Objective: To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis. Methods: An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs. Results: A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal. Conclusion Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

OBJECTIVE: To investigate the characteristics and regularity of ADR cases caused by leflunomide, and to provide reference for rational use of it. METHODS: Literatures about leflunomide-inducing ADR were retrieved from CNKI between 1994 and Apr. 2010. Those literatures were statistically analyzed in respect of patient’s age and gender, route of administration, dosage of drugs, onset time of ADR, organs and systems involved in ADR and its clinical manifestations, treatment and outcomes, etc. RESULTS: 37 pieces of literatures were obtained with standard cases of 45. The incidence of ADR cases in female(75.56%) was higher than in males (24.44%). 28 ADR cases were in 50～60 group. 39 patients were treated with leflunomide 10～30 mg once a day. After treatment, the most common gastrointestinal adverse events occurred in 1～15 d. Leflunomide-inducing ADR was digestive system reaction (75.56%) the most. Patients who took medicine less than 10 days with mild ADR need not to stop taking medicine when clinical symptoms reduced or disappeared after symptomatic treatment. Patients who took medicine more than 10 days with severe ADR need to stop taking medicine and receive symptomatic treatment. CONCLUSION: Clinical physicians should pay attention to rational use of leflunomide and ADR during treatment course to reduce the harm due to adverse events.

OBJECTIVE:To study the effects of clozapine on blood glucose and insulin levels in schizophrenic patients. METHODS:This is a self-controlled study in which the levels of blood glucose and insulin in clozapine group(n=63) were compared before and after treatment,and which were compared with the levels in the control group(n=64).Insular cellular antibody(ICA) and insulin autoantibody(IAA) were detected in patients with high level of blood glucose.RESULTS:After treatment for 8 weeks,the blood glucose level was increased in clozapine group as compared with the same group before treatment and the control group,showing significant differences(P

BACKGROUND: In patients with obstructive sleep apnea(OSA),the degree of severity of OSA is mostly related to the sleep time spent in the supine position. According to the apnea-hypopnea index(AHI), positional and n onpositional OSA has been distinguished.OBJECTIVE: To compare the clinical characteristics of positional and nonpositional OSA and investigatethe relationship between sleep position and respiratory function of patients with OSA.DESIGN: A comparative clinica] observation based on the OSA patients.SETTING: Center of Sleep Disorders,Nanjing General Hospital of Nanjing Military Area Command of Chinese PLA.PARTICIPANTS: From October 1998 to May 2002,225 patients were examined with overnight polysomnography in the Center of Sleep Disorders,Department of Respiratory Disease, Nanjing General Hospital of Nanjing Command. According to the inclusion criteria of ① AHI≥10 times/hour;② Sleep time in supine and lateral positions≥30 minutes; ③ Over 20years of age; 225 patients were selected from the total of 415 consecutive patients,including 63 with positional and 162 with nonpositional OSA.METHODS: All patients received overnight monitoring with HMS-5500polysomnography system(Respironics Inc USA) in the sleep laboratory. Queries for a detailed case history and physical examination were performed with the pulmonary functions evaluated with body p lethysmography. The clinical data and results of polysomnographic and pulmonary function tests were compared between the two groups of patients and a multiple stepwise regression analysis was employed to evaluate the determinant factors for sleep position dependence of the patients' condition.MAIN OUTCOME MEASURES: Main outcome: Comparisons of the clinical data,polysomnographic result and pulmonary function between the two groups. Secondary outcome: Correlation between classification of OSA and the clinical data.RESULTS: Totally 63 (28%) of the 225 OSA patients were identified as the positional type,who had significantly greater body mass index (BMI)then the nonpositional type patients [(43.46 ± 16.43) kg/m2 vs (23.90 ± 12.36) kg/m2,t =3. 977,P<0.01]. Except for sleeping time in lateral and supine positions, minimal SatO2 and basic SatO2 before the matching for BMI,all the other factors in polysomnograms of the two groups were significant different(P<0.05 or P<0.01). After BMI matching,all the measurements were identical to those recorded for the primary grouping with the exception of nocturnal limb movement frequency,which differed but insignificant between the two groups. The pulmonary function in the two groups was no significant difference(P>0.05) . Multiple stepwise regression analysis indicated that AHI and BMI were the two determinant factors for positional dependence of OSA with a predictive power of 26. 2%. Linear correlation analysis showed correlation of AHI and SatO2 with BMI in the whole group and nonpositional group(P<0.05 or P<0.01),but not in the positional group (P>0.05).CONCLUSION: About one-third of the OSA patients shows sleep position dependence,who may respond favorably to sleep position training. Sufficient patency can be retained in the upper airway of these patients to relieve respiratory obstruction during sleep and improve the respiratory function.

OBJECTIVE: To establish GC-MS method for the determination of the Menthol in inclusion complex of compound essential oil-? -cyclodextrin. METHODS: Menthol was determined with ion fragment peak ( M/Z=71) . The chromatographic column was DM-5 fused silica capillary column ( 0. 25mm? 30m) ; the internal standard was naphthol and the temperature programming was 80～ 180℃ . RESULTS: The calibration curves of Menthol were linear in the ranges of 1. 344～ 10. 752? g? mL-1( r=0. 999 8) and the average recovery was 97. 52% , RSD=1. 56% . CONCLUSION: The method is rapid, accurate and reproducible, and suitable for the quality control of the same kind of the preparation.

Objectives: To analyze the strategies of the diagnosis and treatment in patients with the pulmonary infection after renal transplantation. Methods: A retrospective analysis was made on 28 cases of pulmonary infections among 285 patients undergoing renal transplantation. Results: The morbidity of pulmonary infection was 9.82%(28/285). The majority pathogens of pulmonary infection in this study were pseudomonas, staphylococcus epidermidis, canadida and cytomegalovirus. Chest X ray was important in the diagnosis, but there was no specificity to determine the pathogens. The mortality in 28 pulmonary infection patients was 32.1%(9/28). Most of the patients suffered from pulmonary infection within 4 months after the operation, and the postoperative period from 2 months to 4 months was a high risk time window for death caused by pulmonary infections. Conclusions: The morbidity and mortality of pulmonary infections, especially severe pneumonia, in patients with renal transplantation, are higher than healthy people. Treatment following clinical epidemiology and strategy of microbiology play a very important role to reduce the mortality in those patients.

OBJECTIVETo study Chlamydia pneumoniae (C. pneumoniae) infection in 110 patients with respiratory tract infection admitted to our hospital from January to December 1995 in Nanjing.

METHODSSputum and throat swab specimens were taken and C. pneumoniae DNA was detected by using polymerase chain reaction (PCR) with the HM-1-HR-1 primer pair. At the same time, serum samples were taken and immunoglobulin G and M (IgG and IgM) fractions of antibodies to C. pneumoniae were studied by microimmunofluorescence test.

RESULTSPrevalence of specific IgG was 70% in patients with respiratory tract infection. Seventeen patients (15.5%) were serologically diagnosed as having recent C. pneumoniae infections and 12 patients (10.9%) had positive PCR in sputum and/or swab specimens. The total positive rate was 22.7% (25/110) detected by PCR combined with serological tests. Acute infection of C. pneumoniae was common in patients with asthma (57.1%), pneumonia (35.0%), COPD (25.9%) and bronchitis (25.0%). Clinical features between C. pneumoniae infection and non-C. pneumonia infection showed no significant differences.

CONCLUSIONSChlamydia pneumoniae is an important pathogen that causes infection of the human respiratory tract and attention should be drawn to this special illness.

Acute Disease ; Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Antibodies, Bacterial ; blood ; Chlamydophila pneumoniae ; genetics ; immunology ; DNA, Bacterial ; analysis ; Female ; Humans ; Immunoglobulin G ; blood ; Male ; Middle Aged ; Pneumonia, Bacterial ; blood ; microbiology ; Polymerase Chain Reaction

Objectives:To evaluate lung injury mechanism in SD rat with nitrogen dioxide(NO2) exposure. 　Methods:In the test-control study, pulmonary malondialdehyde(MDA),glutathione(GSH) and total-antioxidant content(T-AOC) were determined in 10 SD rats with long-term NO2 exposure,10 SD rats with short-term NO2 exposure and 10 SD rats with fresh air as control. 　Results: Pulmonary MDA content was increased and T-AOC was decreased significantly in SD rat exposed to NO2. Pulmonary GSH was decreased significantly in long-term NO2 exposure group as compared with short-term NO2 exposure group and control group. 　Conclusions: Imbalance between oxidant and antioxidant was an important mechanism in the pathogenesis of oxidizing lung injury in SD rat with NO2 exposure.