CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.

INTRODUCTIONStreptococcus agalactiae (Group B Streptococcus, GBS) is an uncommon cause of septic arthritis in the adult population. In recent years, there has been an increase in the incidence of GBS septic arthritis. This study aims to compare the clinical presentation, investigations, microbiology and outcome of management in patients with GBS and non-GBS septic arthritis.

METHODSRetrospective review of hospital surgical records was done to identify all patients treated surgically at our institution from January 2011 to January 2016 for primary septic arthritis. Patients were categorised into two groups: those with culture-proven GBS septic arthritis and those with causative pathogens that were not GBS. Patients who were medically unfit for surgical intervention as well as those who declined interventional procedures were excluded from the study.

RESULTSA total of 83 patients were included in the study: 62 (74.7%) had non-GBS septic arthritis and 21 (25.3%) had GBS septic arthritis. Patients with GBS septic arthritis were more likely to have polyarticular involvement (p < 0.001) and involvement of less common sites such as the elbow joint. They were also more likely to have elevated inflammatory markers (C-reactive protein > 150 mg/L; p = 0.017) and positive blood cultures (p = 0.02), and were typically healthy adults with no medical comorbidities (p = 0.012).

CONCLUSIONPatients with GBS septic arthritis were more likely to present with polyarticular involvement, positive blood cultures and higher levels of C-reactive protein on admission, and tended to be healthier individuals with no medical comorbidities.

BackgroundAlthough much attention has been paid to the pharmacokinetics (PKs) of different factor VIII (FVIII) concentrates in persons with hemophilia A (HA), limited information is available in young boys with severe HA. In this study, we aimed to assess the PK parameters of FVIII products in boys with severe HA in China.

MethodsA total of 36 boys (plasma-derived [pd]-FVIII, n = 15; recombinant [r] FVIII, n = 21) were enrolled between January 2015 and May 2016 in Beijing Children's Hospital. PK characteristics of FVIII products were studied according to a reduced 4-sampling time point design (1 h, 9 h, 24 h, and 48 h postinfusion).

ResultsThe mean FVIII half-life (t) was 10.99 ± 3.45 h (range 5.52-20.02 h), the mean in vivo recovery (IVR) was 2.01 ± 0.42 IU/dl per IU/kg (range 1.24-3.02 IU/dl per IU/kg) and mean clearance (CL) of FVIII is 4.34 ± 1.58 ml·kg·h (range 2.29-7.90 ml·kg·h). We also analyzed the influence of several parameters that potentially modulate FVIII PK. The age was closely associated with FVIII half-life (R = 0.32, P < 0.01). The tof FVIII increased by 0.59 h per year. Besides age, von Willebrand factor antigen (VWF:Ag) also was associated with FVIII half-life (R = 0.52, P < 0.01). Patients with blood Group O had a shorter FVIII half-life than patients with non-O blood group (9.40 ± 0.68 h vs. 12.3 ± 0.79 h, t = 2.70, P = 0.01). The FVIII IVR correlated with age (R = 0.21, P < 0.01) and VWF:Ag level (R = 0.28, P < 0.01). CL rates were faster in young patients and in those with low-VWF:Ag levels. CL rates of FVIII are higher in blood Group O versus non-blood Group O persons (5.02 ± 0.38 vs. 4.00 ± 0.32 ml·kg·h, t = 2.53, P = 0.02).

ConclusionsChinese boys with severe HA have similar PK values to other ethnic groups and large differences in FVIII PK between individual patients. Age, blood group, and VWF:Ag levels are important determining factors for FVIII CL.

Adolescent ; Blood Coagulation Tests ; Child ; Child, Preschool ; China ; Factor VIII ; pharmacokinetics ; Hemophilia A ; drug therapy ; Humans ; Male ; von Willebrand Factor