Buzhong Wenyang Tang combined with levothyroxine sodium for pregnant patients with hypothyroidism

doi:10.3760/cma.j.issn.1007-1245.2024.17.021

Abstract

Abstract:

Objective　To evaluate the effect of traditional Chinese medicine combined with thyroid hormone on lipid regulation and maternal and neonatal health in pregnant patients with hypothyroidism. Methods　Ninety-eight pregnant women with hypothyroidism treated at Second Hospital, Shaanxi University of Traditional Chinese Medicine from July 2022 to June 2023 were selected for the randomized controlled trial, and were divided into a control group and a combination group by the random number table method, with 49 cases in each group. The control group were 27-36 (31.67±4.81) years old; their body mass index at admission was (22.43±3.67) kg/m²; their gestational age was (19.09±1.34) weeks. The combination group were 29-39 (32.07±5.13) years old; their body mass index at admission was (22.19±3.28) kg/m²; their gestational age was (19.84±1.17) weeks. Both groups took levothyroxine sodium tablets at an initial dosage of 25 μg/d; they revisited every 4 weeks; if their level of thyroid-stimulating hormone (TSH) did not return to normal, they took the tablets 50-100 μg/d according to their resistance until their TSH level was normal; they were treated for 12 weeks. In addition, the combination group took Buzhong Wenyang Tang in the morning and at night one dosage per day for 12 weeks. After 12 weeks' treatment, the free thyroxine (FT4), TSH, thyroid peroxidase antibody (TPOAb) positive rates, serum total cholesterol (TC), triglycerides (TAG), low-density lipoprotein cholesterol (LDL-C), maternal and neonatal outcomes, neonatal development [assessed by the Bayley Scales of Infant Development (BSID)], and overall clinical efficacies in both groups were observed and analyzed. t and χ² tests were used. Results　The overall clinical efficacy in the combination group was higher than that in the control group [85.71% (42/49) vs. 67.35% (33/49)], with a statistical difference (χ²=4.60, P<0.05). After delivery, the levels of TSH and TPOAb and TPOAb positive rate in the combination group were lower than those in the control group [(1.97±0.46) IU/ml vs. (2.87±0.62) IU/ml, (8.12±1.47) IU/ml vs. (10.96±1.82) IU/ml, and 6.12% (3/49) vs. 20.41% (10/49)], with statistical differences (t=8.16 and 8.50; χ²=4.35; all P<0.05). After delivery, the levels of TC, TAG, and LDL-C in the combination group were lower than those in the control group, with statistical differences (all P<0.05). Three months after birth, the scores of Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI) in the combination group were higher than those in the control group [(86.94±5.86) vs. (80.27±5.14) and (85.72±5.15) vs. (80.98±5.23)], with statistical differences (both P<0.05). There was no statistical difference in the incidence of adverse outcomes between the combination group and the control group [4.08% (2/49) vs. 16.33% (8/49); χ²=4.01; P<0.05]. Conclusion　Buzhong Wenyang Tang combined with low-dose levothyroxine sodium for pregnant women with hypothyroidism can effectively improve their thyroid function and neonatal development, lower their lipid levels, optimize maternal and neonatal outcomes.

Key words:

Hypothyroidism, , Period of pregnancy, , Buzhong Wenyang Tang, , Low-dose levothyroxine sodium, , Blood lipid levels, , Maternal and neonatal outcomes

摘要：

目的　探讨中药配合甲状腺激素治疗对妊娠期合并甲状腺功能减退症（简称“甲减”）患者血脂调节效果，以及对母婴健康的影响。方法　选取陕西中医药大学第二附属医院2022年7月至2023年6月就诊的98例妊娠期合并甲减患者进行随机对照试验，通过随机数字表法分为对照组和联合组，每组各49例。对照组：年龄27～36（31.67±4.81）岁；入院体重指数（BMI）为（22.43±3.67）kg/m²；孕周为（19.09±1.34）周；予低剂量左甲状腺素钠片治疗，初始剂量为25 μg/d，每隔4周进行复诊，如促甲状腺激素（TSH）水平未恢复正常，则根据患者耐受程度，依次将剂量调整为50～100 μg/d，直到TSH水平恢复正常，共持续治疗12周。联合组：年龄29～39（32.07±5.13）岁；入院BMI为（22.19±3.28）kg/m²；孕周为（19.84±1.17）周；在对照组基础上联合补中温阳汤，水煎服，每日1剂，早、晚餐后分2次服用，连续服用12周。通过12周的持续治疗，观察分析两组患者的游离四碘甲状腺原氨酸（FT₄）、TSH、甲状腺过氧化物酶自身抗体（TPOAb）阳性率、血清总胆固醇（TC）、甘油三酯（TAG）、低密度脂蛋白胆固醇（LDL-C）、母婴结局、新生儿发育水平以及临床总有效率。统计学方法采用t检验、χ²检验。结果　联合组临床总有效率高于对照组［85.71%（42/49）比67.35%（33/49）］，差异有统计学意义（χ²=4.60，P<0.05）。分娩后，联合组TSH、TPOAb水平、TPOAb阳性率均低于对照组［（1.97±0.46）IU/ml比（2.87±0.62）IU/ml、（8.12±1.47）IU/ml比（10.96±1.82）IU/ml、6.12%（3/49）比20.41%（10/49）］，差异均有统计学意义（t=8.16、8.50，χ²=4.35，均P<0.05）；联合组血脂水平各项指标均低于对照组，差异均有统计学意义（均P<0.05）。联合组新生儿出生3个月后智力发育指数（MDI）、运动发育指数（PDI）评分均高于对照组［（86.94±5.86）分比（80.27±5.14）分、（85.72±5.15）分比（80.98±5.23）分］，差异均有统计学意义（t=5.99、4.52，均P<0.05）。两组不良母婴结局发生率比较［4.08%（2/49）比16.33%（8/49）］，差异有统计学意义（χ²=4.01，P<0.05）。结论　采用补中温阳汤联合低剂量左甲状腺素钠片治疗妊娠合并甲减患者，可有效改善患者甲状腺功能，降低血脂水平，优化母婴结局，提升新生儿发育水平。

关键词:

甲状腺功能减退症, 妊娠期, 补中温阳汤, 低剂量左甲状腺素钠片, 血脂水平, 母婴结局

Xu Shan, Duan Bei, Zhang Xiaocai, Wang Min, Song Lihua.

Buzhong Wenyang Tang combined with levothyroxine sodium for pregnant patients with hypothyroidism [J]. International Medicine and Health Guidance News, 2024, 30(17): 2926-2930.

徐珊段蓓张小菜王敏宋丽华.

补中温阳汤联合左甲状腺素钠在妊娠合并甲状腺功能减退症患者中的应用 [J]. 国际医药卫生导报, 2024, 30(17): 2926-2930.

References

[1] 王霞,罗娇,郝坤. 合并亚临床甲状腺功能减退症对妊娠结局的影响及其危险因素分析[J]. 中国计划生育和妇产科,2023,15(11):63-67. DOI:10.3969/j.issn.1674-4020. 2023.11.16.
[2] 樊祯翠,徐志红. 妊娠期甲状腺功能减退发生情况及影响因素[J]. 中国计划生育学杂志,2021,29(2):388-391. DOI:10.3969/j.issn.1004-8189.2021.02.044.
[3] 陈丽君,方丽华,周林英,等. 妊娠期合并亚临床甲状腺功能减退症的危险因素及对产后出血的影响[J]. 中国妇幼保健,2021,36(11):2597-2599. DOI:10.19829/j.zgfybj.issn.1001-4411.2021.11.048.
[4] 刘田田,孙敏,周晶敏,等. 妊娠合并甲状腺功能减退症对后代出生结局及早期神经行为发育的影响[J]. 同济大学学报(医学版),2021,42(6):814-818. DOI:10.12289/j.issn.1008-0932.21272.
[5] 孙亚玲,辛春,郭明,等. 左甲状腺素钠片治疗妊娠期合并甲状腺功能减退症的疗效观察[J]. 中国医院用药评价与分析,2020,20(7):788-791. DOI:10.14009/j.issn.1672-2124. 2020.07.006.
[6] 王琛,高天舒,王智民,等. 从"有故无殒,亦无殒也"论仲景对妊娠期甲状腺疾病的治疗[J]. 中华中医药学刊,2023,41(3):123-125. DOI:10.13193/j.issn.1673-7717.2023.03.027.
[7] 谭俊,黄勇,何浩森,等. 补肾温阳止痛汤联合推拿治疗腰椎骨质增生的疗效及对患者中医证候、腰功能及生活质量的影响[J]. 辽宁中医杂志,2020,47(5):106-108. DOI:10.13192/j.issn.1000-1719.2020.05.032.
[8] 陈玉链,何日明,罗粤铭,等. 杨曙东运用温法治疗慢性肾脏病经验[J]. 山东中医杂志,2023,42(7):756-759. DOI:10.16295/j.cnki.0257-358x.2023.07.018.
[9] «妊娠和产后甲状腺疾病诊治指南»(第2版)编撰委员会,中华医学会内分泌学分会,中华医学会围产医学分会.妊娠和产后甲状腺疾病诊治指南(第2版)[J]. 中华内分泌代谢杂志,2019,35(8):636-665. DOI:10.3760/cma.j.issn.1000- 6699.2019.08.003.
[10] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社, 2002:45.
[11] 丁艳华,徐秀,冯玲英,等. 贝莉婴儿发育量表-Ⅱ在我国的引进和使用初探[J]. 中国儿童保健杂志,2007,15(2):147-148. DOI:10.3969/j.issn.1008-6579.2007.02.016.
[12] 胡敏慧,刘瑞霞,赵蓉,等. 妊娠期亚临床甲状腺功能减退症与妊娠期高血压疾病关系的研究进展[J]. 国际妇产科学杂志,2023,50(6):679-683. DOI:10.12280/gjfckx.20230471.
[13] 王亚宁,徐倩,王芳,等. 妊娠期亚临床甲状腺功能减退相关危险因素研究进展[J]. 河北医科大学学报,2023,44(11):1344-1348. DOI:10.3969/j.issn.1007-3205.2023.11.019.
[14] 刘娟弟,王瑞,何菊仙. 甲状腺功能减退与孕早期自发性流产的相关性分析[J]. 医学临床研究,2022,39(2):232-235. DOI:10.3969/j.issn.1671-7171.2022.02.021.
[15] 黄凯坤,范雅丽,刘瑞霞,等. 妊娠期亚临床甲状腺功能减退症对子代神经智力发育的影响研究进展[J]. 实用妇产科杂志,2023,39(8):587-590.
[16] 施友文,甘雨,谢倩倩,等. 不同剂量左甲状腺素钠片治疗对妊娠期甲状腺功能减退症孕妇甲状腺激素妊娠结局及子代心理发育功能的影响研究[J]. 河北医学,2022,28(10):1748-1753. DOI:10.3969/j.issn.1006-6233.2022.10.031.
[17] 杨晓彦,王儒. 左甲状腺素钠片不同初始剂量治疗对先天性甲减患儿的治疗价值[J]. 贵州医药,2021,45(8):1272-1273. DOI:10.3969/j.issn.1000-744X.2021.08.051.
[18] 张煜雪,谭爱华,石和元,等. 基于"阳主阴从"辨治桥本甲状腺炎甲减的探讨[J]. 四川中医,2023,41(2):32-34.
[19] 周良军. 自拟"消瘿汤"肝、脾、肾三脏同调辨治桥本甲状腺炎的临床研究[J]. 国际医药卫生导报,2023,29(24):3580-3584. DOI:10.3760/cma.j.issn.1007-1245. 2023.24.012.
[20] 周佳慧,杨晗,陈锐. 基于"阳虚阴结"理论从脾肾阳虚辨治甲状腺肿[J]. 环球中医药,2023,16(11):2307-2311. DOI:10.3969/j.issn.1674-1749.2023.11.027.
[21] 宋锦华,张宁. 温补消和法治疗甲状腺功能减退症探讨[J]. 北京中医药,2021,40(11):1228-1230. DOI:10.16025/j.1674-1307.2021.11.016.
[22] 尚靖智,袁岳鹏,刘淑妍. 温补脾肾汤联合左甲状腺素钠片治疗甲状腺功能减退症临床观察[J]. 西部中医药,2021,34(6):106-109. DOI:10.12174/j.issn.2096-9600. 2021.06.26.
[23] 沈佳燕,张煜. 补中温阳汤联合左甲状腺素钠片治疗甲状腺功能减退症31例[J]. 中国中医药科技,2020,27(6):929-930.
[24] 郑勰,任跃忠,蒋飞,等. 左甲状腺素强化治疗对妊娠期亚临床甲状腺功能减退症的效果[J]. 中国临床药理学杂志,2022,38(6):483-486. DOI:10.13699/j.cnki.1001-6821. 2022.06.001.
[25] 李军,徐筱青,李璐璐,等. 耳穴贴压联合左甲状腺素钠片治疗桥本甲状腺炎甲状腺功能减退的临床效果观察[J]. 中国医药,2023,18(6):907-911. DOI:10.3760/j.issn.1673- 4777. 2023.06.024.
[26] 高丹,蒋素玲,丁金萍. 中药联合针刺、艾灸治疗妊娠合并甲状腺功能减退症临床研究[J]. 新中医,2021,53(18):76-79. DOI:10.13457/j.cnki.jncm.2021.18.021.
[27] 张爽,李楠,董微,等. 经LT 4治疗的妊娠期亚临床甲状腺功能减退症对子代0~36月龄生长发育及神经心理影响的队列研究 [J]. 中华内分泌代谢杂志,2022,38(2):112-117. DOI:10.3760/cma.j.cn311282-20210520-00316.
[28] 姚璇,钟丹妮. 早产儿体格生长与神经行为发育的回顾性研究[J]. 中国妇幼健康研究,2022,33(7):7-12. DOI:10.3969/j.issn.1673-5293.2022.07.002.
[29] 朱太彩,张水荣,谷青青,等. 补肾养血安胎汤联合左甲状腺素钠片治疗妊娠伴甲状腺功能减退临床研究[J]. 新中医,2019,51(7):186-189. DOI:10.13457/j.cnki.jncm.2019. 07.055.