Combined therapy with early initiation of infliximab following drainage of perianal fistulising Crohn's disease: a retrospective cohort study.

BACKGROUND: Recent studies have confirmed that combined surgery and anti-TNF therapy could improve outcomes in patients with perianal fistulising Crohn's disease (PFCD). However, the optimal timing for infliximab infusion after surgical intervention is uncertain. We aimed to determine the long-term efficacy of early initiation of infliximab following surgery among PFCD patients. METHODS: We performed a retrospective cohort study of PFCD patients who received combined infliximab and surgical treatment between 2010 and 2018 at a tertiary referral hospital. Patients were grouped according to the time interval between surgery and infliximab infusion, with < 6 weeks into early infliximab induction group and > 6 weeks into delayed infliximab induction group. The primary outcome was to compare surgical re-intervention between early and delayed infliximab induction groups. The secondary outcomes were fistula healing and predictors associated with these outcomes of early infliximab induction approach. RESULTS: One hundred and seventeen patients were included (73 in early infliximab induction, 44 in delayed infliximab induction). The median interval between surgery and infliximab initiation was 9.0 (IQR 5.5-17.0) days in early infliximab induction group and 188.0 (IQR 102.25-455.75) days in delayed infliximab induction group. After followed-up for a median of 36 months, 61.6% of patients in early infliximab induction group and 65.9% in delayed infliximab induction group attained fistula healing (p = 0.643). The cumulative re-intervention rate was 23%, 32%, 34% in early infliximab induction group and 16%, 25%, 25% in delayed infliximab induction group, at 1, 2, and 3 years respectively (p = 0.235). Presence of abscess at baseline (HR = 5.283; 95% CI, 1.61-17.335; p = 0.006) and infliximab maintenance therapy > 3 infusions (HR = 3.691; 95% CI, 1.233-11.051; p = 0.02) were associated with re-intervention in early infliximab induction group. Presence of abscess at baseline also negatively influenced fistula healing (HR = 3.429, 95% CI, 1.216-9.668; p = 0.02). CONCLUSION: Although no clear benefit was shown compared with delayed infliximab induction group, early initiation of infliximab after surgery could achieve promising results for PFCD patients. Before infliximab infusion, durable drainage is required for patients with concomitant abscess or prolonged infliximab maintenance therapy.

Immunogenicity and safety of human diploid cell vaccine (HDCV) vs. purified Vero cell vaccine (PVRV) vs. purified chick embryo cell vaccine (PCECV) used in post-exposure prophylaxis: a systematic review and meta-analysis.

This study comprehensively evaluated and compared three human rabies vaccines. Seven electronic databases were systematically searched. The Cochrane Handbook v5.1.0 was used to assess the risk of bias. A random-effects model was used to combine individual rates, and network meta-analysis was used for pairwise comparisons. Twenty-seven articles were included, with a total of 18,630 participants. The pooled incidence of the total adverse reaction to HDCV was significantly lower than that of PCECV. HDCV administration resulted in a lower incidence of local pain, fever, and weakness than purified Vero cell vaccine. HDCV caused a lower incidence of local pain and fever than PCECV. No significant difference was observed in terms of the seroconversion rate on day 7 or the rabies virus-neutralizing antibody titer on day 14. HDCV demonstrated superiority in terms of safety compared with the other two rabies vaccines, while the same was not observed in terms of immunogenicity.

[Probabilistic evaluation of dietary exposure to lead and age-related exposure centile for residents in Jiangsu].

OBJECTIVE: To establish a probabilistic model for evaluation of dietary exposure to lead and construct age-related exposure centiles for the residents in Jiangsu. METHODS: Lead contamination data were obtained from the national food contamination monitoring program during 2001 - 2006 and 2791 samples from 232 food products in Jiangsu were included. Food consumption data were from the national diet and nutrition survey conducted in 2002, including 3938 subjects in Jiangsu. A non-parametric probabilistic model using Monte Carlo simulation was applied to derive the intake distribution. The intake data was then analyzed using the LMS method, which constructs exposure percentiles adjusted for the median (M), the coefficient of variation (S) and the skewness (L) of the intake distribution. RESULTS: The median and P(99) of the lead exposure for the residents in Jiangsu were 1.02 µg×kg(-1)×d(-) and 9.29 µg×kg(-1)×d(-1), respectively.6.38% of the total population showed to have a lead intake exceeding the tolerable limit, which for the urban and rural population were 4.31% and 7.06%, respectively. The exceeding rate for children of 2 - 10 years old from the urban and rural areas were 13.17% and 17.70%, respectively. CONCLUSION: There was a large variation in the lead exposure level of the population in Jiangsu; People in rural areas are in greater risk for higher lead exposure than urban people; The dietary exposure to lead for children and the high-end population was serious.

[Establishment of non-parametric probabilistic model for evaluation of Chinese dietary exposure].

OBJECTIVE: To establish a non-parametric probabilistic model for evaluation of Chinese dietary exposure and to improve the assessment accuracy while integrating into the global risk assessment on food safety. METHODS: Contamination data was from the national food contamination monitoring program during 2000 - 2006, including heavy metals, pesticides and mycotoxins, amounting to 135 contaminants with 499 commodities and 487 819 samples. Food consumption data was obtained from the national diet and nutrition survey conducted in 2002 with three consecutive days by 24-hour recall method, and 66 172 consumers were included. Monte Carlo simulation was applied to derive the intake distribution, and the uncertainty of each percentile was estimated using the Bootstrap sampling. RESULTS: Different non-parametric probabilistic models for dietary exposure evaluation on heavy metals, pesticides and some of the toxins were established for Chinese people, and intake distributions with 95% confidence intervals of these contaminants were estimated. Taking acephate as an example, the results of its model shows that, for the 7 - 10 year-old children, the median dietary exposure in urban and rural areas were 1.77 microg x kg(-1) x d(-1) and 2.48 microg x kg(-1) x d(-1) respectively, with a 95% confidence interval of (1.59 - 2.06) microg x kg(-1) x d(-1) and (2.33 - 2.80) microg x kg(-1) x d(-1) respectively. CONCLUSION: The non-parametric probabilistic model can quantify the variability and uncertainty of exposure assessment and improve the assessment accuracy.

[Establishment of database for food classification and coding in Chinese dietary exposure assessment].

OBJECTIVE: To establish the basis for Chinese dietary exposure assessment database by classifying and coding the data from the national dietary survey and pollutant surveillance. METHODS: The method, which combined CODEX food classifying and coding of Codex Alimentarius Commission (CAC) with Chinese food classification of food composition table, was applied to classify and code the data of 1 810 703 Chinese dietary consumption and 487 819 pollutant surveillance. The coding system was according to the first two letters of the respective food group that represent the type or source of foods, the last four digits represent the serial number of the food in the CAC food classification. If the foods can be found in CAC food code system, its original food code is used. The new codes corresponding with the foods which are not exist in CAC food code system, is added according to CAC coding methods. RESULTS: Dietary consumption data were divided into 6 major categories, 19 types, 75 groups, the agricultural products of pollutant surveillance corresponding to 499 codes. Comparing with CAC food coding system, Chinese dietary consumption data have added F (candy snacks) and G (beverages) 2 major categories, 4 types, 33 groups, 302 new codes. The additional groups most were the processing food groups with Chinese characteristics, such as canned, beverages, candy, meat products. CONCLUSION: The foundation of data communication to dietary exposure assessment has been established, and the connection of Chinese food classifying and coding with CAC data have been achieved.

[Development and verification of Chinese dietary exposure evaluation model software].

OBJECTIVE: To develop the dietary exposure evaluation model software accredited of Chinese intellectual property rights and to verify the rationality and accuracy of the results from the probabilistic model in Chinese dietary exposure evaluation model software according to international standards. METHODS: The software of SAS was used to build various evaluation model based on the data from Chinese dietary survey and the chemical compound in food surveillance and to design an operation interface. The results from probabilistic dietary exposure model for children 2 - 7 years old were compared with that from duplicate portion study of 2-7 years children dietary exposure in Jinhu, Jiangsu province in order to analyze the rationality of model. The results from probabilistic model of dietary exposure were compared with the results from @Risk software to verify the correction of the probabilistic model by using the same data of randomly selected 10 000 study subjects from national dietary survey. While, the mean drift was used as an internal index to illustrate the accuracy of the computation. RESULTS: Chinese dietary exposure evaluation software was developed successfully. On the rationality, the results from probabilistic model were lower than that from the point estimation (e.g., cucumber: the result of point estimation of acephate was 4.78 microg x kg(-1) x d(-1), while the results of probabilistic model which was 0.39 microg x kg(-1) x d(-1)). Meanwhile the results from probabilistic model were higher than the results of duplicate portion study (on the P95, the result of probabilistic model of Pb exposure in children was 11.08 microg x kg(-1) x d(-1), while the results of duplicate portion study was 5.75 microg x kg(-1) x d(-1)). On accuracy, the results from @Risk and the probabilistic model were highly consistent (on the P95, the result of probabilistic assessment of acephate diet exposure was 4.27 microg x kg(-1) x d(-1), while the results of duplicate portion study was 4.24 microg x kg(-1) x d(-1)), and the mean drift was of random distribution, the drift region varied from 0.05% to 11.9%. CONCLUSION: The results computed by the software of Chinese dietary exposure evaluation model are reliable and reasonable, which is a meaningful step to improve the dietary exposure evaluation technique in China.

Renal Impairment Increases Serum Cancer Antigen 125 Levels in Patients with Type 2 Diabetes Mellitus.

OBJECTIVE: Poor glycemic control increases the risk of diabetes complications. Serum cancer antigen 125 (CA125) has been associated with diabetes status in patients with type 2 diabetes mellitus (T2DM). Our aim was to focus on the association between serum CA125 and renal impairment in patients with T2DM. METHODS: Retrospective study included 151 patients with T2DM, with review of clinical and laboratory data. RESULTS: Serum CA125 levels were positively correlated with urinary microalbumin and 24-hours urinary protein (r=0.170, p=0.037; r=0.186, p=0.022) in T2DM patients. Patients with 24-hours urinary protein positive maintained higher serum CA125 levels than those with 24-hours urinary protein negative (p=0.047). Multiple linear regression analysis indicated that serum CA125 was independently correlated with urinary microalbumin and 24-hours urinary protein in T2DM patients (beta=0.192, p=0.042; beta=0.203, p=0.025). CONCLUSIONS: Serum CA125 levels are positively correlated with urinary microalbumin and 24-hours urinary protein in T2DM patients; renal impairment may increase serum CA125 levels in T2DM patients.

First-Trimester Platelet Count as a Predictive Biomarker for Neonatal Birth Weight Among Pregnant Women at Advanced Maternal Age.

The aim of this study was to investigate the association between first-trimester platelet count and neonatal birth weight in pregnant woman at advanced maternal age. Our study included 148 pregnancy women of advanced maternal age, the clinical and laboratory materials were retrospective obtained from medical record system. The neonatal birth weight was positively correlated with maternal body mass index and fetus gestational age (r = 0.332, P < .001; r = 0.469, P < .001), even more interestingly, the neonatal birth weight was positively correlated with first-trimester platelet count in pregnant women of advanced maternal age (r = 0.203, P = .013). Multiple linear regression analysis revealed that neonatal birth weight had an independently association with first-trimester platelet count in pregnant women of advanced maternal age (multiple-adjusted r values 0.167, P = .013). First-trimester platelet count is positively associated with neonatal birth weight, suggesting that first-trimester platelet count may be a predictive biomarker for neonatal birth weight in pregnant women of advanced maternal age.

Probiotics improve glucose and lipid metabolism in pregnant women: a meta-analysis.

BACKGROUND: This study aims to assess the effects of probiotic supplementation on the maternal metabolism and the risk of development of gestational diabetes mellitus (GDM) in the pregnant women by a meta-analysis of relevant randomized controlled trials (RCTs). METHODS: The medical literature was searched from PubMed, Web of Science and the Cochrane Library since inception to October 2017. Two investigators independently performed the data extraction and quality assessment. The mean differences (MD) or standardized mean differences (SMD) or relative risk (RR) with 95% confidence intervals (CIs) were calculated with the random-effects model. RESULTS: From 648 citations, a total of ten RCTs published in 13 articles with 1,139 participants met the inclusion criteria. The meta-analysis showed that probiotics supplementation effectively reduced the fasting blood glucose (FBG) levels (MD -0.11 mmol/L, P=0.0003), serum insulin levels (MD -2.06 µU/mL, P<0.00001), insulin resistance (HOMA-IR) (MD -0.38, P<0.00001). The study found a significant effect of probiotics on decreasing the risk of GDM [risk ratio (RR) 0.52, P=0.003) in early pregnancy. Additionally, there were statistically significant reductions in the total cholesterol and triglycerides levels after probiotic interventions (SMD -0.56, P=0.03; SMD -0.66, P=0.04), respectively. CONCLUSIONS: Our study shows that the probiotic use was associated with improved glucose and lipid metabolism in the pregnant women, and might also contribute to the reduced risk of GDM.

Correction to: Correlation analysis on serum inflammatory cytokine level and neurogenic pulmonary edema for children with severe hand-foot-mouth disease.

The original publication of this article [1] contained two erroneous paragraphs related to the time and place for the admission of the pediatric patients with clinically diagnosed severe HFMD. The updated information has been indicated in bold.

Correlation analysis on serum inflammatory cytokine level and neurogenic pulmonary edema for children with severe hand-foot-mouth disease.

OBJECTIVE: This study aims to discuss the correlation between serum inflammatory cytokines and neurogenic pulmonary edema (NPE) in children with severe hand-foot-mouth disease (HFMD). METHODS: A total of 89 patients with severe HFMD were enrolled into this study. These patients were divided into two groups, according to the presence of NPE: central nervous system disease (CNSD) group and NPE group. Serum IL-4, IL-10, IL-6, IL-17, tumor necrosis factor-α (TNF-α), and interferon-γ (IFN-γ) levels were measured in patients by enzyme-linked immunosorbent assay at 1, 3, and 5 days after admission. Furthermore, risk factors for NPE were screened using multivariable logistic regression analysis. RESULTS: IL-6, TNF-α, IL-10, and interferon-γ (IFN-γ) levels in the NPE group were higher than in the CNSD group. TNF-α, IL-10, and IFN-γ levels reached a peak on the 3rd day of admission. Age, continuous fever, blood sugar, white blood cell count, and IL-10 were risk factors for the occurrence of NPE in severe HFMD. CONCLUSION: The dynamic unbalance of inflammatory cytokines is related to the occurrence and progress of NPE.

The immunogenicity and safety of a Hib-MenAC vaccine: a non-inferiority randomized, observer-blind trial in infants aged 3-5 months.

BACKGROUND: The objective of this study was to evaluate the immunogenicity and safety of the novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine (Hib-MenAC). METHODS: We conducted a non-inferiority, randomized, observer-blind, positive control clinical trial in 900 healthy infants aged between 3-5 months in Funing County, Jiangsu Province, China. Participants were randomly allocated, in a ratio of 2:1 (block = 6), to receive experimental combined Hib-MenAC vaccines co-administrated with placebo or the co-administration of licensed Hib vaccine and MenAC vaccine, according to a three-dose immunization schedule. The seroconversion of antibody titer against meningococcal serogroups A, C and Hib was the primary endpoint. RESULTS: The experimental vaccines was non-inferior to the licensed two control vaccines. Participants receiving experimental Hib-MenAC vaccines showed a seroconversion rate of 99.0%, 96.1% and 97.7% for rSBA-MenA, rSBA-MenC and anti-PRP antibodies, respectively. The Hib-MenAC vaccine did not result in an increase in adverse reaction, and no serious adverse event was judged to be related to the vaccination. CONCLUSIONS: The novel combined Hib-MenAC conjugate vaccine was safe and highly immunogenic in infants aged between 3 to 5 months.

Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: To identify the efficacy of auricular acupressure on pain and disability for chronic LBP by systematic review. METHODS: A search of randomized controlled trials was conducted in four English medical electronic databases and three Chinese databases. Two reviewers independently retrieved related studies, assessed the methodological quality, and extracted data with a standardized data form. Meta-analyses were performed using all time-points meta-analysis. RESULTS: A total of 7 trials met the inclusion criteria, of which 4 had the low risk of bias. The findings of this study showed that, for the immediate effect, auricular acupressure had large, significant effects in improving pain within 12 weeks. As for the follow-up effect, the pooled estimates also showed promising effect at 4-week follow-up after 4-week intervention (standardized mean difference = -1.13, 95% CI (-1.70, -0.56), P < 0.001). But, for the disability level, the therapeutic effect was not significant (mean difference = -1.99, 95% CI (-4.93, 0.95), P = 0.18). No serious adverse effects were recorded. CONCLUSIONS: The encouraging evidence of this study indicates that it is recommended to provide auricular acupressure to patients with chronic low back pain. However, a more accurate estimate of the effect will require further rigorously designed large-scale RCTs on chronic LBP for improving pain and disability.

Safety and immunogenocity of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine in healthy Chinese children aged 6 months to 5 years old.

A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine (Hib-MenAC vaccine) has been developed to protect children against diseases caused by Hib, MenA, and MenC. This study investigated the safety and immunogenicity of the Hib-MenAC vaccine administered in 2-dose series to children aged 6-23 months and in a single dose to children aged 2-5 y. A randomized, positive-controlled, non-inferiority clinical trial was conducted for 1200 healthy participants in each age group. Within each age group, participants were randomly allocated to the Hib-MenAC group or the control group at a ratio of 1:1. Adverse reactions were recorded within 28 d after each dose. Blood samples were obtained to assess immunogenicity on day 0 and at 28 d after a complete vaccination course. For the investigational vaccine, the incidence of total adverse reactions in vaccinees aged 6-23 months was 46.8% and that in vaccinees aged 2-5 y was 29.8%. Most adverse reactions were mild or moderate. One non-fatal serious adverse event occurred in the Hib-MenAC group, but was unrelated to vaccination. The seroconversion rate to the 3 components reached 94.0%, and the proportion of vaccinees with rSBA titers ≥ 1:8 and PRP ≥ 0.15 g/mL reached 97.0% in both age groups. The safety and immunogenicity of the Hib-MenAC vaccine were non-inferior when compared to the licensed vaccines. It was concluded that the novel vaccine would be expected to protect children against all of the targeted diseases.

Efficacy of auriculotherapy for constipation in adults: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. METHODS: Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. RESULTS: Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; p<0.00001). The 15 RCTs also showed a moderate, significant effect of auriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13-1.44; p<0.0001). For other symptoms associated with constipation, such as abdominal distension or anorexia, results of the meta-analyses showed no statistical significance. Subgroup analysis revealed that use of S. vaccariae and use of magnetic pellets were both statistically favored over the control in relieving constipation. CONCLUSIONS: Current evidence illustrated that auriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

[Evaluation on the case management program of hypertension in Zhongguancun community, Beijing].

OBJECTIVE: To explore a suitable model regarding community-based case management of hypertension in the urban areas. METHODS: Based on the guidelines set by the Chinese Hypertension League (CHL), the goal of case management of hypertension was set as: to maintain blood pressure at the normal range. Family doctors were guided to take care of case management. Hypertension patients who had been contracted to the family doctors were followed by a team of family doctors for half a year. RESULTS: After the 6-month intervention, the rate of hypertension under control had increased from 50.44% to 69.84% (P < 0.0001) while the means of systolic blood pressure decreased by 3.72 mm Hg and diastolic blood pressure decreased by 2.67 mm Hg (P < 0.0001) respectively. The means of SBP decreased by 8.59 mm Hg and diastolic blood pressure decreased by 5.26 mm Hg in patients whose baseline blood pressure were not under control. The rates of smoking, higher salt intake and no physical exercise had significantly decreased (P < 0.05). The mean number of hospital visits in the six-month follow-up period was 7.69 +/- 2.37. The "rate of control" among those who had followed schedule was higher than that of those who were not on schedule (P < 0.0001). The rate among those who had followed the schedule tended to have increased with aging and the level of education (P < 0.001). CONCLUSION: The community-based case management program on hypertension played an important and effective role in the control of hypertension in urban areas. Patients received great benefit when following the guidance from their doctors.