糖尿病患者糖尿病足溃疡复发风险预测模型的构建及初步验证

郭庆娇; 欧阳静; 饶佳琴; 张艺之; 余丽红; 徐婉莹; 龙锦花; 高秀花; 吴晓艳; 顾颖

doi:10.3760/cma.j.cn501225-20231101-00166

糖尿病患者糖尿病足溃疡复发风险预测模型的构建及初步验证

doi: 10.3760/cma.j.cn501225-20231101-00166

1.
遵义医科大学附属口腔医院护理部，遵义　　550002
2.
贵州医科大学附属医院消毒供应中心，贵阳　　550004
3.
贵州医科大学附属医院急诊重症监护病房，贵阳　　550004
4.
贵州医科大学护理学院，贵阳　　550004
5.
贵州健康职业学院，铜仁　　554300
6.
贵州医科大学附属医院神经内科,贵阳　　550004
7.
贵州医科大学第二附属医院护理部，凯里　　556000
8.
贵州医科大学附属医院心内科,贵阳　　550004
9.
贵州中医药大学第二附属医院急诊科，贵阳　　550003
10.
贵州医科大学附属医院护理部，贵阳　　550004

基金项目:

贵州省卫生健康委员会科学技术基金项目 gzwkj2023-585

贵州医科大学附属医院护理基金项目 GYHLB202219

详细信息

通讯作者:
顾颖，Email：1014348500@qq.com

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出版历程
- 收稿日期: 2023-11-01

Construction and preliminary validation of a risk prediction model for the recurrence of diabetic foot ulcer in diabetic patients

1.
Nursing Department, Hospital of Stomatology of Zunyi Medical University, Zunyi 550002, China
2.
Central Sterile Supply Department, Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
3.
Emergency Intensive Care Unit, Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
4.
School of Nursing, Guizhou Medical University, Guiyang 550004, China
5.
Guizhou Health Vocational College, Tongren 554300, China
6.
Neurology Department, Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
7.
Nursing Department, the Second Affiliated Hospital of Guizhou Medical University, Kaili 556000, China
8.
Department of Cardiology, Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China
9.
Emergency Department, the Second Hospital of Guizhou University of Chinese Medicine, Guiyang 550003, China
10.
Nursing Department, Affiliated Hospital of Guizhou Medical University, Guiyang 550004, China

Funds:

Guizhou Provincial Health Commission Science and Technology Fund Program gzwkj2023-585

Nursing Fund Project of Affiliated Hospital of Guizhou Medical University GYHLB202219

More Information

Corresponding author: Gu Ying, Email: 1014348500@qq.com

摘要

摘要: 目的构建糖尿病患者糖尿病足溃疡（DFU）复发风险预测模型并初步验证其预测价值。方法采用荟萃分析联合回顾性队列研究方法。检索中国生物医学文献数据库、中国知网、万方数据库、维普数据库及PubMed、Embase、Cochrane Library、Web of Science中公开发表的有关DFU复发危险因素的中英文文献，检索时限为各数据库建立之日至2022年3月31日；筛选、评价文献并提取资料，用RevMan 5.4.1统计软件进行荟萃分析，筛选DFU复发的危险因素；采用Egger线性回归法评估研究结果的发表偏倚情况。将≥3篇文献均提到的且荟萃分析中具有统计学意义的DFU复发危险因素作为自变量，构建DFU复发的logistic回归风险预测模型。收集2019年1月—2022年6月贵州医科大学附属医院收治的符合入选标准的101例DFU患者的病历资料，患者中男69例、女32例，年龄（63±14）岁；绘制前述构建的DFU复发预测模型预测效果的受试者操作特征（ROC）曲线，并计算ROC曲线下面积、最大约登指数及此时的敏感度、特异度。用RStudio软件模拟生成包含10 000例患者8个DFU复发危险因素的数据和DFU复发率的数据集并绘制散点分布图，确定划分DFU复发风险的2个概率。用8个DFU复发危险因素对应的 β系数×10并取整数作为各因素系数权重的分值并求和得到总分，按总分×用于DFU复发风险划分的2个概率计算风险等级划分节点分值。结果最终纳入20篇文献，包括3篇病例对照研究和17篇队列研究，总病例数4 238例，DFU复发率为22.7%~71.2%。荟萃分析结果显示，糖化血红蛋白>7.5%、足底溃疡、伴有糖尿病周围神经病变、伴有糖尿病周围血管病变、吸烟、伴有骨髓炎、截肢/截趾、伴有多重耐药菌感染均是DFU复发的危险因素（比值比分别为3.27、3.66、4.05、3.94、1.98、7.17、11.96、3.61，95%置信区间分别为2.79~3.84、2.06~6.50、2.50~6.58、2.65~5.84、1.65~2.38、2.29~22.47、4.60~31.14、3.13~4.17， P<0.05）。糖尿病周围神经病变、糖尿病周围血管病变、糖化血红蛋白>7.5%、足底溃疡、吸烟、多重耐药菌感染、骨髓炎发表偏倚均不具有统计学意义（ P>0.05），截肢/截趾发表偏倚具有统计学意义（ t=-30.39， P<0.05）。预测模型ROC曲线下面积为0.81（95%置信区间为0.71~0.91），最大约登指数为0.59，此时的敏感度为72%、特异度为86%。最终将29.0%、44.8%分别作为DFU复发低风险和中风险、中风险和高风险概率划分节点，DFU复发低、中、高风险对应总分分别是<37分、37~57分、58~118分。结论通过荟萃分析筛选出8个DFU复发的危险因素并建立DFU复发风险预测模型，该模型预测准确性适中，能够为医护人员针对DFU复发风险人群采取干预措施提供指导。
- 糖尿病足 /
- 溃疡 /
- 复发 /
- 危险因素 /
- 荟萃分析 /
- 预测模型
Abstract: Objective To develop a risk prediction model for the recurrence of diabetic foot ulcer (DFU) in diabetic patients and primarily validate its predictive value. Methods Meta-analysis combined with retrospective cohort study was conducted. The Chinese and English papers on risk factors related to DFU recurrence publicly published in China Biology Medicine disc, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and PubMed, Embase, Cochrane Library, and Web of Science, and the search time was from the establishment date of each database until March 31 ^st, 2022. The papers were screened and evaluated, the data were extracted, a meta-analysis was performed using RevMan 5.4.1 statistical software to screen risk factors for DFU recurrence, and Egger's linear regression was used to assess the publication bias of the study results. Risk factors for DFU recurrence mentioned in ≥3 studies and with statistically significant differences in the meta-analysis were selected as the independent variables to develop a logistic regression model for risk prediction of DFU recurrence. The medical records of 101 patients with DFU who met the inclusion criteria and were admitted to Affiliated Hospital of Guizhou Medical University from January 2019 to June 2022 were collected. There were 69 males and 32 females, aged (63±14) years. The receiver operating characteristic (ROC) curve of the predictive performance of the above constructed predictive model for DFU recurrence was drawn, and the area under the ROC curve, maximum Youden index, and sensitivity and specificity at the point were calculated. Dataset including data of 8 risk factors for DFU recurrence and the DFU recurrence rates of 10 000 cases was simulated using RStudio software and a scatter plot was drawn to determine two probabilities for risk division of DFU recurrence. Using the β coefficients corresponding to 8 DFU recurrence risk factors ×10 and taking the integer as the score of coefficient weight of each risk factor, the total score was obtained by summing up, and the cutoff scores for risk level division were calculated based on the total score × two probabilities for risk division of DFU recurrence. Results Finally, 20 papers were included, including 3 case-control studies and 17 cohort studies, with a total of 4 238 cases and DFU recurrence rate of 22.7% to 71.2%. Meta-analysis showed that glycosylated hemoglobin >7.5% and with plantar ulcer, diabetic peripheral neuropathy, diabetic peripheral vascular disease, smoking, osteomyelitis, history of amputation/toe amputation, and multidrug-resistant bacterial infection were risk factors for the recurrence of DFU (with odds ratios of 3.27, 3.66, 4.05, 3.94, 1.98, 7.17, 11.96, 3.61, 95% confidence intervals of 2.79-3.84, 2.06-6.50, 2.50-6.58, 2.65-5.84, 1.65-2.38, 2.29-22.47, 4.60-31.14, 3.13-4.17, respectively, P<0.05). There were no statistically significant differences in publication biases of diabetic peripheral neuropathy, diabetic peripheral vascular disease, glycosylated hemoglobin >7.5%, plantar ulcer, smoking, multidrug-resistant bacterial infection, or osteomyelitis ( P>0.05), but there was a statistically significant difference in the publication bias of amputation/toe amputation ( t=-30.39, P<0.05). The area under the ROC curve of the predictive model was 0.81 (with 95% confidence interval of 0.71-0.91) and the maximum Youden index was 0.59, at which the sensitivity was 72% and the specificity was 86%. Ultimately, 29.0% and 44.8% were identified respectively as the cutoff for dividing the probability of low risk and medium risk, and medium risk and high risk for DFU recurrence, while the corresponding total scores of low, medium, and high risks of DFU recurrence were <37, 37-57, and 58-118, respectively. Conclusions Eight risk factors for DFU recurrence are screened through meta-analysis and the risk prediction model for DFU recurrence is developed, which has moderate predictive accuracy and can provide guidance for healthcare workers to take interventions for patient with DFU recurrence risk.
- Diabetic foot /
- Ulcer /
- Recurrence /
- Risk factors /
- Meta-analysis /
- Prediction model
郭庆娇：研究设计、论文撰写及文献检索；欧阳静、顾颖：研究指导、论文修改、经费支持；饶佳琴、徐婉莹、高秀花、吴晓艳：资料收集；张艺之、余丽红、龙锦花：文献检索、文献评价、数据提取

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1 101例糖尿病足溃疡患者溃疡复发风险预测模型的受试者操作特征曲线

注：对角直线为参考线，曲线为预测模型

下载: 全尺寸图片幻灯片

2 RStudio软件模拟生成包含10 000例患者糖尿病足溃疡复发率的数据集

注：2个红色点为复发风险划分节点

下载: 全尺寸图片幻灯片

表1 纳入荟萃分析的20篇关于DFU复发的文献的基本特征

表1. Basic characteristics of the 20 papers on DFU recurrence included in the meta-analysis

第1作者	年份	研究类型	复发率（复发例数/总例数）	年龄（岁）	随访时间（个月）	DFU复发的危险因素
钱泓洁 ^{［ 13］}	2012	队列研究	23.4%（33/141）	68±10	12	糖尿病病程、胆固醇
胡细玲 ^{［ 14］}	2014	队列研究	24.7%（57/231）	58.3±10.2	36	糖化血红蛋白>7.5%、糖尿病病程、年龄、骨髓炎、体重指数、既往DFU持续时间
常小霞 ^{［ 15］}	2017	队列研究	27.7%（97/350）	65.25±11.49	37.14±17.60	糖尿病病程、年龄、体重指数、外在诱因、性别、手术治疗、出院至随访间隔时间
谢朝云 ^{［ 16］}	2018	队列研究	30.9%（51/165）	72.6±8.0	24	糖尿病周围血管病变、糖化血红蛋白>7.5%、吸烟、多重耐药菌感染、糖尿病足Wagner分级为Ⅲ级或Ⅳ级、血浆黏度≥1.5 mPa·s
莫泽纬 ^{［ 17］}	2018	队列研究	45.0%（85/189）	66.6±9.80	44.83±16.69	糖尿病周围神经病变、糖尿病周围血管病变、足底溃疡、年龄
程玉霞 ^{［ 18］}	2019	病例对照研究	—	61.2±11.4	—	截肢/截趾、血管介入史、室外活动时不穿袜
谢晓玲 ^{［ 19］}	2020	队列研究	29.3%（43/147）	45~85	10	糖尿病周围神经病变、糖化血红蛋白>7.5%、足底溃疡、多重耐药菌感染、营养状态
申金付 ^{［ 20］}	2020	病例对照研究	47.0%（87/185）	56~84	36	糖尿病周围神经病变、年龄、总胆红素、白蛋白、行走障碍
王美君 ^{［ 21］}	2021	队列研究	71.2%（208/292）	63.8±11.1	60	糖尿病周围血管病变、糖化血红蛋白>7.5%、年龄、骨髓炎、足部护理行为、照顾者反应、终末期肾病5期
邬亦华 ^{［ 22］}	2021	队列研究	22.7%（25/110）	68.51±6.98	24	糖尿病周围神经病变、糖尿病周围血管病变、多重耐药菌感染、糖尿病足Wagner分级Ⅲ级或Ⅳ级
吕静 ^{［ 23］}	2022	队列研究	26.2%（67/256）	65.8±12.2	12	糖尿病周围神经病变、吸烟、足胼胝、足部皮肤颜色异常、冠心病
Peters EJ ^{［ 24］}	2007	队列研究	60.5%（49/81）	—	27.1±9.2	糖尿病周围血管病变、足底溃疡
Dubsk􀆪 M ^{［ 25］}	2013	队列研究	57.5%（42/73）	—	36	糖化血红蛋白>7.5%、足底溃疡、骨髓炎、C反应蛋白>5 mg/L
Waaijman R ^{［ 26］}	2014	队列研究	41.5%（71/171）	63.3±10.1	18	既往DFU持续时间、足部存在轻微损伤（包括胼胝、出血或水疱）、每日步数
Khalifa WA ^{［ 27］}	2018	队列研究	61.3%（57/93）	51.73±9.45	24	糖尿病周围神经病变、糖尿病周围血管病变、糖化血红蛋白>7.5%、足底溃疡、糖尿病病程、吸烟、胆固醇、足干燥、足畸形、适当足部护理、穿适当的鞋子
Tabanjeh SF ^{［ 28］}	2020	队列研究	58.5%（76/130）	59.9±11.5	24	骨髓炎、足畸形
Cheng Y ^{［ 29］}	2021	病例对照研究	—	53~70	—	糖尿病病程、截肢/截趾、血管介入史、足胼胝
Felipe RR ^{［ 30］}	2021	队列研究	32.3%（31/96）	55.8±9.9	12	糖尿病周围神经病变、足底溃疡、足部溃疡超过1处
Fournier C ^{［ 31］}	2021	队列研究	54.1%（46/85）	63.39±11.82	12	截肢/截趾、有过溃疡史（非首次复发）
Gazzaruso C ^{［ 32］}	2021	队列研究	37.1%（172/464）	71.1±8.8	42.8±23.3	糖尿病周围血管病变、有过溃疡史（非首次复发）、心血管疾病史
注：DFU为糖尿病足溃疡；“—”表示无此项；文献[ 19]、[ 20]、[ 29]中年龄数据以范围表示，其余有年龄数据的文献中该数据以 x ¯ ± s 表示；文献[ 15]、[ 17]、[ 24]、[ 32]随访时间数据以 x ¯ ± s 表示，其余有随访时间数据的文献中该数据以具体数值表示

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