Objective To investigate the effects of early nasal intermittent positive pressure ventilation (NIPPV) compared with early continuous positive airway pressure (NCPAP) in low birth weight preterm infants with respiratory distress syndrome (RDS).Methods We performed a prospective,randomized controlled trial involving 364 low birth weight preterm infants with respiratory distress syndrome within 6 hours of birth.The infants were randomly assigned to NIPPV (n=188) or NCPAP (n=176) groups.Non invasive ventilation was initiated in the neonatal intensive care unit (NICU).The rate of mechanical intubation (within 3 days or 7 days),the use of pulmonary surfactant (PS),the rate of complications and mortality were compared between the two groups.Mann Whitney U,t and Chi-square tests were used for statistical analysis.Results The average time of invasive mechanical ventilation in NIPPV group were lower than that in NCPAP group[2.0 (1.0-4.0) d vs 7.0 (3.0-8.5) d,U=-3.457,P=0.001].The need for intubation and mechanical ventilation by day 3 and day 7 in the NIPPV group were less than those in the NCPAP group [day 3:4.8％ (9/188) vs 10.8％ (19/176),x2=4.621,P=0.032; day 7:9.0％ (17/188) vs 16.5％ (29/176),x2=4.551,P=0.033].In the NIPPV group,infants who got PS therapy was less than that in the NCPAP group [3.2％ (6/188) vs 8.5％ (15/176),x2=4.752,P=0.029].There was no significant difference in the fatality rate between the NIPPV and the NCPAP group [12.8％ (24/188) vs 10.8％ (19/176),P ＞ 0.05].There were no significant difference in the incidence of air leak,intracranial hemorrhage,periventricular leukomalacia,retinopathy of prematurity,necrotizing enterocolitis,patent ductus arteriosus,and bronchopulmonary dysplasia between the NIPPV group and the NCPAP group.Conclusion Among low birth weight prcterm infants with RDS,the early use of NIPPV reduces the need for PS,intubation and invasive ventilation compared with NCPAP.

OBJECTIVETo investigate the expression and significance of CD151 in pituitary adenomas.

METHODSThirty-six pituitary adenomas were collected immediately after surgery together with five normal pituitary tissue. Real time-PCR, Western blot and immunohistochemistry analysis were performed to detect the expression of CD151 mRNA and protein in thirty-six pituitary adenomases and five normal pituitary tissues.

RESULTSThe expression of CD151 in all pituitary adenomases was observed to be significantly higher than that in normal pituitary tissues by Western blot, real time PCR, and immunohistochemistry analysis (P < 0.01). The expression levels of protein and mRNA in invasive pituitary adenomas were much higher than those in non-invasive pituitary adenomas (P < 0.01).

CONCLUSIONThe results suggested that the expression of CD151 was closely correlated with malignant degree of pituitary adenomas, which indicated the expression of CD151 was intimately correlated with occurrence and development of pituitary adenomas. Detecting CD151 might be a vital index to predict prognosis of pituitary adenomas.

Adenoma ; metabolism ; Blotting, Western ; Humans ; Immunohistochemistry ; Pituitary Gland ; pathology ; Pituitary Neoplasms ; metabolism ; Prognosis ; RNA, Messenger ; Real-Time Polymerase Chain Reaction ; Tetraspanin 24 ; metabolism

OBJECTIVETo study the ECG features in children with dilated cardiomyopathy (DCM), and related factors for the occurrence of arrhythmia secondary to DCM.

METHODSData from 68 children with DCM from January 1998 to March 2011 were studied. The children were classified into three groups: severe arrhythmia (n=42), non-severe arrhythmia (n=20) and non-arrhythmia (n=6). Left ventricular end diastolic diameter (LVED), left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were compared.

RESULTSAbnormal ECG results were found in all of the 68 children with DCM. Sinus tachycardia (91%) and ectopic pulsatile (86%) were common. LVED in the severe arrhythmia group (74±6 mm) was greater than that in the non-severe arrhythmia group (65±4 mm; P<0.05) and non-arrhythmia group (61±3 mm; P<0.05). LVED in the non-severe arrhythmia group was also greater than that in the non-arrhythmia group (P<0.05). LVEF and LVFS in the severe arrhythmia group were (30±11)% and (22±4)%, respectively, which were lower than those in the non-severe arrhythmia group［(37±12)% and (28±5)%, respectively］and non-arrhythmia group［(45±9)% and (34±7)%, respectively］(P<0.05). There were also significant differences in the LVEF and LVFS between the non-severe arrhythmia and non-arrhythmia groups (P<0.05).

CONCLUSIONSThe common abnormal ECG findings are sinus tachycardia and ectopic pulsatile in children with DCM. Arrhythmia is one of the main clinical manifestations of DCM. The occurrence of arrhythmia is associated with the left ventricular size and heart function.

Adolescent ; Arrhythmias, Cardiac ; etiology ; Cardiomyopathy, Dilated ; complications ; physiopathology ; Child ; Child, Preschool ; Electrocardiography ; Female ; Humans ; Infant ; Male

The three-step dissolution experiment was established to investigate the in vitro release of budesonide colon-specific tablet and to elucidate the drug release mechanism by fitting to different mathematical models. The physiological parameters of stomach, small intestine and colon such as pH value, intestinal flora, specific organic enzyme, vermiculation and conveying time were mimicked to plot the in vitro dissolution, separately. Sample were taken at predetermined time intervals in 24 h and the accumulated drug releases were determined by using HPLC method. Drug release curves of the localization tablets were fitted to various mathematical models. It shows that no drug release was found in 2 h. About 5% release was determined after 6 h while 77.5% accumulated release was reached within 24 h. Drug release from the in house formulation fitted well into first-order model. The three-step dissolution method could be used to evaluate the colon-specific characteristics of budesonide colonic localization tablet. The drug release behavior of the localization tablet conforms to the drug release mechanisms of controlled porosity osmotic pump where osmotic pressure is the main driving force for controlled delivery of drugs.
Animals ; Anti-Inflammatory Agents ; administration & dosage ; pharmacokinetics ; Budesonide ; administration & dosage ; pharmacokinetics ; Colon ; metabolism ; Delayed-Action Preparations ; Drug Carriers ; Drug Compounding ; Drug Delivery Systems ; methods ; Excipients ; Hydrogen-Ion Concentration ; In Vitro Techniques ; Intestinal Secretions ; Models, Theoretical ; Rats ; Tablets

AIMTo study the erosion behaviour during dissolution of matrices using different molecular weight polyethylene oxide (PEO) as hydrophilic polymer.

METHODSPEO hydrophilic matrix tablets with no added drug and excipients were prepared by direct compression method. The erosion rates of matrices comprised of pure or blending PEO polymers were evaluated in distilled water at (37 +/- 0.5) degrees C with rotating rate of 50 r x min(-1). The relationship between PEO molecular weight and erosion rate of matrices was investigated by experimental and mathematical model methods.

RESULTSThe gravimetric erosion experimental results indicated that the power-law relationship which relates the polymer erosion rate and weight average molecular weight: k infinity (M(w)) -1.30 4 was proved to have great potential utility in predicting the degree of polymer erosion of matrices comprised of either intermediate molecular weight (97. 98 x 10(4) - 553. 36 x 10(4)) or blends of lower and higher molecular weight polymers. Based on the semiempirical equation for mass transfer rate: Jp = (fp < Dp > (2/3) v (-1/6) omega (1/2)) C(p,dis), a theoretical mathematic model was developed for describing the relationship between PEO erosion rate and PEO weight average molecular weight: Jp infinity M(-1.241), where the exponent of -1. 241 was very close to the exponent of - 1. 130 4 obtained from practical determination.

CONCLUSIONPEO was proved to be a good candidate of hydrophilic polymer and appeared to have great potential for controlled release applications. The mathematic model presented together with the utilization of the erosion behaviour discussed in our study could provide a guide line to predict the degree of polymer erosion for other intermediate polymer grades and / or mixture of the polymers utilized in this study, which could play an active role in designing PEO hydrophilic sustained delivery systems.

Delayed-Action Preparations ; chemistry ; Drug Carriers ; chemistry ; Drug Delivery Systems ; Drug Stability ; Excipients ; chemistry ; Molecular Weight ; Polyethylene Glycols ; administration & dosage ; chemistry ; Polymers ; Solubility ; Tablets ; Water

Hydroxycamptothecin (HCPT) loaded PEG modified nanostructured lipid carriers (HCPT-PEG-NLC) and nanostructured lipid carriers (HCPT-NLC) were prepared by melt emulsification and homogenization method. The morphology, particle size and encapsulation efficiency of them were investigated. HCPT concentrations in plasma, heart, liver, spleen, lung, kidney and ovary were determined after iv of HCPT injection, HCPT-PEG-NLC and HCPT-NLC in mice. The targeting indexes of HCPT-PEG-NLC and HCPT-NLC were calculated. The transmission electron microscope imaging showed that HCPT-PEG-NLC and HCPT-NLC exhibited a spherical shape. The particle sizes of them were (88.6 +/- 22.5) and (127.2 +/- 43.4) nm. The encapsulation efficiency were (90.51 +/- 3.29)% and (84.37 +/- 2.81)%, respectively. After iv injection into the tail vein of mice, HCPT plasma concentrations of HCPT-PEG-NLC and HCPT-NLC were higher than that of HCPT injection at each sampling time. They also showed longer elimination time in every tissue. HCPT-NLC accumulated in endothelial system (RES), Re and Ce of it in liver and spleen were significantly higher than HCPT-PEG-NLC. HPCT-PEG-NLC prolonged circulation time and increased bioavailability of HCPT. MRT and AUC0-24 h of it were 19.80 and 17.02 times higher than those of HCPT injection. It also significantly reduced phagocytosis of RES, and showed lung targeting effect (Re and Ce were 14.51 and 41.35). To summarize, HCPT-PEG-NLC could prolong the circulation time of HCPT in vivo, and had the lung targeting effect. It was a promising carrier to increase therapeutic effect of HCPT in treating lung cancer.
Animals ; Antineoplastic Agents, Phytogenic ; administration & dosage ; blood ; chemistry ; pharmacokinetics ; Biological Availability ; Camptothecin ; administration & dosage ; analogs & derivatives ; blood ; chemistry ; pharmacokinetics ; Delayed-Action Preparations ; Drug Delivery Systems ; Drug Stability ; Female ; Lipids ; chemistry ; Lung ; metabolism ; Mice ; Mononuclear Phagocyte System ; physiology ; Nanoparticles ; Particle Size ; Phagocytosis ; drug effects ; Polyethylene Glycols ; chemistry ; Tissue Distribution

Self-microemulsifying drug delivery systems (SMEDDS) were developed to overcome the problems of delivery and administration of piroxicam, a drug with low bioavailability and gastrointestinal irritation, The in vitro properties of it were assessed. The solubility of piroxicam in several oils and surfactants was determined, and the compatibility of various oils and surfactants was investigated. Ternary phase diagrams were constructed to optimal area of microemulsion, and the influence of different oily phases, surfactants and co-surfactants was studied. The droplet size and dissolution of optimal formulation were determined to prove that the dosage form is a useful delivery system for piroxicam. In the optimized piroxicam SMEDDS, cinnamic alcohol was selected that gave the maximal solubility to piroxicam. Labrafil M 1944CS, Cremophor EL and Transcotol P were used as oils, surfactant and co-surfactant, respectively. Droplet size and distribution of three piroxicam SMEDDS formulations were (32.2 +/- 5.0), (40.1 +/- 6.4), (81.9 +/- 12.2) nm individually. And the releasing of piroxicam was rapid and complete. The optimized SMEDDS for piroxicam was obtained.
Administration, Oral ; Drug Compounding ; methods ; Drug Delivery Systems ; Emulsions ; Glycerides ; chemistry ; Glycerol ; analogs & derivatives ; chemistry ; Particle Size ; Piroxicam ; chemistry ; Polyethylene Glycols ; chemistry ; Propanols ; chemistry ; Solubility ; Solvents ; chemistry ; Surface-Active Agents ; chemistry

A new type of floating osmotic pump of dipyridamole was designed in this paper. Apparatus three (Chinese Pharmacopeia 2005, appendix XD) was employed for in vitro dissolution test in order to evaluate the release and floating behavior in a same experiment. The system was optimized using central composite design-response surface methodology; where similarity factor (f2) between the dissolution profile of prepared formulation and the target dissolution profile was taken as dependent factor, usage amount of polyoxyethylene (X1, mg), NaCl (X2, mg) and pore former (PEG4000, X3, %) were taken as independent factors. The optimization model was f2 = -29.3 + 2.35X3 - 0.123X1(2) - 0.046X2(2) + 0.145X1X2 (R = 0.996). It was found that the dissolution profile could match the target dissolution profile under the condition of weight gain 8%-9%, X1 (20-34), X2 (30-57), X3 = 50. It is also found that the minimum usage percentage of pore former is 35.1%. The prediction results of the optimization model were good in the experiments.
Administration, Oral ; Delayed-Action Preparations ; Dipyridamole ; administration & dosage ; chemistry ; Drug Compounding ; methods ; Drug Delivery Systems ; Osmosis ; Osmotic Pressure ; Platelet Aggregation Inhibitors ; administration & dosage ; chemistry ; Polyethylene Glycols ; chemistry ; Sodium Chloride ; chemistry ; Solubility ; Surface Properties

AIMTo study the pharmacokinetics and bioequivalence of acipimox sustained-release tablets (SRT) after a single and multiple oral dose in healthy dogs.

METHODSThe plasma concentrations of of SRT and reference capsules with a single and multiple oral doses.

RESULTSThe drug concentration-time profiles fitted to a noncompartment model. After a single dose administration of sustained-release tablets and capsules, the pharmacokinetic parameters were as follows: AUC were (158 +/- 30) and (147 +/- 37) microg x h x mL(-1); Tmax were (4.3 +/- 0.8) and (2.6 +/- 1.3) h; Cmax were (29 +/- 6) and (42 +/- 10) microg x mL(-1); T(1/2) were (2.3 +/- 0.7) and (1.60 +/- 0.10) h; MRT were (6.0 +/- 0.8) and (3.9 +/- 0.7) h, respectively. The relative bioavailability of the sustained-release tablet was (108 +/- 16) %. After a multiple oral administration of sustained-release tablets and capsules, the pharmacokinetic parameters were as follows: AUC were (209 +/- 23) and (195 +/- 26) microg x h x mL(-1); Tmax were (6.3 +/- 0.8) and (3.4 +/- 1.5) h; Cmax were (27 +/- 4) and (36 +/- 5) microg x mL(-1); Cmmin were (2.2 +/- 1.0) and (0.20 +/- 0.20) microg x mL(-1); Cav were (8.7 +/- 1.0) and (8.1 +/- 1.1) micro x mL(-1); FI were (293 +/- 73) % and (448 +/- 91) % , respectively. The relative bioavailability of the sustained-release tablet was (114 +/- 19) %.

CONCLUSIONThe results of two one-side test from single dose administration shown that two preparations were bioequivalent. The Cmax of sustained-release tablet was lower than that of capsules, while the Tmax and MRT of sustained-release tablet were higher than that of capsule, which indicating a good retarding effect. The results from multiple dose administration also shown that two preparations were bioequivalent and the DF of sustained-release tablet was significant lower than that of capsule.

Administration, Oral ; Animals ; Area Under Curve ; Biological Availability ; Capsules ; Delayed-Action Preparations ; Dogs ; Dose-Response Relationship, Drug ; Hypolipidemic Agents ; administration & dosage ; pharmacokinetics ; Pyrazines ; administration & dosage ; pharmacokinetics ; Random Allocation ; Tablets ; Therapeutic Equivalency

Pure and drug hydrophilic matrix tablets were prepared by direct compression method with theophylline as a model drug. The characteristics of four hydrophilic matrix polymers, hydroxypropylmethylcellulose (HPMC), polyethylene oxide (PEO), sodium alginate (NaAlg) and xanthan gum (XG), were compared by investigating the water absorption, swelling, erosion and gel layer strength. The sequence of water absorption rate was XG > NaAlg (H) > PEO > NaAlg (L) > HPMC; The sequence of swelling index was XG > PEO > HPMC > NaAlg; The sequence of erosion rate was NaAlg (L) > NaAlg (H) > PEO80 > PEO200 > PEO300 > XG approximately PEO400 approximately K4M > K15M > PEO600 approximately K100M; The sequence of the gel layer strength was PEO > HPMC > XG > NaAlg. For the PEO and HPMC matrix tablets, with the polymer molecular weight increased, the drug release mechanism was gradually transferred from mainly depending on the erosion to the diffusion; for SAL matrix tablets, the drug release mainly depends on erosion mechanism; and for XG matrix tablets, the drug release mainly depends on non-Fick diffusion mechanism. Comparison of the performance difference between the polymer materials will contribute to rational design and prediction of drug release behaviors from matrix tables and ultimately to achieve clinical needs.
Alginates ; chemistry ; Bronchodilator Agents ; administration & dosage ; Delayed-Action Preparations ; Drug Carriers ; Drug Compounding ; Drug Delivery Systems ; Excipients ; chemistry ; Glucuronic Acid ; chemistry ; Hexuronic Acids ; chemistry ; Hypromellose Derivatives ; Methylcellulose ; analogs & derivatives ; chemistry ; Molecular Weight ; Polyethylene Glycols ; chemistry ; Polymers ; chemistry ; Polysaccharides, Bacterial ; chemistry ; Tablets ; Theophylline ; administration & dosage ; Water