目的：通过Meta分析的方法系统评价中西医结合治疗肾性血尿的有效性。方法：计算机综合检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、中国生物医学文献服务系统(CBM)、PubMed、Web of Science等国内外数据库，收集建库至2022年1月有关中西医结合治疗肾性血尿相关的随机对照试验。由2名研究员依据纳入和排除标准进行筛选文献，依据Cochrane系统评价方法进行文献质量评价，采用RevMan 5.3软件进行结局指标分析。结果：入选21项研究，涉及1760名肾性血尿患者。Meta分析结果显示：在西医常规治疗基础上联合中医药治疗可进一步降低尿红细胞数(Z = 4.34, MD = −7.88 [−11.44, −4.32], P < 0.00001; Z = 4.96, MD = −5.36 [−7.48, −3.24], P < 0.00001)、尿蛋白定量(24 h) (Z = 7.63, MD = −0.36 [−0.46, −0.27], P < 0.00001)、血肌酐(Z = 4.52, MD = −13.28 [−19.04, −7.52], P < 0.00001)、尿素氮(Z = 4.40, MD = −1.97 [−2.84, −1.09], P < 0.0001)。结论：中西医结合治疗肾性血尿相较于纯西药治疗具有一定的临床优势，但未来仍然需要更大样本量、设计更加完善、质量更高的临床研究来进一步论证本次结论。 Objective: Systematic evaluation of the efficacy of integrated traditional Chinese and western medicine in the treatment of renal hematuria by Meta analysis. Methods: The computer comprehensively searched the domestic and foreign databases such as CNKI, Wanfang Data, VIP, CBM and Web of Science, and collected the randomized controlled trials related to integrated traditional Chinese and western medicine (since the establishment of the databases to January 2022). Literature was screened according to inclusion and exclusion criteria by two researchers, literature quality was evaluated according to Cochrane systematic review method, and outcome indicators were analyzed using RevMan 5.3 software. Results: 21 RCTs were finally included, a total of 1760 patients with renal hematuria. The results of Meta analysis show that on the basis of routine treatment of western medicine combined with traditional Chinese medicine could further reduce the number of urinary red blood cells (Z = 4.34, MD = −7.88 [−11.44, −4.32], P < 0.00001; Z = 4.96, MD = −5.36 [−7.48, −3.24], P < 0.00001), 24 h urine protein (Z = 7.63, MD = −0.36 [−0.46, −0.27], P < 0.00001), serum creatinine (Z = 4.52, MD = −13.28 [−19.04, −7.52], P < 0.00001), urea nitrogen (Z = 4.40, MD = −1.97 [−2.84, −1.09], P < 0.0001). Conclusion: The combination of traditional Chinese and western medicine in the treatment of renal hematuria has certain clinical advantages compared with pure western medicine, but clinical studies with larger sample size, better design and higher quality are still needed in the future to further demonstrate this conclusion.
目的：通过Meta分析的方法系统评价中西医结合治疗肾性血尿的有效性。方法：计算机综合检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、中国生物医学文献服务系统(CBM)、PubMed、Web of Science等国内外数据库，收集建库至2022年1月有关中西医结合治疗肾性血尿相关的随机对照试验。由2名研究员依据纳入和排除标准进行筛选文献，依据Cochrane系统评价方法进行文献质量评价，采用RevMan 5.3软件进行结局指标分析。结果：入选21项研究，涉及1760名肾性血尿患者。Meta分析结果显示：在西医常规治疗基础上联合中医药治疗可进一步降低尿红细胞数(Z = 4.34, MD = −7.88 [−11.44, −4.32], P < 0.00001; Z = 4.96, MD = −5.36 [−7.48, −3.24], P < 0.00001)、尿蛋白定量(24 h) (Z = 7.63, MD = −0.36 [−0.46, −0.27], P < 0.00001)、血肌酐(Z = 4.52, MD = −13.28 [−19.04, −7.52], P < 0.00001)、尿素氮(Z = 4.40, MD = −1.97 [−2.84, −1.09], P < 0.0001)。结论：中西医结合治疗肾性血尿相较于纯西药治疗具有一定的临床优势，但未来仍然需要更大样本量、设计更加完善、质量更高的临床研究来进一步论证本次结论。
肾性血尿，中西医结合治疗，Meta分析
Jing Xiong*, Yuxiang Cao, Shi Wu
Clinical School of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan Hubei
Received: May 10th, 2023; accepted: Jun. 21st, 2023; published: Jun. 30th, 2023
Objective: Systematic evaluation of the efficacy of integrated traditional Chinese and western medicine in the treatment of renal hematuria by Meta analysis. Methods: The computer comprehensively searched the domestic and foreign databases such as CNKI, Wanfang Data, VIP, CBM and Web of Science, and collected the randomized controlled trials related to integrated traditional Chinese and western medicine (since the establishment of the databases to January 2022). Literature was screened according to inclusion and exclusion criteria by two researchers, literature quality was evaluated according to Cochrane systematic review method, and outcome indicators were analyzed using RevMan 5.3 software. Results: 21 RCTs were finally included, a total of 1760 patients with renal hematuria. The results of Meta analysis show that on the basis of routine treatment of western medicine combined with traditional Chinese medicine could further reduce the number of urinary red blood cells (Z = 4.34, MD = −7.88 [−11.44, −4.32], P < 0.00001; Z = 4.96, MD = −5.36 [−7.48, −3.24], P < 0.00001), 24 h urine protein (Z = 7.63, MD = −0.36 [−0.46, −0.27], P < 0.00001), serum creatinine (Z = 4.52, MD = −13.28 [−19.04, −7.52], P < 0.00001), urea nitrogen (Z = 4.40, MD = −1.97 [−2.84, −1.09], P < 0.0001). Conclusion: The combination of traditional Chinese and western medicine in the treatment of renal hematuria has certain clinical advantages compared with pure western medicine, but clinical studies with larger sample size, better design and higher quality are still needed in the future to further demonstrate this conclusion.
Keywords:Renal Hematuria, Integrated Traditional Chinese and Western Medicine, Meta Analysis
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肾性血尿是指由于肾小球损伤从而引起的血尿，临床可表现为肉眼血尿、镜下血尿，并伴见蛋白尿、水肿等，且病情多迁延难愈，常见于由各种原发性肾小球疾病，如IgA肾病、系膜增生性肾炎等 [
1) 文献研究类型：于2022年1月前在国内外杂志上发表的中医药联合西医常规疗法治疗肾源性水肿的临床性随机对照研究试验(randomized controlled trial, RCT)的中、英文文献。2) 研究对象：临床上确诊为肾性血尿的患者，其年龄、性别、种族不限。3) 干预措施：实验组在西医常规治疗基础上联合中医药治疗，对照组为西医常规治疗。4) 结局指标：尿红细胞计数、尿红细胞数(高倍视野)、24 h尿蛋白定量、血肌酐、血尿素氮。
1) 非RCT。2) 重复发表的文献。3) 实验组为单纯中药治疗肾性血尿的文献。4) 无法获取有效结局指标或结局指标存在严重错误的文献。5) 无法获取全文的文献。
计算机综合检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、中国生物医学文献服务系统(CBM)、Web of Science等国内外数据库,收集建库至2021年11月有关中西医结合治疗肾性血尿相关的RCT。手工检索湖北中医药大学图书馆与本病相关的医学期刊。中文检索词：“肾性血尿”“肾炎”“肾病”“血尿”“中医”“中药”“中西医结合治疗”“随机对照试验”等。英文检索词：“Renal Hematuria”“Nephritis”“KIDNEY DISEASES”“Chinese medicine”“Chinese Herb”“TCM WM THERAPY”“Randomized Controlled Trial”等，以主题词与自由词相结合进行检索。
2名研究员根据纳入、排除标准将通过按照制定的检索策略所获得的文献进行筛选汇总。当遇到分歧时，由双方讨论决定或向第3名研究员共同协商解决。
2名研究员员采用Cochrane协作网提供的质量评价标准对所纳入研究的偏倚风险进行评估。评价条目包括：随机序列产生、分配隐藏、对病人实验人员实施盲法、对结局评估者实施盲法、不完全结局资料、选择性结局报告、其他偏倚等7方面。根据每项条目的结果，以“低风险”“高风险”“不明确风险”作为对文献偏倚风险评价判断。
使用RevMan 5.3进行结局指标的数据分析。计数资料采用相对危险度(Risk Ratio, RR)表示，连续变量采用权重均数差(Weighted Mean Difference, WMD)表示，且二者均提供95%置信区间(95% CI)，绘制出结局指标的Meta分析森林图。采用I2检验评价异质性，当结果提示异质性不明显(I2≤ 50%, P > 0.10)时，采用固定效应模型进行分析；当结果提示异质性显著(I2≥ 50%, P < 0.1)时采用随机效应模型进行分析并找出其异质性的原因。采用漏斗图来判断是否存在发表偏倚。
最终纳入研究的文献共计21篇 [
共有4项研究 [
图1. 文献筛选流程图
图2. 纳入文献产生偏倚风险的项目所占比例
共纳入7项研究。各研究之间存在异质性(P < 0.00001, I2= 98%)，但无临床异质性，选择随机效应模型。合并效应量：Z = 4.34，MD = −7.88 [−11.44, −4.32]，P < 0.00001，具有统计学意义，提示在联合中医药后降低尿红细胞方面效果更优。见图3。
共纳入7项研究。各研究之间存在异质性(P < 0.00001, I2= 88%)，但无临床异质性，选择随机效应模型。合并效应量：Z = 4.96，MD = −5.36 [−7.48, −3.24]，P < 0.00001，具有统计学意义，提示在联合中医药后降低尿红细胞方面效果更优。见图4。
图3. 尿红细胞计数森林图
图4. 高倍视野下尿红细胞计数森林图
共纳入13项研究。各研究之间存在异质性(P < 0.00001, I2= 96%)，但无临床异质性，选择随机效应模型。合并效应量：Z = 7.63，MD = −0.36 [−0.46, −0.27]，P < 0.00001，具有统计学意义，提示在联合中医药后降低尿蛋白方面效果更优。见图5。
图5. 尿蛋白定量(24 h)森林图
共纳入15项研究。各研究之间存在异质性(P < 0.00001, I2= 99%)，但无临床异质性，选择随机效应模型。合并效应量：Z = 4.52，MD = −13.28 [−19.04, −7.52]，P < 0.00001，具有统计学意义，提示在联合中医药后降低血肌酐方面效果更优。见图6。
图6. 血肌酐森林图
共纳入12项研究。各研究之间存在异质性(P < 0.00001, I2= 95%)，但无临床异质性，选择随机效应模型。合并效应量：Z = 4.40，MD = −1.97 [−2.84, −1.09]，P < 0.0001，具有统计学意义，提示在联合中医药后降低尿素氮方面效果更优。见图7。
图7. 尿素氮森林图
血尿是肾脏疾病常见的临床伴随症状，在治疗前首先需要明确的就是其血尿的来源，按照血尿的来源，通常分为肾性血尿和非肾性血尿。肾性血尿多见于原发性肾小球疾病，如IgA肾病，系膜增生性肾炎等，临床上表现为单纯性血尿，或血尿伴蛋白尿、水肿，多数患者经常反复发作，长期迁延难治。单纯西医治疗虽在一定程度上缓解患者症状，但由于其病情的反复以及伴随的并发症，往往使患者预后不佳 [
本研究结果显示，中医药治疗联合西医常规治疗相较于单纯西医治疗能进一步有效降低肾性血尿患者尿红细胞数、24 h尿蛋白定量、血肌酐、尿素氮等指标。本次研究存在的一些局限性：本研究仅纳入21篇RCT研究，样本总量仅1760例，在纳入文献中随机方法、分配隐藏及盲法方面不够完善，在一定程度上影响风险偏倚。虽在一定程度上证实中西医结合治疗肾性血尿相较于纯西药治疗具有一定的临床优势，但仍期待在今后循证医学研究中纳入更大样本量、设计更加完善、质量更高的临床研究来进一步论证本次结论。
熊 静,曹宇翔,吴 师. 中西医结合治疗肾性血尿Meta分析Meta-Analysis of Renal Hematuria Treated by Combination of Traditional Chinese and Western Medicine[J]. 中医学, 2023, 12(06): 1462-1469. https://doi.org/10.12677/TCM.2023.126218