2013 Vol. 4, No. 1

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Original Contributions
Abstract:
  Objective  To investigate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of buagafuran after single, and twice-daily repeated oral doses of 60 or 120 mg.  Methods  In this double-blind, randomized, placebo-controlled, parallel study, 7 male and 7 female healthy subjects were enrolled in each dosing cohort and were administered with buagafuran or placebo based on a 5:2 randomized allocation schedule. Subjects took a single oral dose of buagafuran or placebo on the first day. After 48 hours, subjects started to receive twice daily repeated administration for 4.5 days. Within the 48 hours following the first and the last study doses, the serial blood and urine samples were collected for PK assays. Meanwhile, PD measurements were performed, which included body sway, choice reaction time, digit span task, visual analogue scale (VAS) of Bond and Lader, and VAS of Bowdle.  Results  After the single oral dose of buagafuran, the mean PK parameters were: Cmax, (37.7±18.4) ng/ml and (95.8±34.8) ng/ml; area under the plasma concentration-time curve (AUC)0-t, (108±46) h·ng/ml and (336±104) h·ng/ml; apparent clearance, (581±203) L/h and (367±122) L/h; t1/2, (10.4±7.1) hours and (19.8±6.5) hours for 60 and 120 mg buagafuran, respectively. With twice daily repeated administration for 4.5 days, the mean Cmax were (48.5±32.2) ng/ml and (118.0±20.3) ng/ml, with a mean AUC0-t of (241±122) h·ng/ml and (656±135) h·ng/ml for 60 and 120 mg, respectively. No PD parameters showed clinically or statistically significant difference between these two dosing schemes except for VAS alertness, VAS external feeling, and VAS internal feeling.  Conclusions  The plasma exposure of buagafuran attains a steady state with approximately 2-3 times of accumulation after twice-daily repeated dosing for 24 hours. The oral administrations with 60 or 120 mg buagafuran were safe and well tolerated in the healthy subjects. The absence of PD findings may be attributed to the insufficient validation of the PD measurements.
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  Objective  To detect the basal metabolic rate (BMR) of Beijing adult residents who participate in light physical activity and to investigate the correlation of BMR with body composition.  Methods  Healthy adult residents in Beijing who participated in light physical activity were enrolled in this study. The BMR and body composition of the subjects were detected with indirect calorimetry and body composition analyzer, respectively. The difference between the detected BMR and the calculated BMR (based on Schofield equation) was compared. The correlation between BMR and body composition values was tested by the Pearson's method.  Results  Fifty-seven healthy subjects, including 30 males with a mean age of (26.87±7.33) years (19- 43 years) and 27 females with a mean age of (25.89±7.38) years (18- 43 years) were included in this study. The mean detected BMR value was (5259.62±715.55)kJ/d in males and (4114.55±804.33)kJ/d in females, which were significantly lower than those calculated using Schofield equation, (7113.72±539.95) kJ/d in males and (5428.24±361.46) kJ/d in females (both P < 0.0001). The measured BMR was positively correlated with the body weight, body mass index, fat mass, muscle mass, and fat free mass (all P < 0.05). The correlation of BMR to height was significant in male subjects (P=0.012), but not among the females (P=0.433).  Conclusions  The BMR of healthy residents in Beijing is lower than the currently recommended value based on the Schofield equation. The BMR is positively correlated with the body weight, body mass index, fat mass, muscle mass, and fat free mass.
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  Objective  To investigate the clinical features of patient with aortic aneurysm-associated chronic disseminated intravascular coagulation (AA-DIC).  Methods  The clinical data of 174 hospitalized patients from Peking Union Medical College Hospital who were diagnosed with aortic aneurysm from September 2009 to September 2011 were collected. The difference between aortic aneurysm patients with DIC (AA-DIC group) and those without DIC (non-DIC group) was compared.  Results  Among these 174 patients with aortic aneurysm, 37 cases (21.3%) were associated with chronic DIC, including 4 (2.3%) with typical DIC and 33 (19.0%) with non-typical DIC. Patients from AA-DIC group has a significantly longer course than those from the non-DIC group (P=0.041). Abdominal aortic aneurysm and true aneurysm were most common seen in both groups. The proportion of mural thrombus and the incidences of complications including atherosclerosis, hypertension, and diabetes in the AA-DIC group were significantly higher than those in the non-DIC group (all P < 0.01). Patients with non-typical DIC also had abnormal coagulation disorders of varying degrees. Heparin/low molecular weight heparin (LMWH) improved both the clinical symptoms and laboratory parameters of patients in the AA-DIC group.  Conclusions  Aortic aneurysm, especially abdominal aortic aneurysm, whether itself or in the perioperative period, can present as chronic DIC or coagulation disorders such as DIC. When patients with aortic aneurysm have a performance of mural thrombus formation or complicated with atherosclerosis, hypertension, or diabetes, they might appear chronic DIC. Aortic aneurysm should be considered when a patient shows manifestations of chronic DIC.
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  Objective  To analyze the recent use of moxifloxacin injection in a tertiary hospital in Beijing.  Methods  The use of moxifloxacin injection among inpatients in Peking Union Medical College Hospital in 2010 and the first quarter of 2011 was analyzed based on the hospital information system database. Meanwhile, the clinical records of 53 patients were reviewed for relevant data including medication purpose, dosage, and surgical procedures.  Results  Compared to the first quarter of 2010, the total usage of moxifloxacin injection increased by 5.15% and the preoperative prophylaxis usage by 20.51% in the first quarter of 2011. The individual consumption also showed a growing tendency(P=0.003). With the number of patients younger than 18 years increased from 2 in the first quarter of 2010 to 6 in the first quarter of 2011. Of 45 patients who had preoperatively received moxifloxacin, 39 (86.7%) were for prophylaxis purpose. Of 21 patients with infectious diseases, etiological inspection was performed in 11 patients (52.38%).  Conclusion  Moxifloxacin injection has been widely used in our hospital. However, its administration is not always rational, especially when applied for preoperative prophylaxis.
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  Objective  To describe the clinical, laboratory, and radiographic characteristics of antisynthetase syndrome (ASS) patients with anti-threonyl tRNA synthetase (anti-PL-7) antibody.  Methods  The clinical, laboratory, and radiographic data of five ASS cases with positive anti-PL-7 antibody hospitalized in Peking Union Medical College Hospital from August 2010 to December 2011 were retrospectively analyzed.  Results  All these five patients demonstrated myositis, including symmetrical proximal muscle weakness (4/5), increased serum creatine phosphokinase (5/5), myogenic damage on electromyography (4/5), and positive results on biopsy (3/3). Four patients met the classification criteria for polymyositis (PM), and one patient presented typical rash of dermatomyositis (DM). Four patients had fever at onset, and two patients showed inflammatory arthritis. None of these patients developed Raynaud phenomenon or mechanic hands. Four patients demonstrated a cytoplasmic pattern when testing for antinuclear antibodies by immunofluorescent assay, and all had anti-PL-7 antibodies. Three patients had positive anti-Ro-52 antibodies. All patients had evidence of interstitial lung disease (ILD) by clinical examination, imaging, or pulmonary function testing. Four patients presented dry cough, gradual dyspnea, and crackles at lung base. Three patients presented with a restrictive pulmonary pattern and impaired gas exchange. High-resolution computed tomography scan revealed (predominantly basilar) reticular and ground-glass opacities, accompanied by a loss of lung volume, traction bronchiectasis, and scattered (usually peribronchovascular) areas of consolidation. This distinct pattern is highly suggestive of ASS-related ILD. Patients were responsive to high-dose corticosteroid plus cyclophosphamide and/or methotrexate.  Conclusion  Anti-PL-7 antibody is closely associated with PM/DM with ILD, which may be accompanied with fever and arthritis. Treatment with high-dose glucocorticosteroid and immunosuppressants may result in good response.
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  Objective  To investigate the role of Bakri balloon insertion following unsuccessful medical management of postpartum haemorrhage (PPH).  Methods  The clinical features of patients with PPH managed with Bakri balloon in our department between January and July 2012 were retrospectively reviewed. The therapeutic role of Bakri balloon was analyzed.  Results  Eight cases were managed with Bakri balloon during the study period. Caesarean section (CS) was performed in all these cases, among whom seven were due to placenta previa. Two cases had disseminated intravascular coagulation (DIC). Three cases needed a second procedure to stop the bleeding, among whom two had placenta previa, previous CS, and placenta accreta. No patient experienced postpartum abdominal pain or fever.  Conclusions  Bakri balloon tamponade is effective and safe in the management of PPH unresponsive to standard management. Patients should be carefully monitored after the placement of Bakri balloon. Central placenta previa with a history of CS, placenta accreta or placenta adherence may impact the success of Bakri balloon placement.
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  Objective  To investigate the influence of artifacts produced by two types of implants and porcelain fused to metal crowns on magnetic resonance imaging (MRI).  Methods  Two types of implants (ITI and BLB) were separately attached on a volunteer's bilateral skins of the mandible on the first molars, then the Au-Pt alloy crown and Ni-Cr alloy crown with the same volume were fixed on the ITI and BLB implants, respectively. Before and after the fixation of the crowns, the artifacts produced by implants and crowns under coronal MRI were observed. The magnetic field intensity was 3.0T, and TSE/EPI sequence was used.  Results  Both the implants produced artifacts on the MRI. The areas of the artifacts produced by ITI and BLB implants were 2.7 cm2 and 4.0 cm2, respectively. After fixation of Au-Pt alloy crown and Ni-Cr alloy crown, the areas of artifacts became 4.9 cm2 and 7.3 cm2.  Conclusion  The artifacts produced by pure titanium implant and porcelain fused to noble metal crowns had smaller impacts on the MRI than those produced by BLB implant and Ni-Cr alloy crown.
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