Page 22 - 中国全科医学2022-20

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4.Henan Academy of Chinese Medicine，Zhengzhou 450000，China
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Corresponding author：FU Yu，Associate chief TCM physician；E-mail：kybfuyu@126.com
【Abstract】 Background Early treatment is crucial to the delay of the progression of type 2 diabetes mellitus with
stable angina pectoris （T2DM-SAP），which has poor prognosis，such as high rates of disability and mortality. As traditional
Chinese medicine（TCM） has unique advantages in preventing diseases，developing a model with TCM and western medicine
factors associated with major adverse cardiovascular and cerebrovascular events （MACCEs） incorporated may be a reliable tool
that could be used to predict the risk of MACCEs in patients with T2DM-SAP. Objective To develop and assess the applicability
of a risk prediction model for MACCEs in T2DM-SAP patients using identified risk factors associated with MACCEs in this group.
Methods Participants were 674 inpatients with T2DM-SAP who received diagnostic and treatment services from The First
Affiliated Hospital of Henan University of CM from 2012 to 2019. Through the hospital information system，electronic medical
records and follow-up data of these patients were collected，including demographics，clinical characteristics，laboratory
parameters，TCM symptoms and syndrome differentiation，and outcome（prevalence of MACCEs）. Patients were classified
into a MACCEs group（n=190） and a non-MACCEs group（n=484） by prevalence of MACCEs. Independent risk factors
for MACCEs in T2DM with SAP were identified using univariate and multivariate Logistic regression，and used to develop a
nomogram-based predictive model. Then the model was internally validated using the bootstrap approach，and its predictive value
was estimated using ROC analysis，C-index，calibration plot，Hosmer-Lemeshow test and decision curve analysis. Results
Based on the multivariate Logistic regression analysis，the factors associated with MACCEs in T2DM-SAP patients （P<0.05）
included age〔OR=1.033，95%CI（1.014，1.052）〕，cerebrovascular disease history〔OR=3.799，95%CI（2.529，
5.750）〕，serum creatinine〔OR=1.005，95%CI（1.002，1.008）〕，dark purple tongue〔OR=2.756，95%CI（1.285，
5.935）〕，decreased tongue coating〔OR=2.083，95%CI（1.025，4.166）〕，thready pulse〔OR=5.822，95%CI（1.867，
20.359）〕，and obstruction of collateral channels caused by wind-phlegm〔OR=2.525，95%CI（1.466，4.387）〕. The
predictive model constructed using the above-mentioned factors showed moderate predictive power｛C-index=0.769〔95%CI
（0.729，0.809）〕，sensitivity=69.47%，specificity=75.00%｝，indicating a good degree of distinction. The calibration plot
showed the average absolute error between the predictive and actual adverse outcome risks was 0.011，with a C-index of 0.761
2
after fitting bias correction. The Hosmer-Lemeshow test showed a good calibration（χ =6.004，P=0.647）. The decision curve
analysis displayed a threshold probability of >30%，indicating that the model may be clinically beneficial. Conclusion The risk
predictive model for MACCEs in T2DM-SAP patients was developed using the associated factors（including age，cerebrovascular
disease history，serum creatinine，dark purple tongue，decreased tongue coating，thready pulse，and obstruction of collateral
channels caused by wind-phlegm） identified by us，which has been proven to have good discrimination，calibration，and
clinical effectiveness，and could be used as a tool for assessing the risk of MACCEs in patients with T2DM-SAP.
【Key words】 Diabetes mellitus；Stable angina pectoris；Cardiovascular and cerebrovascular events；Clinical
predictive model；Traditional Chinese Medical

2 型糖尿病（type 2 diabetes mellitus，T2DM）合并
行业贡献：
稳定型心绞痛（stable angina pectoris，SAP）患者是发
针对 2 型糖尿病合并稳定型心绞痛（T2DM-SAP）
生主要不良心脑血管事件（major adverse cardiovascular 患者进行中西医结合治疗是预防主要不良心脑血管事
and cerebrovascular events，MACCE）的高危人群 ［1］ ，
件（MACCE）发生的关键环节，但其 MACCE 发生风
现代医学主要通过控制其危险因素来降低 MACCE 发生 险的把握只停留于主观定性分析而无定量的精准化风
率，但在有效减少 MACCE 方面仍面临严峻挑战 ［2-3］ 。
险预测。而融合中医元素的临床预测模型的构建，不
基于传统医学的“治未病”理念，中医药防治 T2DM- 仅体现了中医个体化辨证论治的优势，也为 T2DM-
SAP 方面具有独特的临床优势 ［4-5］ 。但“治未病”理念
SAP 患者提供了基于循证证据的数字化风险评估，实
对 T2DM-SAP 患者的预后评估具有主观性，风险预测
现临床精准医疗，做到早评估、早发现、早防治，为
不明确，临床防治工作证据不足。而融合中医元素的临
临床中西医结合防治 T2DM-SAP 提供科学依据。
床预测模型的构建不仅体现了个体化辨证论治的优势，
同时给予数字化精准的风险预测，将辨证论治的经验转 第一附属医院诊治的 965 例 T2DM-SAP 的住院患者作
为循证医学的证据，为临床中西医结合防治 T2DM-SAP 为研究对象。诊断标准参照1999年世界卫生组织（WHO）
患者发生 MACCE 提供可靠依据。 制定的糖尿病诊断标准 ［6］ 以及 2007 年中华医学会心血
1 资料与方法 管病学分会制定的《慢性稳定性心绞痛诊断与治疗指
1.1 研究对象 选取 2012—2019 年在河南中医药大学 南》 ［7］ 。纳入标准：（1）符合诊断标准；（2）年龄、