丹参川芎嗪注射液治疗慢性肺源性心脏病Meta分析

Meta analysis of calviae miltiorrhizae and ligustrazine hydrochloride injection in treatment of chronic pulmonary heart disease

目的采用Meta分析方法评价丹参川芎嗪注射液治疗慢性肺源性心脏病(CCP)的临床疗效和安全性。方法计算机及手工检索以丹参川芎嗪注射液为干预措施治疗CCP的随机对照研究。所有研究均在中国大陆进行,其中对照组(C组)患者予以常规治疗,治疗组(T组)患者在此基础上静脉滴注丹参川芎嗪注射液。由2名研究者按纳入与排除标准独立选择研究、交叉核对、评价质量、提取数据,并进行数据分析。二分类变量采用比值比(OR)作为分析统计量,且所有分析均计算其95%可信区间(95%CI)。结果最终纳入17项随机对照研究,均为Jadad评分小于3分的低质量中文研究,共计1 429例患者,C组684例,T组745例。Meta分析结果显示,T组治疗CCP有效率[90.1%(583/647)]优于C组[72.4%(417/576)],差异有统计学意义[OR=3.95,95%CI(2.77,5.63),P<0.01],且安全性良好。以每天注射液剂量5、10、20 m L做亚组分析,剂量为10 m L/d静脉滴注效果最佳,与C组比较,差异有统计学意义[OR=4.28,95%CI(2.89,6.32),P<0.01]。与C组比较,T组更有效改善肺源性心脏病患者血气、肺动脉收缩压、左心室射血分数及血液流变学等指标。结论丹参川芎嗪注射液治疗CCP疗效较好,且不良反应发生率低,通过改善CCP患者血气、肺动脉高压、左心室射血分数和血流流变学等多个途径发挥作用。

Objective To evaluate the clinical curative effects and safety of salviae miltiorrhizae and ligustrazine hy-drochloride injection on chronic pulmonary heart disease by a Meta analysis. Methods The documents on salviae miltiorrhizae and ligustrazine hydrochloride injection in the treatment of CCP were randomly comprised and searched by computer and hand ,all of which were engaged in Chinese Mainland,including the treatment group（group T） and the control group（group C）. The group C was given regular treatment while the group T with salviae miltiorrhizae and ligustrazine hydrochloride injection based on it. Two researchers were conducted independently the qualified researches selection according to the inclusion and exclusion criterias , cross-check,quality assessment,data extraction and data analysis. The binary variables were adopted OR as analysis statistics, which were all within 95%confidence interval. Results A total of 17 randomly controlled studies were low-quality in Chinese with their Jadad score less than 3 points including 1 429 patients ,684 cases in group C and 745 cases in group T. Meta analysis showed that the effective rate[90.1%（583/647）] in group T in treatment of CCP was better than that of the group C[72.4%（417/576）], whose difference was statistically significant[OR=3.95,95%CI（2.77,5.63）,P＜0.01] but its safety was good. Analyzing the sub-groups with the dose of 5,10,20 ml per day,the best way is intravenous with 10 mL/d. Compared with the group C,the differ-ences had statistic significance[OR=4.28,95%CI（2.89,6.32）,P＜0.01]. Compared with group C,it was more effective in improving the indicators such as blood gas analysis,pulmonary arterial systolic pressure,left ventricular ejection fraction and blood rheology. Conclusion Salviae miltiorrhizae and ligustrazine hydrochloride injection had a better effect in the adjuvant treatment of CCP with a low incidence rate of adverse reactions,which really works by blood gas analysis,pulmonary arterial systolic pressure,left ventricular ejection fraction and blood rheology.