补脾益气疗法联合甲状腺激素治疗桥本氏甲状腺功能减退症的疗效与安全性：系统综述与meta分析

Efficacy and safety of the tonifying spleen and reinforcing Qi therapy combined with thyroid hormone in Hashimoto’s hypothyroidism: a systematic review and meta-analysis

    摘要
  • 摘要:
    目的 本系统综述旨在评估补脾益气（TSRQ）疗法联合甲状腺激素替代疗法（THRT）治疗桥本氏甲状腺功能减退症的有效性和安全性。
    方法 通过检索PubMed、Web of Science、Cochrane、Embase、中国知网、万方、维普及中国生物医学文献数据库等数据库，收集自建数据库至2025年1月14日的相关研究信息。纳入对象为评估TSRQ结合THRT治疗桥本甲减的有效性和安全性的随机对照试验（RCT）。质量评估后，使用 Stata 15.1 软件进行荟萃分析和系统综述。采用亚组分析以识别异质性的来源。采用推荐意见分级、制定和评价系统（GRADE）评分对结局指标进行证据质量分级。
    结果 本研究共纳入了 30 项研究性临床试验，包括 2687 名桥本甲减患者。整体方法学质量符合系统评价的纳入质量要求，没有存在高偏倚风险的研究。荟萃分析结果表明，与单纯甲状腺激素替代相比，联合TSRQ疗法能更有效地提高血清游离三碘甲状腺原氨酸（fT3）标准化平均差（SMD）= 0. 76，95% 置信区间 （CI）：0.57～0.94，P < 0.001和游离甲状腺素（fT4）（SMD = 0.86， 95% CI：0.61～1.11，P < 0.001），并降低促甲状腺激素（TSH）水平（SMD = – 0.99，95% CI：– 1.20～– 0.78，P < 0.001）。此外，TSRQ方法与THRT结合可显著改善抗甲状腺过氧化物酶抗体（TPOAb）（SMD = – 1.46， 95% CI：– 1.79～– 1.13，P < 0.001）和抗甲状腺球蛋白抗体（TgAb）（SMD = – 1.46，95% CI：– 1.80～– 1.11，P < 0.001）水平。TSRQ治疗不会影响甲状腺激素替代的安全性。然而，尽管部分异质性来源已被识别（例如个别检测方法, I2 = 0.0%, P = 0.938），仍存在未能解释的异质性部分（例如发表年份，I² = 93.4%, P < 0.001），这降低了对这些合并估计值的信心。fT3、fT4 和 TSH 的证据等级有限，而 TPOAb 和 TgAb 的证据等级更为有限。
    结论 TSRQ疗法联合THRT可能改善桥本氏甲状腺功能减退症患者的甲状腺功能，并调节免疫失衡，同时不会增加不良事件的发生率。

     

    Abstract:
    Objective To evaluate the effectiveness and safety of the tonifying spleen and reinforcing Qi (TSRQ) therapy combined with thyroid hormone replacement therapy (THRT) for treating Hashimoto’s hypothyroidism.
    Methods From database foundation to January 14, 2025, PubMed, Web of Science, Cochrane, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Data, China Science and Technology Journal Database (VIP), and China Biomedical Literature Database (CBM) were searched for relevant information. Randomized clinical trials (RCTs) evaluating the efficacy and safety of TSRQ therapy combined with THRT for Hashimoto’s hypothyroidism were eligible for inclusion. Following quality assessment, data were analyzed using Stata 15.1 to conduct a meta-analysis and systematic review. Subgroup analysis was used to identify the sources of heterogeneity. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was adopted to evaluate the certainty of the evidence.
    Results This study included 30 RCTs, comprising 2 687 patients with Hashimoto’s hypothyroidism. Overall methodological quality was acceptable, with no studies exhibiting a high risk of bias. Meta-analysis demonstrated that TSRQ therapy combined with THRT significantly enhanced serum free triiodothyronine (fT3) levels standardized mean difference (SMD) = 0.76, 95% confidence interval (CI): 0.57 to 0.94, P < 0.001 and free thyroxine (fT4) levels (SMD = 0.86, 95% CI: 0.61 to 1.11, P < 0.001), while reducing thyroid-stimulating hormone (TSH) levels (SMD = – 0.99, 95% CI: – 1.20 to – 0.78, P < 0.001) compared with THRT alone. Furthermore, the combination therapy significantly decreased anti-thyroid peroxidase antibody (TPOAb) levels (SMD = – 1.46, 95% CI: – 1.79 to – 1.13, P < 0.001) and anti-thyroglobulin antibody (TgAb) levels (SMD = – 1.46, 95% CI: – 1.80 to – 1.11, P < 0.001). TSRQ therapy did not adversely impact the safety profile of THRT. However, while some sources of heterogeneity have been identified (e.g., specific detection methodologies, I² = 0.0%, P = 0.938), there remains a portion of unexplained heterogeneity (e.g., publication year, I² = 93.4%, P < 0.001), which has undermined confidence in these pooled estimates. The evidence ratings for fT3, fT4, and TSH were limited, and those for TPOAb and TgAb were even more limited.
    Conclusion TSRQ therapy combined with THRT may strengthen thyroid function and modulate immune dysregulation in patients with Hashimoto’s hypothyroidism without increasing adverse event incidence.

     

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