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Three Years Randomized Controlled Study Of Entecavir And Adefovir Dipivoxil For Chronic Hepatitis B

Posted on:2012-04-30Degree:MasterType:Thesis
Country:ChinaCandidate:X J GuFull Text:PDF
GTID:2154330332496092Subject:Infectious disease science
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Objective The comparison of the efficacy, drug resistance and adverse events of entecavir (ETV) and adefovir dipivoxil (ADV) for the chronic hepatitis B(CHB) patients in the past three years.Methods 91 CHB patients who were treated in the First Affiliated Hospital of Shanxi Medical university from March 2007 to September, were randomly divided into 2 groups, ETV an ADV. The changes of virological indicators such as HBV DNA were observed in two groups at years 0.5,1,2,3, the level of HBV DNA of drug resistance detection was detected and various adverse events was followed-up during treatment.The resultsI. The differences of negative conversion rates of HBV DNA at the years 0.5,1,2,3, in two groups had no statistically significant, but the decrease of HBV DNA levels were significant, the ETV group was higher; Two groups conversion rates of serological HBeAg conversion had not statistically significant (P>0.05), in HBV DNA load of low titer (≤105), The negative conversion rates of two groups of HBV DNA were not statistically significant (P> 0.05),in medium and higher load, the differences of negative conversion rates had no statistically significant, the ETV group was higher. the proportion of primary virus-free response had no differences (P>0.05) Abdominal ultrasonography showed the changes of hepatic portal vein diameter had no statistically significant, so did the comparison between two groups. There was no statistically significant between the patients who had treated with lamivudine (LVD) of the negative conversion rates of taking a double dose (1.0 mg) ETV and single dose(0.5mg) ETV treatment for the first time(P>0.05). Viral rebound occurred in both groups of patients, mostly due to poor dependencies.2. RtM204V, rtL180M, RtT180L variations happened in a patient of ETV group, and no such cases in ADV group.3. A few patients seemed weak, dizziness and sleepiness, and anorexia, nausea, stomach bilge digesting system symptoms, and rhinitis symptoms, etc, patients was able to tolerance and no patients terminate the treatment. During the treatment, two female patients had a pregnancy in ADV group, a male patient whose wife had a pregnancy and birth. Two cases in ETV group also had a pregnancy and birth after the HBV DNA was negative, the five babies above were healthy,and the age of the five babies were from 6 months to 20 months, no forms of physics and intellectual abnormalities was found, so do HBV infection. Two patients in ETV groups were respectively diagnosed primary liver cancer in the first treatment year and third year, after radio frequency ablation and interventional treatment, the condition is stable. And one patient in ADV group occurred hepatocellular carcinoma. Two patients in ADV groups died of primary liver cancer.Conclusion1. Compare the effects of the virus inhibitory, the ETV was greater than ADV. it could decend the HBV DNA load. But during the 3 years observation, ETV had no clear advantages on the negative conversion ratio.2. The treatment of ETV was greater for the patients whose HBV DNA load≥1053.The cases of no answer primary virus occurred, ADV group was more than ETV group, especially in patients with HBV DNA> 10'before treatment, but the difference had no statistically significant, still cannot make conclusion because of the limitation of sample size,so we need to increase the sample size for verification.4. The tolerability of ETV and ADV were both good, and the rate of resistance was lower than other drugs.5. We found no exception of physical and intellectual in five cases of baby, which provides a certain amount of information for using nucleotide analogs to pregnancy, but the long-term effects in teratogenic effect was not conclusive.6. Compliance of patients had a greater impact on efficacy in Long-term treatment.
Keywords/Search Tags:entecavir, adefovir dipivoxil, chronic hepatitis B, curative effect
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