XMAT) cohort. We compared the support vector machine (SVM), random forest (RF), eXtreme Gradient Boosting (XGB), and Wide and Deep (W&D) models. The area under the receiver operating curve (AUC) and accuracy (ACC) were used to evaluate the diagnostic efficiency of the models. RESULTS: The WCHAT cohort, which included a total of 4057 participants for the training and testing datasets, and the XMAT cohort, which consisted of 553 participants for the external validation dataset, were enrolled in this study. Among the four models, W&D had the best performance (AUC = 0.916 ± 0.006, ACC = 0.882 ± 0.006), followed by SVM (AUC =0.907 ± 0.004, ACC = 0.877 ± 0.006), XGB (AUC = 0.877 ± 0.005, ACC = 0.868 ± 0.005), and RF (AUC = 0.843 ± 0.031, ACC = 0.836 ± 0.024) in the training dataset. Meanwhile, in the testing dataset, the diagnostic efficiency of the models from large to small was W&D (AUC = 0.881, ACC = 0.862), XGB (AUC = 0.858, ACC = 0.861), RF (AUC = 0.843, ACC = 0.836), and SVM (AUC = 0.829, ACC = 0.857). In the external validation dataset, the performance of W&D (AUC = 0.970, ACC = 0.911) was the best among the four models, followed by RF (AUC = 0.830, ACC = 0.769), SVM (AUC = 0.766, ACC = 0.738), and XGB (AUC = 0.722, ACC = 0.749). CONCLUSIONS: The W&D model not only had excellent diagnostic performance for sarcopenia but also showed good economic efficiency and timeliness. It could be widely used in primary health care institutions or developing areas with an aging population. TRIAL REGISTRATION Chictr.org, ChiCTR 1800018895.
Humans ; Aged ; Sarcopenia/diagnosis* ; Deep Learning ; Aging ; Algorithms ; Biomarkers

Circular RNAs(circRNAs)are involved in various biological processes and disease pathogenesis.However,only a small number of functional circRNAs have been identified among hundreds of thousands of circRNA species,partly because most current methods are based on cir-cular junction counts and overlook the fact that a circRNA is formed from the host gene by back-splicing(BS).To distinguish the expression difference originating from BS or the host gene,we pre-sent differentially expressed back-splicing(DEBKS),a software program to streamline the discov-ery of differential BS events between two rRNA-depleted RNA sequencing(RNA-seq)sample groups.By applying to real and simulated data and employing RT-qPCR for validation,we demon-strate that DEBKS is efficient and accurate in detecting circRNAs with differential BS events between paired and unpaired sample groups.

【Objective】 To establish and evaluate a nephelometric assay for the determination of immunoglobulin A (IgA) residues in human intravenous immunoglobulin(IVIG). 【Methods】 BN ProSpec^© automatic protein analyzer and its supporting immunoglobulin A determination kit (nephelometry) produced by German Siemens and the national standard of human IgA were used to establish the nephelometric assay to determine IgA residue in test products and verify the methodology. The test products include IVIG (pH4) prepared by low-temperature ethanol protein separation process and a novel IVIG prepared by chromatography. 【Results】 The average deviation of three calibration curves for IgA residues determination by the nephelometric assay were 1.08%, 0.95% and 1.54%,, and the three deviations of the quality control were 4.00%, -2.30% and -0.20%, respectively, which indicated good calibration and quality control. In the specificity test, the average recovery rates of IgA for reference substance 1 containing 100g/L maltose and reference substance 2 containing 20g/L glycine were 102.7% and 105.8%, respectively. The relative standard deviation (RSD) values of the repeatability tests of the two test products were 3.9% and 1.9%, and the RSD values of the intermediate precision test were 3.6% and 2.3%, respectively.The difference values at each time point in the durability test of test products′ storage time were all less than 10%, and the RSD values of the two test products in the durability test of kits of different batches were 2.8% and 2.2%, respectively. In the accuracy test, the average recovery rates of IVIG (pH4) added to the standard were 94.2%, 101.7% and 96.2%, respectively, and the average recovery rates of the novel IVIG added to the standard were 102.8%, 106.3% and 99.7%, respectively. The average recovery rate of the limit quantification test was 101.0%, and the RSD was 4.0%. 【Conclusion】 Nephelometric assay has the advantages of strong specificity, high precision and accuracy, good repeatability, simple and rapid operation, and automation, and can be used for the determination of IgA residue in IVIG (pH4) and novel IVIG products.

Objective To establish a risk warning model for surgical site infection(SSI), provide support for screening high risk population and finding suspected cases.Methods Clinical data of 5 067 patients who underwent abdominal surgery in 6 domestic hospitals from January 2013 to December 2015 were collected retrospectively, all cases were randomly divided into modeling group and validation group according to a 6:4 ratio, warning model was established by employing logistic regression, the area under the receiver operating characteristic curve (AUC) was used to evaluate discriminant ability of evaluation model, the maximum Youden index was as the optimum cut-off point.Results For the warning model of high-risk patients, AUC was 0.823, sensitivity and specificity were 78.81% and 74.33% respectively, positive predictive value and negative predictive value were 19.67% and 97.78% respectively.For the discriminant model of suspected infection cases, AUC was 0.978, sensitivity and specificity were 93.38% and 95.62% respectively, positive predictive value and negative predictive value were 62.95% and 99.45% respectively.Conclusion The early-warning model established in this study has better discrimination ability, which can provide a reference for the development of early warning and discrimination of healthcare-associated infection information system.

Objective To understand the development of healthcare-associated infection(HAI)management organ-izations in China in the past 30 years.Methods Development of HAI management organizations in 12 provinces (municipalities,autonomous regions)in China was surveyed.Results A total of 166 hospitals were surveyed,96 (57.83%)were tertiary hospitals.Among 164 hospitals which had a history of development of HAI management department,46(28.05%)before 1995,63(38.14%)in 1995-2005,and 55(33.54%)in 2005-2015 set up HAI management departments.HAI management professionals per 1 000 beds in 165 hospitals decreased from 4.80 in 1995 to 4.09 in 2015,occupational categories in HAI management departments in 1995 -2015 were significantly different (χ2 =26.22,P <0.01).The constituent ratios of education background and profession of HAI manage-ment professionals in each province in 1995-2015 were significantly different(χ2 =242.91,47.10,respectively,all P <0.01).In 1995 and 2005,70.81%,53.30% of professionals were with college degree or below;in 2015,the percentage of professionals with bachelor’s degree,doctoral degree,and master’s degree were 53.79%,2.45%, and 22.86% respectively.Most professionals were nursing staff,but the percentage decreased from 58.38% in 1995 to 45.96% in 2015.Conclusion Although HAI management organizations have developed for 30 years and made some achievements,there still remain some problems,the proportion of professionals needs to be enhanced,and personnel structure should be optimized.

Objective To explore the direct economic loss caused by healthcare-associated infection(HAI)in general hospitals in China.Methods 68 hospitals were selected,a retrospective 1:1 matched survey was conducted to compare the direct medical cost in patients with and without HAI between January 1,2015 and December 31,2015. Results A total of 2 123 pairs of patients with and without HAI were included in the survey.The average cost of hospitalization in HAI and non-HAI groups were ￥25 845.30 and ￥12 006.14 respectively,￥13 839.16 on average was increased due to HAI.The average economic loss in provincial and ministerial levels of hospitals were￥21 409.83.The average economic loss in different regional hospitals were ￥9 725.42-￥18 909.59,and north China ranked the first.Economic loss caused by bloodstream infection and lower respiratory tract infection were more than other sites,which were ￥23 190.09 and ￥18 194.50 respectively.Conclusion HAI resulted in considerable direct economic loss.Prevention and control of HAI,especially bloodstream infection and lower respiratory tract infection should be paid more attention.

Objective To understand the current situation of occupational exposure and protection among health care workers (HCWs ), and provide evidence for formulating preventive measures of occupational exposure. Methods From April 6,2016 to May 6,2016,questionnaire surveys were conducted in 158 different levels of hos-pitals in 13 provinces in China,occupational exposure,protection management,and monitoring of occupational expo-sure in the first year,2010,and 2015 was surveyed by cluster random sampling method.Results Occupational ex-posure in 81.65% (129/158)of hospitals was responsible by healthcare-associated infection management depart-ments;98.73%(156/158)of hospitals set up the relevant rules and regulations;77.22%(122/158)of hospitals had missing report of occupational exposure.A total of 11 116 times of occupational exposure occurred (1 542 cases in the first year,2 474 in 2010,and 7 100 in 2015).Of various types of occupational exposure,sharp injury accounted for 96.76%;among HCWs sustained occupational exposure,nursing staff accounted for 53.90%;the major de-partment that HCWs who sustained occupational exposure were general wards,operating rooms,and intensive care units;the main medical appliances related to occupational exposure were syringes,scalp needles,and surgical suture needles;high-risk behavior causing occupational exposure were intravenous injection,putting needles into the sharp con-tainers,and surgical suturing;among occupational exposure sources,HBV accounted for 58.69%.Conclusion HCWs in China face a high risk of occupational exposure,occurrence of occupational exposure should be reduced through gov-ernment legislation,application of safety appliances,standardizing behavior of HCWs,proper using of personal pro-tective equipment,strengthening education and training of HCWs,and establishing a sound occupational exposure report,evaluation and follow-up system.