现代中西医结合杂志
現代中西醫結閤雜誌
현대중서의결합잡지
MODERN JOURNAL OF INTEGRATED TRADITIONAL CHINESE AND WESTERN MEDICINE
2014年
35期
3888-3894
,共7页
刘辽%周渝敏%杨代喜%程玲%王时芬
劉遼%週渝敏%楊代喜%程玲%王時芬
류료%주투민%양대희%정령%왕시분
红景天注射液%心绞痛%系统评价%Meta 分析%随机对照试验
紅景天註射液%心絞痛%繫統評價%Meta 分析%隨機對照試驗
홍경천주사액%심교통%계통평개%Meta 분석%수궤대조시험
rhadiola injection%angina pectoris%systematic review%Meta -analysis%randomized controlled trial
目的：系统评价红景天注射液治疗心绞痛的疗效及安全性。方法计算机检索 PubMed、Embase、Cochrane Library、CNKI、万方及 VIP 数据库中所有红景天注射液治疗心绞痛的疗效及安全性的随机对照研究，按照纳入和排除标准筛选文献、提取资料，并依据 Co－chrane Handbook 5．0．1的质量评价标准评价纳入研究的方法学质量。主要结果包括疾病疗效、心绞痛疗效、心电图疗效、中医证候总积分及不良反应。根据异质性检验结果选择固定效应模型或随机效应模型进行 Meta 分析。结果共纳入12个随机对照试验，合计1442例患者。 Meta 分析主要结果显示：①红景天注射液＋西医常规治疗组与西医常规治疗组比较，疾病疗效（RR ＝1．27，95％CI（1．09，1．48））、心绞痛疗效（RR ＝1．25，95％CI（1．14，1．38））及心电图疗效（RR ＝1．21，95％CI（1．10，1．34））差异均有统计学意义。②红景天注射液组与复方丹参注射液组比较，疾病疗效（RR ＝1．25，95％CI（1．04，1．50））、心电图疗效（RR ＝1．28，95％CI（1．09，1．50））及中医证候疗效（RR ＝1．09，95％CI（1．00，1．18））差异均有统计学意义，然而心绞痛疗效差异无统计学意义（RR ＝1．10，95％CI（0．92，1．32））；与血塞通注射液组比较，心绞痛疗效（RR ＝1．08，95％CI（0．84，1．39））及心电图疗效（RR ＝1．13，95％CI（0．87，1．47））差异均无统计学意义。③红景天注射液组与单硝酸异山梨酯组比较，心绞痛疗效（RR ＝1．06，95％CI（0．96，1．16））及心电图疗效（RR ＝1．04，95％CI（0．97，1．11））差异均无统计学意义。治疗期间未发现严重不良反应。结论现有证据表明，红景天注射液治疗心绞痛有一定疗效且相对安全。但受纳入研究的质量影响解释结果应谨慎，尚需严格、高质量的临床试验进一步证实。
目的：繫統評價紅景天註射液治療心絞痛的療效及安全性。方法計算機檢索 PubMed、Embase、Cochrane Library、CNKI、萬方及 VIP 數據庫中所有紅景天註射液治療心絞痛的療效及安全性的隨機對照研究，按照納入和排除標準篩選文獻、提取資料，併依據 Co－chrane Handbook 5．0．1的質量評價標準評價納入研究的方法學質量。主要結果包括疾病療效、心絞痛療效、心電圖療效、中醫證候總積分及不良反應。根據異質性檢驗結果選擇固定效應模型或隨機效應模型進行 Meta 分析。結果共納入12箇隨機對照試驗，閤計1442例患者。 Meta 分析主要結果顯示：①紅景天註射液＋西醫常規治療組與西醫常規治療組比較，疾病療效（RR ＝1．27，95％CI（1．09，1．48））、心絞痛療效（RR ＝1．25，95％CI（1．14，1．38））及心電圖療效（RR ＝1．21，95％CI（1．10，1．34））差異均有統計學意義。②紅景天註射液組與複方丹參註射液組比較，疾病療效（RR ＝1．25，95％CI（1．04，1．50））、心電圖療效（RR ＝1．28，95％CI（1．09，1．50））及中醫證候療效（RR ＝1．09，95％CI（1．00，1．18））差異均有統計學意義，然而心絞痛療效差異無統計學意義（RR ＝1．10，95％CI（0．92，1．32））；與血塞通註射液組比較，心絞痛療效（RR ＝1．08，95％CI（0．84，1．39））及心電圖療效（RR ＝1．13，95％CI（0．87，1．47））差異均無統計學意義。③紅景天註射液組與單硝痠異山梨酯組比較，心絞痛療效（RR ＝1．06，95％CI（0．96，1．16））及心電圖療效（RR ＝1．04，95％CI（0．97，1．11））差異均無統計學意義。治療期間未髮現嚴重不良反應。結論現有證據錶明，紅景天註射液治療心絞痛有一定療效且相對安全。但受納入研究的質量影響解釋結果應謹慎，尚需嚴格、高質量的臨床試驗進一步證實。
목적：계통평개홍경천주사액치료심교통적료효급안전성。방법계산궤검색 PubMed、Embase、Cochrane Library、CNKI、만방급 VIP 수거고중소유홍경천주사액치료심교통적료효급안전성적수궤대조연구，안조납입화배제표준사선문헌、제취자료，병의거 Co－chrane Handbook 5．0．1적질량평개표준평개납입연구적방법학질량。주요결과포괄질병료효、심교통료효、심전도료효、중의증후총적분급불량반응。근거이질성검험결과선택고정효응모형혹수궤효응모형진행 Meta 분석。결과공납입12개수궤대조시험，합계1442례환자。 Meta 분석주요결과현시：①홍경천주사액＋서의상규치료조여서의상규치료조비교，질병료효（RR ＝1．27，95％CI（1．09，1．48））、심교통료효（RR ＝1．25，95％CI（1．14，1．38））급심전도료효（RR ＝1．21，95％CI（1．10，1．34））차이균유통계학의의。②홍경천주사액조여복방단삼주사액조비교，질병료효（RR ＝1．25，95％CI（1．04，1．50））、심전도료효（RR ＝1．28，95％CI（1．09，1．50））급중의증후료효（RR ＝1．09，95％CI（1．00，1．18））차이균유통계학의의，연이심교통료효차이무통계학의의（RR ＝1．10，95％CI（0．92，1．32））；여혈새통주사액조비교，심교통료효（RR ＝1．08，95％CI（0．84，1．39））급심전도료효（RR ＝1．13，95％CI（0．87，1．47））차이균무통계학의의。③홍경천주사액조여단초산이산리지조비교，심교통료효（RR ＝1．06，95％CI（0．96，1．16））급심전도료효（RR ＝1．04，95％CI（0．97，1．11））차이균무통계학의의。치료기간미발현엄중불량반응。결론현유증거표명，홍경천주사액치료심교통유일정료효차상대안전。단수납입연구적질량영향해석결과응근신，상수엄격、고질량적림상시험진일보증실。
Objective It is to systematically assess the clinical effectiveness and safety of rhadiola injection for angina pec-toris.Methods The databases such as PubMed,Embase,Cochrane Library,CNKI,WanFang and VIP were searched to collect all randomized control trials(RCTs)about the clinical effectiveness and safety of rhadiola injection for angina pectoris.Litera-tures were screened according to the inclusive and exclusive criteria,the data were extracted,the methodological quality of the included studies was assessed in line with Cochrane Handbook 5.0.1.The primary outcome measure including therapeutic effect, angina treatment effect, electrocardiogram ( ECG) curative effect, general integral of traditional Chinese medicine (TCM) symptoms and adverse drug reaction.The meta-analysis was performed with the fixed -effect model or random-effect model according to heterogeneity.Results Twelve RCTs with 1442 patients were included.The outcomes of meta-analyses showed that, ①rhadiola injection plus western drugs vs.western drugs alone: compared with western drugs alone, significant differences were found in the therapeutic effect (RR =1.27, 95%CI(1.09,1.48)), angina treatment effect (RR =1.25, 95%CI(1.14,1.38)), and ECG measurements(RR =1.21, 95%CI(1.10,1.34)).②rhadiola injection vs.other TCM:compared with ompound Salvia militorrhiza (danshen) injection, significant differences were found in the therapeutic effect (RR =1.25, 95%CI(1.04,1.50)), ECG measurements (RR =1.28, 95%CI(1.09,1.50)), and general integral of TCM symptoms(RR =1.09, 95%CI(1.00,1.18)).while, angina treatment effect was not significantly different(RR =1.10, 95%CI(0.92,1.32));compared with Xuesaitong injection, no significant differences was found in the angina treatment effect (RR =1.25, 95%CI(1.04,1.50)), ECG measurements(RR =1.13, 95%CI(0.87,1.47)).③ rhadiola injection vs. isosorbide mononitrate: there was no significant difference both for ECG improvement(RR =1.08, 95%CI(0.84,1.39))and for angina treatment effect (RR =1.06, 95%CI(0.96,1.16)).No severe adverse events were found in all included studies. Conclusion As the current evidence shows, rhadiola injection has some effects and is relatively safe to treat angina pectoris. <br> However,the results should be interpreted with caution because of the low quality of the induded studies.more rigorous trials with high quality are needed to give high level of evidence.
