ObjectiveTo investigate the incidence and pathogen distribution of neonatal early-onset sepsis (EOS) following exposure to antenatal antibiotics.MethodsOne hundred and eighty-four neonates who were admitted to Maternal and Child Care Hospital of Xiamen and identified as having EOS from January 2010 to December 2015 were enrolled. The clinical data were retrospectively analyzed. According to antenatal antibiotic exposure time, the infants were divided into the antibiotics group (≥4 hours) and the control group (<4 hours). Women in late pregnancy (35-37 weeks of gestation) underwent group BStreptococcus (GBS) screening using standard bacterial culture beginning from Janaury 2014 as screening group. Intrapartum antibiotic prophylaxis was given if the GBS culture was positive. Infants delivered before January 2014 were included in the no-screening group. Pathogen distribution and the difference in drug resistance between the two groups were compared by a two-independent samplest-test andChi-square test.ResultsIn the antibiotics group, the percentages of birth weight lower than 2 500 g, preterm infants, asphyxia, and positive rates of GBS and blood culture were 24.3%(17/70), 14.3% (10/70), 2.9% (2/70), 7.1% (5/70) and 70.0% (49/70), respectively, and were significantly lower than those in the control group [39.5%(45/114), 28.1% (32/114), 14.9% (17/114), 19.3%(22/114) and 88.6% (101/114), respectively] (χ2=4.478, 4.678, 6.807, 5.118 and 9.957, allP<0.05). There was no difference in the positive rate of coagulase-negativeStaphylococci andE. coli culture, or in the incidence of purulent meningitis, septic shock, disseminated intravascular coagulation, hospital stay and fatality rate between the antibiotics group and control group (allP>0.05). Compared with the no-screening group, the positive rate of GBS decreased [7.6% (5/66) vs 18.6% (22/118)] and the positive rate of fungal infection increased [7.6%(5/66) vs 1.7% (2/118)] in the screening group (χ2=4.141,P=0.042;χ2=4.000,P=0.046). The distribution of other pathogenic bacteria such as coagulase-negativeStaphylococci andE. coli was not significantly different between the two groups (P>0.05, respectively). Drug resistance rates ofStaphylococcus (Staphylococcus aureus and coagulase-negativeStaphylococcus) to oxacillin and piperacillin-sulbactam were higher in the screening group than in the no-screening group [82.6% (19/23) vs 52.9% (18/34),χ2=5.302; 78.3% (18/23) vs 47.1% (16/34),χ2=5.549; bothP<0.05], and no vancomycin resistant bacterial strains were found.ConclusionsAntenatal antibiotic exposure may be effective in reducing the occurrence of prematurity, asphyxia,and GBS infection, but it increases the rate of fungal infection, and is not effective in reducing the incidence of complications and mortality or in changing the distribution of the other pathogens in EOS. Rational indications and timing of antenatal antibiotic exposure should be taken into consideration to reduce drug resistance.

Objective To evaluate the value of procalcitonin(PCT)in different periods for diagno-sis of early-onset of neonatal bacterial infection.Methods One hundred and ninety-five newborns with intra-uterine infection risk factors were divided into two groups:infection group(24cases)and non-infection group(171cases).The levels of PCT,C-reactive protein(CRP)and WBC were measured in 2hours,6to 12hours,12to 36hours and more than 48hours after birth.The sensitivity and specificity of PCT in different periods in the diagnosis of early-onset infection were analyzed.Results There were no significant differ-ences in the positive rate of PCT,CRP and WBC in infection group in 2hours after birth(P﹥0.05).The sensitivity and specificity for diagnosis of early-onset infection of PCT were 91.7% and 86.5% at 6to 12hours after birth,which were higher than those of CRP and WBC.After birth in 12to 36hours was the physiologic peak of PCT,so it couldn′t have higher sensitivity and specificity.According to threshold of 0.5ng/ml,2ng/ml,and 10ng/ml for PCT,the sensitivity was 100%,91.7% and 100% respectively,and the specificity was 5.8%,53.8%and 95.9%respectively.Conclusion PCT in 6to12hours after birth,ac-cording to threshold of 2ng/ml,can reach higher sensitivity and specificity for diagnosis of early-onset neo-natal bacterial infection.

Objective To investigate the clinical and etiologic characteristics and drug-resistance features of ventilator-associated pneumonia(VAP)in neonatal intensive care unit.Methods A retrospective study was conducted in 712 newborns with VAP who were admitted to the NICU from January 2007 to December 2010 and had received mechanical ventilation.The pathogenic bacteria spectrum of hospital infection were statistically analyzed.Results VAP was occurred in 69 out of 712 newborns with mechanical ventilation (incidence rate of 9.7％).The top four pathogens were saccharomyces albicans(39.2％),stenotrophomonas maltophilia(20.3％),staphylococcus epidermidis(13.5％)and klebsiella pneumoniae(9.5％),respectively.Conclusion Implementing strict measures to control the nosocomial infection can significantly reduce the incidence of VAP.Saccharomyces albicans,stenotrophomonas maltophilia,staphylococcus epidermidis and klebsiella pneumoniae were the pathogens most commonly involved.

ObjectiveTo study the effects of group BStreptococcus (GBS) colonization in late pregnancies on neonatal GBS infection.MethodsA total of 17 019 pregnant women who received antenatal care and delivered in Xiamen Maternal and Child Care Hospital from June 1, 2014 to May 31, 2015 were enrolled in this study. Secretions from the lower third of the vagina in the pregnant women at 35-37 weeks of gestation or having premature baby(regardless of gestational age) were obtained to test GBS by standard bacterial culture, and 1 472 cases underwent GBS DNA test by real-time fluorescent quantitative-polymerase chain reaction (PCR) meanwhile. The pregnant women colonized with GBS (GBS culture and/or PCR DNA test positive) were given intrapartum antibiotic prophylaxis (IAP) during parturition or rupture of fetal membranes. Detection rate of the two methods was compared, and the effects of GBS colonization and IAP on neonatal GBS infection were analyzed to identify the risk factors of neonatal early-onset GBS disease (GBS-EOD). Two independent samplest-test,Chi-square test and Logistic regression analysis were used for statistical analysis. ResultsThe detection rate of GBS culture and PCR DNA test was 14.43% (2 456/17 019) and 14.13%(288/1 472), respectively. The total colonization rate was 14.52%(2 472/17 019). Based on the culture results as golden criteria, the sensitivity, specificity, positive predictive value and negative predictive value of PCR assay were 95.05%, 98.74%, 92.31% and 99.21%, respectively. There were 17 332 deliveries from the 17 019 pregnant women, of which 31 cases had GBS-EOD. The incidence of neonatal GBS-EOD in maternal GBS colonization [1.05%(26/2 472)] was 31 times higher than in pregnant women without GBS colonization [0.34‰(5/14 547)]. Among the 31 infants with GBS-EOD, 24 had pneumonia, five had sepsis, and two had meningitis. The case fatality rate was 6.45%(2/31). Logistic regression analysis found that chorioamnionitis was an independent risk factor of neonatal GBS-EOD (OR=40.425, 95%CI: 7.514-379.782,P=0.000). Compared with the non-IAP group,IAP group had a lower incidence of GBS-EOD among the pregnant women colonized with GBS [0.94%(23/2 443) vs 10.34%(3/29),χ2=24.350,P<0.01].ConclusionsGBS colonization in late pregnant women has adverse effects. Therefore, routine maternal rectovaginal culture of GBS may be necessary and IAP should be applied in those with GBS colonization.

Objective: To analyze clinical features, treatment, prognosis and risk factors for death of capillary leak syndrome (CLS) in neonates. Methods: This retrospective study involved 68 neonates with CLS treated in the Department of Neonatology, Women and Children's Hospital, School of Medicine, Xiamen University from January 2013 to December 2017. Clinical data, including features, causes, treatment and outcomes of those CLS cases were analyzed. Chi-square test and multivariate logistic regression analysis were performed. Results: Among the 68 cases consisting of 49 males and 19 females, 86.7% (59/68) were born at ≥ 35 gestational weeks. Fifty-three neonates (77.9%) developed symptoms within three days after admission. Forty-two cases (61.8%) had respiratory distress syndrome and 35 (51.5%) had septicemia. The mortality rate was 23.5% (16/68). Among the survivors, 38.5% (20/52) showed abnormal cranial MRI. Univariate analysis with Chi-square test showed that neonatal death due to CLS was associated with the lactic acid level >10 mmol/L, oliguria lasting for 12 h or anuria for 8 h, no negative fluid balance occured within seven days, adrenaline infusion >0.6 μg/(kg·min) and administration of 3% sodium chloride. Multivariate logistic regression analysis showed that lactic acid level, oliguria/anuria duration and the time achieve negative fluid balance were independent risk factors for neonatal death of CLS. Conclusions Neonatal CLS is a condition with high fatality rate and poor prognosis. Respiratory distress syndrome and septicemia are the common causes. The prognosis of CLS might be improved by treatment with 3% sodium chloride. Lactic acid level, oliguria/anuria duration and the time achieve negative fluid balance are independent risk factors for neonatal death due to CLS.

OBJECTIVETo study the short tandem repeat (STR) polymorphism in Chinese Drungs (Tulungs).

METHODSThe genetic distributions of fifteen STR loci were investigated with the use of coamplification, genescan and genotype from 67 Drungs.

RESULTSThere were 144 STR alleles in Drung nationality, with their frequencies ranging from 0.0077 to 0.7846, heterozygosity(H) 0.3723-0.8639, discrimination power(DP) 0.5567-0.9548, probability of paternity exclusion(EPP) 0.2738-0.8358, polymorphism information content (PIC) 0.3461-0.8456 the accumulative DP 0.99999998 and EPP 0.99999894.

CONCLUSIONThe results of this study on the STR polymorphism in Chinese Drungs could be used as a basis for the genetic structure of Chinese ethnic groups and also be of significant application in anthropology and forensic science.

Alleles ; China ; DNA ; chemistry ; genetics ; Gene Frequency ; Genotype ; Humans ; Polymorphism, Genetic ; Sequence Analysis, DNA ; Tandem Repeat Sequences ; genetics

Controlled Clinical Trials as Topic ; Humans ; Randomized Controlled Trials as Topic

Objective To investigate the impact of the change in anti-hepatitis B virus (HBV) therapy indication on treatment rate and the features of the population requiring treatment. Methods The treatment-naïve patients with chronic hepatitis B (CHB) in the China Registry of Hepatitis B (CR-HepB) database were selected as subjects, and related demographic, virological, hematological, and biochemical data were collected. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups; the chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. Results A total of 3640 treatment-naïve CHB patients were included in this study, among whom 64.4% were male, 68.7% had an age of 30-59 years, and 46.8% had an indeterminate clinical stage. According to the 2015 and 2019 editions of Guidelines for the prevention and treatment of chronic hepatitis B and the 2022 edition of expert consensus, the number of patients who had the indication for antiviral therapy was 625(17.2%), 1333(36.6%), and 2890(79.4%), respectively. The number of patients requiring treatment was increased by 1557 according to the 2022 edition of expert consensus, among whom 1424(91.5%) met the treatment threshold of alanine aminotransferase (ALT) > 30 U/L for male patients or ALT > 19 U/L for female patients. The additional patients requiring treatment according to the 2022 edition of expert consensus had significantly higher levels of ALT and HBV DNA and significantly lower scores of APRI and FIB-4 than the additional patients requiring treatment according to the 2019 edition of Guidelines (all P < 0.05). Conclusion The expansion of antiviral therapy indications for CHB may significantly increase the proportion of CHB patients receiving antiviral treatment and help mild CHB patients at the risk of disease progression to receive timely treatment and achieve the improvement in long-term prognosis.

Objective: To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. Methods: An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. Results: A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. Conclusion Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

Objective: To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg, twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection. Methods: A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial was conducted in mainland China, Korea, and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha /pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection. Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A), or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks. Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment, and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed. Results: A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1:1 ratio. The rates of SVR12 and SVR24 were 99% (95% CI: 94.8% - 99.8%) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100% in treated patients (95% CI: 96.3% - 100%). Different baseline characteristics had no effect on SVR12 and SVR24 rates. Most of the adverse events occurred were mild, asymptomatic, and≥ 3 laboratory abnormalities during treatment were rare, including elevation of alanine aminotransferase (2 cases in double-blind stage A group), aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group); however, those mild adverse events could be recovered after drug withdrawal or discontinuation. only1 person discontinued drugs due to adverse events (Group B, open-label phase). Conclusion The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99% ~ 100% rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection, and the tolerance and safety were good.