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目的 系统评价中药对轻度认知障碍（MCI）的治疗效果和安全性。
方法 通过计算机检索中英文数据库中关于中药治疗MCI的临床随机对照试验，检索时限为数据库成立截止至2025年12月31日。采用Cochrane偏倚风险评价工具对纳入文献进行质量评价，使用Stata 17.0 软件进行Meta分析。
结果 共纳入77项研究，包含7 997例患者。研究结果表明，中药显著提高患者认知水平[标准平均差（SMD）=0.78，95%CI（0.67，0.89），P＜0.001]和日常生活活动能力（ADL）[SMD=-0.64，95%CI（-0.90，-0.38），P＜0.001]。亚组分析结果显示，中西药联合效果较佳，但在ADL方面，中药vs.西药和中药vs.空白/安慰剂差异无统计学意义（P ＞0.05）。29项研究报告了安全性数据，中药组不良反应发生率与对照组差异无统计学意义[相对危险度（RR）=0.72，95%CI（0.51，1.02），P=0.066]。
结论 中药可有助于改善MCI患者的认知水平以及ADL，其中以中西药联合效果相对更佳。但由于一些研究样本量较小和方法不严谨，因此需要采用严格的方法进一步验证。
轻度认知障碍（mild cognitive impairment，MCI）是痴呆症的临床前阶段，其特征是至少在一个领域存在认知缺陷，并伴有日常生活活动能力（activity of daily living，ADL）的轻微下降。随着年龄的增长，MCI的患病率逐渐上升，从60~65岁的6.7%至80~84岁的25.2%不等[1]。此外，患有MCI的个体比同龄的健康个体患痴呆的风险更高，超过50%的MCI患者在4~6年内发展为阿尔茨海默病、路易体痴呆或其他类型的痴呆[1-2]。一项流行病学研究Meta分析显示，中国50岁及以上人群中MCI的患病率为15.4%[3]。因此，为提高MCI患者的生活质量，减少痴呆的发病率，减轻社会的经济和医疗负担，对MCI进行优先干预至关重要。目前，MCI发病机制复杂，尚无有效治疗方法[4]。现阶段临床最常用的两种药物是胆碱酯酶抑制剂（如多奈哌齐、卡巴拉汀、加兰他敏等）和谷氨酸受体拮抗剂（美金刚），其他药物，如钙通道阻滞剂、单胺能受体激动药物和改善脑循环、脑代谢的药物，也可以改善认知功能，但这些药物作用有限，且部分药物存在严重不良反应[5]。
近年来，中药因其疗效较好、不良反应较少，在治疗MCI方面受到了广泛关注[6]。MCI属于中医的“失忆”范畴，包括“语言错误”“失忆”、“白痴”和“思维迟钝”。发病机制涉及虚、痰、郁。大脑是受累的主要器官，但也会累及肾脏、心脏、肝脏和脾脏[7]。基于中医理论基础，辨证应用中药治疗MCI取得了一定进展。目前中医药治疗MCI的研究水平参差不齐。因此，本研究通过系统评价与Meta分析，评估中药治疗MCI患者的疗效及安全性，为临床治疗提供参考。
1 资料与方法
1.1 纳入与排除标准
纳入标准：①研究对象：MCI患者，诊断依据参照国际或国内公认的临床诊断标准，包括但不限于《中国痴呆与认知障碍诊治指南》[5]；②干预措施：中药单独应用或与西药及其他疗法的共同干预；③ 对照组：西药疗法、安慰剂或无干预。④研究类型：随机对照试验（randomized controlled trials，RCT）；⑤结局指标：主要结局是认知功能的变化或改善情况，次要结局是ADL的改变，安全性指标是不良反应发生状况。
排除标准：①除MCI之外的其他形式认知功能障碍（痴呆）、诊断不明确或合并精神疾病及其他严重并发症的患者；②对照组干预措施中包含了中药的研究；③研究方案、评论、综述、会议摘要、系统评价、学位论文、动物实验、正在进行的试验和无足够数据进行分析的研究；④随访时间＜3月或样本量＜50例的研究；⑤低质量研究（如试验过程不清，统计方法错误，结果数据不全或存在明显错误等）。
1.2 文献检索策略
对PubMed、Web of Science 、Cochrane Library、Embase、ClinicalTrials.gov、万方、维普（VIP）、中国知网（CNKI）和中国生物医学文献数据库（SinoMed）进行系统检索。检索时间为数据库成立至2025年12月31日。中文检索词包括“轻度认知障碍”“中药”“随机对照”，英文检索词包括“mild cognitive impairment”“Chinese traditional medicine”“randomized controlled trial”。为了扩大搜索范围，采用医学主题词搭配自由词进行检索。以中国知网为例，检索策略见框1。
1.3 文献筛选及提取流程
2名作者独立进行文献筛选，确定最终纳入的研究。数据提取包括作者、发表日期、地点、随机方法、样本量、参与者年龄、性别、干预措施（剂量、时间）、随访时间、结局指标等。采用蒙特利尔认知评估量表（Montreal Cognitive Assessment，MoCA）、简易精神状态量表（Mini-Mental State Examination，MMSE）或其他认知量表等评估患者MCI状况。ADL用于评估患者独立完成穿衣、进食、洗漱、行走等基本生活行为的能力，是反映 MCI 患者功能状态的重要指标。若试验的主要结局是认知评分的变化或认知和功能评分的组合，本研究在分析中提取主要结局；在认知评分变化为次要结果的情况下，本研究从3个量表[MMSE、MoCA或阿尔茨海默病评估量表-认知分量表（Alzheimer's Disease Assessment Scale-Cognitive Subscale，ADAS-Cog）]中的1个提取相关数据。如有争议，通过讨论或与第三方协商后解决。
1.4 文献质量评价
文献质量评估采用Cochrane偏倚风险评价工具[8]。评估内容主要涵盖7个核心维度，分别为：随机序列生成、分配隐藏、受试者与研究者盲法、结局评估盲法、结局数据的完整性、选择性报告结局以及其他偏倚。每个评估维度均按照“低风险”“高风险”“不确定”3个等级进行判定。
1.5 数据分析
由于认知功能和ADL常采用不同的评定量表进行评估，故将结果转换成标准平均差（standardized mean differences，SMD）和95%CI。测量认知功能和ADL的不同量表可能有不同的解释。如在MMSE和MoCA中，更高的分数表明更好的表现，而在ADAS-Cog中，更低的分数表明更好的结果。因此，在认知功能中，当结果有利于干预时，将SMD定义为正值；在ADL中，当结果有利于干预时，将SMD定义为负值。对于二分类变量采用相对危险度（relative risk，RR）和95%CI表示。采用χ2检验和I2统计量分析异质性。依据Cochrane系统评价手册，I2值的判定标准如下：0%~25% 提示轻微异质性；25%~50%提示中度异质性；50%~75%提示实质性异质性；75%~100%提示高度异质性，本研究选用随机效应模型。为探索异质性来源及评估结果的稳定性，本研究进行以下亚组变量进行分析：①干预措施类型（中药vs.西药、中西医结合vs.西药、中药vs.空白/安慰剂）；②随访时间（＜6个月vs. ≥6个月）；③疾病类型（单纯MCI vs. MCI合并其他基础疾病）。同时，采用逐一剔除文献法进行敏感性分析。当某一结局指标纳入的文献数量≥10篇时，绘制漏斗图并采用 Egger's 线性回归法检验是否存在潜在的发表偏倚。使用 Stata 17.0 软件对结果进行Meta分析，以P＜0.05为差异有统计学意义。
2 结果
2.1 一般情况
初始检索2 439篇文献，经筛选后最终纳入77篇文献，其中英文文献5篇（6.49%），中文文献72篇（93.51%）。具体文献筛选流程见图1。
2.2 纳入文献的基本特征
纳入的77篇文献中4篇文献为3臂试验，因此，本研究拆分为两个比较组后共计81个比较组。36个比较组为中西医联合vs.西药，20个比较组为中药vs.空白对照或安慰剂，25个比较组为中药vs.西药。研究共包含7 997例患者，治疗组4 179例，对照组3 818例。患者年龄≥34岁，随访时间3~36月。只有1项试验在德黑兰开展，其余均在中国开展。所有文献均报道了认知功能结果，有30篇文献报道了ADL结果，49 篇文献报道了安全性结局，其中29篇文献报道了不良反应的具体例数。纳入文献的基本特征见表1。
2.3 纳入文献的风险偏倚评估
对77项试验进行了偏倚风险评估。① 对于选择偏倚，使用SAS软件或随机数字表法生成随机化序列的45项试验被评估为低偏倚风险，其余32项试验未指定随机化方法，因此被评估为不清楚。② 大多数纳入的试验没有报道隐藏分配的方法，只有4项试验在分配隐藏方面被评估为低风险。③15项试验对参与者和人员进行了充分的盲法；其余62项试验被评估为高风险。④2 项试验对结果评估者进行了充分的盲法；其余75 项试验没有描述结果评估者的盲法。⑤69 项试验报告无缺失数据，并将所有参与者纳入数据分析，因此评估为低风险，1项试验存在高风险，7项试验未报告退出信息被评估为不清楚。⑥1项试验的选择性报道的风险较低，其余76项试验由于缺乏预先发表的试验方案被评估为不清楚。⑦16 项试验未报告资助被评估为不清楚，其余61项试验被评为低风险。纳入文献的总体质量评价具体见图2。
2.4 Meta分析结果
2.4.1 认知功能
纳入的77篇文献均报道了认知功能，其中36项RCT为中西药联合vs.西药，20项RCT为中药vs.空白或安慰剂，25项RCT为中药vs.西药。研究结果显示，中药干预可有效提高患者认知水平[SMD=0.78，95%CI（0.67，0.89），P ＜0.001]。不同干预措施、疾病类型、随访时间亚组分析结果均显示，中药干预可有效提高患者认知功能，具体结果见表2。通过逐篇排除文献法进行敏感性分析，均对主分析结果影响较小，结果稳健。
2.4.2 ADL
共有30项RCT报道了治疗前后ADL评分变化观察日常生活自立能力改善情况，其中15项RCT为中西药联合vs西药，4项RCT为中药vs.空白/安慰剂，11项RCT为中药vs.西药。Meta分析结果显示，中药治疗可提高患者的ADL [SMD=-0.64，95%CI（-0.90，-0.38），P＜0.001]。干预措施的亚组分析结果显示，中药vs.西药组或中药vs.空白/安慰剂差异无统计学意义（P＞0.05）。具体结果见表2。
2.4.3 发表偏倚
经Egger's检验（P=0.048）中药治疗MCI认知功能研究存在发表偏倚，漏斗图显示存在不对称（图3）。中药治疗MCI、ADL的Egger's检验（P＜0.001）同样提示研究存在发表偏倚，漏斗图显示存在不对称（图4）。
2.4.3 不良反应发生率
共有51项RCT涉及不良反应的报道，其中21项RCT报道未见任何不良反应，29项RCT报道了具体的不良反应例数，1项RCT仅报道了治疗组的不良反应例数，未报道对照组的不良反应例数。分析结果显示，中药干预MCI患者的不良事件发生率与对照组比较差异无统计学意义[RR=0.72，95%CI（0.51，1.02），P=0.066]。亚组分析结果显示，中药与西药相比，中药的不良反应发生率较低[RR=0.33，95%CI（0.24，0.44），P＜0.001]；而其他干预方式差异无统计学意义（P＞0.05）。具体结果见图5。
3 讨论
本系统评价纳入了77项RCT，涉及7 997例患者，分析结果显示无论是单独使用中药还是中西医结合治疗，均能显著改善MCI患者的认知功能和ADL。亚组分析结果显示，中西药联合效果较佳。此外，安全性分析结果显示中药组的不良反应发生率与西药组差异无统计学意义，未发现明显的不良反应风险。
既往虽有关于中药治疗MCI的系统评价研究[1, 4, 86-88]，但本文通过优化纳入排除标准与更新证据体量，提供了更为全面且稳健的循证证据。首先，针对不同研究采用MMSE、MoCA等不同量表导致难以合并的问题，以往的Meta分析多采用分开描述或分别分析的策略，这在一定程度上分散了统计学功效。本研究采用SMD作为效应指标，有效整合了不同量表的结局数据，从而更准确地评估了中药对认知功能的整体改善效应。其次，在比较模式上，Yu等[1]主要聚焦于“中药联合多奈哌齐”的增效作用，这种设计难以剥离中药作为单一疗法的绝对效应。相比之下，本研究纳入了“中药vs.安慰剂/空白”及“中药vs.西药”的多种对比模式，不仅证实了中西药联合方案的疗效较好，也明确了中药单药治疗的临床价值。此外，鉴于该领域临床试验增长迅速，本研究将检索时间延伸至2025年12月，纳入了此前Meta分析未能涵盖的大量研究[4, 86]。最终纳入的77项研究显著提升了Meta分析的统计效能，克服了小样本量研究结果不稳定的缺陷。
尽管MCI被认为是阿尔茨海默病防治的“黄金窗口期”，但目前临床治疗方案仍面临严峻挑战。虽然美国食品药品监督管理局（U.S. Food and Drug Administration，FDA）近期批准了针对β-淀粉样蛋白病理的疾病修饰药物（如Lecanemab和Donanemab）用于早期阿尔茨海默病（含MCI阶段）[89-90]，但其高昂的治疗成本、严格的输注要求以及潜在的淀粉样蛋白相关影像学异常风险，限制了其在广泛人群中的普及应用。相比之下，传统胆碱酯酶抑制剂（如多奈哌齐）虽被指南推荐超适应证使用，但其仅能提供暂时的症状缓解，且长期使用的胃肠道副作用往往导致患者依从性下降[91-92]。本研究的亚组分析显示，“中西医联合治疗”的效果较好，西药针对单一神经递质传递进行快速干预，而中药通过多成分发挥神经保护和全身调节作用，两者结合可能产生了协同作用。
中药的多种有效成分对MCI的多种致病因素和病理改变发挥着多种生物学效应。目前，中药已被证明可通过延缓β 淀粉样蛋白沉积和Tau病变、调节胆碱能神经递质、改善脑循环脑代谢、防止海马神经元凋亡等途径改善认知功能[6]。如复方菖蒲益智汤可降低血清乙酰胆碱脂酶活性与同型半胱氨酸水平，从而提高患者认知功能与生活质量；丹参酮IIA可降低皮层氧化应激水平，上调谷氨酸和γ-氨基丁酸水平，达到抗炎和神经保护作用等[93]。
本研究也存在一些不足：第一，纳入的部分研究存在较高偏倚风险，可能会影响研究结果的可信度；第二，统计分析结果显示存在较高的异质性，这可能与研究之间的纳入人群、不同的中药干预、结局的评定方式、随访时间等相关；第三，漏斗图显示研究结果具有发表偏倚，对研究结果存在一定的影响。由于阴性结果往往难以发表，发表偏倚常常难以避免；第四，安全性结局报告不足，仅有25项试验报告了具体不良事件的数据，影响安全性评价的准确性；第五，本研究的纳入与排除标准可能会剔除一些小样本或发表在非核心期刊上的研究，这可能会对研究结果的全面性产生一定影响。
综上所述，中药可有助于提高MCI患者的认知水平和ADL，其中以中西药联合治疗效果相对更佳，且中药不良反应发生率低于西药。虽然本研究纳入研究数量较多，但由于文献质量偏低，未来需要更大规模、高质量的研究以进一步验证中药是否有益于MCI，为临床治疗方案的选择提供更科学的依据。
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