【目的】系统评价软坚散结方联合左甲状腺素钠治疗甲状腺癌术后的疗效，为临床治疗甲状腺癌术后提供循证依据。 【方法】计算机检索国内外主要数据库中有关软坚散结方联合左甲状腺素钠治疗甲状腺癌术后的临床随机对照试验 （randomized controlled trials，RCTs）。根据文献纳入与排除标准筛选文献后，采用Cochrane系统评价员手册推荐的偏倚风险 评估工具和改良JADAD评分量表进行纳入文献的质量评价，采用RevMan 5.4软件进行Meta分析。【结果】最终纳入11篇文 献，涉及749例患者。Meta分析结果显示：与单纯左甲状腺素钠比较，软坚散结方联合左甲状腺素钠能显著提高甲状腺癌术 后患者的疗效（RR=1.30，95%CI [1.21，1.41]，Z = 6.81，P＜0.000 01），改善甲状腺功能指标血清促甲状腺激素（TSH） （SMD = -1.75，95%CI[-2.38，-1.13]，Z = 5.47，P＜0.000 01）、甲状腺球蛋白（TG）（SMD=-1.13，95%CI [-1.71，-0.55]， Z = 3.81，P = 0.000 1）、游离三碘甲状腺原氨酸（FT3）（SMD=3.42，95%CI [0.73，6.10]，Z = 2.50，P = 0.01）、游离甲状腺素 （FT4）（SMD=1.85，95%CI[0.05，3.66]，Z = 2.02，P = 0.04）、甲状腺球蛋白抗体（TgAb）（SMD=-0.63，95%CI [-1.11，-0.15]， Z = 2.55，P = 0.01），改善Karnofsky功能状态（KPS）评分（SMD=2.19，95%CI [1.30，3.08]，Z = 4.81，P＜0.000 01），缩短甲 状腺癌术后临床症状改善时间（MD=-4.67，95%CI [-5.38，-3.96]，Z = 12.87，P＜0.000 01），减小甲状腺癌术后最大甲状腺 结节直径（MD=-2.51，95%CI [-3.13，-1.89]，Z = 7.94，P＜0.000 01），调节免疫功能指标T淋巴细胞群CD3+（MD=8.68， 95%CI [4.97，12.39]，Z = 4.59，P＜0.000 01）、CD4+（MD=10.77，95%CI [5.46，16.08]，Z = 3.97，P＜0.000 1）水平，降低甲 状腺癌术后并发症发生率（RR=0.34，95%CI [0.18，0.65]，Z = 3.26，P = 0.001），差异均有统计学意义（P＜0.05）。【结论】软 坚散结方联合左甲状腺素钠能提高甲状腺癌术后患者的疗效，且其在改善甲状腺功能指标、KPS评分、临床症状改善时间、 最大甲状腺结节直径、免疫功能指标、并发症发生率等方面优于单纯左甲状腺素钠。但因纳入本研究的文献数量较少，且 因软坚散结法所用的方药也并未统一，本研究结论有待更多高质量、多中心、大样本的临床随机对照试验加以证实。

Objective To systematically evaluate the clinical efficacy of the prescriptions for softening hardness to dissipate mass combined with Levothyroxine Sodium in the treatment of postoperative thyroid cancer， and to provide evidence-based medical proof for clinical treatment of postoperative thyroid cancer. Methods Computer search was performed in the major domestic and oversea databases for the retrieval of clinical randomized controlled trials（RCTs）of prescriptions for softening hardness to dissipate mass combined with Levothyroxine Sodium for the treatment of postoperative thyroid cancer. After screening the literature according to the inclusion and exclusion criteria，the quality of the included literature was evaluated using the tools for analysis of the bias recommended by 广州中医药大学学报 Journal of Guangzhou University of Traditional Chinese Medicine 2024年3月第41卷第3期 798 March 2024，Vol. 41，No. 3 Cochrane Reviewer’s Handbook and the modified JADAD rating scale，and meta-analysis was performed using RevMan 5.4 software. Results A total of 11 RCTs involving 749 patients were eventually included. The results of meta-analysis showed that compared with Levothyroxine Sodium alone， prescriptions for softening hardness to dissipate mass combined with Levothyroxine Sodium significantly enhanced the efficacy of postoperative patients with thyroid cancer（RR=1.30， 95% CI [1.21， 1.41]， Z = 6.81， P＜0.000 01）， and improved the thyroid functions parameters of serum thyroid stimulating hormone（TSH）（SMD=-1.75，95%CI [-2.38，-1.13]，Z = 5.47，P＜0.000 01），thyroglobulin（TG）（SMD=-1.13，95%CI [-1.71，-0.55]，Z = 3.81，P = 0.000 1）， free triiodothyronine（FT3）（SMD=3.42， 95%CI [0.73， 6.10]， Z = 2.50， P = 0.01）， free thyroxine（FT4） （SMD=1.85，95%CI [0.05，3.66]，Z = 2.02，P = 0.04），and thyroglobulin antibody（TgAb）（SMD=-0.63， 95%CI [-1.11，-0.15]，Z = 2.55，P = 0.01），increased Karnofsky Performance Status（KPS）scores（SMD= 2.19，95% CI [1.30，3.08]，Z = 4.81，P＜0.000 01），shortened the time for the relief of clinical symptoms after thyroid cancer surgery（MD=-4.67， 95% CI [-5.38， -3.96]， Z = 12.87， P＜0.000 01）， reduced the diameter of the largest thyroid nodule after thyroid cancer surgery（MD=-2.51，95% CI [-3.13，-1.89]，Z = 7.94，P＜ 0.000 01），regulated the immune function indicators of T lymphocyte population CD3+（MD=8.68， 95%CI [4.97，12.39]，Z = 4.59，P＜0.000 01）and CD4+（MD=10.77，95%CI [5.46，16.08]，Z = 3.97，P＜ 0.000 1）levels，and reduced the incidence of postoperative complications of thyroid cancer（RR=0.34，95% CI [0.18， 0.65]， Z = 3.26， P = 0.001）. The differences were all statistically significant（P＜0.05）. Conclusion prescriptions for softening hardness to dissipate mass combined with Levothyroxine Sodium can enhance the efficacy of postoperative patients with thyroid cancer. The combined therapy is superior to Levothyroxine Sodium alone in improving thyroid function indicators，KPS score，time for the relief of clinical symptoms，diameter of the largest thyroid nodule， immune function indicators， and the incidence of postoperative complications. However，due to the small amount of included trials and the fact that the prescriptions for softening hardness to dissipate mass vary in the composition， the conclusions of the analysis need to be confirmed by more highquality， multi-center，large-sample clinically randomized controlled trials.

R273.61