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Bicyclol for chronic hepatitis B

  • Review
  • Intervention

Authors


Abstract

Background

Bicyclol is a novel synthetic 'anti-hepatitis' drug, used in China for chronic hepatitis B. Until now, systematic reviews of bicyclol therapy have not been performed.

Objectives

To study the benefits and harms of bicyclol for patients with chronic hepatitis B.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2005), The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2005), MEDLINE (1950 to July 2005), EMBASE (1980 to July 2005), Science Citation Index Expanded (1945 to July 2005), The Chinese Biomedical Database (1994 to August 2005), VIP Chinese Science and Technique Journals Database (1994 to August 2005), and China National Infrastructure (CNKI)(1994 to August 2005). We also contacted manufacturers and researchers in the field.

Selection criteria

Randomised clinical trials with bicyclol versus no intervention, placebo, or other interventions were included, irrespective of blinding, publication status, or language.

Data collection and analysis

The primary outcome measures were mortality (total and liver-related) and liver-related morbidity (eg, cirrhosis and carcinoma). Secondary outcome measures were viral response and liver histology.

Main results

The search identified one randomised clinical trial comparing bicyclol with bifendate (biphenyldicarboxylate) for patients with hepatitis B. The follow-up was three months. There was no evidence that bicyclol was superior to bifendate for loss of HBeAg (RR 1.38, 95% CI 0.95 to 2.00), seroconversion of HBeAg to HBeAb (RR 1.44, 95% CI 0.90 to 2.29), loss of HBV DNA (RR 1.19, 95%CI 0.93 to 1.53), or number of patients with normalised alanine aminotransferase and aspartate aminotransferase activity (RR 0.88, 95% CI 0.70 to 1.11 and RR 0.97, 95% CI 0.79 to 1.20, respectively).

Authors' conclusions

Only one randomised clinical trial has examined the potential benefit of bicyclol for patients with chronic hepatitis B. This small, short-term trial found no evidence to support or refute its use. Large, randomised double-blind clinical trials with long-term follow-up are needed to examine the possible benefits and harms associated with bicyclol. Bicyclol can only be recommended for use in randomised trials.

摘要

背景

以Bicyclol治療慢性B型肝炎

Bicyclol是中國一種新型治療慢性B型肝炎的合成‘抗肝病’ 藥物。到目前為止,仍未有對Bicyclol進行系統性文獻回顧。

目標

研究Bicyclol治療慢性B型肝炎病人的利弊。

搜尋策略

搜尋Cochrane HepatoBiliary Group Controlled Trials Register (2005年7月)、Cochrane Library的The Cochrane Central Register of Controlled Trials (2005年第2期), MEDLINE (1950年至2005年7月)、EMBASE (1980年至2005年7月)、Science Citation Index Expanded (1945年至2005年7月),Chinese Biomedical Database (1994年至2005年8月), VIP Chinese Science and Technique Journals Database (1994年至2005年8月)和China National Infrastructure (CNKI)(1994年至2005年8月)。 我們同時聯繫該領域的廠商和研究人員。

選擇標準

收納Bicyclol相對於無處置、安慰劑或其他處置的隨機臨床試驗。沒有盲法,發表狀況或語言限制。

資料收集與分析

主要結果測量是死亡率 (全部和肝臟相關)和肝臟相關的發病率(例如肝硬化和肝癌)。次要結果測量是病毒反應和肝臟病理

主要結論

找出一個Bicyclol與bifendate(biphenyldicaboxylate)比較治療B型肝炎病人的隨機臨床試驗。追蹤3個月。在清除HBeAg (RR 1.38, 95% CI 0.95 2.00)、HBeAg血清轉化為HBeAb (RR 1.44, 95% CI 0.90 2.29)、清除HBV DNA (RR 1.19, 95%CI 0.93 – 1.53)、或 alanine aminotransferase 與 aspartate aminotransferase恢復正常化的病人數(分別是RR 0.88, 95% CI 0.70 – 1.11與RR 0.97, 95% CI 0.79 1.20)等方面,沒有證據指出Bicyclol優於bifendate。

作者結論

只有一項隨機臨床試驗檢視Bicyclol治療慢性B型肝炎病人的潛在好處。本小規模的短期試驗發現沒有證據能夠支持或反對該藥物的使用。需要大規模的隨機雙盲長時間追蹤的臨床試驗檢視Bicyclol相關潛在的利弊。Bicyclol只建議在隨機試驗中使用。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有發現有關Bicyclol治療慢性C型肝炎的利弊的證據。Bicyclol是一種新型合成‘抗肝病’ 藥物,在中國主要用來治療慢性B型肝炎病人。發現沒有任何適當設計的隨機臨床試驗來評估Bicyclol對治療慢性B型肝炎病人可能帶來的好處或害處。臨床照護人員應注意Bicyclol仍然缺乏這方面的證據。

Plain language summary

Evidence on beneficial or harmful effects of bicyclol for chronic hepatitis C is not found

Bicyclol is a novel synthetic 'anti-hepatitis' drug, used primarily in China for patients with chronic hepatitis B. No well-designed randomised clinical trials were found evaluating the benefits or possible harms of bicyclol for patients with chronic hepatitis B. Clinicians should be aware of this lack of evidence for bicyclol.