Construction of an efficacy prediction model for active ulcerative colitis

WANG Xuehui; CHEN Yunru; ZHENG Youyou; WANG Xinyue; SUN Huiyi; WANG Jianyun; LI Junxiang; SONG Zhenmei; LIU Fang; BU Zhijun; LIU Jianping; LIU Zhaolan

doi:10.3969/j.issn.1006-2157.2023.04.012

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Construction of an efficacy prediction model for active ulcerative colitis

Chinese Medical Informatics | 更新时间：2023-05-09

- Construction of an efficacy prediction model for active ulcerative colitis
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 4, Pages: 528-535(2023)
- 作者机构：
  
  1.北京中医药大学循证医学中心　北京　100029
  2.北京中医药大学第三附属医院
  3.北京中医药大学东直门医院
  4.北京中医药大学东方医院
  5.中日友好医院
- 作者简介：
  
  Prof. LIU Zhaolan, Ph.D., Doctoral Supervisor.Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, No.11, Beisanhuan Donglu Road, Chaoyang District, Beijing 100029. E-mail: lzl1019@163.com
- 基金信息：
  
  National Natural Science Foundation of China(81904052);National Key Research and Development Program of China(2018YFC1705401－1)
- DOI：10.3969/j.issn.1006-2157.2023.04.012
  CLC： R211
- Received：15 November 2022，
  
  Published Online：09 March 2023，
  
  Published：30 April 2023
- 稿件说明：
移动端阅览
WANG Xuehui, CHEN Yunru, ZHENG Youyou, et al. Construction of an efficacy prediction model for active ulcerative colitis[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(4): 528-535.
DOI：

WANG Xuehui, CHEN Yunru, ZHENG Youyou, et al. Construction of an efficacy prediction model for active ulcerative colitis[J]. Journal of beijing university of traditional chinese medicine, 2023, 46(4): 528-535. DOI： 10.3969/j.issn.1006-2157.2023.04.012.

摘要

目的

基于五味苦参肠溶胶囊治疗溃疡性结肠炎的患者数据，探讨中医药疗效预测模型构建的可行性及其方法要点。

方法

选择五味苦参肠溶胶囊Ⅲ期临床试验的试验组(五味苦参肠溶胶囊)作为研究对象，经过8周试验后，数据资料完整的患者共274例。统计分析软件使用R语言4.1.0，纳入全部待筛选变量构建多因素Logistic回归模型，筛选

0.05的变量纳入最终模型；绘制列线图；采用Bootstrap法重复抽样1 000次对模型进行内部验证，计算C指数并绘制校准图，评价模型的区分度及校准度；并进行Hosmer-Lemeshow拟合优度检验和外部验证，对模型进行总体评价。

结果

筛选出溃疡性结肠炎完全缓解的促进因素为：患者(15～65岁)接受治疗时年龄小(

＝0.96

95%

CI:

0.94～0.99

＝0.002 )、非慢性持续型(与初发型比，

＝0.36

95%

：0.18～0.74

＝0.005)、镜下无出血(

＝0.42，95%

：0.22～0.82，

＝0.011)、红细胞沉降率降低(

＝0.97，95%

：0.95～0.99，

＝0.006)。使用上述变量构建最终模型，并绘制列线图，校正后的C指数为0.735(95%

：0.672～0.797)，模型区分度尚可；绘制校准图可见校准曲线与标准线大致贴合，模型校准度尚可。对模型进行Hosmer-Lemeshow拟合优度检验(

＝7.07，

＝0.53)，模型拟合良好。对模型进行外部检证，C指数及置信区间为0.54(95%

：0.44～0.65)。

结论

利用随机对照试验的数据进行预测模型构建具有一定可行性；根据本研究的数据所建立的预测模型，经过大样本验证后，有可能为临床监测和针对性治疗提供有效的测评工具。

Abstract

Objective

Based on the data of patients with ulcerative colitis treated with Five-Flavor Sophora Flavescens Radix Enteric-coated Capsules

we discuss the feasibility and methodology of constructing a prediction model of the efficacy of traditional Chinese medicine.

Methods

Based on phase Ⅲ clinical trial data of Five-Flavor Sophora Flavescens Radix Enteric-coated Capsules

a total of 274 patients with active ulcerative colitis with complete population data after 8 weeks of treatment in the experimental group (Five-Flavor Sophora Flavescens Radix Enteric-coated Capsules) were selected. R 4.1.0 was used for statistical analysis. First

all the variables to be screened were included to construct a multivariate Logistic regression model. Then

variables with

0.05 were screened for inclusion in the final model. The nomogram was plotted. The bootstrap method was used to resample 1 000 times for internal validation of the model

the C index was calculated

and the calibration chart was plotted to evaluate the discrimination and calibration of the model. The model was evaluated by the Hosmer-Lemeshow goodness of fit test and external validation. The overall evaluation of the model was performed by the above methods.

Results

The prognostic factors for complete remission of ulcerative colitis were younger age (15-65 years old) (

=0.96

95%

: 0.94-0.99

=0.002)

non-chronic persistent (compared with primary type) (

=0.36

95%

: 0.18-0.74

=0.005)

no microscopic bleeding (

=0.42

95%

: 0.22-0.82

=0.011)

and decreased erythrocyte sedimentation rate (

=0.97

95%

: 0.95-0.99

=0.006). We used the above variables to construct the final model and drew a nomogram. The corrected C index was 0.735 (95%

: 0.672-0.797)

indicating that the model’s discrimination was acceptable. The calibration diagram shows that the calibration curve and the standard line roughly fit

indicating the calibration model is acceptable. The Hosmer-Lemeshow goodness of fit test (χ

=7.07

=0.53) showed that the model was well fitted. We conducted an external test of the prediction model. The C index and confidence interval were 0.54(95%

: 0.44-0.65).

Conclusion

It is feasible to construct a prediction model by using data from randomized controlled trials. A prediction model based on the study data may provide an effective evaluation tool for clinical monitoring and targeted therapy after large sample validation.

关键词

Keywords

references

MOONS KG , ROYSTON P , VERGOUWE Y , et al . Prognosis and prognostic research: what, why, and how? [J/OL]. BMJ ， 2009 ， 23 ( 338 )： b375 [ 2022－09－24 ]. https：//www.bmj.com/content/338/bmj.b375.long https：//www.bmj.com/content/338/bmj.b375.long .

谷鸿秋，周支瑞，章仲恒，等 . 临床预测模型：基本概念、应用场景及研究思路 [J]. 中国循证心血管医学杂志， 2018 ， 10 ( 12 ): 1454 － 1456 .

张轩，祖丽胡玛尔·艾尼瓦尔，刘忠第，等．基于运气理论探讨伤寒副伤寒与气象因素的相关性并建立预测模型 [J]. 北京中医药大学学报， 2013 ， 36 ( 12 )： 797 － 801 .

HAYBITTLE JL , BLAMEY RW , ELSTON CW , et al . A prognostic index in primary breast cancer [J/OL]. Br J Cancer , 1982 ， 45 ( 3 )： 361 － 366 [ 2022－09－24 ]. https：//sci-hub.se/10.1038/bjc.1982.62 https：//sci-hub.se/10.1038/bjc.1982.62 .

朱文翔，王庆国，王雪茜，等．基于“治未病”理论的《金匮要略》湿病、痰饮病、水气病治则解析 [J]. 北京中医药大学学报， 2017 ， 40 ( 7 )： 533 － 536 .

眭瑞卿，朱超林 . 从肿瘤精准医疗创新性临床试验探讨中医辨证论治科学性 [J]. 中国中医药信息杂志， 2019 ， 26 ( 4 ): 1 － 4 .

袁冰．建立精准的状态调控体系：中医学走向精准之路(二) [J]. 北京中医药大学学报， 2016 ， 39 ( 4 )： 273 － 276 .

黄忠营，孙卫强，邓宏勇，等 . 中医随机对照试验元数据完整性的评价 [J]. 中国循证医学杂志， 2021 ， 21 ( 10 ): 1211 － 1218 .

PAJOUHESHNIA R , GROENWOLD RHH , PEELEN LM , et al . When and how to use data from randomised trials to develop or validate prognostic models [J/OL]. BMJ , 2019 ， 29 ( 365 )： l2154 [ 2022－09－24 ]. https：//sci-hub.se/10.1136/bmj.l2154 https：//sci-hub.se/10.1136/bmj.l2154 .

谷鸿秋，王俊峰，章仲恒，等 . 临床预测模型：模型的建立 [J]. 中国循证心血管医学杂志， 2019 ， 11 ( 1 ): 14 － 16 .

中华医学会消化病学分会．对炎症性肠病诊断治疗规范的建议 [J]. 中华消化杂志， 2001 ， 21 ( 4 ): 236 － 239 .

沈洪，唐志鹏，唐旭东，等 . 消化系统常见病溃疡性结肠炎中医诊疗指南(基层医生版) [J]. 中华中医药杂志， 2019 ， 34 ( 9 ): 4155 － 4160 .

TONG ZQ , YANG B , CHEN BY , et al . A multi-center, randomized, single-blind, controlled clinical study on the efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis [J]. Chin J Integr Med ， 2010 ， 16 ( 6 )： 486 － 492 .

仝战旗，杨波，童新元，等 . 复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎多中心、随机、双盲、对照研究 [J]. 中国中西医结合杂志， 2011 ， 31 ( 2 ): 172 － 176 .

孙屿昕，侯文斌，陈韵如，等 . 中医药个体预后与诊断预测模型研究报告规范：TRIPOD-TCM清单 [J]. 中医杂志， 2022 ， 63 ( 10 ): 936 － 942 .

陈香萍，张奕，庄一渝，等 . PROBAST：诊断或预后多因素预测模型研究偏倚风险的评估工具 [J]. 中国循证医学杂志， 2020 ， 20 ( 6 ): 737 － 744 .

梁笑楠，尹凤荣，张晓岚 . 炎症性肠病诊断与治疗的共识意见(2018年，北京)溃疡性结肠炎部分解读 [J]. 临床荟萃， 2018 ， 33 ( 11 ): 987 － 990 .

中国中西医结合学会消化系统疾病专业委员会 . 溃疡性结肠炎中西医结合诊疗指南(草案) [J]. 中国中西医结合消化杂志， 2011 ， 19 ( 1 ): 61 － 65 .

中国中西医结合学会消化系统疾病专业委员会．溃疡性结肠炎中西医结合诊疗共识意见(2017年) [J]. 中国中西医结合消化杂志， 2018 ， 26 ( 2 ): 105 － 111 .

杨慧婷，蒋金兰，金林珍，等 . 针灸治疗中风恢复期临床预测模型的建立和分析 [J]. 中国针灸， 2021 ， 41 ( 8 ): 855 － 860 .

AHO K , DERRYBERRY D , PETERSON T . Model selection for ecologists: the worldviews of AIC and BIC [J]. Ecology ， 2014 ， 95 ( 3 )： 631 － 636 .

王萍，史彬，温艳东，等 . 胃癌前病变病证结合风险预测模型的构建研究 [J]. 中国中西医结合杂志， 2018 ， 38 ( 7 ): 773 － 778 .

黄平，冯慧芬，王芳，等 . 重症手足口病列线图预测模型的建立 [J]. 郑州大学学报(医学版) , 2019 ， 54 ( 1 ): 93 － 97 .

王俊峰，章仲恒，周支瑞，等 . 临床预测模型：模型的验证 [J]. 中国循证心血管医学杂志， 2019 ， 11 ( 2 ): 141 － 144 .

STEYERBERG EW , VERGOUWE Y . Towards better clinical prediction models: seven steps for development and an ABCD for validation [J]. Eur Heart J ， 2014 ， 35 ( 29 )： 1925 － 1931 .

魏戌，谢雁鸣，田峰，等 . 病证结合构建慢病风险预测模型的思路与方法 [J]. 中国中医基础医学杂志， 2017 ， 23 ( 2 ): 180 － 183 .

丁丽，郭炫，赵珊，等 . Cox比例风险模型在原发性肝癌患者凝血功能分析中的应用 [J]. 西安交通大学学报(医学版) , 2012 ， 33 ( 1 ): 99 － 103 .

高原，杨娇，赵凌，等 . 运用人工神经网络技术结合穴位敏化理论探索慢性稳定性心绞痛疾病辅助预测模型的构建思路 [J]. 世界科学技术－中医药现代化， 2021 ， 23 ( 2 ): 628 － 634 .

刘建平，程锦泉，张仁利，等 . 应用分类树模型构建缺血性脑卒中发病风险的预测模型 [J]. 中国慢性病预防与控制， 2012 ， 20 ( 3 ): 254 － 258 .

王子涵，张瑾，兰天仪，等 . 基于Markov模型的中西医结合治疗心力衰竭远期疗效评价研究 [J]. 中医杂志， 2022 ， 63 ( 15 ): 1449 － 1455 .

王新月，王建云 . 溃疡性结肠炎中医药治疗的关键问题与优势对策 [J]. 中华中医药杂志， 2012 ， 27 ( 2 ): 263 － 267 .

DORRESTEIJN JA , VISSEREN FL , WASSINK AM , et al . Development and validation of a prediction rule for recurrent vascular events based on a cohort study of patients with arterial disease: the SMART risk score [J]. Heart , 2013 ， 99 ( 12 )： 866 － 872 .

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