作者：Laurie Barclay, MD
出處：WebMD醫學新聞
September 5, 2008 — 美國食品藥物管理局(FDA)日前核准第一種B型肝炎病毒(HBV)核酸檢測(COBAS TaqMan HBV Test, Roche Diagnostic Division公司)，測量血中的病毒DNA，以估計病毒量；此項檢測使醫師可以評估慢性HBV感染病患的抗病毒治療反應。
FDA的醫療器材與輻射保健中心主任Daniel G. Schultz醫師在新聞稿中表示，測量病患的HBV病毒量是治療慢性B型肝炎感染的重要觀念；COBAS TaqMan檢測給予健康照護提供者一個新的有敏感性的工具。
高度敏感性的檢測選出之後，放大人類血漿或血清的病毒DNA；測量病毒DNA可以在開始抗病毒治療前確認基礎程度，治療期間持續測量可以評估治療反應。
該檢測並不會取代其他實驗室參數，如生化和血清檢測。
根據世界衛生組織的資料，全球每年約有20億例HBV感染，雖然美國在1982年已經有HBV疫苗，疾病控制與預防中心估計美國的HBV感染約有125萬人，每年的新感染率約有60,000人，B型肝炎相關併發症死亡率約為每年5,000例。
HBV感染患者約有70%的症狀為腹痛、黃膽、疲勞、厭食、噁心和/或嘔吐；傳染途徑是經由病毒曝露、共用被病毒污染的針具、或者HBV感染母親垂直傳染給胎兒。
FDA Approves Test for Hepatitis B Viral Load
By Laurie Barclay, MD
Medscape Medical News
September 5, 2008 — The US Food and Drug Administration (FDA) approved yesterday the first nucleic acid test for hepatitis B virus (HBV) that measures blood levels of viral DNA as an estimate of viral load (COBAS TaqMan HBV Test, Roche Diagnostic Division). The test allows clinicians to assess therapeutic response to antiviral therapy in patients with chronic HBV infection.
"Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections," Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health, said in a news release. "The COBAS TaqMan test gives healthcare providers a new and sensitive tool for this process."
The highly sensitive test extracts and then amplifies sections of viral DNA from human plasma or serum. Measurement of viral DNA sections allows determination of a baseline level before beginning antiviral treatment, and ongoing measurement during therapy allows assessment of treatment response.
The test is not intended to supplant other laboratory parameters such as biochemical and serological tests.
According to the World Health Organization, global incidence of HBV infection is about 2 billion annually. Although an HBV vaccine has been available in the United States since 1982, the Centers for Disease Control and Prevention estimate US prevalence of HBV infection to be approximately 1.25 million. The new infection rate in the United States is about 60,000 individuals per year, and the rate of death from hepatitis B–related complications is about 5000 deaths per year.
Approximately 70% of patients with HBV infection have symptoms of abdominal pain, jaundice, fatigue, anorexia, nausea, and/or vomiting. Transmission is via sexual exposure, sharing needles contaminated with the virus, or from an HBV-infected mother to her infant during delivery.
[ 本帖最後由 goodcat1111 於 2008-9-15 15:40 編輯 ] |
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