To develop a LC-MS/MS method for the determination of five kinds of trace ginkgolic acids in diterpene ginkgolides meglumine injection materials, the column was Agilent ZORBAX Eclipse plus C18 (3.0 mm x 50 mm, 1.8 µm), and the mobile phase consisted of methanol-water (containing 0.2% formic acid) (95:5) at a flow rate of 0.5 mL · min(-1). The multiple reaction ion monitoring (MRM) with an ESI interface in the negative ion mode was selected. The results showed that the linear ranges of five kinds of ginkgolic acids were in the range of 0.2-36.0 µg · L(-1) (r ≥ 0.999 5). The lowest limit of quantification (LOQ) of ginkgo acid C13: 0, C15:1, C17:2, C15:0 and C17:1 were 0.18, 0.18, 0.21, 0.10 and 0.20 µg · L(-1), respectively. The average recovery was between 73.28% and 87.56%, and the average content of total ginkgolic acids in three batches of samples was in the range of 0.023-0.028 µg · g(-1), which was much lower than 2 µg · g(-1) prescribed in drug registration standards. This method is simple and rapid with high sensitivity, which can be used for the determination of five kinds of trace ginkgolic acids in diterpene ginkgolides meglumine injection materials.
Chromatography, Liquid ; methods ; Ginkgolides ; analysis ; Injections ; Limit of Detection ; Salicylates ; analysis ; Tandem Mass Spectrometry ; methods

Andrographolide total ester sulfonate (ATES) injection is one of the products of traditional Chinese medicine (TCM) currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-word clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86％ were contraindicated.Irregular medication of adults and children accounted for 1.91％ and 23.38％,respectively.Improper choice of solvent accounted for 3.18％.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events (AEs) was observed in the monitoring period,and the incidence of adverse drug reaction (ADR) of ATES injection was 0.12％.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.

The changes of microRNA expression in rat hippocampus after traumatic brain injury (TBI) were explored. Adult SD rats received a single controlled cortical impact injury, and the ipsilateral hippocampus was harvested for the subsequent microarray assay at three time points after TBI: 1st day, 3rd day and 5th day, respectively. We characterized the microRNA expression profile in rat hippocampus using the microRNA microarray analysis, and further verified microarray results of miR-142-3p and miR-221 using quantitative real-time PCR. Totally 205 microRNAs were identified and up-/down-regulated more than 1.5 times. There were significant changes in 17 microRNAs at all three time points post-TBI. The quantitative real-time PCR results of miR-142-3p and miR-221 indicated good consistency with the results of the microarray method. MicroRNAs altered at different time points post-TBI. MiR-142-3p and miR-221 may be used as potentially biological markers for TBI assessment in forensic practice.

Objective To analyze the Product-Specific Guidances(PSGs)for generic drugs published by the Food and Drug Administration(FDA),and study the evaluation logic for generic drugs.Methods By querying the official website of the FDA,we collected 2 032 generic PSGs published as of August 31,2022,identified the specific product's active ingredient,dosage forms,administration routes,recommended bioequivalence(BE)research requirements,and research methods,analyzed the FDA's different evaluation requirements for generic products with different administration routes,dosage forms,and complexity levels.Results and Conclusion This article proposed the evaluation logic of Generic Drugs.That is,the evaluation process of generic drugs is based on product characteristics,risk control through scientific comparative tests with reference preparations,and the process of reducing residual risk to an acceptable level.

Objective To discuss characteristics of height growth such as Peak Height Velocity (PHV) and Age at Peak Height Velocity (PHA) during adolescence,and to compare the results with other research findings.Methods Primary and middle school students' annual physical examination data of Zhongshan in 2005-2010 was used.The height velocity by age,PHV,PHA,height velocity by PHA were calculated.Results The average peak height velocity boys was ( 10.03 ± 1.67 ) cm/yr.and that of the girls was ( 8.39 ± 1.05 ) cm/yr.Both findings were close to the results from previous similar findings.The average age at which peak height velocity reached 12.28± 1.30 years for boys and 10.78 ± 1.04 years for girls,both lower than the previous findings.The correlation coefficients,between height level and PHA were -0.357 (P＜0.001) for boys and -0.338 (P＜0.001) for girls.Conclusion The height levels were positively related to the height velocity before PHA.The Zhongshan students' PHA was lower than the Beijing,Shanghai and Shenyang students,also lower than American and Britain students',but their PHVs were similar.

OBJECTIVETo evaluate the efficacy and safety of antifungal prophylaxis of itraconazole in patients with acute myeloid leukemia (AML) to probe the relationship of the antifungal effect and the adverse events with serum concentration.

METHODSFrom April 2009 to May 2011, a total of 310 courses from 112 patients referred to our institute were enrolled in this study; of them, 297 courses were eligible for analysis. Eligible cases were randomized into oral group and injection/oral group according to different chemotherapy of induction and consolidation. Blood samples were collected at different time points for measurements of serum itraconazole levels. The morbidity of IFI and the adverse events were analyzed.

RESULTSThe morbidities of IFI in injection/oral and oral groups were 10.1% and 20.9%, respectively (P=0.010). 7 and 9 cases in injection/oral and oral groups, respectively were withdrawn from the study because of adverse events, and the difference between these two groups was of no significance. Serum itraconazole levels of injection/oral and oral groups were 672(299-1097) μg/L and 534(210-936) μg/L, respectively (P<0.01).

CONCLUSIONAntifungal prophylaxis with itraconazole in AML patients was effective and safe. Prophylactic effect with injection/oral itraconazole was superior to oral itraconazole solution; moreover, prophylactic effect of itraconazole was highly correlated with its serum level.

Adolescent ; Adult ; Antibiotic Prophylaxis ; Antifungal Agents ; therapeutic use ; Female ; Humans ; Itraconazole ; blood ; therapeutic use ; Leukemia, Myeloid, Acute ; drug therapy ; microbiology ; Male ; Middle Aged ; Mycoses ; etiology ; prevention & control ; Young Adult

OBJECTIVETo explore the incidence, pathogenesis, risk factors, prophylaxis and treatment of acute kidney injury (AKI) after myeloablative allogeneic hematopoietic stem cell transplantation (allo-HSCT).

METHODSClinical data of 120 patients received myeloablative allo-HSCT were retrospectively analyzed.

RESULTSSerum creatinine level in the patients showed significantly higher than baseline value at 28-60 days after transplantation (P<0.05). 73 patients (60.8%) developed AKI at a median of 33 days after allo-HSCT, including grade 2 in 32 patients (26.7%). Patients with grade 1 AKI showed significant higher serum cyclosporine A (CsA) levels (P<0.05). Hepatic veno-occlusive disease( HVOD), acute graft-versus-host disease (aGVHD) and total bilirubin > 40 micromol/L were high risk factors of occurring AKI (P<0.05). 19 patients died within 100 days after allo-HSCT, grade 2 AKI was a high risk factor of mortality (P< 0.05). 180-day survival rate was significantly lower in patients with grade 2 AKI after allo-HSCT (P<0.05).

CONCLUSIONAKI is one of the major complications after myeloablative allo-HSCT. Prophylaxis and treatment of AKI might reduce mortality in early stage of transplantation.

Acute Kidney Injury ; etiology ; prevention & control ; Adolescent ; Adult ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Middle Aged ; Postoperative Complications ; prevention & control ; Retrospective Studies ; Risk Factors ; Transplantation Conditioning ; Transplantation, Homologous ; Young Adult

OBJECTIVETo investigate the risk factors of intestinal acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

METHODSThe clinical data of 534 cases of 533 patients undergoing allo-HSCT during Jan 2004 and Sep 2012 were retrospectively analyzed. The effects of donor-recipient HLA mismatching, recipient age, donor age, donor-recipient sex combination, donor-recipient relationship, HSC source, conditioning regimen with or without total body irradiation (TBI) and HLA loci on intestinal aGVHD with different severity were analyzed by Logistic regression.

RESULTSIntestinal aGVHD occurred in 123(23.0%) cases, with 86(16.1%) cases of stage 1 intestinal aGVHD(16.1%) and 37(6.9%) cases of stage 2 to 4 intestinal aGVHD. Multivariate analysis showed that donor-recipient HLA mismatching (OR=2.519, P=0.002), increasing donor age (OR=1.034, P=0.003), female donor for male recipient (OR=1.855, P=0.007) were risk factors for intestinal aGVHD, HLA-B38 (OR=0.256, P=0.032) was its protective factor. Donor-recipient HLA mismatching (OR=2.799, P=0.011), increasing donor age (OR=1.045, P=0.012), HLA-A1 (OR=4.157, P=0.002), A30 (OR=3.143, P=0.005) were risk factors for stage 2 to 4 intestinal aGVHD.

CONCLUSIONOccurrence of intestinal aGVHD and its severity are associated with donor-recipient HLA mismatching, donor age, donor-recipient sex relationships and some HLA loci.

Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Graft vs Host Disease ; epidemiology ; Hematopoietic Stem Cell Transplantation ; adverse effects ; Humans ; Intestinal Diseases ; epidemiology ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Tissue Donors ; Transplantation, Homologous ; adverse effects ; Young Adult

OBJECTIVECervical vertebra semidislocation was one of major pathological aspects of cervical spondylosis, and it was also the target of manipulation to treat cervical spondylosis. The aim of this study was to combine the technology of three dimensional finite element analysis to investigate the method to construct the cervical vertebra semidislocation model.

METHODSA cervical spondylosis patient (male, 28 years old,176 cm tall, weight 69 kg) was randomly chosen, who was diagnosed cervical vertebra semidislocation by dynamic and static palpation and X-ray,and CT scanned from C1 to C7 by 0.75 mm slice thickness. Based on the CT data, the software was used to construct the three dimensional finite element model of cervical vertebra semidislocation (C4-C6).

RESULTSThe model showed the three dimensional changes of vertebra semidislocation clearly. C5 had a three-dimensional abnormal position, which was downward translation for 0.9 mm and clockwise rotation for 4.5 degrees around X-axis. So C5 was diagnosed as hypokinesis-type semidislocation.

CONCLUSIONThe method to construct the three dimensional finite element model of cervical vertebra semidislocation is reliable, which provide a base study to analyse the mechanism of manipulation to treat vertebra semidislocation.

Adult ; Cervical Vertebrae ; Finite Element Analysis ; Humans ; Image Processing, Computer-Assisted ; Internet ; Joint Dislocations ; complications ; diagnostic imaging ; Male ; Models, Anatomic ; Spondylosis ; complications ; Tomography, X-Ray Computed

Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Hematopoietic Stem Cell Transplantation ; adverse effects ; Hepatic Veno-Occlusive Disease ; etiology ; Humans ; Male ; Middle Aged ; Young Adult