The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.
Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
439
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. First month: ozone concentration: 20µg \~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.
Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.
Nanfang Hospital
Guangzhou, Guangdong, China
HBV DNA
To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL
Time frame: up to 77 weeks
HBeAg
Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.
Time frame: up to 77 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.