Abstract: Background Diabetic foot ulcers（DFU）represent prevalent chronic wounds with significant negative impacts on patients' health and socioeconomic status. Antibiotic bone cement（ABC）has emerged as a therapeutic option，though its efficacy and safety require comprehensive evaluation. Objective To perform a meta-analysis of randomized controlled trials（RCT）assessing the efficacy and safety of ABC for DFU，thereby providing evidence-based guidance for clinical practice. Methods We systematically searched CNKI，Wanfang，VIP website，China Biomedical Literature Database，PubMed，Cochrane Library，Embase，and Web of Science for RCT published until January 2025. Thirteen RCT involving 843 patients were included. The intervention group received ABC combined with vacuum sealing drainage（VSD），while controls received VSD alone. Outcomes included wound healing time，clinical efficacy rate，bacterial clearance time，hospital stay，surgical frequency，amputation rate，visual analogue scale（VAS）scores，and adverse events. RevMan 5.3 was used with random effects models for heterogeneous data. Results The meta-analysis demonstrated that combined ABC therapy significantly：reduced wound healing time（MD=-14.46，95%CI=-19.69 to -9.23；P<0.05），increased clinical efficacy rates（OR=7.81，95%CI=3.94 to 17.48，P<0.05），shortened bacterial clearance time（MD=-4.04，95%CI=-5.13 to -2.94，P<0.05）， decreased positive bacterial cultures at 1-week post-treatment（OR=0.27，95%CI 0.14 to 0.50，P<0.05），lowered amputation rates（OR=0.14，95%CI=0.03 to 0.62，P=0.01），reduced surgical frequency（MD=-1.77，95%CI=-2.52 to -1.03，P<0.05）；decreased VAS scores（MD=-1.96，95%CI=-2.35 to -0.57，P<0.05）. Additionally，no adverse events were reported across the included studies. For wound healing time，it was divided into Wagner 5 group and non-Wagner 5 group according to different research subjects，and divided into combination group and monotherapy group according to different types of antibiotics. The results of the non-Wagner 5 group showed that ABC combined with VSD treatment could significantly shorten the wound healing time of DFU patients compared with VSD treatment alone（MD=-6.31，95%CI=-7.88 to -4.74，P<0.05）；The results of the Wagner grade 5 group showed that there was no significant difference between the experimental group and the control group（MD=-8.02，95%CI=-20.11 to 4.07，P=0.19）. The results of the antibiotic alone group showed that ABC combined with VSD treatment could shorten the wound healing time of DFU patients compared with VSD alone（MD=-4.52，95%CI=-5.81 to -3.23，P<0.05）. The results of the combination antibiotic group showed that ABC combined with VSD treatment could significantly shorten the wound healing time of DFU patients compared with VSD alone（MD=-14.21，95%CI=-18.20 to -10.21，P<0.05）. For the length of hospitalization，according to the age of the study subjects，they were divided into the average age greater than 60 years old group and the average age less than 60 years group. The results of the mean age group greater than 60 years showed that ABC combined with VSD treatment could shorten the hospital stay of DFU patients compared with VSD treatment alone（MD=-6.82，95%CI=-10.93 to -2.71，P=0.001）. The results of the average age less than 60 years old group showed that there was no significant difference between the experimental group and the control group（MD=-5.11，95%CI=-17.78 to 7.56，P=0.45）. For the number of surgeries，according to the wound treatment methods，it is divided into a group with skin graft and a group without skin grafting. The results of the no skin graft group showed that ABC combined with VSD treatment could reduce the number of surgeries in DFU patients compared with VSD treatment alone（MD=-1.79，95%CI=-2.13 to -1.46，P<0.05）. The results of the skin graft group showed that ABC combined with VSD treatment could significantly reduce the number of surgeries in patients with DFU compared with VSD treatment alone（MD=-1.89，95%CI=-3.27 to 0.50，P=0.008）. Sensitivity analysis was performed and the results of this study were found. Conclusion In this study，ABC combined with VSD is a safe and effective therapy for DFU，especially for non-Wagner grade 5 patients and the elderly，and the combination of antibiotics and skin grafting can further enhance the efficacy.

Key words: Cementoplasty；Antibiotic bone cements；Diabetic foot；Foot ulcer, diabetic；Negative-pressure wound therapy；Vaccum sealing drainage；Wound healing；Meta-analysis

摘要： 背景 糖尿病足溃疡（DFU）是常见的慢性难愈性创面，给患者的健康和经济带来了严重的负面影响。近年来，抗生素骨水泥（ABC）被逐渐应用于DFU的治疗。然而，其有效性和安全性尚未得到充分评估。目的 本研究通过Meta分析整合随机对照试验（RCT）数据，评估ABC治疗DFU的有效性及安全性，从而为临床治疗提供方向。方法 计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、Pubmed、Cochrane Library、Embase、Web of science等数据库，检索建库至2025年1月发表的ABC治疗糖尿病足的RCT。由2名研究者独立筛选文献并提取数据，最终纳入13项RCT，包含843例患者，试验组为ABC联合负压封闭引流技术（VSD）治疗，对照组为单纯的VSD治疗。采用RevMan 5.3软件对创面愈合时间、临床有效率、细菌转阴天数、住院时间、手术次数、截肢率、视觉模拟量表（VAS）评分、治疗1周后细菌培养阳性率、不良反应进行Meta分析，异质性较高时采用随机效应模型。结果 Meta分析显示，联合ABC治疗能显著缩短DFU的创面愈合时间（MD=-14.46，95%CI=-19.69~-9.23，P<0.05），提高临床有效率（OR=7.81，95%CI=3.94~17.48，P<0.05），缩短细菌转阴天数（MD=-4.04，95%CI=-5.13~-2.94，P<0.05），减少治疗1周后细菌培养阳性结果的发生（OR=0.27，95%CI=0.14~0.50，P<0.05），降低截肢率（OR=0.14，95%CI=0.03~0.62，P=0.01），减少手术次数（MD=-1.77，95%CI=-2.52~-1.03，P<0.05），降低VAS（MD=-1.96，95%CI=-1.96~-0.57，P<0.05）。同时，所有纳入的研究中ABC治疗DFU均未声明发生不良反应。对于创面愈合时间，根据研究对象的不同分为Wagner 5级组和非Wagner 5级组，又根据负载抗生素的种类不同分为联用组和单用组。非Wagner 5级组结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能显著缩短DFU患者的创面愈合时间（MD=-6.31，95%CI=-7.88~-4.74，P<0.05）；Wagner 5级组的结果显示，试验组与对照组比较，差异无统计学意义（MD=-8.02，95%CI=-20.11~4.07，P=0.19）。单用抗生素组的结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能缩短DFU患者的创面愈合时间（MD=-4.52，95%CI=-5.81~-3.23，P<0.05）；联用抗生素组的结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能显著缩短DFU患者的创面愈合时间（MD=-14.21，95%CI=-18.20~-10.21，P<0.05）。对于住院时间，根据研究对象的年龄不同，分为平均年龄大于60岁组和平均年龄小于60岁组。平均年龄大于60岁组结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能缩短DFU患者的住院时间（MD=-6.82，95%CI=-10.93~-2.71，P=0.001）；平均年龄小于60岁组结果显示，试验组和对照组比较，差异无统计学意义（MD=-5.11，95%CI=-17.78~7.56，P=0.45）。对于手术次数，根据创面处理的方式不同分为有植皮组和无植皮组。无植皮组的结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能减少DFU患者的手术次数（MD=-1.79，95%CI=-2.13~-1.46，P<0.05）；有植皮组的结果显示，与单纯的VSD治疗相比，ABC联合VSD治疗能明显减少DFU患者的手术次数（MD=-1.89，95%CI=-3.27~0.50，P=0.008）。进行敏感性分析发现，本研究的结果稳健。结论 ABC联合VSD是DFU的安全高效疗法，尤其适用于非Wagner 5级患者及老年群体，联用抗生素及联合植皮术可进一步增效。

关键词: 骨水泥成形术；抗生素骨水泥；糖尿病足；足溃疡, 糖尿病性；负压伤口疗法；负压封闭引流；创面愈合；Meta分析