Objective To evaluate the therapeutic efficacy and safety of HIFU ablation for uterine fibroids in patients with abdominal surgical scars in acoustic pathway causing acoustic attenuation width ＜10 mm.Methods Totally 861 patients with uterine fibroids were referred for HIFU treatment and underwent contrast-enhanced MR scans before and after HIFU ablation.Among all patients,202 had abdominal surgical scars causing width ＜10 mm acoustic attenuation (abdominal scars group) and 659 had no abdominal surgical scars (without abdominal scars group).The outcomes,intra-operative adverse reactions and post-operative complications between the two groups were compared.Results HIFU ablation was successfully performed in all patients.The volume ablation rate was (80.31 ± 18.16)％ in abdominal scars group and (79.60±17.57)％ in without abdominal scars group (P＝0.620).The rate of ‘hot'skin sensation during HIFU procedure in abdominal scars group (52.97％ [107/202]) was higher than that in without abdominal scars group (41.58％ [274/ 659];P＝0.004).Anterior abdominal wall edema was found in 40 cases (40/202,19.80％) in abdominal scars group and 98 cases (98/659,14.87％) in without abdominal scars group on post-operation MRI (P＝ 0.095).Conclusion Prior abdominal surgical scars in acoustic pathway causing width ＜10 mm acoustic attenuation has not significantly influence on the efficacy and safety of HIFU treatment for uterine fibroid.

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.