OBJECTIVETo investigate protective effect of paeonol (Pae) on human umbilical vein endothelial cells (HUVECs)injured by hyperlipidemic serum and explore its possible mechanism.METHODS The injury model was induced by 20％ hyperlipidemic serum incubating HUVECs for 24 h.Pae 124,247 and 495.μmol· L-1 were given followed by administration of hyperlipidemic serum for 24 h.The morphological changes were observed under inverted microscope,cell survival rate was evaluated by MTT method,the nitric oxide (NO) content was measured by nitric acid reductase method and the endothelial nitric oxide synthase (eNOS) mRNA expression was determined by RT-PCR.RESULTSCompared with normal contorl group,most cells in model group split and exfoliated.However,the morphology was tending to normal level after intervention with Pae.Pae significantly improved cell viability(P ＜0.01).Compared with model group,the survival rate increased from (53.0 ±10.1 ) ％ to ( 68.4 ± 9.1 ) ％,( 84.5 ± 6.7 ) ％ and (98.1 ± 7.5 ) ％,respectively.The NO content and eNOS mRNA expression both increased greatly in Pae groups(P ＜ 0.01 ).Compared with model group,content of NO increased from 54 ± 4 to 79 ± 6,115 ± 5 and ( 136 ± 6) μmol · L- 1,respectively.The expression level of eNOSmRNA improved from 0.215 ± 0.060 to 0.451 ± 0.045,0.563 ± 0.013,0.704 ± 0.068,respectively.CONCLUSIONPae exerts protective effect on HUVECs injured by hyperlipidemic serum by increasing eNOS mRNA expression,which might therefore improve the content of NO.

Objective To investigate the clinical and pathological characteristics,diagnosis,differential diagnosis,treatment and prognosis of giant neurofibroma of penis in the child.Methods The clinical data including general data,imaging data,treatment methods,pathological characteristics of a case with giant neurofibroma of penis in a child were analyzed retrospectively and the relevant literature was reviewed.Results Gross appearance of the penile shaft neurofibroma was about 9 cm × 11 cm × 15 cm,with local ulceration.Computerized tomography scan revealed a giant mass in the penile shaft,about 9.0 cm × 10.0 cm × 13.4 cm.Partial excision of the penis was performed.Postoperative appearance of the residual penile shaft was about 2 cm long.The HE staining showed spindle cells with the red dye cytoplasm,spindle or elliptic nuclei and arranged in wavy partly.Positive immunostaining was presented with S-100 protein and Vimentin.The pathologic examination revealed a neurofibroma.There was no evidence of recurrence and the penis of the boy had normal sensation and erection by follow-up in 2 years.Conclusions Neurofibroma of penis in the child is extremely rare and the differential diagnosis of soft-tissue tumors of penis should be considered.The operative method should be individualized,the treatment goal is the complete resection;however,this goal must be weighed against detriment to functioning and the cosmetics of the involved organ.

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.