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发表于 2005-9-8 03:11
Long-term adefovir dipivoxil therapy. Stephanos Hadziyannis and others randomized 185 HBeAg-negative patients with chronic hepatitis B to receive adefovir dipivoxil 10 mg or placebo once daily for 48 weeks (2:1). After week 48, controls were switched to adefovir dipivoxil and patients in the original adefovir dipivoxil group received an additional 48 weeks of the drug (continued adefovir group) or placebo (adefovir-placebo group). Week 96 serum HBV DNA levels were <1,000 log copies/mL in 71% of patients in the continued adefovir group compared with only 8% of patients in the adefovir-placebo group (P <0.001). At week 144, serum HBV DNA levels were <1,000 copies/mL in 79% of patients in the continued adefovir group. Adefovir-resistant mutations were identified in only 5.9% of patients, and an increase in serum creatinine was observed in 3 patients after 144 weeks. These findings demonstrate that continuation of adefovir dipivoxil therapy beyond week 48 is required to maintain virologic responses in HBeAg-negative patients with chronic hepatitis B. However, long-term therapy is associated with a small but increasing risk of resistance and nephrotoxicity. (Hadziyannis SJ, et al. N Engl J Med. 2005;352:2673–2681) |
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