CAJ | 학술논문

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1429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 mL做亚组分析，剂量为10 mL/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。
목적：채용Meta분석방법평개단삼천궁진주사액치료만성폐원성심장병（CCP）적림상료효화안전성。방법계산궤급수공검색이단삼천궁진주사액위간예조시치료CCP적수궤대조연구。소유연구균재중국대륙진행，기중대조조（C조）환자여이상규치료，치료조（T조）환자재차기출상정맥적주단삼천궁진주사액。유2명연구자안납입여배제표준독립선택연구、교차핵대、평개질량、제취수거，병진행수거분석。이분류변량채용비치비（OR）작위분석통계량，차소유분석균계산기95%가신구간（95%CI）。결과최종납입17항수궤대조연구，균위Jadad평분소우3분적저질량중문연구，공계1429례환자，C조684례，T조745례。Meta분석결과현시，T조치료CCP유효솔[90.1%（583/647）]우우C조[72.4%（417/576）]，차이유통계학의의[OR=3.95，95％CI（2.77，5.63），P＜0.01]，차안전성량호。이매천주사액제량5、10、20 mL주아조분석，제량위10 mL/d정맥적주효과최가，여C조비교，차이유통계학의의[OR=4.28，95％CI（2.89，6.32），P＜0.01]。여C조비교，T조경유효개선폐원성심장병환자혈기、폐동맥수축압、좌심실사혈분수급혈액류변학등지표。결론단삼천궁진주사액치료CCP료효교호，차불량반응발생솔저，통과개선CCP환자혈기、폐동맥고압、좌심실사혈분수화혈류류변학등다개도경발휘작용。
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.