1.Observation about using cold stimulation in the rehabilitative training for elder patients with swallowing obstacle
Zengying WANG ; Yuexin JIAO ; Huiping WU ; Aihui WEN ; Xiaoqing HONG ; Qiumei XIAO
Chinese Journal of Practical Nursing 2006;0(30):-
Objective To study the effects of cold stimulation on the swallowing obstacle among elder patients. Methods Divided 55 elder patients with swallowing obstacle into the A (31 cases) and B (24 cases) group. The traditional nursing cares were used in the B group, while the cold stimulation was used in the A group additionally. Results The effective radio in the A and B group was 83.87% and 58.33% respectively, there was significant difference between them,P
2. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin in Asian adult patients with chronic HCV genotype 1b infection and compensated cirrhosis
Lai WEI ; Guiqiang WANG ; Kopecky-Bromberg SARAH ; Jun CHENG ; Qing XIE ; Maorong WANG ; Min XU ; Zhongping DUAN ; Jinlin HOU ; Mingxiang ZHANG ; Yuexin ZHANG ; Hong TANG ; Wei ZHAO ; Shumei LIN ; Zhansheng JIA ; Junqi NIU ; Zhiliang GAO ; Hong YUAN ; Minghua LIN ; Xinmin ZHOU ; Yan LUO ; Fredrick LINDA ; Mobashery NILOUFAR ; Ye WANG ; Jidong JIA
Chinese Journal of Hepatology 2018;26(5):353-358
Objective:
To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis.
Methods:
An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs.
Results:
A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal.
Conclusion
Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.
3. Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C
Bo FENG ; Jia SHANG ; Shuhuan WU ; Hong CHEN ; Ying HAN ; Yueqi LI ; Dazhi ZHANG ; Longfeng ZHAO ; Shaofeng WEI ; Qing MAO ; Zhibiao YIN ; Tao HAN ; Maorong WANG ; Shijun CHEN ; Jun LI ; Qing XIE ; Zhen ZHEN ; Zhiliang GAO ; Yuexin ZHANG ; Guozhong GONG ; Dongliang YANG ; Chen PAN ; Jifang SHENG ; Hong TANG ; Qin NING ; Guangfeng SHI ; Junqi NIU ; Guanghan LUO ; Yongtao SUN ; Hong YOU ; Guiqiang WANG ; Lunli ZHANG ; Jie PENG ; Qin ZHANG ; Jiajun LIU ; Chengwei CHEN ; Xinyue CHEN ; Wei ZHAO ; Runhua WANG ; Li SUN ; Lai WEI
Chinese Journal of Hepatology 2017;25(3):187-194
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%
4. Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients
Fengqin HOU ; Yalin YIN ; Lingying ZENG ; Jia SHANG ; Guozhong GONG ; Chen PAN ; Mingxiang ZHANG ; Chibiao YIN ; Qing XIE ; Yanzhong PENG ; Shijun CHEN ; Qing MAO ; Yongping CHEN ; Qianguo MAO ; Dazhi ZHANG ; Tao HAN ; Maorong WANG ; Wei ZHAO ; Jiajun LIU ; Ying HAN ; Longfeng ZHAO ; Guanghan LUO ; Jiming ZHANG ; Jie PENG ; Deming TAN ; Zhiwei LI ; Hong TANG ; Hao WANG ; Yuexin ZHANG ; Jun LI ; Lunli ZHANG ; Liang CHEN ; Jidong JIA ; Chengwei CHEN ; Zhen ZHEN ; Baosen LI ; Junqi NIU ; Qinghua MENG ; Hong YUAN ; Yongtao SUN ; Shuchen LI ; Jifang SHENG ; Jun CHENG ; Li SUN ; Guiqiang WANG
Chinese Journal of Hepatology 2017;25(8):589-596
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 (