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睡茄作为新诊断痰涂片阳性肺结核患者直接督导下短程化疗辅助药物的效果比较研究

Comparative study of effect of Withania somnifera as an adjuvant to DOTS in patients of newly diagnosed sputum smear positive pulmonary tuberculosis.

作者信息

Kumar Ranjeet, Rai Jaswant, Kajal N C, Devi Pushpa

机构信息

Senior Resident, Department of Pharmacology, Government Medical College and Hospital, Amritsar, Punjab 143001, India.

Professor and Head, Department of Pharmacology, Government Medical College and Hospital, Amritsar, Punjab 143001, India.

出版信息

Indian J Tuberc. 2018 Jul;65(3):246-251. doi: 10.1016/j.ijtb.2017.05.005. Epub 2017 May 21.

Abstract

BACKGROUND

Ashwagandha (Withania somnifera Linn.) a rejuvenative herb has long been used as an immunomodulator in Indian subcontinent. As immunity plays an important role in pathogenesis and treatment of tuberculosis (TB), so role of W. somnifera as an adjuvant has been studied on selected parameter.

METHOD

A randomized, double-blind placebo-control study was conducted in two groups of 60 newly diagnosed sputum smear positive pulmonary TB patients on Directly Observed Treatment - short course (DOTS) regime. W. somnifera root extract or placebo capsules were given as add-on therapy for duration of 12 weeks. Effects on sputum conversion, Hemoglobin (Hb), body weight, Erythrocyte Sedimentation Rate (ESR), RBC counts, WBC counts, CD4 and CD8 counts, Serum Glutamic-Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), serum uric acid and HRQL (Health Related Quality of Life) Index scores were studied.

RESULTS

At the end of 8 weeks, sputum conversion was seen in 86.6% patients in study group and 76.6% in placebo group. At the end of 12 weeks a highly significant increase was seen in both CD4 and CD8 counts in study group. A raised SGOT and SGPT levels (>35IU/L) were observed in 16.6% and 33.3% patients in study group; 43.33% and 53.33% in the placebo group of patients. Elevated serum uric acid levels (>6mg/dl) were observed in 20% and 33.33% in study and placebo group respectively. Average gain in HRQL score was better in patients of study group.

CONCLUSION

Use of W. somnifera as an adjuvant in conjunction with anti-TB drugs used as DOTS showed a favorable effect on symptoms and immunological parameters in patients with pulmonary TB.

摘要

背景

印度人参(Withania somnifera Linn.)是一种具有恢复活力功效的草药,在印度次大陆长期被用作免疫调节剂。由于免疫在结核病(TB)的发病机制和治疗中起着重要作用,因此对印度人参作为辅助剂在选定参数方面的作用进行了研究。

方法

对两组各60例新诊断的痰涂片阳性肺结核患者进行了一项随机、双盲、安慰剂对照研究,采用直接观察短程治疗(DOTS)方案。给予印度人参根提取物或安慰剂胶囊作为辅助治疗,持续12周。研究了其对痰菌转阴、血红蛋白(Hb)、体重、红细胞沉降率(ESR)、红细胞计数、白细胞计数、CD4和CD8计数、血清谷草转氨酶(SGOT)、血清谷丙转氨酶(SGPT)、血清尿酸和健康相关生活质量(HRQL)指数评分的影响。

结果

8周结束时,研究组86.6%的患者痰菌转阴,安慰剂组为76.6%。12周结束时,研究组的CD4和CD8计数均显著增加。研究组分别有16.6%和33.3%的患者SGOT和SGPT水平升高(>35IU/L);安慰剂组患者中这一比例分别为43.33%和53.33%。研究组和安慰剂组血清尿酸水平升高(>6mg/dl)的患者分别为20%和33.33%。研究组患者的HRQL评分平均改善情况更好。

结论

印度人参作为辅助剂与DOTS方案中使用的抗结核药物联合使用,对肺结核患者的症状和免疫参数显示出有利影响。

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