摘要
目的系统评价AAIR和DDDR两种生理性起搏模式比较治疗病窦综合征的有效性及安全性。方法采用Cochrane系统评价方法,计算机检索Cochrane图书馆临床对照试验数据库(2009年第2期)、MEDLINE(1980~2009.6)、EMbase(1980~2009.6)、CBM(1990~2009.6),同时手工检索相关期刊,纳入AAIR对比DDDR起搏治疗病窦综合征的随机对照试验、半随机对照试验及随机交叉试验,评价所有纳入研究的方法学质量,并提取有效数据采用RevMan5.0软件进行Meta分析。结果共纳入AAIR对比DDDR起搏治疗病窦综合征的随机对照试验6个和随机交叉试验2个,合计509例患者,但研究质量均不高。Meta分析结果显示:AAIR起搏模式较之DDDR起搏模式治疗不伴房室传导阻滞的病窦综合征可能更能缩小左房直径[MD=2.09,95%C(I0.22,3.97)]、左室舒张末内径[MD=3.00,95%CI(–1.58,7.58)]和减低房颤的发生(P=0.026),改善患者生活质量(P<0.05),但在治疗中由于患者发生房室传导阻滞需要重调或更换起搏器事件较多;对于患者的全因病死率(P=0.51)、心血管原因病死率(P=0.43)、心衰(P=0.17)、中风(P=0.32)、左室收缩末内径[MD=1.21,95%CI(–0.85,3.28)]及左室射血分数[MD=–2.91,95%CI(–6.53,0.70)]的改善二者相似;未见明显副作用。结论 AAIR起搏模式较之DDDR起搏模式治疗病窦综合征可能更能缩小患者左房直径及左室舒张末径,减低房颤的发生,改善生活质量,但同时也存在较多的重调或更换起搏器事件。由于纳入研究质量普遍偏低,样本量普遍偏少,尚不能确定其疗效及安全性,今后尚需开展大样本、高质量的随机对照试验以证实。
Objective To evaluate the effectiveness and safety of AAI pacing mode versus DDD pacing mode for treating sick sinus syndrome (SSS).
Methods We electronically searched CENTRAL (Issue 2, 2009), MEDLINE (1980 to June 2009), EMbase (1980 to June 2009) and CBM (1990 to June 2009). Randomized controlled trials (RCTs), quasi- RCTs and cross-over studies were identified and assessed, and then RevMan 5.0 software was used to perform metaanalysis.
Results A total of 509 patients of six parallel and two crossover RCTs were identified, and the quality of reporting was found poor. Studies showed a statistically significant preference to AAI pacing mode for the reduction of left atrial diameter (MD=2.09, 95%CI 0.22 to 3.97), left ventricular end-diastolic diameter (MD=3.00, 95%CI –1.58 to 7.58), the prevention atrial fibrillation (P=0.026) and the improvement of life quality (P〈0.05), but with more replacement or remodulation. Non-significant preference was shown to the prevention of all-cause mortality (P=0.51), cardiovascular mortality (P=0.43), stroke (P=0.32) and heart failure (P=0.17), the reduction of left ventricular end-systolic diameter (MD=1.21, 95%CI –0.85 to 3.28) and left ventricular ejection fraction (MD= –2.91, 95%CI –6.53 to 0.70). No significant adverse effects were reported.
Conclusion The review shows a trend towards AAI pacing mode compared with DDD pacing mode in terms of effectiveness. However, because of the high bias risk of the included trials, the evidence is insufficient, so more large-sample and high-quality RCTs are needed.
出处
《中国循证医学杂志》
CSCD
2010年第5期558-563,共6页
Chinese Journal of Evidence-based Medicine
基金
国家自然基金面上项目(编号:30670850)
四川省科技厅科技攻关项目(2006z09-018)