化痰活血消瘿方治疗结节性甲状腺肿痰瘀互结证的临床研究
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摘要
目的：探讨中医学对结节性甲状腺肿的认识,采用化痰活血消瘿方治疗结节性甲状腺肿痰瘀互结证。通过随机对照临床试验,观察化痰活血消瘿方对结节性甲状腺肿痰瘀互结证的治疗效果,探讨其治疗本病的机理。
方法：采用随机对照的研究方法,将符合结节性甲状腺肿痰瘀互结证诊断标准的患者,随机分为治疗组和对照组。在生活方式干预和西药常规治疗的基础上,治疗组加用化痰活血消瘿方,水煎剂,每日1剂,疗程24周；对照组仅生活方式干预和西药常规治疗。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测甲状腺形态学、实验室检测指标游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)、甲状腺球蛋白(TG)、细胞因子(IL-6、TNF-α)、血液流变学等指标,以及患者的不良反应、依从性。全部数据以SPSS15.0统计软件进行统计学分析。
结果：确诊并纳入的结节性甲状腺肿痰瘀互结证60例(治疗组30例,对照组30例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性(P>0.05)。其结果：①在中医证候疗效方面：治疗组总有效率86.67%,明显优于对照组的50.00%(P<0.05)。②症候疗效方面：治疗组总有效率90.00%,明显优于对照组的56.67%,经统计学分析(P<0.05)。③血清甲状腺激素谱、甲状腺球蛋白：治疗组游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)、甲状腺球蛋白(TG)较对照组有差异(P<0.05)；④细胞因子IL-6、TNF-α:两组治疗后IL-6、TNF-α均较治疗前升高,治疗组与对照组比较有差异(P<0.05)。⑤甲状腺形态学改善方面：两组治疗后甲状腺肿大、甲状腺结节最大直径均较治疗前降低,治疗组与对照组比较有差异(P<0.05)。⑥安全性指标：肝肾功能检查均在正常范围。两组均未见不良反应。
结论：临床研究提示,西药治疗合用化痰活血消瘿方效果优于单纯西药治疗,中药治疗既改善结节性甲状腺肿痰瘀互结证患者的临床症状,而且改善了患者的甲状腺形态学、血清甲状腺谱、甲状腺球蛋白、细胞因子IL-6、TNF-a、血液流变学,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
Purpose:To discuss the understanding of traditional Chinese medicine about nodular goite, using Removing Phlegm and Activating Blood Circulation to Eliminating Goiter Decoction to interfere in the Syndrom of Turbid Phlegm and Blood Stasis.To observe the therapeutic efficacy of this decoction in treating the Syndrom of Turbid Phlegm and Blood Stasis.
Methods:A randomized, controlled trial was conducted60patients with nodular goite were randomly classified into two groups.On the basic of modern medicine, the patients of treated group (n=30) were treated by Chinese medicine while the patients of controlled group (n=30) were not.Six months was a course of treatment.The observed indexes included both curative effect indexes, such as clinic symptoms, Thyroid morphology, serum the thyroid spectrum, thyroglobulin, IL-6, TNF-a, hemorheology,and safety indexes,such as routine urine,blood and stool test,ECG,the function of live and kidney and harmful reaction.The complete data carries on statistics analysis by the SPSS15.0statistics software.
Results:Prior treatment, the gender, age, course of disease of the two groups patients had no differeces.①The total effective rate of treated group patients TCM was86.67%; while the controlled group was50.00%.The treated group had an advantage than the controlled group(P<0.05).②Symptom efficacy:treatment group total effective rate was90.00%, significantly better than56.67%of the control group (P<0.05) by statistical analysis.③Spectra of serum thyroid hormone, thyroglobulin:treatment group free the triiodo thyroid thyroxine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), thyroglobulin (TG) than the control group difference (P<0.05).④Cytokines IL-6, TNF-a:After treatment, IL-6, TNF-a compared with before treatment, the treatment group compared with control group differences (P <0.05).⑤Thyroid morphology improvement:After treatment, goiter, maximum diameter of thyroid nodules than before treatment to reduce the treatment group and control group difference (P<0.05).⑥Safety indicators:Liver and kidney function tests were within normal range. Both groups were no adverse reactions.
Conclusion:The results of the study indicated Chinese medicine of removing phlegm and activating blood circulation to eliminating goiter decoction combined with western medicine can't only inprove the clinical manifestation,but also some indexes of the patients',such as Thyroid morphology, serum the thyroid spectrum, thyroglobulin, IL-6, TNF-α, hemorheology and so on.It has sure curative effected in treating nodular goiter. It is worth studying deeply and developing further.
方法：采用随机对照的研究方法,将符合结节性甲状腺肿痰瘀互结证诊断标准的患者,随机分为治疗组和对照组。在生活方式干预和西药常规治疗的基础上,治疗组加用化痰活血消瘿方,水煎剂,每日1剂,疗程24周；对照组仅生活方式干预和西药常规治疗。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测甲状腺形态学、实验室检测指标游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)、甲状腺球蛋白(TG)、细胞因子(IL-6、TNF-α)、血液流变学等指标,以及患者的不良反应、依从性。全部数据以SPSS15.0统计软件进行统计学分析。
结果：确诊并纳入的结节性甲状腺肿痰瘀互结证60例(治疗组30例,对照组30例),治疗前两组的性别、年龄、病程等基线数据经统计学处理无显著性差异,有可比性(P>0.05)。其结果：①在中医证候疗效方面：治疗组总有效率86.67%,明显优于对照组的50.00%(P<0.05)。②症候疗效方面：治疗组总有效率90.00%,明显优于对照组的56.67%,经统计学分析(P<0.05)。③血清甲状腺激素谱、甲状腺球蛋白：治疗组游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺激素(TSH)、甲状腺球蛋白(TG)较对照组有差异(P<0.05)；④细胞因子IL-6、TNF-α:两组治疗后IL-6、TNF-α均较治疗前升高,治疗组与对照组比较有差异(P<0.05)。⑤甲状腺形态学改善方面：两组治疗后甲状腺肿大、甲状腺结节最大直径均较治疗前降低,治疗组与对照组比较有差异(P<0.05)。⑥安全性指标：肝肾功能检查均在正常范围。两组均未见不良反应。
结论：临床研究提示,西药治疗合用化痰活血消瘿方效果优于单纯西药治疗,中药治疗既改善结节性甲状腺肿痰瘀互结证患者的临床症状,而且改善了患者的甲状腺形态学、血清甲状腺谱、甲状腺球蛋白、细胞因子IL-6、TNF-a、血液流变学,且安全、有效,具有广泛的应用前景,值得进一步深入研究。
Purpose:To discuss the understanding of traditional Chinese medicine about nodular goite, using Removing Phlegm and Activating Blood Circulation to Eliminating Goiter Decoction to interfere in the Syndrom of Turbid Phlegm and Blood Stasis.To observe the therapeutic efficacy of this decoction in treating the Syndrom of Turbid Phlegm and Blood Stasis.
Methods:A randomized, controlled trial was conducted60patients with nodular goite were randomly classified into two groups.On the basic of modern medicine, the patients of treated group (n=30) were treated by Chinese medicine while the patients of controlled group (n=30) were not.Six months was a course of treatment.The observed indexes included both curative effect indexes, such as clinic symptoms, Thyroid morphology, serum the thyroid spectrum, thyroglobulin, IL-6, TNF-a, hemorheology,and safety indexes,such as routine urine,blood and stool test,ECG,the function of live and kidney and harmful reaction.The complete data carries on statistics analysis by the SPSS15.0statistics software.
Results:Prior treatment, the gender, age, course of disease of the two groups patients had no differeces.①The total effective rate of treated group patients TCM was86.67%; while the controlled group was50.00%.The treated group had an advantage than the controlled group(P<0.05).②Symptom efficacy:treatment group total effective rate was90.00%, significantly better than56.67%of the control group (P<0.05) by statistical analysis.③Spectra of serum thyroid hormone, thyroglobulin:treatment group free the triiodo thyroid thyroxine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), thyroglobulin (TG) than the control group difference (P<0.05).④Cytokines IL-6, TNF-a:After treatment, IL-6, TNF-a compared with before treatment, the treatment group compared with control group differences (P <0.05).⑤Thyroid morphology improvement:After treatment, goiter, maximum diameter of thyroid nodules than before treatment to reduce the treatment group and control group difference (P<0.05).⑥Safety indicators:Liver and kidney function tests were within normal range. Both groups were no adverse reactions.
Conclusion:The results of the study indicated Chinese medicine of removing phlegm and activating blood circulation to eliminating goiter decoction combined with western medicine can't only inprove the clinical manifestation,but also some indexes of the patients',such as Thyroid morphology, serum the thyroid spectrum, thyroglobulin, IL-6, TNF-α, hemorheology and so on.It has sure curative effected in treating nodular goiter. It is worth studying deeply and developing further.
引文
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