Child ; China ; Humans ; Rheumatic Diseases

Objective To make suggestions for China's drug safety supervision through an introduction of the status of pharmacovigilance system in the United States (US).Methods Through legal research and document research,the author introduced and analyzed the current situation of pharmacovigilance system in the US from the organization and responsibilities of Food and Drug Administration,system of laws and regulations,risk management and evaluation methods of post-marketing drugs etc.Results The US has now established a relatively mature pharmacovigilance system.This system has a perfect drug safety supervision organization structure,a sound system of laws and regulations and a scientific evaluation system of drug risk management.Conclusion The relevant experience of the US can be learned by China,such as the communication & collaboration between pre-and post-market drug regulatory agencies,instillation of drug risk management and establishment of guidance for industry to promote the development and improvement of China's drug safety supervision.

Objective To investigate the emotional memory impairment in patients with primary insomnia (PI) and explore the neurobiological mechanisms underlying primary insomnia through emotional memory tasks involving different valance of emotional pictures.Methods Thirty patients with primary insomnia(PI group) and twenty healthy controls(HC group) were given emotional memory tasks using positive,neutral and negative valence images.The emotional memory was evaluated by the recognition of emotional pictures.Results Compared with healthy controls (positive (11.60±4.00) , neutral (11.05± 3.73) and negative (12.60± 2.06) , respectively), patients with PI (positive (11.30±3.75),neutral (11.47±3.21) and negative (11.43±4.12) ,respectively) showed no significant difference in appraisal of the emotional pictures (P＞0.05).Compared with healthy controls (43.40± 4.88) for the emotional images memorizing task,patients with PI (39.40±6.43) exhibited evident deficit of all emotional images (P＜0.05).Furthermore, the accuracy in recognizing both positive (12.60± 2.42) and neutral (12.87±3.18) valence pictures were significantly lower in patients with P1 than those in healthy controls(positive (14.05±2.19) and neutral (14.75± 1.80)) (P＜0.05).There was no significant difference in negative stimulus between PI group(13.93±1.76) and HC group(14.70±1.59) (P＞0.05).Conclusion The results suggest thant emotional memory is impaired in patients with PI.Moreover,the emotional memory for positive and neutral vanlence pictures is impaired but the emotional memory for negative is relatively spared in patients with primary insomnia.The results also indicate that impaired emotional memory with different valences may relate with distinct neuromechanisms.

AIM:To study alterations of cardiac sarcoplasmic reticulum (SR) function in vitamin D 3-induced calcium overload rats. METHODS: The Ca-overload rat models were prepared by vitamin D 3 plus nicotine. Cardiac SR was seperated by centrifuging. The measurement of SR Ca 2+ uptake and Ca 2+ release activities were preformed by the Millimore filtration technique. Specific SR [ 3H]-ryanodine binding capacity was measured by radioligand method. RESULTS: Compared with control,myocardial calcium content in calcium overload rats increased by 78%( P

Objective To explore the clinical value and typing characteristic of prenatal ultrasonography for fetal cystic adenomatoid malformation of the lung(CAML).Methods Ultrasonographic features and typing of fetal CAML in 41 cases detected by prenatal ultrasonography were analyzed retrospectively.All cases were followed up until to the induction of labor or birth.Results (1)Site of tumor: in the 41 cases,there were 22 cases on the left side,15 on the right side and 4 on bilateral.(2)Typing diagnosis of prenatal ultrasonography: three cases were CAML type Ⅰ,14 were type Ⅱ,and 24 cases were type Ⅲ.(3)Pathology diagnosis: thirty two cases were induced abortion.CAML was confirmed in 29 cases by autopsy and the classifications were consistent with the prenatal diagnosis of ultrasonography.Three pulmonary sequestration cases were prenatally misdiagnosed as CAML type Ⅲ by ultrasonography.(4)The other nine cases were followed up to birth.Three masses decreased gradually and then disappeared.Six newborns were confirmed as CAML by CT.Their typings were consistent with the postnatal diagnosis.(5)The diagnostic accuracy rate of prenatal ultrasonography for CAML was 92.7%(38/41).Its misdiagnostic rate was 7.3%(3/41).Conclusions Prenatal ultrasonography has a high accuracy rate for the diagnosis and classification of CAML and is the first choice to detect CAML early in pregnancy.It has an important clinical value.Pulmonary sequestration should be distinguished from CAML type Ⅲ because they tend to be confused.

Background Interleukin-17 (IL-17)is a potent pro-inflammatory cytokine and plays a pathogenic role in autoimmune disease.It was confirmed that IL-17 is implicated in allograft rejection of many transplanted organs.Recent studies have foensed on the effect of IL-17 antagonists on allograft rejection.Objective This study aimed to investigate the inhibitory effect of anti-mouse IL-17 monoclonal antibody (mAb) on corneal allograft rejection.Methods Twenty-five 8 to 10-week-old C57BL/6 mice and 50 BALB/c mice were collected.Donor cornea grafts with 2 mm diameter from 25 C57BL/6 mice was transplanted to 50 eye of BALB/c mice to establish a model of corneal transplantation.The recipients were randomized into 2 groups,and neutralizing mouse IL-17antibody or isotype control antibody was intraperitoneally injected immediately after transplantation for experimental treatment,respectively.Allografts were scored clinically at appropriate time points after treatment based on Plskova criteria,and ≥5 was confirmed as rejection.Infiltrating cells in corneal graft were detected qualitatively and quantitatively by immunohistochemistry and reverse transcription-PCR separately.The cytokine levels of T helper type 1 (Th1),Th2,and Th17 in recipients' spleen wer(c) analyzcd by ELISA.The use of the animals followed the Statement of ARVO.Results Compared with the isotype control antibody group,the survival of grafts was improved in the IL-17mAb group(P＜0.05).The levels of neutrophile granulocyte mRNA,CD4+ and CD8+ T lymphotes mRNA were 2.22±0.10,1.64±0.04 and 1.32±0.10 in the IL-17 mAb group,showing a significant decline in comparison with those of the isotype control antibody group(3.61 ±0.08,2.69±0.06 and 2.17±0.04) (P=0.000,0.000,0.000).Interferon-γ(IFN-γ),IL-12 p40 and IL-17 concentrations in recipients ' splenocytes were (529.80 ± 13.83) ng/L,(539.58 ±10.74) ng/L and(173.70±8.11)ng/L in the IL-17 mAb group,and thosc in the isotype control antibody group were (741.48± 10.51) ng/L,(1156.90 ± 69.93) ng/L and (366.13± 7.93) ng/L,with significant differences between them (P=0.000,0.001,0.000).Conclusions Neutralization IL-17 bioactivity inhibits mouse corneal allograft rejection to a certain extent.

Objective To investigate the diagnostic value of the recombinant surface antigen 1 (rSAG1) in immunodiagnosis of toxoplasmosis. Methods Isopropyl β-D- 1 -thio-galaetopyranoside (IPTG) was used to induce the expression of recombinant plasmid pET28a-SAG1 of Escherich coli(pET28a-SAG1/BL21 ). The expression products (rSAG1) of pET28a-SAG1/BL21 were identified by Western blotting. The serum of mice infected with Toxoplasma gondii tachyzoites, normal mouse serum and the serum from 10 toxoplasma gondii patients were used as primary anti-Toxoplasma gondii antibodies, and the rSAG1 gene products were identified by Western blotting, by which the diagnostic value of rSAG1 in Toxoplasmosis was compared. Results After induction and purification, rSAG1 protein was obtained and its relative molecular mass was 38.5 × 103. The fusion protein could be recognized by the serum of mouse infected with Toxoplasma gondii tachyzoites, rSAG1 of expression products of surface membrane antigen SAG1 gene from Toxoplasma Gondii could be detected in 4 cases from 10 patients by Westem blotting.Conclusion The rSAG1 has a potential value in the immunodiagnosis of Toxoplasmosis.

OBJECTIVETo investigate the best choice of operation opportunity and operation plan for limb fractures combined with severe craniocerebral trauma in children.

METHODSFrom January 2005 to July 2012,36 patients with limb fractures and severe craniocerebral trauma were received,including 24 males and 12 females aged from 1 to 13 years old (mean, 6.1 +/- 3.0). The time from injury to hospital was (18.0 +/- 15.0) h. Glasgow coma score were less than 8 with an average of 6.4 +/- 1.3. AIS-ISS score were 25.9 +/- 8.1. Thirteen patients were open fracture, 23 were closed fracture. Patients were divided into immediate operation group (21 patients) received fracture fixation with 24 h, the average time was (15.0 +/- 7.4) h, and delayed operation group (15 patients) received fracture fixation after 24 h, the average time was (165.4 +/- 114.6) h. All patients were treated by open reduction, and 33 cases by internal fixation, 3 cases were external fixation. Operative time, blood loss, fracture healing time and brain trauma,physical trauma, postoperative rehabilitation situation were observed and evaluated.

RESULTSAll patients were healed at stage I ,and no dead, aggravating of coma, disorders of breathing and circulation occurred during operation. Operative time,blood loss,healing time in immediate operation group was (44.5 +/- 25.3) min, (47.1 +/- 36.5) ml, (2.7 +/- 0.5) months, respectively; while in delayed operation group was (87.0 +/- 40.0) min, (112.7 +/- 67.5) ml, (3.8 +/- 1.2) months,respectively; and there were obvious differences between two groups. There was no siginificant meaning in Glasgow coma score and Fugl-Meyer motor function between immediate operation group (4.7 +/- 0.6, 97.9 +/- 2.7) and delayed operation group (4.7 +/- 0.5, 97.7 +/- 3.9) (t = 0.23, P > 0.05; t = 0.11, P > 0.05).

CONCLUSIONThe condition of limb fractures combined with severe craniocerebral trauma in children is seriously, comfortable surgical opportunity should according to particular case, and immediate operation can performed on the condition of stabled vital signs.

Adolescent ; Child ; Child, Preschool ; Craniocerebral Trauma ; surgery ; Extremities ; injuries ; surgery ; Female ; Follow-Up Studies ; Fracture Fixation ; Fracture Fixation, Internal ; Fractures, Open ; surgery ; Humans ; Infant ; Male

OBJECTIVETo establish a method for rapid identification of micro-constituents in monoammonium glycyrrhizinate by high-pressure solid phase extraction-high performance liquid chromatography-mass spectrometry.

METHODHPLC preparative chromatograph was adopted for determining the optimal method for high-pressure solid phase extraction under optimal conditions. 5C18-MS-II column (20.0 mm x 20.0 mm) was used as the extraction column, with 35% acetonitrile-acetic acid solution (pH 2. 20) as eluent at the speed of 16 mL x min(-1). The sample size was 0.5 mL, and the extraction cycle was 4.5 min. Then, extract liquid was analyzed by high performance liquid chromatography-mass spectrometry (HPLC-MS) after being concentrated by 100 times.

RESULTUnder the optimal condition of high-pressure solid phase extraction-high performance liquid chromatography-mass spectrometry, 10 components were rapidly identified from monoammonium glycyrrhizinate raw materials. Among them, the chemical structures of six micro-constituents were identified as 3-O-[beta-D-glucuronopyranosyl-beta-D-glucuronopyranosyl]-30-0-beta-D-apiopyranosylglycyrrhetic/3-O- [P-D-glucuronopyranosyl-beta-D-glucuronopyranosyl]-30-O-beta-D-arabinopyranosylglycyrrhetic, glycyrrhizic saponin F3, 22-hydroxyglycyrrhizin/18alpha-glycyrrhizic saponin G2, 3-O-[beta-D-rhamnopyranosyl]-24-hydroxyglycyrrhizin, glycyrrhizic saponin J2, and glycyrrhizic saponin B2 by MS(n) spectra analysis and reference to literatures. Four main chemical components were identified as glycyrrhizic saponin G2, 18beta-glycyrrhizic acid, uralglycyrrhizic saponin B and 18alpha-glycyrrhizic acid by liquid chromatography, MS(n) and ultraviolet spectra information and comparison with reference substances.

CONCLUSIONThe method can be used to identify chemical constituents in monoammonium glycyrrhizinate quickly and effectively, without any reference substance, which provides basis for quality control and safe application of monoammonium glycyrrhizinate-related products.

Chromatography, High Pressure Liquid ; methods ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Glycyrrhiza ; chemistry ; Glycyrrhizic Acid ; chemistry ; isolation & purification ; Mass Spectrometry ; methods ; Molecular Structure ; Solid Phase Extraction ; methods

Objective To investigate the effect of depression symptoms on surgical outcome of posterior decompression among cervical spondylotic myelopathy (CSM) patients. Methods Between October 2006 and October 2011 in our hospital, lami?nectomy or laminoplasty was performed in 396 cases that were enrolled in the study. There were 132 males and 264 females with an average age of 60.2 years(ranged,39-84 years). All patients were divided into depression group and non?depressed group by the 21?item Beck Depression Inventory (BDI). There were no statistically significant differences between groups in age, sex, smok?ing status, duration of symptoms, and employment status (whether in the current working). The Japanese Orthopedic Association (JOA) scores, Neck disability index (NDI) and visual analogue scale (VAS) were compared after 1.5 months postoperatively. Re?sults All of 396 cases were followed up. The mean follow up duration was 32 months (range,24-50 months). There were no statistically significant differences in the CCI decline (7.1%±2.1% versus 6.8%±1.5%), expansion degree[(130.9±7.0) mm2 versus (150.8 ± 5.2) mm2] and the drift?back distance of the spinal cord [(5.7 ± 1.2) mm versus (6.2 ± 0.8) mm]. However, pa?tients with continuous depression showed poorer improvement than non?depressed patients in the surgery outcome: JOA im?proved (1.42±0.56 versus 6.76±3.12); NDI declined (7.31±2.18 versus 21.11±11.36); and VAS lightened (16.08±19.76 versus 23.85±20.79). Conclusion Depression contributed a dissatisfied surgery outcome after posterior decompression on functional re?covery, disability index and pain scores among patients of the cervical spondylotic myelopathy.