Graves病131I疗效与131I转换率、残留量及临床资料的相关性研究

Correlation study on the efficacy of 131I therapy for Graves disease with 131I conversion rate, residual 131I level, and clinical data

  • 摘要:
    目的  探讨 131I 转换率、治疗后甲状腺 131I 残留量及临床资料与Graves病患者131I 治疗疗效的相关性,筛选独立影响因素以指导个体化治疗。
    方法  采用回顾性队列研究,纳入 2017 年 9 月至2022 年 9 月于昆明医科大学第一附属医院接受 131I治疗的Graves 病患者1117例。根据病例资料完整程度将患者分为核心队列(938 例,含完整临床资料与随访资料)和扩展队列(179 例,额外含 131I残留量数据)。根据《131I治疗格雷夫斯甲亢指南(2021版)》分为临床治愈组和临床未治愈组。计量资料的组间比较采用 Mann-Whitney U秩和检验;计数资料的组间比较采用 χ2 检验或 Fisher 确切概率法。采用Spearman 相关性分析评估各指标与疗效的相关性,采用多因素二元logistic 回归筛选131I 治疗疗效的独立影响因素。
    结果  核心队列的患者被分为临床治愈组440 例和临床未治愈组 498 例,临床治愈组的 2 h/24 h、4 h/24 h 131I 转换率均低于临床未治愈组0.59%(0.48%, 0.73%)对0.80%(0.62%, 0.94%), 0.78%(0.67%, 0.90%)对0.96%(0.82%, 1.03%),Z=−11.836、−12.427,均 P<0.001,且均与疗效呈负相关(r=−0.387、−0.406,均P<0.001),其中4 h/24 h 131I转换率的相关性更强。单因素分析结果显示,包括年龄等20项临床资料与疗效相关。多因素回归分析结果显示,4 h/24 h 131I转换率(OR=0.082,影响权重最高)、年龄(OR=0.981)、合并桥本甲状腺炎(OR=1.453)、甲状腺重量(OR=0.964)、131I 治疗后联合抗甲状腺药物(ATD)(OR=0.477)、甲状腺球蛋白(Tg)水平(OR=0.999)等 6 项指标为独立影响因素(均 P<0.05)。扩展队列的患者被分为临床治愈组110例和临床未治愈组69例,临床治愈组在治疗后 2个月和3 个月的甲状腺 131I残留量均显著低于临床未治愈组5594.0(2020.0, 15862.0) cpm对11512.0(4458.0, 31669.0) cpm,77.5(18.3, 367.3) cpm对353.0(54.5, 779.0) cpm,Z=−3.024、−3.729,均 P<0.001,且均与疗效呈负相关(r=−0.227、−0.279,均 P<0.01)。
    结论  4 h/24 h 131I转换率、治疗后 2个月及3个月甲状腺 131I残留量、年龄、甲状腺重量、131I治疗后联合ATD、Tg水平与131I治疗疗效均呈负相关;合并桥本甲状腺炎与131I治疗疗效呈正相关。

     

    Abstract:
    Objective To explore the correlations of the 131I conversion ratio, post-therapeutic thyroid 131I residual activity, and clinical data with the therapeutic efficacy of 131I therapy in patients with Graves disease, and to identify independent influencing factors to guide individualized treatment.
    Methods A retrospective cohort study was performed. A total of 1 117 patients with Graves disease who received 131I therapy at the First Affiliated Hospital of Kunming Medical University between September 2017 and September 2022 were enrolled. According to data completeness, patients were divided into a core cohort (938 patients with complete clinical and follow-up data) and an extended cohort (179 patients with additional data on thyroid 131I residual activity). Patients were classified into the clinically cured group and the non-clinically cured group in accordance with "Clinical Guidelines for 131I Therapy of Graves′ Hyperthyroidism (2021 Edition)". Between-group comparisons of quantitative data were conducted using the Mann-Whitney U rank-sum test; categorical data were compared using the χ2 test or Fisher′s exact test. Spearman correlation analysis was applied to assess associations between variables and treatment response. Multivariate binary logistic regression was used to screen independent predictors of 131I therapeutic efficacy.
    Results Within the core cohort, 440 patients were assigned to the clinically cured group, whereas 498 were allocated to the non-clinically cured group. The 2 h/24 h and 4 h/24 h 131I conversion ratios in the clinically cured group were lower than those in the non-clinically cured group (0.59% (0.48%, 0.73%) vs. 0.80% (0.62%, 0.94%); 0.78% (0.67%, 0.90%) vs. 0.96% (0.82%, 1.03%); Z=−11.836, −12.427; all P<0.001). Both ratios were negatively correlated with therapeutic efficacy (r=−0.387, −0.406, all P<0.001), with the 4 h/24 h 131I conversion ratio showing a stronger correlation than the 2 h/24 h 131I conversion ratio. Univariate analysis demonstrated that 20 clinical variables including age were associated with treatment outcome. Multivariate regression identified 6 independent influencing factors (all P<0.05): 4 h/24 h 131I conversion ratio (OR=0.082, highest weight of influence), age (OR=0.981), concomitant Hashimoto′s thyroiditis (OR=1.453), thyroid weight (OR=0.964), combined post-131I antithyroid drug (ATD) therapy (OR=0.477), and thyroglobulin (Tg) level (OR=0.999). In the extended cohort, 110 patients comprised the clinically cured group, and 69 were in the non-clinically cured group. Thyroid ¹³¹I residual counts at 2-month and 3-month follow-up after therapy were significantly lower in the cured group than in the non-clinically cured group (5594.0 (2020.0, 15862.0) cpm vs. 11512.0 (4458.0, 31669.0) cpm; 77.5 (18.3, 367.3) cpm vs. 353.0 (54.5, 779.0) cpm; Z=−3.024, −3.729; all P<0.001), and both measurements were negatively correlated with efficacy (r=−0.227, −0.279; all P<0.01).
    Conclusions The 4 h/24 h 131I conversion ratio and thyroid 131I residual counts at 2 and 3 months after treatment, age, thyroid weight, post-131I combined ATD therapy, and Tg level were negatively correlated with 131I therapeutic efficacy. Concomitant Hashimoto′s thyroiditis was positively correlated with treatment response.

     

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