Yang Xunzhe, Zeng Xiaoxi, Wu Taixiang
West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan, China, 610041.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD006765. doi: 10.1002/14651858.CD006765.pub2.
Stroke is a major healthcare problem and is one of the leading causes of death and serious long-term disability. Prevention of stroke is considered an important strategy. Chuanxiong is traditionally used in China in the treatment and prevention of stroke. In recent years, Chinese researchers have developed new patented Chuanxiong preparations.
To assess the effects and safety of Chuanxiong preparations in preventing stroke in high-risk adults.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2008, Issue 1), MEDLINE (1950 to March 2008), EMBASE (1980 to March 2008), AMED (1985 to March 2008), Chinese Biomedical Database (CBM) (1975 to March 2008), China National Knowledge Infrastructure (CNKI) (1994 to March 2008), and the VIP Database (1989 to March 2008). Trials registers were searched for ongoing studies. No language restrictions were applied.
Randomised controlled trials (RCTs) studying the effects of Chuanxiong preparations in preventing stroke were included.
Three reviewers independently selected studies for inclusion and two reviewers independently extracted data. Authors of identified RCTs were telephoned to confirm the randomisation procedure. Outcomes assessed included: stroke, composite cardiovascular outcomes, changes in cardiovascular and cerebrovascular haemodynamic indices and adverse events. Peto odds ratio (OR) with 95% confidence intervals (CI) were calculated for dichotomous variables and mean differences for continuous outcomes.
Three RCTs (5042 participants) were included. One higher quality study (4415 participants) compared Nao-an capsule with aspirin for primary prevention in high-risk stroke populations. Nao-an capsule appeared to reduce the incidence of stroke compared with aspirin (OR 0.56 95% CI 0.33 to 0.96). One study of low methodological quality indicated that a self-prepared Xifenwan tablet reduced the incidence of stroke in people with transient ischaemia attack (TIA) (OR 0.18, 95% CI 0.04 to 0.78). The remaining low quality study indicated that "apoplexy 2 preventing dry ointment powder" appeared to reduce both fatal stroke and incidence of stroke (OR 0.21, 95% CI 0.10 to 0.43, and OR 0.28, 95% CI 0.16 to 0.49, respectively).
AUTHORS' CONCLUSIONS: Nao-an capsule may be a choice for the primary prevention of stroke. However, the design of the study providing this evidence means that there was potential for results to have been affected by bias from the way participants may have been selected, or from investigators' conflicts of interests. There was a lack of description of the methodology in the two other studies therefore evidence from these was considered too weak to draw any firm conclusions. Further high quality research is required.
中风是一个主要的医疗保健问题,是导致死亡和严重长期残疾的主要原因之一。预防中风被视为一项重要策略。在中国,川芎传统上用于治疗和预防中风。近年来,中国研究人员开发了新的川芎专利制剂。
评估川芎制剂在预防高危成年人中风方面的效果和安全性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(2008年第1期)、MEDLINE(1950年至2008年3月)、EMBASE(1980年至2008年3月)、AMED(1985年至2008年3月)、中国生物医学数据库(CBM)(1975年至2008年3月)、中国知网(CNKI)(1994年至2008年3月)和维普数据库(1989年至2008年3月)。检索试验注册库以查找正在进行的研究。未设语言限制。
纳入研究川芎制剂预防中风效果的随机对照试验(RCT)。
三名综述员独立选择纳入研究,两名综述员独立提取数据。致电已识别RCT的作者以确认随机化程序。评估的结局包括:中风、复合心血管结局、心血管和脑血管血流动力学指标变化以及不良事件。对二分类变量计算Peto比值比(OR)及95%置信区间(CI),对连续结局计算均值差。
纳入三项RCT(5042名参与者)。一项质量较高的研究(4415名参与者)比较了脑安胶囊与阿司匹林用于高危中风人群的一级预防。与阿司匹林相比,脑安胶囊似乎降低了中风发生率(OR 0.56,95%CI 0.33至0.96)。一项方法学质量较低的研究表明,自制的息风丸片降低了短暂性脑缺血发作(TIA)患者的中风发生率(OR 0.18,95%CI 0.04至0.78)。其余质量较低的研究表明,“中风2号预防干膏粉”似乎降低了致命性中风和中风发生率(分别为OR 0.21,95%CI 0.10至0.43,以及OR 0.28,95%CI 0.16至0.49)。
脑安胶囊可能是中风一级预防的一种选择。然而,提供此证据的研究设计意味着结果可能受到参与者选择方式或研究者利益冲突所导致的偏倚影响。另外两项研究缺乏方法学描述,因此认为这些研究的证据过于薄弱,无法得出任何确凿结论。需要进一步开展高质量研究。