Background/Aims: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy. Methods: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. Results: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset. Conclusions Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

OBJECTIVES: To investigate the risk factors for neonatal asphyxia in Hubei Enshi Tujia and Miao Autonomous Prefecture and establish a nomogram model for predicting the risk of neonatal asphyxia. METHODS: A retrospective study was conducted with 613 cases of neonatal asphyxia treated in 20 cooperative hospitals in Enshi Tujia and Miao Autonomous Prefecture from January to December 2019 as the asphyxia group, and 988 randomly selected non-asphyxia neonates born and admitted to the neonatology department of these hospitals during the same period as the control group. Univariate and multivariate analyses were used to identify risk factors for neonatal asphyxia. R software (4.2.2) was used to establish a nomogram model. Receiver operator characteristic curve, calibration curve, and decision curve analysis were used to assess the discrimination, calibration, and clinical usefulness of the model for predicting the risk of neonatal asphyxia, respectively. RESULTS: Multivariate logistic regression analysis showed that minority (Tujia), male sex, premature birth, congenital malformations, abnormal fetal position, intrauterine distress, maternal occupation as a farmer, education level below high school, fewer than 9 prenatal check-ups, threatened abortion, abnormal umbilical cord, abnormal amniotic fluid, placenta previa, abruptio placentae, emergency caesarean section, and assisted delivery were independent risk factors for neonatal asphyxia (P<0.05). The area under the curve of the model for predicting the risk of neonatal asphyxia based on these risk factors was 0.748 (95%CI: 0.723-0.772). The calibration curve indicated high accuracy of the model for predicting the risk of neonatal asphyxia. The decision curve analysis showed that the model could provide a higher net benefit for neonates at risk of asphyxia. CONCLUSIONS The risk factors for neonatal asphyxia in Hubei Enshi Tujia and Miao Autonomous Prefecture are multifactorial, and the nomogram model based on these factors has good value in predicting the risk of neonatal asphyxia, which can help clinicians identify neonates at high risk of asphyxia early, and reduce the incidence of neonatal asphyxia.
Infant, Newborn ; Humans ; Male ; Pregnancy ; Female ; Nomograms ; Retrospective Studies ; Cesarean Section ; Risk Factors ; Asphyxia Neonatorum/etiology*

The articles on alarm management of clinical medical equipment from January 2000 to January 2023 were collected with common databases in the world as search sources.CiteSpace software was used for trend drawing of annual publication distribution,author cooperation network mapping,country/institution cooperation network mapping and keyword knowledge mapping,and for analyzing related issues in depth.The annual publication of medical equipment alarm management research showed a fluctuating upward trend,the authors had good cooperative relationship with the organizations,the hotspots included ventilator,alarm and alarm fatigue in Chinese and alarm fatigue,intensive care unit and patient safety in English,and the research frontier involved in alarm fatigue,false alarm and alarm management.References were provided for conducting related research in China.

Objective: To summarize the application experience and the therapeutic effect of Nirmatrelvir-Ritonavir (trade name: Paxlovid) for COVID-19 in children. Methods: A retrospective analysis was performed on the clinical data, including collecting the clinical manifestations and clinical outcomes, dynamically monitoring the blood routine, hepatic and renal function and SARS-CoV-2 nucleic acid results, and observing the related side effects during the treatment, etc, of 3 cases with COVID-19 treated with Paxlovid admitted to Shanghai Children's Hospital (designated referral hospital for SARS-CoV-2 infection in Shanghai) from May 1^st to June 1^st, 2022. Results: The 3 cases were 12, 14, 17 years of age, among which 2 cases were males, 1 case was female. All 3 cases were mild cases with underlying diseases and risk of developing into severe COVID-19, with symptoms of high fever, sore throat and dry cough. The treatment of Paxlovid at 3^rd day of symptom onset contributed to the symptom-free after 1-2 days and negative results of SARS-CoV-2 nucleic acid after 2-4 days. All patients had no adverse manifestations of gastrointestinal tract and nervous system but a case had little skin rashes, which recovered after the withdrawal of Paxlovid. Three cases had normal hepatic and renal function during the Paxlovid treatment. At 3 months after discharge, no clinical manifestations of post-COVID syndrome were found in all 3 cases. Conclusion: Paxlovid was effective and relatively safe in the treatment of 3 children with COVID-19.
Child ; Male ; Humans ; Female ; COVID-19 ; SARS-CoV-2 ; Ritonavir/therapeutic use* ; Retrospective Studies ; China ; Nucleic Acids ; COVID-19 Drug Treatment

Objective: To understand the characteristics and associated factors of viral nucleic acid conversion in children infected with Omicron variant strain of SARS-CoV-2 in Shanghai. Methods: The clinical symptoms, laboratory results and other data of 177 children infected with SARS-CoV-2 who were hospitalized in Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University (designated hospital for SARS-CoV-2 infection in Shanghai) from April 25 to June 8, 2022 were retrospectively analyzed. According to the chest imaging findings, the children were divided into mild and common type groups. According to their age, the unvaccinated children were divided into<3 years old group and 3-<18 years old group. According to the vaccination status, the children aged 3-<18 year were divided into non-vaccination group, 1-dose vaccination group and 2-dose vaccination group. Comparison between groups was performed by independent sample t-test and analysis of variance, and multivariate linear regression analysis was used for multivariate analysis. Results: Among the 177 children infected with Omicron variant of SARS-CoV-2, 96 were males and 81 were females, aged 3 (1, 6) years. The time of viral nucleic acid negative conversion was (10.3±3.1) days. The 177 children were 138 cases of mild type and 39 cases of common type. Among the children aged 3-<18 years old, 55 cases were not vaccinated, 5 cases received 1-dose and 36 cases received 2-dose vaccination. Among the 36 children who received 2 doses of vaccination, the time of viral nucleic acid negative conversion was shorter in those vaccinated within 6 months than those over 6 months ((7.1±1.9) vs. (10.8±3.0) d, t=-3.23, P=0.004). Univariate analysis showed that the time of nucleic acid negative conversion of SARS-CoV-2 was associated with age, underlying diseases, gastrointestinal symptoms, white blood cell count, proportion of neutrophils, proportion of lymphocytes, and the number of doses of SARS-CoV-2 vaccine (t=3.87, 2.55, 2.04, 4.24, 3.51, 2.92, F=16.27, all P<0.05). Multiple linear regression analysis showed that older age (β=-0.33, 95% CI -0.485--0.182, P<0.001) and more doses of vaccination (β=-0.79, 95% CI -1.463--0.120, P=0.021) were associated with shortened nucleic acid negative conversion time in children, while lower lymphocyte proportion (β=-0.02, 95% CI -0.044--0.002, P=0.031) and underlying diseases (β=1.52, 95% CI 0.363-2.672, P=0.010) were associated with prolonged nucleic acid negative conversion time in children. Conclusion: The children infected with Omicron variant of SARS-CoV-2 with reduced lymphocyte proportion and underlying diseases may have longer time of viral nucleic acid negative conversion,while children with older age and more doses of vaccination may have shorter time of viral nucleic acid negative conversion.
Child ; Female ; Male ; Humans ; Child, Preschool ; Adolescent ; SARS-CoV-2 ; COVID-19 Vaccines ; Nucleic Acids ; COVID-19 ; Retrospective Studies ; China/epidemiology* ; Translocation, Genetic ; Hospitals, Pediatric

Objective To study the influence of diet on the pharmacoki-netic of Picika oral solution in healthy subjects.Methods This study taken random , before and after self-control design.Twelve subjects were randomly divided into 2 groups, each group was 6 cases, then they were given Picika oral solution 60 mL respectively before and after meal.Before and after administration , blood and urine samples were collected at different points , the plasma and urine concentration was measured and pharmacokinetic parameters were calculated.Results Before and after administration of Picika oral solution 60 mL, the drug pharmacokinetic parameters of active ingredients -CKL-A03 were listed as follows:t1/2 was ( 126.13 ± 74.04 ) , ( 104.81 ± 68.44 ) min; tmax were (53.75 ±10.03 ) and (58.75 ±11.89 ) min;Cmax were (3.06 ±0.86 ) and ( 3.81 ±2.82 )μg· L-1; AUC0-t were ( 268.81 ±84.25 ) and (355.03 ±177.82 )μg· L-1 · min in plasma respectively.t1/2 was (1.14 ± 0.12 ), ( 1.24 ± 0.16 ) h in the urine respectively.Conclusion Diet may affect the absorption and eliminate speed of the drug.

Objective To evaluate the pharmacokinetic changes of Picika oral solution in healthy subjects after single dose.Methods This study taken random , three cross experiment design , 12 subjects were randomly divided into 6 groups, each group was 2 cases, then they were respec-tively given single oral doseof Picika oral solution (60, 90, 120 mL) in each cycle.Before and after administration , biological samples were col-lected for detection of blood drug concentration and urine drug concentra-tion, furthermore, calculation of blood and urine drug pharmacokinetic parameters.Results After single oral dose of 60, 90, 120 mL Picika oral solution, the main pharmacokinetic parameters of plasma CKL -A03, Cmax were (3.08 ±0.92), (3.63 ±0.75), (4.29 ±1.00)μg· L-1, tmax were (57.50 ±17.90 ), (52.50 ±20.73 ), (56.25 ±19.32 ) min, t1/2 were (197.51 ±106.35 ), (233.86 ±196.75 ), (141.34 ±65.16 ) min, AUC0-t were ( 383.28 ± 86.42 ) , ( 479.00 ± 136.25 ) , (540.59 ±102.87)μg · L-1 · min, AUC0-∞ were (710.06 ±233.03 ), (916.59 ±378.62 ), (782.65 ±130.40 )μg· L-1 · min, respectively. The main pharmacokinetic parameters of urine CKL -A03, t1/2 were (1.29 ±0.33), (1.23 ±0.20), (1.11 ±0.11) h, total urine discharge rates were (0.28 ±0.22)%, (0.20 ±0.11)%, (0.18 ±0.09)%, urine discharge amount were (74486.02 ±57923.42 ), (80015.14 ±43379.01 ), (93017.33 ±46658.61 ) mg.Conclusion The maximum oral absorption amount of Picika oral solution is possible 90 mL.And there is no apparent proportional relationship between the total urine discharge rate , urine discharge amount and the increased doses.

BACKGROUNDWith the progress of perinatal medicine and neonatal technology, more and more extremely low birth weight (ELBW) survived all over the world. This study was designed to investigate the short-term outcomes of ELBW infants during their Neonatal Intensive Care Unit (NICU) stay in the mainland of China.

METHODSAll infants admitted to 26 NICUs with a birth weight (BW) < l000 g were included between January l, 2011 and December 31, 2011. All the data were collected retrospectively from clinical records by a prospectively designed questionnaire. The data collected from each NICU transmitted to the main institution where the results were aggregated and analyzed. Categorical variables were performed with Pearson Chi-square test. Binary Logistic regression analysis was used to detect risk factors.

RESULTSA total of 258 ELBW infants were admitted to 26 NICUs, of whom the mean gestational age (GA) was 28.1 ± 2.2 weeks, and the mean BW was 868 ± 97 g. The overall survival rate at discharge was 50.0%. Despite aggressive treatment 60 infants (23.3%) died and another 69 infants (26.7%) died after medical care withdrawal. Furthermore, the survival rate was significantly higher in coastal areas than inland areas (53.6% vs. 35.3%, P = 0.019). BW < 750 g and GA < 28 weeks were the largest risk factors, and being small for gestational age was a protective factor related to mortality. Respiratory distress syndrome was the most common complication. The incidence of patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity was 26.2%, 33.7%, 6.7%, 48.1%, and 41.4%, respectively. Ventilator associated pneumonia was the most common hospital acquired infection during hospitalization.

CONCLUSIONSOur study was the first survey that revealed the present status of ELBW infants in the mainland of China. The mortality and morbidity of ELBW infants remained high as compared to other developed countries.

China ; Female ; Humans ; Infant ; Infant Mortality ; Infant, Extremely Low Birth Weight ; Infant, Newborn ; Intensive Care Units, Neonatal ; statistics & numerical data ; Male ; Morbidity ; Respiratory Distress Syndrome, Newborn ; mortality ; Retrospective Studies ; Surveys and Questionnaires

Objective To evaluate the clinical effect of Kanggu Zengsheng capsule on treatment of knee -osteoarthritis and its effect on anti -inflammation and anti -oxidation. Methods One hundred patients with knee-osteoarthritic were randomly divided into two groups . Patients in the treatment group ( n=50 ) were orally administrated with 3 Kanggu Zengsheng capsules each time , tid, and those in the control group (n=50) were given diacerein (50 mg bid, po) and celecoxib (200 mg qd, po) for four weeks.The data of Visual Analogue Scale ( VAS ) , Womac score , Lequesne index and interleukin 1 beta ( IL-1β) , tumor necrosis factor alpha ( TNF-α) , matrix metallopro-teinases-3 ( MMP-3 ) , hyaluronic acid ( HA ) , nitric oxide ( NO ) , nitric oxide synthase ( iNOS ) , lipid peroxide ( LPD ) and superoxide dismutase ( SOD ) in serum and synovia were observed in two groups . Results After treatment , the data of VAS score , Womac score , Lequesne index in two groups were significantly improved , and the abilities to inhibit IL-1β, TNF-α, MMP-3 , NO, iNOS and LPD in treatment group were better than the control group .The treatment group also displayed a better capability in increasing SOD compared with the control group. Conclusion Kanggu Zengsheng capsule has a better efficacy on knee -OA than traditional treatment methods ( diacereinand plus celecoxib ).