Objective To evaluate the bioequivalence of lamivudine tenofovir tablets in Chinese healthy volunteers.Methods A randomized,open,single-dose,two-period,double-crossover drug trial design was conducted.24 subjects were randomly divided into two groups,and administered orally one tablet of test preparation or one tablet of each reference preparation per period under fasting and fed condition respectively.The concentrations of lamivudine and tenofovir in plasma were determined by HPLC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence was compared by non-compartment model of WinNonlin 7.0 program.Results The pharmacokinetic parameters of test and reference preparations after fasting oral administration:lamivudine Cmax were(2 777.74±702.55)and(2 985.00±979.23)ng·mL-1,AUC0-t were(11 977.14±2 550.67)and(12 450.22±2 336.41)ng·h·mL-1,AUC0-∞ were(12 177.69±2 526.02)and(12 660.98±2 333.30)ng·h·mL-1,respectively;tenofovir Cmax were(316.72±63.79)and(301.46±79.82)ng·mL-1,AUC0-t were(2 584.72±619.04)and(2 474.94±636.05)ng·h·mL-1,AUC0-∞ were(2 789.87±701.97)and(2 666.35±676.21)ng·h·mL-1,respectively.The pharmacokinetic parameters of test and reference preparations after fed oral administration:lamivudine Cmax were(2 079.46±583.92)and(2 084.28±517.59)ng·mL-1,AUC0-t were(10 628.86±1 751.63)and(10 573.70±2 059.54)ng·h·mL-1,AUC0-∞ were(10 827.86±1 734.39)and(10 791.93±2 098.91)ng·h·mL-1,respectively;tenofovir Cmax were(286.97±85.91)and(271.79±63.64)ng·mL-1,AUC0-t were(3 087.01±707.76)and(3 023.48±612.46)ng·h·mL-1,AUC0-∞ were(3 307.08±746.76)and(3 221.56±672.44)ng·h·mL-1,respectively.The statistical results of the 90％confidence intervals of the geometric mean ratios of Cmax,AUC0-t and AUC0-∞(test preparation/reference preparation)were all within the equivalent range of 80.00％-125.00％.Conclusion The test and reference preparations of lamivudine tenofovir tablets were bioequivalent in healthy Chinese subjects under fasting and fed conditions.

Processing of Chinese medicinals with vinegar is one of the characteristic processing techniques. Vinegar is vital for the quality of vinegar-processed decoction pieces. However, there have been no specified standards for adjuvants. Through consulting relevant literature and monographs, we comprehensively reviewed the historical evolution of processing with vinegar in records, selection and application of vinegar, and summarized the relevant standards and current status of vinegar as an adjuvant in China. According to the records in literature, vinegar is effective in activating blood, moving qi, dispersing blood stasis, removing toxin, promoting appetite, and nourishing the liver. Traditionally, rice vinegar is chosen in processing. Nowadays, the vinegar made from rice under solid-state fermentation should be chosen. At present, only food standards can be taken for reference for vinegar in the processing. Integrative and specific inspection indicators are lacking, so the standards for adjuvants need to be improved urgently. In addition, the inadequacy in quality control and management is also a major problem to be solved. Through literature research, we reviewed the historical evolution and research advance in vinegar to provide a reference for the standardization and further research of vinegar used in the Chinese medicinal processing.
Acetic Acid ; Adjuvants, Pharmaceutic ; Drugs, Chinese Herbal ; Oryza ; Quality Control

Tweety-homolog 1 (Ttyh1) is expressed in neural tissue and has been implicated in the generation of several brain diseases. However, its functional significance in pain processing is not understood. By disrupting the gene encoding Ttyh1, we found a loss of Ttyh1 in nociceptors and their central terminals in Ttyh1-deficient mice, along with a reduction in nociceptor excitability and synaptic transmission at identified synapses between nociceptors and spinal neurons projecting to the periaqueductal grey (PAG) in the basal state. More importantly, the peripheral inflammation-evoked nociceptor hyperexcitability and spinal synaptic potentiation recorded in spinal-PAG projection neurons were compromised in Ttyh1-deficient mice. Analysis of the paired-pulse ratio and miniature excitatory postsynaptic currents indicated a role of presynaptic Ttyh1 from spinal nociceptor terminals in the regulation of neurotransmitter release. Interfering with Ttyh1 specifically in nociceptors produces a comparable pain relief. Thus, in this study we demonstrated that Ttyh1 is a critical determinant of acute nociception and pain sensitization caused by peripheral inflammation.

Brain ; pathology ; Electroconvulsive Therapy ; adverse effects ; Humans ; Schizophrenia ; therapy

To characterize long-term nonprogressors (LTNPs) and viremia controllers (VCs), infected with HIV-1 through contaminated blood donation or transfusion between 1992 and 1996 in Henan, China. LTNPs and VCs were defined by CD4+T lymphocyte (CD4) count and viral load (VL). Of 29,294 patients infected with HIV-1 via contaminated blood donation or transfusion that had conducted for more than 20 years, 92 were LTNPs/VCs. There were 70 LTNPs (0.24%), 43 VCs (0.15%), and 48 LTNPs+VCs- (0.16%). VCs had a significantly lower CD4 nadir, compared to LTNPs and LTNPs+VCs-, and no significant differences for the highest VL and HIV-1 DNA. Cases P4 and P5 were LTNPs, while their VL reached approximately 4.3 log copies/mL. P6 was a VC, but with CD4 < 500 cells/μL constantly. Data from the LTNPs/VCs cohort provided valuable information, future research is needed.

BACKGROUNDThis study evaluated the efficacy of percutaneous nucleoplasty using coblation technique for the treatment of chronic nonspecific low back pain (LBP), after 5 years of follow-up.

METHODSFrom September 2004 to November 2006, 172 patients underwent percutaneous nucleoplasty for chronic LBP in our department. Forty-one of these patients were followed up for a mean period of 67 months. Nucleoplasty was performed at L3/4 in 1 patient; L4/5 in 25 patients; L5/S1 in 2 patients; L3/4 and L4/5 in 2 patients; L4/5 and L5/S1 in 7 patients; and L3/4, L4/5, and L5/S1 in 4 patients. Patients were assessed preoperatively and at 1 week, 1 year, 3 years, and 5 years postoperatively. Pain was graded using a 10-cm Visual Analogue Scale (VAS) and the percentage reduction in pain score was calculated at each postoperative time point. The Oswestry Disability Index (ODI) was used to assess disability-related to lumbar spine degeneration, and patient satisfaction was assessed using the modified MacNab criteria.

RESULTSThere were significant differences among the preoperative, 1-week postoperative, and 3-year postoperative VAS and ODI scores, but not between the 3- and 5-year postoperative scores. There were no significant differences in age, sex, or preoperative symptoms between patients with effective and ineffective treatment, but there were significant differences in the number of levels treated, Pfirrmann grade of intervertebral disc degeneration, and provocative discography findings between these two groups. Excellent or good patient satisfaction was achieved in 87.9% of patients after 1 week, 72.4% after 1 year, 67.7% after 3 years, and 63.4% at the last follow-up.

CONCLUSIONSAlthough previously published short- and medium-term outcomes after percutaneous nucleoplasty appeared to be satisfactory, our long-term follow-up results show a significant decline in patient satisfaction over time. Percutaneous nucleoplasty is a safe and simple technique, with therapeutic effectiveness for the treatment of chronic LBP in selected patients. The technique is minimally invasive and can be used as part of a stepwise treatment plan for chronic LBP.

Adolescent ; Adult ; Diskectomy, Percutaneous ; methods ; Female ; Humans ; Low Back Pain ; surgery ; Male ; Middle Aged ; Retrospective Studies ; Treatment Outcome ; Young Adult

Animals ; Cellular Reprogramming ; Dentate Gyrus ; cytology ; Fibroblasts ; cytology ; Mice ; Neural Stem Cells ; cytology ; transplantation ; Swine

Objective To understand the prevalence of drug resistance in AIDS patients who had been receiving HAART in a long run,in Shenqiu county,Henan province.Methods This crosssectional study included 120 HIV infected patients who began receiving ART (antiretroviral therapy) in 2003.Viral loads and CD4 +T cells counts were measured,and In-house drug resistance test was performed in VL ＞ 1000 copies/ml patients.Results 114 cases out of 120 patients had complete viral load data.Among them,33 cases having viral loads less than 50 copies/ml,and the remaining viral loads showed an average of lg (4.09 ± 1.10) copies/ml.The average of CD4+ T cell counts was (377 ±2 1 8) cells/ml,with 64 (53.3％) cases showing their CD4+ T cell counts higher than 350 cells/ml.In 67 patients,58 of them showed genotypic resistance,and 40 cases showed reverse transcriptase inhibitors (RTIs) resistance.The ratios of nucleoside reverse transcriptase inhibitors (NRTIs) and nonnucleoside reverse transcriptase inhibitors (NNRTIs) resistance were 53.4％ (31/58) and 67.2％ (39/58),respectively.There were no differences of drug resistance ratio in the three treatment programs.The highest drug resistance rates in NRTIs and NNRTIs were zidovudine,lamivudin,nevirapine.However,protease inhibitors (PIs) resistance variants were not found.Conclusion The prevalence of drug-resistant strains seemed to be high in Shenqiu country,Henan province.Long-term follow-up monitoring strategy should be developed to optimize the timely treatment programs.

BACKGROUNDTracheostomy should be considered to replace endotracheal intubation in patients requiring prolonged mechanical ventilation (MV). However, the optimal timing for tracheostomy is still a topic of debate. The present study aimed to investigate whether early percutaneous dilational tracheostomy (PDT) can reduce duration of MV, and to further verify whether early PDT can reduce sedative use, shorten intensive care unit (ICU) stay, decrease the incidence of ventilator associated pneumonia (VAP), and increase successful weaning and ICU discharge rate.

METHODSA prospective, randomized controlled trial was carried out in a surgical ICU from July 2008 to June 2011 in adult patients anticipated requiring prolonged MV via endotracheal intubation. Patients meeting the inclusion criteria were randomly assigned to the early PDT group or the late PDT group on day 3 of MV. The patients in the early PDT group were tracheostomized with PDT on day 3 of MV. The patients in the late PDT group were tracheostomized with PDT on day 15 of MV if they still needed MV. The primary endpoint was ventilator-free days at day 28 after randomization. The secondary endpoints were sedation-free days, ICU-free days, successful weaning and ICU discharge rate, and incidence of VAP at day 28 after randomization. The cumulative 60-day incidence of death after randomization was also analyzed.

RESULTSTotal 119 patients were randomized to either the early PDT group (n = 58) or the late PDT group (n = 61). The ventilator-free days was significantly increased in the early PDT group than in the late PDT group ((9.57 ± 5.64) vs. (7.38 ± 6.17) days, P < 0.05). The sedation-free days and ICU-free days were also significantly increased in the early PDT group than in the late PDT group (20.84 ± 2.35 vs. 17.05 ± 2.30 days, P < 0.05; and 8.0 (interquartile range (IQR): 5.0 - 12.0) vs. 3.0 (IQR: 0 - 12.0) days, P < 0.001 respectively). The successful weaning and ICU discharge rate was significantly higher in early PDT group than in late PDT group (74.1% vs. 55.7%, P < 0.05; and 67.2% vs. 47.5%, P < 0.05 respectively). VAP was observed in 17 patients (29.3%) in early PDT group and in 30 patients (49.2%) in late PDT group (P < 0.05). There was no significant difference between the two groups in the cumulative 60-day incidence of death after randomization (P = 0.949).

CONCLUSIONSThe early PDT resulted in more ventilator-free, sedation-free, and ICU-free days, higher successful weaning and ICU discharge rate, and lower incidence of VAP, but did not change the cumulative 60-day incidence of death in the patients' anticipated requiring prolonged mechanical ventilation.

Aged ; Aged, 80 and over ; Critical Illness ; Female ; Humans ; Male ; Middle Aged ; Respiration, Artificial ; Time Factors ; Tracheostomy ; methods

BACKGROUNDRisk factors that contribute to younger patients with lung cancer are still relatively unknown. The aim of this study was to compare the clinical characteristics, histological types, stages at diagnosis, treatment modalities and survival rates between young and old patients with lung cancer.

METHODSThe study was designed as a retrospective review of all lung cancer patients admitted to the Third Affiliated Hospital of Harbin Medical University from 1998 to 2008. Survival analyses using univariate and multivariate approaches were performed to compare the survival rates between different age groups and to discover potential prognostic factors.

RESULTSThis research included 3320 patients with primary lung cancer, of whom 626 (18.8%) were 45 years old or younger at the time of diagnosis. The percentage of smokers and the male to female ratios between the young and old patient groups were 51.27% vs. 70.6% (P < 0.001) and 1.99 vs. 2.13 (P = 0.4801), respectively. The young patient group had a higher incidence of adenocarcinoma and fewer surgeries. The 1-year, 3-year and 5-year survival rates in the young patient group were generally lower than those of the old patient group, with significant differences (P = 0.0232). The clinical stage of the tumor was a prognostic factor for both non-small cell lung cancer patients (P < 0.0001) and small cell lung cancer patients (P = 0.0002). Symptoms, diagnostic method, histology, smoking, treatment modality and body mass index were shown to have significant relationships with the survival of lung cancer patients (P < 0.05).

CONCLUSIONSPatients with lung cancer who are younger than 45 years old might have a significantly poorer prognosis than that of older patients. Symptoms, diagnosis method, histology, smoking, treatment modality and body mass index can be independent prognostic factors for lung cancer.

Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Female ; Humans ; Lung Neoplasms ; epidemiology ; Male ; Middle Aged ; Retrospective Studies ; Smoking ; Survival Rate ; Young Adult