PMID- 16732903
OWN - NLM
STAT- MEDLINE
DCOM- 20070710
LR  - 20181201
IS  - 1007-3418 (Print)
IS  - 1007-3418 (Linking)
VI  - 14
IP  - 5
DP  - 2006 May
TI  - [A multicenter, randomized, open-label study of the safety and effectiveness of 
      pegylated interferon alpha 2b and interferon alpha 2b in treating HBeAg positive 
      chronic hepatitis B patients].
PG  - 323-6
AB  - OBJECTIVE: To compare the efficacy and safety of PEG-IFNalpha-2b (Peg-Intron) 
      with IFNalpha-2b (Intron A) in treating HBeAg positive chronic hepatitis B 
      patients. METHODS: Two hundred thirty chronic hepatitis B (CHB) patients eligible 
      to the following criteria were enrolled into this study: HBsAg and HBeAg(Abbott 
      kit) positive for at least 6 months, serum HBV DNA > or =10(5) copies/ml (real 
      time PCR, LLQ <10(3) copies/ml) and ALT > or =2 x ULN. After 1:1 randomization, 
      the patients received PegIntron (group A: 1.0 microg/kg body weight, SC, once a 
      week) or Intron A (group B: 3 MIU SC, three times a week) for 24 weeks, and 
      followed up for 24 weeks. RESULTS: (1) In groups A and B, respectively, 80.87% 
      and 83.48% were males; their median ages were 31.0 and 32.0 years old; their 
      median body weights were 65.6 and 65.5 kg; mean serum HBV DNA loads were 8.06 
      log10 and 7.99 log10; their mean ALT values were 4.17 x ULN and 3.77 x ULN. All 
      of the above parameters between the two groups had no statistically significance 
      differences. (2) At the end of treatment and after follow-up, compared to the 
      Intron A group, the PegIntron group showed better response (including complete 
      and partial response rate, HBV DNA undetectable rate, HBeAg seroconversion rate), 
      but the differences of all of them had no statistical significance. The rate of 
      HBeAg loss was higher in patients receiving PegIntron after follow-up (P = 
      0.0424). (Table 2) (3) PegIntron and Intron A reduced serum HBV DAN persistently 
      during the therapy. Mean reduction at the end of the treatment was much higher in 
      the PegIntron group than in the Intron group (2.22 log10 copies/ml vs 1.66 log10 
      copies/ml, P = 0.0283). (4) The overall incidence of adverse events (AEs) in the 
      PegIntron group was similar to that of the Intron A group (94.78% vs 95.65%). The 
      AEs associated with PegIntron administration were similar in nature to those with 
      Interon A, such as influenza-like symptoms, fever, fatigue, headache, nausea, etc 
      and the differences of their incidences had no statistical significance. 
      CONCLUSIONS: The efficacy and safety of PEG-IFNalpha-2b treatment for CHB 
      patients seems to be better than that of IFNalpha-2b; however, further studies 
      are needed to confirm it.
FAU - Zhao, Hong
AU  - Zhao H
AD  - First Hospital, Beijing University, Beijing 100034, China. minmin2001@126.com
FAU - Si, Chong-wen
AU  - Si CW
FAU - Wei, Lai
AU  - Wei L
FAU - Wan, Mo-bin
AU  - Wan MB
FAU - Ying, You-kuan
AU  - Ying YK
FAU - Hou, Jin-lin
AU  - Hou JL
FAU - Niu, Jun-qi
AU  - Niu JQ
LA  - chi
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Gan Zang Bing Za Zhi
JT  - Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of 
      hepatology
JID - 9710009
RN  - 0 (Antiviral Agents)
RN  - 0 (Hepatitis B e Antigens)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - G8RGG88B68 (peginterferon alfa-2b)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Female
MH  - Hepatitis B e Antigens/*blood
MH  - Hepatitis B, Chronic/*drug therapy/immunology
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Polyethylene Glycols
MH  - Recombinant Proteins
EDAT- 2006/05/31 09:00
MHDA- 2007/07/11 09:00
CRDT- 2006/05/31 09:00
PHST- 2006/05/31 09:00 [pubmed]
PHST- 2007/07/11 09:00 [medline]
PHST- 2006/05/31 09:00 [entrez]
PST - ppublish
SO  - Zhonghua Gan Zang Bing Za Zhi. 2006 May;14(5):323-6.