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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.
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Objective To detect and analyze the haemagglutinin (HA) gene of the first influenza A-H1N1 viral strain isolated in Guangdong Province during an influenza A pandemic in 2009.Methods A-H1N1 virus strain was isolated from the throat swab of the first patient diagnosed with A-H1N1 virus infection in Guangdong Province in 2009. Viral nucleonic acid was extracted from supernatant of cell culture and amplified using reverse transcriptase-polymerase chain reaction (RT-PCR) with HA gene-specific primers. The product was cloned, sequenced, and the homology was analyzed. Results A 1710 bp HA gene of the first influenza A-H1N1 viral strain in Guangdong Province in 2009 was acquired, which was named as A/GuangzhouSB/01/2009 (H1N1) HA with GenBank access No. GQ268003. The homology of the studied HA gene and the 277 influenza A (H1N1) isolates reported in the epidemic areas was 99.0%-99.8%, and as high as 99.8% when compared with the isolates reported in the United States where the patient had traveled. When the studied HA gene was compared with 25 isolates of Chinese seasonal A-H1N1 virus, the homology was 72.3%-85.6%. Conclusions The homology of the first isolated A-H1N1 viral strain in Guangdong Province in 2009 and epidemic influenza A-H1N1 virus is high, while it is low compared with Chinese seasonal A-H1N1 virus.
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OBJECTIVE To explore the effect of the measures of protection and control of nosocomial infection in the period of H1N1 Influenza prevalence.METHODS Established emergency plan and concrete working procedure,enhanced training.Strictly disinfection and isolation and personal protection,supervising and checking were carried out.RESULTS No nosocomial infection happened in our hospital in the diagnosis and treatment of H1N1 Influenza.CONCLUSIONS Carried out general measures of protection and management are the key to provent nosocomial infection.
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Objective To investigate the effect of glucocorticosteroids on pulmonary oxygenation function in severe acute respiratory syndrome(SARS)patients.Methods Two hundred and twenty-five SARS patients in 2003 were analyzed retrospectively.Oxygenation index(OI)was considered as the marker of glucocorticosteroids therapeutic effects.The criteria of effectiveness was that OI increased 20%or more than pre-treatment.The therapeutic effects of glueocorticosteroids were analyzed by analysis of variance and chi-square test.Results Glucocorticosteroids were used in 59.6%(134/225)of SARS cases.The average OI before and after glucocorticosteroids intravenous treatment was 237.08 mm Hg and 335.08 mm Hg,respectively.The average OI increased 110.26 mm Hg(46.4%)after treatment.In 96 SARS patients whose blood gas analysis results were available,85 cases(88.5%)had administrative indication.The average OI increased 103.14 mm Hg(44.4%),which was lower than 190.91 mm Hg(66.8 0A)in patients without administrative indication.There was no significant difference between these two groups of patients.The OI difference before and after glueocorticosteroids treatment was decreased with the increasing OI before treatment,the increase was minimum in patients with OI≥300 mm Hg.Conclusions The SARS patients could obtain pulmonary symptoms and function improvements with appropriate glucoconicosteroids treatment,especially for those who are in accord with acute lung injure or acute respiratory distress syndrome,and OI less than 300 mm Hg before treatment.
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OBJECTIVE To investigate and analyze the antibiotic usage in infectious disease hospital,and offer(scientific) rule for antibiotic usage.METHODS The retrospective investigation of antibiotics usage in 1991 in-(patients) from Sep 2004 to Mar 2005 was carried out.RESULTS From 1991 patients,909 patients used antibiotics,percentage of antibiotic usage was 45.7%;66.7% patients used one antibiotic,28.6% patients used twice,(4.73%) used triple.From them 29.3% were used for prevention,and 70.85% for treatment;of all the unsuitable use,widen range of the indication,longer(usage),changing frequently,etc were the main causes.CONCLUSIONS Unsuitable usage of antibiotics could be found in our hospital.It is necessary for hospital to strengthen the (management) of antibiotic usage in inpatients.
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<p><b>OBJECTIVE</b>To investigate the changes of subgroups of peripheral blood T lymphocytes in patients with severe acute respiratory syndrome (SARS) and its clinical significance.</p><p><b>METHODS</b>Subgroups of blood T lymphocytes in 93 patients with SARS were detected by flow cytometer. The results detected in 64 normal subjects and 50 patients with AIDS served as controls.</p><p><b>RESULTS</b>The numbers of CD(3)(+), CD(4)(+), and CD(8)(+) lymphocytes all significantly decreased in acute phase of patients with SARS [(722 +/- 533)/microliter, (438 +/- 353)/microliter, (307 +/- 217)/microliter] compared with those in normal controls [(1527 +/- 470)/microliter, (787 +/- 257)/microliter, (633 +/- 280)/microliter, all P <0.01], which was different from what we observed in patients with AIDS who had decreased CD(4)(+) [(296 +/- 298)/microliter] but increased CD(8)(+) [(818 +/- 566)/microliter] counts. The counts of CD(3)(+), CD(4)(+), and CD(8)(+) lymphocytes decreased more apparently in patients with severe SARS. All the five patients who died had CD(4)(+) counts less than 200/microliter. As the patients' condition improved, CD(3)(+), CD(4)(+), and CD(8)(+) counts gradually returned to normal ranges.</p><p><b>CONCLUSION</b>The damage of cellular immunity is probably an important mechanism of pathogenesis of SARS.</p>
Subject(s)
Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Acquired Immunodeficiency Syndrome , Allergy and Immunology , Leukocyte Count , Severe Acute Respiratory Syndrome , Allergy and Immunology , T-Lymphocyte Subsets , Allergy and ImmunologyABSTRACT
<p><b>OBJECTIVE</b>To study the chest X-ray image features of patients with severe SARS.</p><p><b>METHODS</b>Chest X-ray image features in 36 patients with severe SARS were retrospectively analyzed. The image characteristics were compared with those of 224 patients with common SARS.</p><p><b>RESULTS</b>The important chest X-ray imaging features of 36 patients with severe SARS included small patch of infiltration (n = 27, 75.0%), large patch of infiltration (n = 22, 61.1%), large area of lung consolidation (n = 10, 27.3%), interstitial lung lesion (n = 26, 72.2%), ground-glass shadow (n = 28, 77.8%), irregular linear opacity (n = 15, 41.7%), diffuse lung lesion (n = 12, 33.3%), with single lung involved (n = 9, 25.0%), and both lungs involved (n = 32, 88.9%). The rates of large patch of infiltration, large area of lung consolidation, ground-glass shadow, diffuse lung lesion and involvement of both lungs in patients with severe SARS were significantly higher than those in patients with common type of SARS (all P < 0.01). Out of the 11 severe SARS patients who died, nine had large area of ground-glass shadow with air bronchogram in both lungs before death.</p><p><b>CONCLUSIONS</b>Large patch of infiltration, large area of consolidation, ground-glass shadow, diffuse lung lesion and involvement of both lungs were the main X-ray image characteristics of patients with severe SARS. Large area of ground-glass shadow with air bronchogram in both lungs indicated a bad prognosis.</p>