Prevalence of recessive infection of pathogens of hand, foot, and mouth disease in healthy people in China: A meta-analysis.

BACKGROUND: To analyze the prevalence of latent infection of pathogens of hand, foot, and mouth disease (HFMD) in Chinese healthy population and its influencing factors, so as to provide reference for the prevention and control of HFMD. METHODS: A systematic literature searching about the incidence of latent infection of HFMD was conducted in Chinese and English databases. The inclusion and exclusion criteria of the retrieved literature were established. The qualified literatures were screened and the data were extracted. The pooled rate and its 95% confidence interval was used to assess the latent infection rate of HFMD pathogens in healthy Chinese population, and subgroup analysis was conducted based on gender and age. All statistical analyses were performed using the STATA version 12.0 software. RESULTS: A total of 31 literatures were included in this meta-analysis. The recessive infection rate of HFMD pathogens reported in the literature of Chinese healthy people ranged from 4.59% to 44.12%. The results of meta-analysis showed that the latent infection rate of human enteroviruses (HEVs) in healthy Chinese population was 17.5% (14.9-20.1%), among which, the latent infection rates of EV-A71, CV-A16, and other HEVs were 3.3% (2.2-4.4%), 1.7% (1.0-2.5%), and 15.1% (11.1-17.1%), respectively. The latent infection rates of HEVs in healthy men and women in China were 16.7% (12.9-20.4%) and 14.4% (10.8-18.0%), respectively. The latent infection rates of HEVs in the healthy population aged 0 to 5 years and over 5 years were 24.4% (20.4-28.5%) and 9.4% (6.5-12.2%), respectively. Meta regression showed that the factors affecting the latent infection rate of HEVs in Chinese healthy population included sampling period, sampling area, and study population. CONCLUSION: The latent infection rate of HEVs is high in healthy people in China, but it is mainly caused by other enteroviruses. The latent infection rate of HEVs in male was higher than that of female and was greater in people aged 0 to 5 than that of aged over 5 years. Limited by the quantity and quality of the included studies, more high-quality studies are needed for further verification in the future.

PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta®): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.

INTRODUCTION: PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta®). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta®) in healthy volunteers. METHODS: A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study. RESULTS: Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups. CONCLUSIONS: Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).

Physiological Effects of Wearing Athletic Mouth Pieces While Performing Various Exercises.

The purpose of this study is to evaluate physiological responses associated with exercise using two different mouthpieces compared with not using a mouthpiece. Improved performance while using the PX3 Bite Regulator (PX3) may significantly reduce the risk of concussions by allowing an athlete to better prepare, react, absorb, and/or avoid impact completely compared with the restricted breathing or mandibular instability that occurs when using mouthguards. Twenty-three subjects completed a battery of five physiological tests; the 1.5-mile run, sit and reach, anaerobic endurance, leg press, and bench press. Each test battery was completed under three conditions: wearing a PX3, wearing a mouthguard, or no mouthpiece respectfully. The PX3 resulted in significantly faster 1.5-mile run times (667.4 ± 9.4 vs. 684.9 ± 9.2 vs. 679 ± 7.9 s, p ≤ 0.05) and significantly longer anaerobic endurance runs (311 ± 23 vs. 283 ± 18 vs. 286 ± 18yds, p ≤ 0.05) compared with the mouthguard and no mouthpiece. The leg press lifts (51.8 ± 4.1 vs. 46.0 ± 4.3, p ≤ 0.05) while wearing the PX3 were significantly greater than when wearing a mouthguard. There were improvements, but no significant differences for sit and reach (16.8 ± 0.8 vs. 15.9 ± 0.8 vs. 16.4 ± 0.8 in., p = 0.73) and bench press (17.7 ± 1.8 vs. 17.2 ± 1.6 vs. 17.2 ± 1.7 lifts, p = 0.94). The increased performance with the PX3 could be a result of better jaw alignment and/or decreased resistance to airflow.