CAJ | 학술논문

目的：系统评价参仙升脉口服液治疗窦性心动过缓的临床疗效及安全性。方法电子检索 CNKI、VIP、CBM、Wan Fang Data、PubMed、The Cochrane Library、Embase,查找有关参仙升脉口服液治疗窦性心动过缓的临床疗效及安全性的 RCT试验,检索时限为2000年4月(临床应用)—2014年11月。由两名研究人员根据纳入和排除标准独立筛选文献、提取资料和评价质量,采用RevMan5.3进行系统评价。评价指标：临床疗效、平均心率、最低心率和不良反应等。结果共纳入5个随机对照研究,包括患者453例。描述性分析结果显示：与对照组比较,3个 RCT表明参仙升脉口服液可明显提高窦性心动过缓临床疗效；分别有4个、1个、3个 RCT显示参仙升脉口服液可显著提升患者动态心电图中平均心率、24 h总心率数、最低心率；1个 RCT显示参仙升脉口服液组显著缩短心电图窦房结恢复时间(SNRT)与窦房传导时间(SACT)；1个 RCT未发现参仙升脉口服液组心电图 PR间期和 QRS波时限的差异。各研究中不良事件及安全性指标未见显著性差异。结论参仙升脉口服液可能对窦性心动过缓患者临床疗效提高、心率提升等有效安全。但由于纳入试验研究的方法学质量普遍较低,期待更多设计合理、方法科学的大样本多中心随机对照临床试验,提供高质量的证据。
목적：계통평개삼선승맥구복액치료두성심동과완적림상료효급안전성。방법전자검색 CNKI、VIP、CBM、Wan Fang Data、PubMed、The Cochrane Library、Embase,사조유관삼선승맥구복액치료두성심동과완적림상료효급안전성적 RCT시험,검색시한위2000년4월(림상응용)—2014년11월。유량명연구인원근거납입화배제표준독립사선문헌、제취자료화평개질량,채용RevMan5.3진행계통평개。평개지표：림상료효、평균심솔、최저심솔화불량반응등。결과공납입5개수궤대조연구,포괄환자453례。묘술성분석결과현시：여대조조비교,3개 RCT표명삼선승맥구복액가명현제고두성심동과완림상료효；분별유4개、1개、3개 RCT현시삼선승맥구복액가현저제승환자동태심전도중평균심솔、24 h총심솔수、최저심솔；1개 RCT현시삼선승맥구복액조현저축단심전도두방결회복시간(SNRT)여두방전도시간(SACT)；1개 RCT미발현삼선승맥구복액조심전도 PR간기화 QRS파시한적차이。각연구중불량사건급안전성지표미견현저성차이。결론삼선승맥구복액가능대두성심동과완환자림상료효제고、심솔제승등유효안전。단유우납입시험연구적방법학질량보편교저,기대경다설계합리、방법과학적대양본다중심수궤대조림상시험,제공고질량적증거。
Objective To systematical y review the clinical effects and safety of Shenxian Shengmai oral liquid (SSOL) for treatment of sinus bradycardia.Methods We searched in CNKI,VIP,CBM,Wan Fang DATA,PubMed,The Cochrane Library ,Embase,and other relevant databases,journals,Internet,proceeding and manufacturer data to identify randomized control ed trials (RCTs)on SSOL for treatment of sinus bradycardia from April 2000(clinical application)to November 2014.Two reviewers independently screened the liter-ature according to the inclusion and exclusion criteria,extracted the data,and assessed the methodological quality.Meta analyses were performed using RevMan 5. 3 software. The evaluation indexes included clinical therapeutic effects,mean heart rate,minimal heart rate,adverse events and safety indicators,etc. Results Five eligible studies included 453 patients. Compared with control groups,the results of descriptive analysis showed that SSOL group could precisely improve the clinical therapeutic effects in 3 RCTs. The results pointed out that SSOL could separately promote mean heart rate in 4 RCTs,total heart rate in 1 RCTs,minimal heart rate in 3 RCTs from Holter Monitor system.1 RCT revealed that SSOL group could obviously reduce SNRT,SACT in the bedside ECG.1 RCT showed that SSOL had rarely change than western medicine alone on the electrocardiogram PR interval and QRS duration.Ad-verse events and safety indicators were also not significantly different in RCTs above.Conclusion SSOL may be effective and safe for the patients of sinus bradycardia in improving the clinical symptoms and Increasing the heart rate.However,the methodological quality of study was low.The current evidence was insufficient to define the efficacy of the treatment,and further large scale,high quality randomized control ed trials were needed.