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Barg-e-Sahajna(Lam.)治疗原发性甲状腺功能减退症的疗效与安全性。

Efficacy and safety of Barg-e-Sahajna ( Lam.) in primary hypothyroidism.

作者信息

Alam Md Anzar, Quamri Mohd Aleemuddin, Haider Nafis

机构信息

Department of Moalajat (Medicine), National Institute of Unani Medicine (Under Ministry of AYUSH), Bangalore, India.

Department of Basic Medical Sciences Unit, Prince Sultan Military College of Health Sciences, Dhahran, Kingdom of Saudi Arabia.

出版信息

Drug Metab Pers Ther. 2021 Aug 13. doi: 10.1515/dmdi-2021-0136.

Abstract

OBJECTIVES

Hypothyroidism is the most common disorder arising from hormone deficiency. It frequently affects women than men. The prevalence of overall hypothyroidism has been reported to be 4.8-11%. Levothyroxine is the treatment of choice for all types of hypothyroidism. The purpose of this pilot study was to evaluate the efficacy and safety of Barg-e-Sahajna (Leaves of Lam.) among diagnosed patients of primary hypothyroidism.

METHODS

This study was an open observational study. A total of 22 patients were screened, out of which 10 were excluded (did not meet inclusion criteria) and 2 refused to consent to be part of the study, rest 10 participants were enrolled after obtaining written informed consent finally 8 subjects completed the study and 2 are dropout in last follow up. The drug was given in the form of decoction at the dose of 5 g fresh leaves twice a day after meal for 45 days.

RESULTS

The study effects on objective parameter thyroid stimulating hormone (TSH), triiodothyronine (T3), and thyroxine (T4) were found extremely significant when compared before (16.62 ± 11.49, 132 ± 19.32, 9.28 ± 1.46) and after (4.75 ± 3.12, 150.37 ± 20.68, 11.84 ± 3.81) treatment with a significant decrease in serum TSH level (p<0.0246) and an increase in serum T3 (p<0.0005) and T4 (p<0.0438) levels. The results were analyzed using paired "t" test.

CONCLUSIONS

The improvements in thyroid profiles (TSH, T3 and T4) after consuming 'Barg-e-Sahajna' show that the test drug is effective in primary hypothyroidism and the relief was considerable. No significant effect on safety parameters (serum-glutamic-oxaloacetic-transaminase [SGOT], serum glutamic-pyruvic transaminase [SGPT], blood urea, and serum creatinine) was observed. Therefore, it may be concluded that the Barg-e-Sahajna is preliminarily safe and effective in the management of primary hypothyroidism.

摘要

目的

甲状腺功能减退症是激素缺乏引起的最常见疾病。女性比男性更易受其影响。据报道,总体甲状腺功能减退症的患病率为4.8% - 11%。左甲状腺素是治疗各类甲状腺功能减退症的首选药物。本初步研究的目的是评估Barg - e - Sahajna(Lam.叶)对已确诊的原发性甲状腺功能减退症患者的疗效和安全性。

方法

本研究为开放性观察研究。共筛查22例患者,其中10例被排除(不符合纳入标准),2例拒绝参与研究,其余10名参与者在获得书面知情同意后入组,最终8名受试者完成研究,2例在最后一次随访时退出。药物以汤剂形式给药,剂量为5克鲜叶,每日饭后服用两次,共服用45天。

结果

与治疗前(16.62±11.49、132±19.32、9.28±1.46)和治疗后(4.75±3.12、150.37±20.68、11.84±3.81)相比,研究对客观参数促甲状腺激素(TSH)、三碘甲状腺原氨酸(T3)和甲状腺素(T4)的影响极为显著,血清TSH水平显著降低(p<0.0246),血清T3(p<0.0005)和T4(p<0.0438)水平升高。结果采用配对“t”检验进行分析。

结论

服用“Barg - e - Sahajna”后甲状腺指标(TSH、T3和T4)的改善表明受试药物对原发性甲状腺功能减退症有效,且缓解效果显著。未观察到对安全参数(血清谷草转氨酶[SGOT]、血清谷丙转氨酶[SGPT]、血尿素和血清肌酐)有显著影响。因此,可以得出结论,Barg - e - Sahajna在原发性甲状腺功能减退症的治疗中初步显示出安全有效。

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