首页|益养丸对分化型甲状腺癌术后气阴两虚证患者心血管不良反应的防治作用

益养丸对分化型甲状腺癌术后气阴两虚证患者心血管不良反应的防治作用

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
目的 评价益养丸防治分化型甲状腺癌术后促甲状腺素(TSH)抑制治疗患者心血管不良反应的有效性和安全性。方法 采用随机双盲安慰剂对照临床试验，纳入 120 例分化型甲状腺癌术后TSH抑制治疗患者，使用SAS 9。4 软件生成随机表，按1∶1比例随机分为2 组，对照组在TSH抑制治疗的同时口服益养丸安慰剂;治疗组在TSH抑制治疗的同时口服益养丸。治疗周期3 个月，比较2 组患者心血管不良反应发生率、血压、血脂、甲状腺功能、优甲乐(TSH抑制剂)用量、中医证候疗效及安全性指标，采用多因素Logistic回归分析患者出现心血管不良反应的影响因素。结果 治疗组心血管不良反应发生率低于对照组(P<0。05)，中医证候疗效明显高于对照组(P<0。05);治疗组治疗后游离四碘甲状腺原氨酸水平较治疗前增高(P<0。05)，对照组收缩压、舒张压均较治疗前升高(P<0。05)。2 组均未见严重安全事件。与对照组比较，治疗组心血管不良反应发生率低;与治疗前优甲乐用量≥100 μg/d比较，治疗前优甲乐用量<100 μg/d患者心血管不良反应发生率低。结论 益养丸能够降低分化型甲状腺癌术后患者心血管不良反应发生率，有效改善中医证候，且安全性良好。益养丸治疗是心血管不良反应发生的保护因素，优甲乐用量≥100 μg/d是其危险因素。
Preventive and therapeutic effects of Yiyang Pill in treating cardiovascular adverse reactions post-surgery in patients with differentiated thyroid cancer and qi and yin deficiency syndrome
Objective To evaluate the effectiveness and safety of Yiyang Pill in preventing and treating cardiovascular adverse reactions in patients with traditional Chinese medicine(TCM)syndrome with qi and yin deficiency and thyroid stimulating hormone(TSH)inhibition after differentiated thyroid cancer(DTC)resection.Methods A randomized,double-blind,placebo-controlled clinical trial was conducted,and 120 patients with TSH inhibition after DTC surgery were enrolled and randomized into two groups in a 1∶1 ratio using SAS 9.4 software generated random tables.The control group received a placebo and TSH suppression therapy,whereas the treatment group received the Yiyang Pill and TSH suppression therapy.The treatment period was 3 months.The incidence of cardiovascular adverse reactions,blood pressure,blood lipids,thyroid function,the dosage of levothyroxine,the efficacy of TCM syndrome,and safety indicators were compared between the two groups.Multivariate Logistic regression was used to analyze the influencing factors of cardiovascular adverse reactions.Results The incidence of cardiovascular adverse reactions in the treatment group was lower than that in the control group(P<0.05),and the efficacy of TCM syndrome treatment was significantly higher than in the control group(P<0.05).The free tetraiodothyronine level in the treatment group was higher than that before treatment(P<0.05),and the systolic and diastolic blood pressure in the control group increased compared to those before treatment(P<0.05).No severe adverse events were observed in either group.Compared with the control group,the cardiovascular incidence in the treatment group was lower,and the cardiovascular incidence in the<100 μg/d group was lower than that in the group with≥100 μg/d before treatment.Conclusion The Yiyang Pill can reduce the incidence of cardiovascular adverse reactions in patients after DTC surgery,effectively improve TCM syndromes,and be safe to use.Yiyang Pill treatment is a protective factor for cardiovascular adverse reactions,and the dosage of levothyroxine≥100 μg/d was a risk factor.

Yiyang Pillqi and yin deficiency patternpostoperative differentiated thyroid cancerthyroid stimulating hormone inhibitioncardiovascular adverse reactions

陆钰原、乔佳君、刘昕怡、楚爱景、刘守尧、夏仲元

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北京中医药大学研究生院 北京 100029

中日友好医院

北京中医药大学第三附属医院

益养丸 气阴两虚证 分化型甲状腺癌术后 促甲状腺素抑制治疗 心血管不良反应

国家高水平医院临床业务费专项临床研究项目首都特色临床应用研究项目

2022-NHLHCRF-LX-02-0115Z181100001718141

2024

10.3969/j.issn.1006-2157.2024.06.003

北京中医药大学学报
北京中医药大学

北京中医药大学学报

CSTPCD北大核心
影响因子：1.568
ISSN：1006-2157
年,卷(期)：2024.47(6)