中药治疗复发性流产的系统综述和方法学研究
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摘要
1研究背景
复发性流产(recurrent miscarriage)是妇科临床较为常见的疾病,其发生率为5%左右。目前,现代医学对复发性流产尚缺乏理想的治疗措施。而中医对复发性流产的认识和治疗具有悠久的历史,历代中医文献记载了丰富宝贵的诊治经验。近20余年来,许多中医药治疗复发性流产的临床研究报告也不断被发表,为临床实践提供了大量的证据,但尚未见到对这些文献的严格评价和系统综述。
2研究目的
全面系统地检索中药治疗复发性流产的随机对照试验和非随机临床对照试验,总结临床研究的证据现状,评价中药对比西药或不同中药治疗复发性流产的疗效和安全性,为临床提供高级别的循证医学证据。并探讨纳入的临床研究中存在的方法学问题,从循证医学的角度,提出相应的设计和报告的改进建议,以期提高国内中药治疗复发性流产的临床研究质量,从而为临床创造更好的证据,使中医临床研究成果得到广泛的认可和应用。
3研究方法
本研究采用Cochrane系统综述的研究方法,对检索纳入的随机对照试验和非随机临床对照试验进行方法学质量评价、资料提取、数据分析和结果报告,并讨论研究结果和临床研究存在的方法学问题,提出改进建议。具体如下：
检索策略：检索电子数据库中国知网、重庆维普中文科技期刊数据库、中国生物医学文献数据库网络版、万方数据、PubMed和Cochrane Library(2011年第12期)。各数据库均从起建库日期开始检索,至2012年1月12日。
纳入标准：所有评价中药治疗复发性流产疗效和安全性的临床对照试验,包括随机对照试验和非随机临床对照试验均被纳入。各研究纳入的研究对象为自然流产连续发生2次或2次以上的患者,采用中药作为治疗组的干预措施,与西药或其他中药治疗进行比较,结局指标为活产率、胚胎发育情况、与复发性流产相关的实验室检查指标,以及不良事件。
资料提取和分析：由两名研究者独立提取资料,参考Cochrane协作网的偏倚风险评估标准评价纳入研究的方法学质量,参考CONSORT声明进行纳入研究的设计和报告质量的评价。采用RevMan5.1.4软件对主要结局指标进行分析。离散型变量资料采用相对危险度(risk ratio, RR),连续性变量资料采用均差(mean difference, MD)作为效应评价,并提供95.0%可信区间(confidence interval, CI)表示结果。如有两项或两项以上研究的治疗和对照措施一致,且报告了相同结局,则进行Meta分析,检验异质性,选择相应的效应模型。
4研究结果
共计63项研究被纳入到本系统综述,其中随机对照试验49项,非随机临床对照试验14项,共有5266名复发性流产的患者被纳入各临床研究中。所纳入的研究质量普遍偏低,存在偏倚的高度风险。26项研究报告了终点结局(活产率),32项未对全部病例观察至终点结局的研究报告了胚胎发育的情况,5项研究仅报告了与复发性流产相关的实验室检查指标,21项研究报告了不良事件的发生情况。
活产率：10项研究为中药与西药的比较,其中8项研究发现中药治疗组的活产率高于西药对照组,2项研究的结果无统计学差异,各研究治疗组的平均活产率为88.6%,对照组的平均活产率为63.6%；12项研究为中药联合西药治疗与单用西药治疗的比较,其中5项研究发现中西药合用的疗效优于单用西药,7项研究未发现统计学差异,各研究治疗组的平均活产率为92.8%,对照组的平均活产率为73.4%；还有4项研究的对照组干预措施为中药或包括中药,导致无法评价中药干预措施的特异性疗效。
胚胎发育情况：14项研究为中药与西药的比较,其中6项研究发现中药治疗优于西药治疗,1项研究的结果显示西药治疗优于中药治疗,7项研究的结果无统计学差异,各研究治疗组的平均有效率为83.6%,对照组的平均有效率为55.6%；10项研究为中药联合西药治疗与单用西药治疗的比较,其中4项研究发现中西药合用的疗效优于单用西药对照组,6项研究未发现统计学差异,各研究治疗组的平均有效率为91.9%,对照组的平均有效率为69.8%；还有8项研究的对照组干预措施为中药或包括中药,导致无法评价中药干预措施的特异性疗效。
相关的实验室指标：15项研究报告了与复发性流产相关的实验室指标,其中2项研究发现中药在降低抗磷脂抗体的阳性率方面优于西医免疫治疗；各有1项研究发现中药在降低抗子宫内膜抗体或巨细胞病毒的阳性率方面优于西医免疫或抗病毒治疗；其他12项研究未发现统计学差异。
不良事件报告：21项研究报告了不良事件的发生情况,其中9项说明无不良事件；9项说明中药治疗组无不良事件；3项研究报告中药组的不良事件为轻度恶心和早产,对照组采用黄体酮、维生素E和少量镇静剂治疗的一项研究报告了1例胎儿畸形,阿司匹林孕前口服导致部分患者月经量增多。
5研究结论
中药复方治疗复发性流产具有潜在的疗效和较好的安全性。中药复方单独应用或与西药治疗联合应用,与单用西药治疗相比,能提高复发性流产患者的活产率,降低再次流产的发生率；部分中药复方对免疫性复发性流产患者具有较好的免疫调节和治疗作用,疗效可能优于现代医学的主动免疫治疗,或与其效果相当。然而,由于研究的数量偏少,缺乏重复验证,以及纳入研究存在的各种方法学问题导致研究结果可能有高度风险的偏倚,以上结论尚有待于进一步的高质量随机对照试验的验证。
中药治疗复发性流产的临床研究在研究设计、受试对象纳入、治疗和对照措施的选择、疗效评价指标等各个环节存在方法学问题。本研究根据随机对照试验的设计原则和复发性流产疾病的特点,针对这些问题提出了相应的改进建议。最后,从系统综述的角度探讨中医药领域随机对照试验的质量,对系统综述与随机对照试验的关系进行了思考,并提出改进中医药随机对照试验质量的几点策略。
Background Recurrent miscarriage is a common clinical problem in reproduction. It is defined as the loss of two or three or more consecutive spontaneous abortions, affecting approximately5%of all couples trying to conceive. Risk factors for recurrent vary widely, such as maternal age, number of previous miscarriages, antiphospholipid syndrome, genetic factors, anatomical deformity of reproductive organs, endocrine disorders, immune factors, and infective agents, but in more than half of such patients, no certain diagnosis could be identified. Various interventions have been used in clinical practice, but for the majority of which, there is still insufficient evidence to evaluate the effect of preventing a miscarriage in women with recurrent miscarriage. In China and other Asian countries, traditional Chinese medicine (TCM) has been widely used for the treatment of recurrent miscarriage for thousands of years. During the past two decades, a series of trials conducted to evaluate the effectiveness and safety of Chinese herbal medicine (CHM) for recurrent miscarriage, but the findings have not yet been systematically summarized.
Objectives To critically appraise the existing randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on CHM for recurrent miscarriage, provide evidence-based evaluation on the effectiveness and safety of CHM for this disease, and offer the suggestions for Chinese medicine researchers to perform good clinical researches by conducting this systematic review.
Material and methods A literature search was conducted in PubMed, Cochrane Library (Issue12,2011), CNKI, CBM and VIP databases until January12,2012. RCTs and CCTs of CHM or CHM plus conventional medicine for recurrent miscarriage patients comparing with placebo or conventional medicine or other CHMs were included. Two reviewers searched literature and extracted data independently. Cochrane Handbook and the Consolidated Standards for Reporting of Trials (CONSORT) statement were used to assess the methodological quality in the design and reporting of included trials. RevMan5.1.4software was used for data analyses. Risk ratio (RR) with a95%confidence interval (CI) was used as effect measure. Meta-analysis was to be used if the trials had a good homogeneity of study design, participants, interventions, control, and outcome measures.
Results A total of63trials (49RCTs and14CCTs) involving5266recurrent miscarriage patients were indentified and included in this systematic review. The majority of trials were of high risk of bias due to poor methodological quality. Live birth rate was reported in26trials, of which13trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine, while9trials showed no significant statistical difference, and outcomes were not assessed in4trials due to the CHM interventions were used in both groups. The status of embryonic development was reported in32trials, of which10trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine;13trials found no significant statistical difference; one trial showed the superior of conventional medicine over CHM; and outcomes were not assessed in8trials due to the CHM interventions were received in both groups. Laboratory parameters related to recurrent miscarriage were reported in15trials, of which3trials found that CHM treatment could benefit patients in improving immune parameters or virus-negative rate, while other12trials found no difference between CHM group and control group.21trials reported adverse events (AEs), and no severe AEs were reported in CHM group. Meta-analysis could not be conducted due to clinical heterogeneity.
Conclusion Overall, there is limited good quality evidence for CHMs for managing recurrent miscarriage. Some CHMs demonstrated potential positive effect and safety for recurrent miscarriage. At the moment the evidence of clinical trials is not sufficient to draw definitive conclusions because most trials are of low methodological quality and lack of large RCTs. Therefore, it is not possible to recommend any kind of CHMs in treating recurrent miscarriage. Further studies with rigorous design and standardized report are needed to evaluate the effectiveness and safety of CHM. We highlighted that four issues should be taken into consideration for Chinese medicine researches:1) basic principles of clinical research in design and reporting of RCTs,2) definite diagnosis criteria and baseline data should be reported in detail,3) appropriate treatment and control interventions should be selected according to the assumption and objective of research,4) clinical endpoint (live birth rate) should be reported and assessed.
复发性流产(recurrent miscarriage)是妇科临床较为常见的疾病,其发生率为5%左右。目前,现代医学对复发性流产尚缺乏理想的治疗措施。而中医对复发性流产的认识和治疗具有悠久的历史,历代中医文献记载了丰富宝贵的诊治经验。近20余年来,许多中医药治疗复发性流产的临床研究报告也不断被发表,为临床实践提供了大量的证据,但尚未见到对这些文献的严格评价和系统综述。
2研究目的
全面系统地检索中药治疗复发性流产的随机对照试验和非随机临床对照试验,总结临床研究的证据现状,评价中药对比西药或不同中药治疗复发性流产的疗效和安全性,为临床提供高级别的循证医学证据。并探讨纳入的临床研究中存在的方法学问题,从循证医学的角度,提出相应的设计和报告的改进建议,以期提高国内中药治疗复发性流产的临床研究质量,从而为临床创造更好的证据,使中医临床研究成果得到广泛的认可和应用。
3研究方法
本研究采用Cochrane系统综述的研究方法,对检索纳入的随机对照试验和非随机临床对照试验进行方法学质量评价、资料提取、数据分析和结果报告,并讨论研究结果和临床研究存在的方法学问题,提出改进建议。具体如下：
检索策略：检索电子数据库中国知网、重庆维普中文科技期刊数据库、中国生物医学文献数据库网络版、万方数据、PubMed和Cochrane Library(2011年第12期)。各数据库均从起建库日期开始检索,至2012年1月12日。
纳入标准：所有评价中药治疗复发性流产疗效和安全性的临床对照试验,包括随机对照试验和非随机临床对照试验均被纳入。各研究纳入的研究对象为自然流产连续发生2次或2次以上的患者,采用中药作为治疗组的干预措施,与西药或其他中药治疗进行比较,结局指标为活产率、胚胎发育情况、与复发性流产相关的实验室检查指标,以及不良事件。
资料提取和分析：由两名研究者独立提取资料,参考Cochrane协作网的偏倚风险评估标准评价纳入研究的方法学质量,参考CONSORT声明进行纳入研究的设计和报告质量的评价。采用RevMan5.1.4软件对主要结局指标进行分析。离散型变量资料采用相对危险度(risk ratio, RR),连续性变量资料采用均差(mean difference, MD)作为效应评价,并提供95.0%可信区间(confidence interval, CI)表示结果。如有两项或两项以上研究的治疗和对照措施一致,且报告了相同结局,则进行Meta分析,检验异质性,选择相应的效应模型。
4研究结果
共计63项研究被纳入到本系统综述,其中随机对照试验49项,非随机临床对照试验14项,共有5266名复发性流产的患者被纳入各临床研究中。所纳入的研究质量普遍偏低,存在偏倚的高度风险。26项研究报告了终点结局(活产率),32项未对全部病例观察至终点结局的研究报告了胚胎发育的情况,5项研究仅报告了与复发性流产相关的实验室检查指标,21项研究报告了不良事件的发生情况。
活产率：10项研究为中药与西药的比较,其中8项研究发现中药治疗组的活产率高于西药对照组,2项研究的结果无统计学差异,各研究治疗组的平均活产率为88.6%,对照组的平均活产率为63.6%；12项研究为中药联合西药治疗与单用西药治疗的比较,其中5项研究发现中西药合用的疗效优于单用西药,7项研究未发现统计学差异,各研究治疗组的平均活产率为92.8%,对照组的平均活产率为73.4%；还有4项研究的对照组干预措施为中药或包括中药,导致无法评价中药干预措施的特异性疗效。
胚胎发育情况：14项研究为中药与西药的比较,其中6项研究发现中药治疗优于西药治疗,1项研究的结果显示西药治疗优于中药治疗,7项研究的结果无统计学差异,各研究治疗组的平均有效率为83.6%,对照组的平均有效率为55.6%；10项研究为中药联合西药治疗与单用西药治疗的比较,其中4项研究发现中西药合用的疗效优于单用西药对照组,6项研究未发现统计学差异,各研究治疗组的平均有效率为91.9%,对照组的平均有效率为69.8%；还有8项研究的对照组干预措施为中药或包括中药,导致无法评价中药干预措施的特异性疗效。
相关的实验室指标：15项研究报告了与复发性流产相关的实验室指标,其中2项研究发现中药在降低抗磷脂抗体的阳性率方面优于西医免疫治疗；各有1项研究发现中药在降低抗子宫内膜抗体或巨细胞病毒的阳性率方面优于西医免疫或抗病毒治疗；其他12项研究未发现统计学差异。
不良事件报告：21项研究报告了不良事件的发生情况,其中9项说明无不良事件；9项说明中药治疗组无不良事件；3项研究报告中药组的不良事件为轻度恶心和早产,对照组采用黄体酮、维生素E和少量镇静剂治疗的一项研究报告了1例胎儿畸形,阿司匹林孕前口服导致部分患者月经量增多。
5研究结论
中药复方治疗复发性流产具有潜在的疗效和较好的安全性。中药复方单独应用或与西药治疗联合应用,与单用西药治疗相比,能提高复发性流产患者的活产率,降低再次流产的发生率；部分中药复方对免疫性复发性流产患者具有较好的免疫调节和治疗作用,疗效可能优于现代医学的主动免疫治疗,或与其效果相当。然而,由于研究的数量偏少,缺乏重复验证,以及纳入研究存在的各种方法学问题导致研究结果可能有高度风险的偏倚,以上结论尚有待于进一步的高质量随机对照试验的验证。
中药治疗复发性流产的临床研究在研究设计、受试对象纳入、治疗和对照措施的选择、疗效评价指标等各个环节存在方法学问题。本研究根据随机对照试验的设计原则和复发性流产疾病的特点,针对这些问题提出了相应的改进建议。最后,从系统综述的角度探讨中医药领域随机对照试验的质量,对系统综述与随机对照试验的关系进行了思考,并提出改进中医药随机对照试验质量的几点策略。
Background Recurrent miscarriage is a common clinical problem in reproduction. It is defined as the loss of two or three or more consecutive spontaneous abortions, affecting approximately5%of all couples trying to conceive. Risk factors for recurrent vary widely, such as maternal age, number of previous miscarriages, antiphospholipid syndrome, genetic factors, anatomical deformity of reproductive organs, endocrine disorders, immune factors, and infective agents, but in more than half of such patients, no certain diagnosis could be identified. Various interventions have been used in clinical practice, but for the majority of which, there is still insufficient evidence to evaluate the effect of preventing a miscarriage in women with recurrent miscarriage. In China and other Asian countries, traditional Chinese medicine (TCM) has been widely used for the treatment of recurrent miscarriage for thousands of years. During the past two decades, a series of trials conducted to evaluate the effectiveness and safety of Chinese herbal medicine (CHM) for recurrent miscarriage, but the findings have not yet been systematically summarized.
Objectives To critically appraise the existing randomized controlled trials (RCTs) and controlled clinical trials (CCTs) on CHM for recurrent miscarriage, provide evidence-based evaluation on the effectiveness and safety of CHM for this disease, and offer the suggestions for Chinese medicine researchers to perform good clinical researches by conducting this systematic review.
Material and methods A literature search was conducted in PubMed, Cochrane Library (Issue12,2011), CNKI, CBM and VIP databases until January12,2012. RCTs and CCTs of CHM or CHM plus conventional medicine for recurrent miscarriage patients comparing with placebo or conventional medicine or other CHMs were included. Two reviewers searched literature and extracted data independently. Cochrane Handbook and the Consolidated Standards for Reporting of Trials (CONSORT) statement were used to assess the methodological quality in the design and reporting of included trials. RevMan5.1.4software was used for data analyses. Risk ratio (RR) with a95%confidence interval (CI) was used as effect measure. Meta-analysis was to be used if the trials had a good homogeneity of study design, participants, interventions, control, and outcome measures.
Results A total of63trials (49RCTs and14CCTs) involving5266recurrent miscarriage patients were indentified and included in this systematic review. The majority of trials were of high risk of bias due to poor methodological quality. Live birth rate was reported in26trials, of which13trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine, while9trials showed no significant statistical difference, and outcomes were not assessed in4trials due to the CHM interventions were used in both groups. The status of embryonic development was reported in32trials, of which10trials showed the superior of CHM or CHM plus conventional medicine over the conventional medicine;13trials found no significant statistical difference; one trial showed the superior of conventional medicine over CHM; and outcomes were not assessed in8trials due to the CHM interventions were received in both groups. Laboratory parameters related to recurrent miscarriage were reported in15trials, of which3trials found that CHM treatment could benefit patients in improving immune parameters or virus-negative rate, while other12trials found no difference between CHM group and control group.21trials reported adverse events (AEs), and no severe AEs were reported in CHM group. Meta-analysis could not be conducted due to clinical heterogeneity.
Conclusion Overall, there is limited good quality evidence for CHMs for managing recurrent miscarriage. Some CHMs demonstrated potential positive effect and safety for recurrent miscarriage. At the moment the evidence of clinical trials is not sufficient to draw definitive conclusions because most trials are of low methodological quality and lack of large RCTs. Therefore, it is not possible to recommend any kind of CHMs in treating recurrent miscarriage. Further studies with rigorous design and standardized report are needed to evaluate the effectiveness and safety of CHM. We highlighted that four issues should be taken into consideration for Chinese medicine researches:1) basic principles of clinical research in design and reporting of RCTs,2) definite diagnosis criteria and baseline data should be reported in detail,3) appropriate treatment and control interventions should be selected according to the assumption and objective of research,4) clinical endpoint (live birth rate) should be reported and assessed.
引文
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