智能化辅助调药系统在甲状腺乳头状癌患者术后内分泌抑制治疗中的应用
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1.上海交通大学附属第六人民医院,甲乳疝外科/上海交通大学甲状腺疾病诊治中心,上海 200233;2.上海交通大学附属第六人民医院,内分泌代谢科,上海 200233;3.上海交通大学附属第六人民医院,临床研究中心,上海 200233;4.上海交通大学超声医学研究所,上海 200233

作者简介:

陈承坤,上海交通大学附属第六人民医院在读硕士研究生,主要从事甲状腺基础与临床方面的研究。

基金项目:

上海交通大学优秀专病诊治中心基金资助项目(2014年4号)。


Application of intelligent dose adjustment assistant system in postoperative endocrine suppression therapy for patients with papillary thyroid carcinoma
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Affiliation:

1.Department of Thyroid-Breast-Hernia Surgery/Thyroid and Parathyroid Center of Shanghai Jiao Tong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China;2.Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China;3.Clinical Research Center, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China;4.Institute of Ultrasonic Medicine, Shanghai Jiao Tong University, Shanghai 200233, China

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    摘要:

    背景与目的 甲状腺癌发病率快速上升,甲状腺乳头状癌(PTC)术后长期内分泌抑制治疗是降低复发的重要手段,然而,患者多次往返门诊明显增加了医疗负荷和医疗费用,且不同医师间可能存在调药标准的差异,因此,临床上需要一种辅助调药系统来方便精准调药。本研究中,笔者自主研发设计了一套智能化的术后内分泌抑制治疗辅助调药系统,以方便和简化临床调药过程。方法 根据促甲状腺激素(TSH)抑制治疗原理及相关指南构建TSH抑制治疗的药物调整目标及药物调整细则,编辑成计算机语言,结合网络服务器、客户端与用户终端构建成调药软件系统。纳入2021年2月—2022年1月期间门诊就诊的PTC术后患者,根据术后时间分为初治期(<1年)和随访期(≥1年)。在患者入组时收集的一般资料包括:性别、年龄、体质量指数(BMI)、手术范围、复发风险分层;调药时记录的参数指标包括:术后复查时间、甲状腺功能指标、甲亢或甲减相关症状发生的例数、调药达标(即TSH值处于目标范围内)的例数。智能化辅助系统的调药程序包括在记录入组时医师调药结果的基础上进行的随后的两次计算机辅助调药。首先根据患者入组时记录的参数,应用系统自动化生成新的用药方案,患者按照新的方案服用左旋甲状腺素直至第2次复查。在第2次复查时再记录调药后产生的新的参数指标,应用系统再次生成新的调药方案,患者按此新的方案再服用左旋甲状腺素直至第3次复查,记录调药后产生的新参数指标即随访结束。分别比较分析两次系统调药结果与系统调药前的医师调药结果之间的达标率,及其他相关的临床指标。结果 研究共纳入初治期患者99例,失访2例(2.0%),97例完成调药随访。与单纯医师调药比较,两次系统调药达标率均更高(57.7% vs. 34.0%,P=0.001;63.9% vs. 34.0%,P<0.001);患者主诉甲亢或甲减相关症状的发生率差异无统计学意义(P=0.791、P=0.267)。纳入随访期患者50例,均完成调药随访,第1次系统调药与医师调药的TSH抑制达标率差异无统计学意义(50.0% vs. 36.0%,P=0.143),但第2次系统调药较医师调药的TSH抑制达标率更高(66.0% vs. 36.0%,P=0.007);患者主诉甲亢或甲减相关症状的发生率差异无统计学意义(P=0.180、P=0.180)。按性别、BMI、手术范围、复发风险分层的亚组分析结果与总体分析的结果基本一致。在初治期患者与随访期患者间比较,医师调药及两次系统调药的达标率差异均无统计学意义(均P>0.05)。结论 PTC术后内分泌抑制治疗过程中,与单纯医师调药相比,智能化的辅助系统调药具有良好的安全性和更高的TSH抑制达标率,可以更好地辅助临床医师进行PTC患者术后左旋甲状腺素片的精准剂量调整。但仍需要大样本、多中心、前瞻性的研究来进一步验证上述结论。

    Abstract:

    Background and Aims The incidence of thyroid cancer is growing rapidly. Long-term endocrine suppression therapy after surgery for papillary thyroid carcinoma (PTC) is an important measure to reduce disease recurrence. However, multiple outpatient clinic visits of patients significantly increase the medical burden and costs, and different physicians may have different standards for drug dose adjustment. Therefore, an assistant medication dispensing system is needed to facilitate accurate dose adjustment in clinical settings. In this study, the authors independently developed and designed a specialized intelligent dose adjustment assistant system for postoperative endocrine suppression therapy, so as to facilitate and simplify the dose adjustment process in clinical practice.Methods According to the principle and related guidelines of thyroid stimulating hormone (TSH) suppression therapy, the medication adjustment goals and detailed rules of TSH suppression therapy were established, and were coded into computer language to build a dose adjustment software system combined with network server, and clients' and users' terminals. The patients who received TSH suppression therapy after surgery for PTC at the outpatient clinic from February 2021 to January 2022 were enrolled, and were categorized according to the postoperative time as initial treatment stage (<1 year) and follow-up stage (≥1 year). The general data were collected when the patients entered the study, which included gender, age, body mass index (BMI), scope of surgery and recurrence risk stratification, and the parameters were recorded during dose adjustment, which included the time of postoperative reexamination, the indexes of thyroid function, the number of cases with hyperthyroidism or hypothyroidism related symptoms, and the number of cases with good control (the TSH value was within the target range). The program of the intelligent dose adjustment assistant system included two computer-aided adjustments following the record of the results of the physician's adjustment. First of all, according to the parameters recorded when the patients entered the study, a new medication plan was automatically generated by the system, and the patients received levothyroxine treatment according to the new scheme until the second reexamination. In the second reexamination, the new parameters produced after dose adjustment were recorded, and a new medication scheme was generated again by the system, the patients were continuously treated with levothyroxine according to the second new scheme until the third reexamination, and the new parameters produced after medication adjustment were recorded at the end of the follow-up. The control rates of TSH level and other relevant clinical variables between the results of two system adjustments and the results of physician's adjustment before system adjustment were compared and analyzed.Results A total of 99 patients in initial treatment stage were included, 2 cases (2.0%) were lost to follow-up, and 97 cases completed dose adjustment follow-up. The control rates of TSH level of the two system adjustments were higher than that of the physician's adjustment (57.7% vs. 34.0%, P=0.001; 63.9% vs. 34.0%, P <0.001). There was no significant difference in the incidence of symptoms related to hyperthyroidism or hypothyroidism (P=0.791, P=0.267). A total of 50 patients in follow-up stage were included, and all of them completed dose adjustment follow-up. There was no significant difference in the control rate of TSH level between the first system adjustment and physician's adjustment (50.0% vs. 36.0%, P=0.143), but the control rate of TSH level of the second system adjustment was higher than that of physician's adjustment (66.0% vs. 36.0%, P=0.007). There was no significant difference in the incidence of symptoms related to hyperthyroidism or hypothyroidism (P=0.180, P=0.180). The results of subgroup analysis stratified by sex, BMI, scope of surgery and recurrence risk were generally consistent with the results of overall analysis. There were no statistical differences in control rates of TSH by physician's adjustment and two system adjustments between patients in initial treatment stage and follow-up stage (all P>0.05).Conclusion In the process of endocrine suppression therapy after surgery for PTC, compared with physician's adjustment, the intelligent dose adjustment assistant system has considerable safety and higher control rates of TSH level, and can better assist clinicians to accurately adjust levothyroxine dose in PTC patients after surgery. However, large sample-sized, multicenter and prospective studies are still needed to further verify the above conclusion.

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陈承坤,陶玄斌,张颖超,邓先兆,郭伯敏,丁政,李鸣,周健,包玉倩,沈力,郑元义,樊友本.智能化辅助调药系统在甲状腺乳头状癌患者术后内分泌抑制治疗中的应用[J].中国普通外科杂志,2022,31(5):597-607.
DOI:10.7659/j. issn.1005-6947.2022.05.005

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  • 收稿日期:2022-01-25
  • 最后修改日期:2022-04-18
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  • 在线发布日期: 2022-06-01