[Efficacy and safety of paritaprevir/ritonavir/ombitasvir combined with dasabuvir in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection: a randomized, double-blind, placebo-controlled study - China data].

Objective: To evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily combined with dasabuvir 250mg, twice daily in non-cirrhotic Chinese adult patients with newly diagnosed and treated chronic HCV genotype 1b infection. Methods: A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial was conducted in mainland China, Korea, and Taiwan.Safety and efficacy of OBV/PTV/r plus DSV administered for 12 weeks were evaluated in a newly diagnosed and treated (interferon alpha /pegylated interferon alpha) and ribavirin non-cirrhotic adults with chronic HCVgenotype 1b infection. Patients randomly received OBV/PTV/r plus DSV for 12 weeks (Group A), or placebo for 12 weeks (Group B) followed by an open-label phase of OBV/PTV/r plus DSV for 12 weeks. Sustained response (SVR12) rate obtained at 12 weeks and (SVR24) 24 weeks after discontinuation of treatment, and the incidence of adverse events and laboratory abnormalities after double-blind and open-label phase treatment were assessed. Results: A total of 410 cases of Chinese patients were included and randomly assigned to group A and B (with 205 cases in each group) in a 1:1 ratio. The rates of SVR12 and SVR24 were 99% (95% CI: 94.8% - 99.8%) in the newly diagnosed patients in group A (205 patients) and the rates of SVR12 and SVR24 were 100% in treated patients (95% CI: 96.3% - 100%). Different baseline characteristics had no effect on SVR12 and SVR24 rates. Most of the adverse events occurred were mild, asymptomatic, and≥ 3 laboratory abnormalities during treatment were rare, including elevation of alanine aminotransferase (2 cases in double-blind stage A group), aspartate aminotransferase (Double-blind stage A (3 cases) and total bilirubin (1 case in open-label phase B group); however, those mild adverse events could be recovered after drug withdrawal or discontinuation. only1 person discontinued drugs due to adverse events (Group B, open-label phase). Conclusion: The 12 weeks treatment course of OBV/PTV/r combined with DSV produced 99% ~ 100% rates of SVR12 and SVR24 in non-cirrhotic Asian adult patients with newly diagnosed and treated chronic HCV genotype 1b infection, and the tolerance and safety were good.

[Diagnostic criteria for HBV-related acute-on-chronic pre-liver failure].

OBJECTIVE: To investigate the diagnostic criteria for HBV-related acute-on-chronic pre-liver failure (pre-ACLF) which can effectively predict the risk of liver failure. METHODS: A total of 1279 patients with severe icteric chronic hepatitis B (CHB) and/or severe acute exacerbation of CHB were enrolled. The influence of serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBil), international normalized ratio (INR) of prothrombin time, sex, and age on the incidence rate of acute-on-chronic liver failure (ACLF) was analyzed, the diagnostic criteria for pre-ACLF and predictive model for ACLF were developed. The chi-square test was used for comparison of categorical variables, and the independent samples t-test was used for continuous data; multivariate logistic regression analysis was performed to evaluate the risk of liver failure. RESULTS: The baseline serum levels of ALT, AST, and TBil, and INR were independent risk factors for liver failure (P < 0.05). The diagnostic criteria for pre-ACLF were as follows: (1) INR≥1.30; (2) AST≥10×upper limit of normal (ULN) and obvious jaundice (TBil≥51.3 µmol/L), or TBil≥342.0 µmol/L. These criteria had a positive predictive value of 45.9%, a negative predictive value of 89.8%, a sensitivity of 69.1%, and a specificity of 76.9%. The predictive model for the risk of ACLF was PY = 1=e(X)/(1+e(X)) (PY represented positive results of logistic regression analysis), X = -10.245+0.026×AST(ULN)-0.025×AST(ULN)+0.046×TBil(mg/dl) + 4.642×INR+0.049×age(years). The patients with higher PY values tended to have a higher incidence rate of ACLF. The incidence rate of ACLF was 75.3% in patients with PY≥0.60, more than 50% in patients with a PY value of 0.40-0.59, and 1.8% in patients with PY < 0.10 (P < 0.01). CONCLUSION: The diagnostic criteria for pre-ACLF and predictive model can effectively evaluate the risk of HBV-related ACLF.

The changes of RNFL thickness and its influence on visual field defect in patients with PXG at different stages.

OBJECTIVE: To investigate the changes of retinal nerve fiber layer (RNFL) thickness and its influence on visual field defect in pseudoexfoliation glaucoma (PXG) patients at different stages, including early stage, middle stage and late stage. PATIENTS AND METHODS: Clinical data of 194 PXG patients who were treated in our hospital from January 2017 to December 2019 were retrospectively analyzed. All patients were grouped according to the disease stage of PXG, including 56 eyes in the early stage, 54 eyes in the middle stage and 84 eyes in the late stage. Meanwhile, 50 cases with normal eyes were selected as the control group. The baseline clinical data, visual field defect and RNFL thickness in different groups were compared and the correlation between RNFL thickness and visual field defect was analyzed. RESULTS: There was no significant difference in baseline clinical data among different groups (p>0.05). There was significant difference in visual field defect and RNFL thickness among different groups (p<0.05). The visual field defect, mean, supratemporal, infratemporal and subnasal of RNFL thickness in the early group were significantly lower than those of control group (p<0.05). The visual field defect, mean, nasal, supranasal, supratemporal, infratemporal and infratemporal of RNFL thickness in the middle group were significantly lower than those of control group (p<0.05). The visual field defect and RNFL thickness in the late group were significantly lower than those of control group and early group (p<0.05). The visual field defect, mean, supratemporal, infratemporal and infratemporal of RNFL thickness in the middle group were significantly lower than those of early group (p<0.05). Pearson correlation analysis showed that there was no correlation between RNFL thickness and visual field defect in pseudoexfoliation glaucoma patients in the early stage (r=-0.09, p=0.63). There was the positive correlation between RNFL thickness and visual field defect in PXG patients in the middle and late stages (r=0.43, 0.60; p=0.04, 0.00). CONCLUSIONS: RNFL thickness is closely related to visual field defect in patients with PXG in middle and late stage. Dynamic monitoring of RNFL thickness can be used for clinical diagnosis, staging and prognosis evaluation.

[Pathologic observations on the peripheral nerves in simple polymyositis].

In 6 cases of polymyositis was performed muscle and sural nerve biopsy. All the 6 patients presented typical clinical pictures of simple polymyositis. Sural nerves showed demyelination and axonal changes, under light and electron microscopy. It seems that simple polymyositis accompanied by the alterations in peripheral nerves is not very rare. In 3 cases, a few small arteries in the interfascicular areas of the nerves were nearly totally occluded due to the intimal proliferation. Clinical examination revealed no evidence of systemic vasculitis. On the basis of these data, the authors suspect that the above mentioned pathological findings probably are partial presentations among the spectrum of allergic disorder, which presents many clinical types and various combinations.

[Heat shock protein 70 expression following transient ischemia in the gerbil].

OBJECTIVE: To study the expression of heat shock protein 70(HSP70) following transient ischemia in the gerbil. METHODS: Immunohistochemistry(IHC) was used to determine the expression of the HSP70 protein in the forebrain during different periods after post-ischemic reperfusion in the gerbil, and the neuronal damage was examined with microscope. RESULTS: The HSP70 protein was only expressed at the 1st day of reperfusion(P < 0.01); and most of the neurons showed damage on the 7th day of reperfusion; heat-preconditioning could increase the expression of HSP70 protein(P < 0.01) and decrease the neuronal damage(P < 0.001) after 6 min of ischemia. CONCLUSION: Heat-preconditioning could protect neural cells from damage by increasing the expression of the HSP70 protein.

[Kindling model of SD rats induced by injection of PTX intraperitoneally].

OBJECTIVE: To observe the kindling model of Sprague-Dawley (SD) rats induced by injection of different doses of picrotoxin (PTX) intraperitoneally, and to evaluate the effect of the drug on the model. METHODS: SD rats were devided randomly into four groups: control group, epilepsy Group I (PTX, 1.5 mg.kg-1.d-1), epilepsy Group II (PTX, 2 mg.kg-1.d-1) and the phenobarbital group. The kindling model of rats was induced by daily injection of PTX intraperitoneally. The seizures in the rats were observed, and the results of electroencephalography (EEG) were recorded. RESULTS: On the 20th day after injection of PTX, 71% SD rats were kindled in epilepsy Group I; 4 rats were dead, 2 rats were at stage IV of convulsions, and 2 rats were at stage V of convulsions in epilepsy Group II; 17% rats were kindled in the phenobarbital group. The EEG demonstrated spike discharges in the kindled rats. CONCLUSIONS: In this models, the better dose of PTX is 1.5 mg.kg-1.d-1, and phenobarbital sodium can protect SD rats injected PTX intraperitoneally from seizure.

[Study on p53 gene expression following transient ischemia in the gerbil].

OBJECTIVE: To study the expression of p53 gene after transient ischemia in the gerbil. METHODS: Northern blot was used to detect the expression of the p53 mRNA in the forebrain during different periods after post-ischemic reperfusion in the gerbil. RESULTS: The expression of p53 mRNA increased in the forebrain during the 6th hour to the 3rd day of reperfusion following 6 min of ischemia (P < 0.05). CONCLUSION: The high level expression of p53 might induce neuronal apoptosis after ischemia.

Quality of life and personality in adults with epilepsy.

PURPOSE: This study was undertaken to understand the quality of life, personality, and associated factors in patients with epilepsy. METHODS: 117 patients with epilepsy and 84 healthy people were studied and tested using the Social Support Scale, the General Well-being Schedule, the Life-Event Scale, the Behavior Pattern Scale, and the Eysenck Personality Questionnaire (EPQ). RESULTS: There were no significant differences between the patients with epilepsy and the control group in the Social Support Scale results. The General Well-being Schedule scores were lower for the case patients than for the control group (p < 0.01). Scores for patients with frequent seizures (once a month or more) were lower than those without frequent seizures (less than once per month). The case patients had higher negative scores in the family-related problem section of the Life Events Scale, compared with the control group (p < 0.05). The patients with epilepsy were also more likely to lie (p < 0.05); their emotions were more changeable (p < 0.01), and their character more introverted (p < 0.05), although their behavior patterns were similar to the controls. We also studied associated factors related to personality, general well-being, and familial-negative life-events. CONCLUSIONS: These results provide information about patients with epilepsy that may be useful in their psychological treatment.