Serum HBV DNA level at week 12 is superior to viral response at week 24 in predicting long-term treatment outcome of telbivudine for chronic hepatitis B patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Telbivudine, one of the five nucleos(t)ide antiviral drugs, was reported to be superior to lamivudine in a better biochemical, virological, and histological response for treatment-naive patients in the GLOBE trial. The aim of this study was to determine the antiviral potency, viral resistance, and the signifcance of early response for long-term telbivudine treatment.</p><p><b>METHODS</b>We recruited 161 patients of chronic hepatitis B (CHB) on telbivudine between January 2009 and September 2011 in Macau, China. The serum hepatitis B virus DNA levels, hepatitis B e antigen (HBeAg) seroconversion, alanine aminotransferase (ALT) normalization, and viral resistance were analyzed.</p><p><b>RESULTS</b>The median age and follow-up duration were 48 years and 16.9 months. All patients were followed up for at least 6 months, while data were collected for 132, 120, 95, and 53 patients at 12, 24, 48, and 96 weeks respectively. The cumulative HBeAg seroconversion rate was 20.8% and only three patients (1.9%) presented with telbivudine low level resistance. The ALT normalization rates were 76.9% at 48 weeks and 77.6% at 96 weeks. Undetectable HBV DNA was achieved by 1.8%, 31.6%, 60%, and 74.1% in HBeAg positive patients and 29.3%, 60.3%, 84%, and 84.6% in HBeAg negative patients at each time point. Week 12 HBV DNA level < 1000 copies/ml (< 200 IU/ml) was a better predictor of viral suppression at 2-year follow-up (P = 0.001, OR = 27.00) than undetectable HBV DNA level at week 24 (P = 0.120, OR = 4.81).</p><p><b>CONCLUSIONS</b>Two-year telbivudine treatment yielded high rates of viral suppression and ALT normalization. Serum HBV DNA level at week 12 is a superior predictor for long-term viral suppression.</p>

Steady-state pharmacokinetics of zidovudine in Chinese HIV-infected patients / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The pharmacokinetics of zidovudine (AZT) are possibly influenced by weight, age, sex, liver and renal functions, severity of disease, and ethnicity. Currently, little information is available on the steady-state pharmacokinetics of AZT in Chinese HIV-infected patients. The current study aimed to characterize the steady-state pharmacokinetics of AZT in a Chinese set-up.</p><p><b>METHODS</b>Eleven Chinese HIV-infected patients were involved in the steady-state pharmacokinetic study. In total, 300 mg of AZT, as a part of combination therapy, was given to patients, and serial blood samples were collected for 12 hours. The samples were measured by a high-performance liquid chromatography (HPLC) assay, and the results were analyzed by both the non-compartment model and the one-compartment model.</p><p><b>RESULTS</b>The C(max) of AZT in Chinese patients was higher than that in non-Asian patients. The half-life of AZT, analyzed by the non-compartment model (P = 0.02), in male patients ((1.02 ± 0.22) hours) was shorter than that of AZT in female patients ((1.55 ± 0.29) hours). The AZT clearance, analyzed by the one-compartment model (P = 0.045), in male patients ((262.60 ± 28.13) L/h) was higher than that in female patients ((195.85 ± 60.51) L/h).</p><p><b>CONCLUSION</b>The present study provides valuable information for the clinical practice of AZT-based highly active antiretroviral therapy in a Chinese set-up.</p>

Impact of baseline CD4(+) T cell counts on the efficacy of nevirapine-based highly active antiretroviral therapy in Chinese HIV/AIDS patients: a prospective, multicentric study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>CD4(+) T cell counts have been used as the indicator of human immunodeficiency virus type 1 (HIV-1) disease progression and thereby to determine when to start highly active antiretroviral therapy (HAART). Whether and how the baseline CD4(+) T cell count affects the immunological and viral responses or adverse reactions to nevirapine (NVP)-containing HAART in Chinese HIV-1 infected adults remain to be characterized.</p><p><b>METHODS</b>One hundred and ninety-eight HIV-seropositive antiretroviral therapy (ART)-naive subjects were enrolled into a prospective study from 2005 to 2007. Data were analyzed by groups based on baseline CD4(+) T cell counts either between 100 - 200 cells/microl or 201 - 350 cells/microl. Viral responses, immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 52, 68, 84, 100.</p><p><b>RESULTS</b>Eighty-six and 112 subjects ranged their CD4(+) T cell counts 100 - 200 cells/microl and 201 - 350 cells/microl, respectively. The pre-HAART viral load in CD4 201 - 350 cells/microl group was significantly lower than that in CD4 100 - 200 cells/microl group (P = 0.000). After treatment, no significant differences were observed between these two groups either in the plasma viral load (pVL) or in the viral response rate calculated as the percentage of pVL less than 50 copies/ml or less than 400 copies/ml. The CD4(+) T cell counts were statistically higher in the 201 - 350 group during the entire follow-ups (P < 0.01) though CD4(+) T cell count increases were similar in these two groups. After 100-week treatment, the median of CD4(+) T cell counts were increased to 331 cells/microl for CD4 100 - 200 cells/microl group and to 462 cells/microl for CD4 201 - 350 cells/microl group. Only a slightly higher incidence of nausea was observed in CD4 201 - 350 cells/microl group (P = 0.05) among all adverse reactions, including rash and liver function abnormality.</p><p><b>CONCLUSIONS</b>The pVLs and viral response rates are unlikely to be associated with the baseline CD4(+) T cell counts. Initiating HAART in Chinese HIV-1 infected patients with higher baseline CD4(+) T cell counts could result in higher total CD4(+) T cell counts thereby achieve a better immune recovery. These results support current guidelines to start HAART at a threshold of 350 cells/microl.</p>

Clinical analysis of otogenic intracranial complications / 中华耳鼻咽喉头颈外科杂志

<p><b>OBJECTIVE</b>To analyze the clinical features and treatment protocols of otogenic intracranial complications in Peking Union Medical College Hospital.</p><p><b>METHODS</b>Retrospective study of 14 patients (10 males and 4 females, aged between 12 - 62 years, mean age 32.1 years) hospitalized from 1982 - 2006. Twelve cases were otitis media (OM) with cholesteatoma, the other 2 cases were non-cholesteatomatous OM. All the otogenic intracranial complications located at the same sides as otologic disorders. Brain abscess was the most common type of otogenic complications and Proteus was the most common microorganism detected. Suppurative ear discharge, headache, high fever and nausea with vomiting were the most common clinical manifestations with very high incidences. All the patients received combined protocols of mastoid surgeries and antibiotics treatment.</p><p><b>RESULTS</b>All the 14 patients recovered clinically. For patients discharged before 1987, there were 4 patients followed up for 22.5 - 24.4 years with a mean time of 23.8 without recurrence, 1 patient died of cardiovascular disease 19.2 years later after discharge, 4 patients lost follow-up. For the 5 patients discharged after 1997, brain abscess recurred in one patient with pseudo-recovery after 24 days and he fully recovered after re-hospitalization and treatment. All the five patients were followed up for 1.5 years to 10.6 years with a mean time of 6.5 years without recurrence.</p><p><b>CONCLUSIONS</b>Youngsters and males seemed to be more vulnerable. Brain abscess was the most common intracranial complication and Proteus was the most common pyogenic microorganism. Combination of mastoid surgery and antibiotics were essential for effectively controlling the intracranial complications and improving the recovery. CT and MRI were essential for correct diagnosis bedtimes and MRI seemed to have a better performance.</p>

Clinical outcomes and immune reconstitution in 103 advanced AIDS patients undergoing 12-month highly active antiretroviral therapy / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Highly active antiretroviral therapy (HAART) produces profound suppression of HIV replication, substantial increase in CD4(+) T cells, and partial reconstitution of the immune system. However, the numbers of subjects were small in previous Chinese studies. This study evaluated the efficacy and side effects of HAART in Chinese advanced AIDS patients.</p><p><b>METHODS</b>One hundred and three antiretroviral drug naive AIDS patients were enrolled in this study and were divided into two groups by their baseline CD4(+) count: < 100 cells/microl or > or = 100 cells/microl. Clinical, virological and immunological outcomes were monitored at baseline and at 1, 3, 6, 9 and 12 months during the course of treatment with HAART.</p><p><b>RESULTS</b>One patient died and another was lost from the follow-up. For the remaining 101 HIV/AIDS patients at the 12th month during the HAART, the plasma viral load (VL) was reduced to (3.2 +/- 0.7) lg copies/ml, the CD4(+) count increased to (168 +/- 51) cells/microl [among which the naive phenotype (CD45RA(+)CD62L(+)) increased to (49 +/- 27) cells/microl and the memory phenotype (CD45RA(-)) increased to (119 +/- 55) cells/microl], and the percentage of CD4(+)CD28(+) cells increased. At the same time, there was a significant reduction of CD8(+) T cell activation. In the 69 patients with the baseline CD4(+) count < 100 cells/microl, 37 had a VL < 50 copies/ml; while in the 34 patients with the baseline CD4(+) count > or = 100 cells/microl, 25 had a VL < 50 copies/ml, the difference between the two groups was statistically significant. The CD4(+) T cell count showed a two-phase increase during HAART and a significant positive correlation was shown between the change of CD4(+) count and plasma VL. Over 12 months of HAART, 10 patients had gastrointestinal side effects, 13 peripheral neuritis, 7 hepatic lesions, 8 hematological side effects, 8 skin rashes, 10 lipodystrophy and 1 renal calculus.</p><p><b>CONCLUSIONS</b>Immune reconstitution as well as the significantly improved clinical outcomes is observed in Chinese advanced AIDS patients after HAART. Side effects are common during HAART and require clinical attention.</p>

Clinical characteristics of 143 Chinese HIV/AIDS patients / 中国医学科学院学报

<p><b>OBJECTIVE</b>To investigate the clinical characteristics of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients in China.</p><p><b>METHODS</b>Totally 143 HIV/AIDS patients who were first diagnosed in Peking Union Medical College Hospital form January 1988 to April 2006 were enrolled in this study. Clinical characteristics were retrospectively analyzed.</p><p><b>RESULTS</b>Among 143 HIV/ AIDS patients, 57 patients had no clinical symptoms and were confirmed by routine examinations; 86 patients had clinical symptoms, including fever (n = 50), weight loss (n = 18), and discomforts involving respiratory system (n = 34), gastrointestinal system (n = 16), and derma and mucosa (n = 17). Opportunistic infections (OIs) such as pneumocystis jiroveci pneumonia (PCP) (n = 27), oropharyngeal candidiasis (n = 16), tuberculosis (n = 15) , and cytomegalovirus (CMV) infection (n = 9) were also observed in patients whose CD4 + T cell counts were less than 200/mm3. Most CMV infection and cryptococcal meningitis occurred in patients whose CD4 + T cell counts were less than 100/mm3. CD4 + T cell count was negatively correlated with plasma viral load (r = -0.420, P = 0.001).</p><p><b>CONCLUSIONS</b>Fever, dyspnea, and weight loss are the most common symptoms in the patients of this study. The respiratory system, gastrointestinal system, derma and mucosa are the most commonly affected areas by OIs, and PCP is the most common OI. The occurrence of OIs corelates with CD4 + T cell count.</p>

Clinical diagnosis, treatment and prognosis of elderly SARS patients / 中国医学科学院学报

<p><b>OBJECTIVE</b>To discuss the clinical manifestations, therapeutic strategy and prognosis of patients with severe acute respiratory syndrome (SARS) older than 60 years.</p><p><b>METHODS</b>Elderly patients diagnosed as SARS in Peking Union Medical College Hospital were compared with younger patients.</p><p><b>RESULTS</b>Twenty-four elderly patients and 53 younger patients were analysed. Elderly patients had more coexisting conditions, such as hypertension, diabetes, coronary heart disease, and renal disease than control group (P < 0.05). Rate of respiratory failure in elderly patients was higher than that in control group (P < 0.05). Elderly patients had more respiratory symptoms, such as cough, sputum, and shortness of breath (P < 0.05). Rate of lymphocytopenia and thrombocytopenia in elderly patients was higher than that in control group. All patients were given ribavirin and antibiotics. More patients in elderly group were given 3rd generation cephalosporin and imipenem. Mortality rate in elderly group was higher than that in control group (33.3% vs 3.8%, P < 0.05). Univariate analysis showed that age, respiratory failure, and thrombocytopenia were risk factors of death, but logistic analysis did not find any independent risk factor.</p><p><b>CONCLUSIONS</b>Though the elderly patients have a lower morbidity of SARS, they have more coexisting conditions. The therapy of elderly patients is more difficult than that of control group, and the mortality in elderly patients is high.</p>