口服中药治疗舒张性心衰随机对照试验的系统评价
摘要
研究背景：近20年流行病学研究显示,舒张性心衰(di as to lic hear t failure, DHF)约占全部心衰患者的一半,发病率呈逐年上升趋势,病死率与收缩性心衰(systol ic heart failure, SHF)相当。同时,DHF以老年人居多在社会人口老龄化的背景下其发病人数和死亡人数的绝对值有可能会超过SHF,防治形势不容乐观。20世纪90年代以来,心衰的治疗取得了重大突破,目前国际上有关临床诊疗指南一致推荐,慢性心衰的治疗应是以神经内分泌拮抗剂(即ACEI、β受体阻滞剂、利尿剂)为主的或再加上地高辛的四大类药物的联合应用。近二十年来国内外虽然进行了一系列西药治疗DHF的临床试验,然而迄今为止尚无以循证医学为基础的治疗方案可以逆转DHF患者病情的演变及结局,以上药物改善慢性心衰预后的有益作用,似乎仅限于SHF,而DHF患者并不能受益。面对DHF日益增长的发病率和死亡率以及所遭遇的治疗困境,加强临床研究势在必行。近十年的中医实践提示,采用口服中药治疗DHF不仅可以缓解症状,改善预后,而且能延长患者生存期并提高生存质量,具有一定的优势和特色。但是,这些研究的质量和疗效尚未得到系统评价,目前还没有符合循证医学要求的试验证据,这在一定程度上影响了中药的推广和应用。
研究目的：本研究拟对目前口服中药干预DHF的随机对照临床试验(randomized clinical trial, RCT)进行系统评价,以期为.口服中药治疗DHF的疗效和安全性提供可靠的循证医学证据,也为今后该领域的临床研究提供指导与借鉴。
研究方法：对国内外6个电子资料库从建库日期开始到2012年12月31日进行全面和系统的检索,无语言限制。纳入研究类型为RCT；研究对象为符合诊断标准的DHF患者；治疗组干预措施为口服单味中药、中药复方汤剂、中成药,或者是以上类型中药的组合,对照组可以为安慰剂、不治疗或西医常规治疗,对于联合用药的试验也予以纳入,只要两组给予相同的治疗方法或药物,疗程至少4周；评价的主要结局指标为全因死亡及心血管病相关死亡、因心衰造成的再次住院、不良反应和生活质量,替代结局指标为心脏舒张功能指标NYHA心功能疗效总有效率、6MWT、 BNP或NT-proBNP资料筛选和提取由两名研究员独立完成。分别采用改良后的Jadad量表以及Cochrane风险偏倚评估标准对纳入文献进行质量评估。应用Cochrane协作网提供的RevMan5.2软件对纳入文献的干预措施效应进行meta分析,等级变量数据的效应值采用相对危险度或比值比,连续型变量数据的效应值采用标准化均数差,以95%的可信区间表示；使用Q检验和计算I2值分析纳入研究之间的异质性,采用随机效应模型合并效应值；根据可能导致异质性的因素进行亚组分析；以敏感性分析评估结果的稳定性；作漏斗图对是否存在发表偏倚进行分析
研究结果：①本研究共纳入22篇比较口服中药联合西医常规治疗(试验组)和单独应用西医常规治疗(对照组)的RCT,组间基线可比,均由一个中心完成,全部为中文发表。②改良后的Jadad评分结果显示,较高质量文献6篇(4分),低质量文献16篇(2-3分)；Cochrane风险偏倚评估显示,全部试验均存在高风险偏倚。③关于主要结局指标,仅有1篇试验报告了对照组1例死亡,无法判断干预措施对死亡的影响；6篇试验报告了试验过程中的不良事件情况,提示口服中药联合西医常规治疗组与单独西医常规治疗组均未发生严重的不良反应。对采用明尼苏达生活质量问卷调查表评价疗效的试验进行meta分析显示,加用中药干预对改善患者生活质量优于常规西药治疗(P<0.0001)。④关于次要结局指标的meta分析显示,与对照组相比,治疗后试验组明显改善E/A比值、IVRT (P值分别为0.003、0.0002)；加用中药干预组对LAD缩小优于常规西药组(P=0.02)；试验组治疗后心功能疗效总有效率及6MWT提高均明显优于对照组(P<0.00001)；治疗后试验组与对照组对患者NT-BNP的影响没有统计学差异(P=0.11),但试验组降低BNP水平优于对照组(P=0.0001)。敏感性分析提示以上结果较稳定。基于E/A比值的亚组分析提示,加用中药干预治疗1m与单独西医常规治疗相比对E/A比值影响无统计学差异(P=0.63),疗程2m试验组提高E/A比值优于对照组(P=0.01),疗程3m、6m试验组提高E/Λ比值显著优于对照组(P=0.006、P<0.00001)；与对照组相比,加甩中成药能明显改善E/A比值(P<0.0001),而加用复方汤药对改善E/A比值无统计学差异(P=0.63)。基于LAD的亚组分析提示,与单独西医常规治疗相比,口服中药联合西医常规治疗2m、3m对LAD的影响无统计学差异(P值分别为0.35、0.22),试验组疗程6m对LAD的改善明显优于对照组(P<0.0001)。倒漏斗图提示存在发表偏倚。
研究结论：.口服中药联合西医常规治疗在改善DHF患者舒张功能、症状体征、运动耐力以及提高患者生活质量等方面优于西医常规治疗,疗程越长对舒张功能的改善越有益。受纳入试验数量和质量限制,仅以本系统评价为基础,尚不能对口服中药治疗DHF的疗效和安全性作出最终的结论。未来应继续开展口服中药治疗DHF的随机对照临床试验,优化设计力案,关注终点结局,鼓励安慰剂对照,严格管理试验实施过程,并参照CONSORT系列声明的条目规范撰写试验报告
Background:
According to the epidemio logical studies of recent20years,nearly half of the heart failure patients have diastolic heart failure (DHF) and the morbidity of DHF is rising yearly as the mortality of DHF close to systolic heart failure (SHF). Meanwhile, DHF is prevalent among elderly. With the development of aging society, the number of patients and death of DHF could exceed SHF in the future and the prevention and treatment of DHF could not be optimistic. Although researchers have already published a series of clinical trials of the treatment of DHF in the recent20years, there is not any treatment regimen which could reverse the process and result of the DHF patients based on EBM.The beneficial effect of drugs on chronic heart failure seem to be limited to SHF,and DHF patients could not benefit from them, so it is imperative to strengthen clinical research.In recent10years, the treatment of oral TCM could not only relieve symptoms, improve prognosis,but also prolong the survival time and improve the living quality of DHF patients, which means oral TCM has advantages and characteristics in the treatment of DHF. However, the quality and efficacy of these studies has not been evaluated systematically and the absence of clinical trail evidence meeting the requirements of EBM has affected the promotion and application of TCM.
Object ive:
To evaluate the effect of oral TCM in the RCTs of DHF systematically, provide reliable evidence of EBM about the efficacy and safety of oral TCM treatment of DHF and provide guidance and reference for the clinical research in this field.
Methods:
CENTRAL, MEDLINE,CNKI,CBM, VIP and Wan fang Database were searched from bui lding datc to Dec31,2012,without language l imit.The type of rev i ewed studies was RCT and the object was the patients accorded with DHF diagnostic standard.The interventions for the experimental group included taking single Chinese herb,Chinese herbal compound,Chinese patent medicine or combinations of above, as for the control group include taking placebo,no treatment, routine treatment or combined treatment in which the two groups given the same treatment or medication, treatment for at least4weeks.The main outcome evaluation indicators and the Surrogate outcome evaluation indicators were identified. Modified Jadad scale and Cochrane risk bias evaluation criteria were used respectively to evaluate the quality of reviewed studies.A meta analysis was performed by RevMan5.2to evaluate the intervention effect of reviewed studies.The efficient rate of categorical variable was described by RR or OR and the data of continuous variable was described by SMD with a95%confidence interval.Q test and calculation of I2were used to analyse the heterogeneity between studics,which was described by random effect model merge effect va1ue. Sub-group analysis was proposed by the heterogeneity factors. Sensitivity analysis was used to assess the stability of the results.A funnel chart was made to analyse if there was publication bias.
Results:(1)This study included22RCTs which compared the combined treatment of TCM and drugs (experimenta1group)with the routine treatment alone (control group), the baseline was comparable between groups.These trials were performed by one center and all published in Chinese.(2) As the result of modified Jadad scale, there were6studies in high quality (4points),16studies in1ow-qua1ity (2-3points); According to Cochrane risk bias evaluation, all of the studies had high risk of bias.(3) According to the main outcome indicators, only1study reported a death case in control group, which made it difficult to evaluate the effcct of interventions on dcath.6trials reported adverse reaction in the process of test, which indicated that neither experimental group nor control group could induce serious adverse reactions. According to the meta analysis of the trails evaluating curative effect by Minnesota Living with Heart Failure Questionnaire, the effect of the experimental group is superior to the control group (P<0.0001).(4) According to the meta analysis of surrogate outcome indicators, compared with the control group, B/A ratio, I VRT, LAD,NY HA heart function and6MWT of the experimental group were improved significantly (P=0.003, P=0.0002, P=0.02, P<0.00001, P<0.00001). The difference of NT-BNP level between the experimental group and control group was not statistically significant (P=0.11), but the decline of BNP level of experimental group was more than that of control group (P=0.0001). Sensitivity analysis indicated that above results were relatively stable. According to the sub-group analysis, there was no statistical difference of E/A ratio between the experimental group and the control group for1month (P=0.63). The experimental group for2months increased more E/A ratio than the control group (P=0.01). The experimental group for3,6months increased more E/A ratio than the control group significantly (P=0.006, P<0.00001). According to the sub-group analysis based on LAD, compared to the control group, the effect of the experimental group for2,3months had no statistical difference (P=0.35, P=0.22), but the effect of the experimental group of6months was significantly decreased (P<0.0001). The funnel chart suggested there was publication bias.
Conelus ion:
Overall,.the report about TCM treatment of DHF is not normative and a mount of quality problems exist, which affects the reliability of conclusion. Studies suggest that the treatment combined with TCM and western medicine could improve patient.s with diastolic function indexes, symptoms and signs, exercise endurance, BNP level and living quality better than the western medicine routine treatment. Besides, with the course extending, the effect of combined treatment on E/A ratio and LAD is more significant, without any serious adverse reaction. However, based on this system review it is difficult to make a final conclusion in the efficacy and safety of TCM treatment of DHF. More randomized double-blind, placebo-controlled trials are required to be designed, performed and reported normatively to prove its curative effect.
研究目的：本研究拟对目前口服中药干预DHF的随机对照临床试验(randomized clinical trial, RCT)进行系统评价,以期为.口服中药治疗DHF的疗效和安全性提供可靠的循证医学证据,也为今后该领域的临床研究提供指导与借鉴。
研究方法：对国内外6个电子资料库从建库日期开始到2012年12月31日进行全面和系统的检索,无语言限制。纳入研究类型为RCT；研究对象为符合诊断标准的DHF患者；治疗组干预措施为口服单味中药、中药复方汤剂、中成药,或者是以上类型中药的组合,对照组可以为安慰剂、不治疗或西医常规治疗,对于联合用药的试验也予以纳入,只要两组给予相同的治疗方法或药物,疗程至少4周；评价的主要结局指标为全因死亡及心血管病相关死亡、因心衰造成的再次住院、不良反应和生活质量,替代结局指标为心脏舒张功能指标NYHA心功能疗效总有效率、6MWT、 BNP或NT-proBNP资料筛选和提取由两名研究员独立完成。分别采用改良后的Jadad量表以及Cochrane风险偏倚评估标准对纳入文献进行质量评估。应用Cochrane协作网提供的RevMan5.2软件对纳入文献的干预措施效应进行meta分析,等级变量数据的效应值采用相对危险度或比值比,连续型变量数据的效应值采用标准化均数差,以95%的可信区间表示；使用Q检验和计算I2值分析纳入研究之间的异质性,采用随机效应模型合并效应值；根据可能导致异质性的因素进行亚组分析；以敏感性分析评估结果的稳定性；作漏斗图对是否存在发表偏倚进行分析
研究结果：①本研究共纳入22篇比较口服中药联合西医常规治疗(试验组)和单独应用西医常规治疗(对照组)的RCT,组间基线可比,均由一个中心完成,全部为中文发表。②改良后的Jadad评分结果显示,较高质量文献6篇(4分),低质量文献16篇(2-3分)；Cochrane风险偏倚评估显示,全部试验均存在高风险偏倚。③关于主要结局指标,仅有1篇试验报告了对照组1例死亡,无法判断干预措施对死亡的影响；6篇试验报告了试验过程中的不良事件情况,提示口服中药联合西医常规治疗组与单独西医常规治疗组均未发生严重的不良反应。对采用明尼苏达生活质量问卷调查表评价疗效的试验进行meta分析显示,加用中药干预对改善患者生活质量优于常规西药治疗(P<0.0001)。④关于次要结局指标的meta分析显示,与对照组相比,治疗后试验组明显改善E/A比值、IVRT (P值分别为0.003、0.0002)；加用中药干预组对LAD缩小优于常规西药组(P=0.02)；试验组治疗后心功能疗效总有效率及6MWT提高均明显优于对照组(P<0.00001)；治疗后试验组与对照组对患者NT-BNP的影响没有统计学差异(P=0.11),但试验组降低BNP水平优于对照组(P=0.0001)。敏感性分析提示以上结果较稳定。基于E/A比值的亚组分析提示,加用中药干预治疗1m与单独西医常规治疗相比对E/A比值影响无统计学差异(P=0.63),疗程2m试验组提高E/A比值优于对照组(P=0.01),疗程3m、6m试验组提高E/Λ比值显著优于对照组(P=0.006、P<0.00001)；与对照组相比,加甩中成药能明显改善E/A比值(P<0.0001),而加用复方汤药对改善E/A比值无统计学差异(P=0.63)。基于LAD的亚组分析提示,与单独西医常规治疗相比,口服中药联合西医常规治疗2m、3m对LAD的影响无统计学差异(P值分别为0.35、0.22),试验组疗程6m对LAD的改善明显优于对照组(P<0.0001)。倒漏斗图提示存在发表偏倚。
研究结论：.口服中药联合西医常规治疗在改善DHF患者舒张功能、症状体征、运动耐力以及提高患者生活质量等方面优于西医常规治疗,疗程越长对舒张功能的改善越有益。受纳入试验数量和质量限制,仅以本系统评价为基础,尚不能对口服中药治疗DHF的疗效和安全性作出最终的结论。未来应继续开展口服中药治疗DHF的随机对照临床试验,优化设计力案,关注终点结局,鼓励安慰剂对照,严格管理试验实施过程,并参照CONSORT系列声明的条目规范撰写试验报告
Background:
According to the epidemio logical studies of recent20years,nearly half of the heart failure patients have diastolic heart failure (DHF) and the morbidity of DHF is rising yearly as the mortality of DHF close to systolic heart failure (SHF). Meanwhile, DHF is prevalent among elderly. With the development of aging society, the number of patients and death of DHF could exceed SHF in the future and the prevention and treatment of DHF could not be optimistic. Although researchers have already published a series of clinical trials of the treatment of DHF in the recent20years, there is not any treatment regimen which could reverse the process and result of the DHF patients based on EBM.The beneficial effect of drugs on chronic heart failure seem to be limited to SHF,and DHF patients could not benefit from them, so it is imperative to strengthen clinical research.In recent10years, the treatment of oral TCM could not only relieve symptoms, improve prognosis,but also prolong the survival time and improve the living quality of DHF patients, which means oral TCM has advantages and characteristics in the treatment of DHF. However, the quality and efficacy of these studies has not been evaluated systematically and the absence of clinical trail evidence meeting the requirements of EBM has affected the promotion and application of TCM.
Object ive:
To evaluate the effect of oral TCM in the RCTs of DHF systematically, provide reliable evidence of EBM about the efficacy and safety of oral TCM treatment of DHF and provide guidance and reference for the clinical research in this field.
Methods:
CENTRAL, MEDLINE,CNKI,CBM, VIP and Wan fang Database were searched from bui lding datc to Dec31,2012,without language l imit.The type of rev i ewed studies was RCT and the object was the patients accorded with DHF diagnostic standard.The interventions for the experimental group included taking single Chinese herb,Chinese herbal compound,Chinese patent medicine or combinations of above, as for the control group include taking placebo,no treatment, routine treatment or combined treatment in which the two groups given the same treatment or medication, treatment for at least4weeks.The main outcome evaluation indicators and the Surrogate outcome evaluation indicators were identified. Modified Jadad scale and Cochrane risk bias evaluation criteria were used respectively to evaluate the quality of reviewed studies.A meta analysis was performed by RevMan5.2to evaluate the intervention effect of reviewed studies.The efficient rate of categorical variable was described by RR or OR and the data of continuous variable was described by SMD with a95%confidence interval.Q test and calculation of I2were used to analyse the heterogeneity between studics,which was described by random effect model merge effect va1ue. Sub-group analysis was proposed by the heterogeneity factors. Sensitivity analysis was used to assess the stability of the results.A funnel chart was made to analyse if there was publication bias.
Results:(1)This study included22RCTs which compared the combined treatment of TCM and drugs (experimenta1group)with the routine treatment alone (control group), the baseline was comparable between groups.These trials were performed by one center and all published in Chinese.(2) As the result of modified Jadad scale, there were6studies in high quality (4points),16studies in1ow-qua1ity (2-3points); According to Cochrane risk bias evaluation, all of the studies had high risk of bias.(3) According to the main outcome indicators, only1study reported a death case in control group, which made it difficult to evaluate the effcct of interventions on dcath.6trials reported adverse reaction in the process of test, which indicated that neither experimental group nor control group could induce serious adverse reactions. According to the meta analysis of the trails evaluating curative effect by Minnesota Living with Heart Failure Questionnaire, the effect of the experimental group is superior to the control group (P<0.0001).(4) According to the meta analysis of surrogate outcome indicators, compared with the control group, B/A ratio, I VRT, LAD,NY HA heart function and6MWT of the experimental group were improved significantly (P=0.003, P=0.0002, P=0.02, P<0.00001, P<0.00001). The difference of NT-BNP level between the experimental group and control group was not statistically significant (P=0.11), but the decline of BNP level of experimental group was more than that of control group (P=0.0001). Sensitivity analysis indicated that above results were relatively stable. According to the sub-group analysis, there was no statistical difference of E/A ratio between the experimental group and the control group for1month (P=0.63). The experimental group for2months increased more E/A ratio than the control group (P=0.01). The experimental group for3,6months increased more E/A ratio than the control group significantly (P=0.006, P<0.00001). According to the sub-group analysis based on LAD, compared to the control group, the effect of the experimental group for2,3months had no statistical difference (P=0.35, P=0.22), but the effect of the experimental group of6months was significantly decreased (P<0.0001). The funnel chart suggested there was publication bias.
Conelus ion:
Overall,.the report about TCM treatment of DHF is not normative and a mount of quality problems exist, which affects the reliability of conclusion. Studies suggest that the treatment combined with TCM and western medicine could improve patient.s with diastolic function indexes, symptoms and signs, exercise endurance, BNP level and living quality better than the western medicine routine treatment. Besides, with the course extending, the effect of combined treatment on E/A ratio and LAD is more significant, without any serious adverse reaction. However, based on this system review it is difficult to make a final conclusion in the efficacy and safety of TCM treatment of DHF. More randomized double-blind, placebo-controlled trials are required to be designed, performed and reported normatively to prove its curative effect.
引文
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