经典尤纳尼药典配方萨富夫-伊-穆哈齐尔治疗高脂血症的评估：一项随机、标准对照临床研究。

Evaluation of a classical unani pharmacopeial formulation safoof-e-muhazzil in hyperlipidemia: A randomized, standard controlled clinical study.

作者信息

Jahangir Umar, Khan Asim Ali, Kapoor Prem, Jalees Farhan, Urooj Shaista

机构信息

Department of Moalejat (Medicine), Faculty of Medicine (U), Jamia Hamdard, New Delhi, India.

Department of Medicine, Hamdard Institute of Medical Sciences and Research, New Delhi, India.

出版信息

J Pharm Bioallied Sci. 2014 Jul;6(3):167-79. doi: 10.4103/0975-7406.130975.

DOI:10.4103/0975-7406.130975

PMID:25035636

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4097930/

Abstract

AIM OF THE STUDY

The aim of the following study is to evaluate the efficacy and tolerability of a compound Unani formulation in hyperlipidemia on clinical and biochemical parameters.

MATERIALS AND METHODS

A total of 90 patients with total cholesterol level of 220 mg/dl and above were included. In Group 'A' thirty patients with total cholesterol 243.5 ± 5.294 mg/dl received Unani formulation safoof-e-muhazzil (SM) in its classical powder form 5 g twice daily orally, in Group 'B' thirty patients with total cholesterol 234 ± 3.822 mg/dl received the SM but in compressed tablet form in the same dosage and in Group 'C' 30 patients with total cholesterol 242.7 ± 5.563 mg/dl received atorvastatin 10 mg as a standard control. Follow-up was carried out on second, fourth and 6th week and patients were evaluated on clinical as well as biochemical parameters.

RESULTS

Group A before treatment had mean total cholesterol of 243.5 ± 5.294 mg/dl which decreased significantly after treatment to 225.6 ± 5.953 mg/dl (P < 0.001) with a percentage change of 7.35%. Group B had mean total cholesterol of 234 ± 3.822 mg/dl which was significantly reduced to 212.67 ± 3.94 mg/dl (P < 0.001) post-treatment with a percentage change of 9.11%. Control Group C having mean total cholesterol of 242.7 ± 5.563 mg/dl before treatment was significantly decreased to 178.73 ± 4.669 mg/dl (P < 0.001) post-treatment with a percentage change of 26.3%. Group A had significant relief 20.72% (P < 0.001) in fatigue, 16.09% (P > 0.5) relief in palpitation and 26.17% (P < 0.001) relief in dyspnea post-treatment. Group B fatigue decreased significantly by 18.14% (P < 0.01), palpitation by 22.91% (P < 0.01) and dyspnea by 20.46% (P < 0.01). In Group C a non-significant increase of 2.2% was observed in fatigue post-treatment, palpitation decreased by 10.22% non-significantly and dyspnea decreased significantly by 17.64% (P < 0.001). Results indicate that the test drug safely and effectively ameliorates the clinical condition of patients with hyperlipidemia while decreasing cholesterol level as well.

摘要

研究目的

以下研究的目的是评估一种复方尤那尼制剂治疗高脂血症对临床和生化指标的疗效及耐受性。

材料与方法

共纳入90例总胆固醇水平在220mg/dl及以上的患者。A组30例总胆固醇为243.5±5.294mg/dl的患者，口服经典粉末状的尤那尼制剂safoof-e-muhazzil（SM），5g，每日两次；B组30例总胆固醇为234±3.822mg/dl的患者，服用相同剂量的SM压制片；C组30例总胆固醇为242.7±5.563mg/dl的患者，服用10mg阿托伐他汀作为标准对照。在第2、4和6周进行随访，并对患者的临床和生化指标进行评估。

结果

A组治疗前平均总胆固醇为243.5±5.294mg/dl，治疗后显著降至225.6±5.953mg/dl（P<0.001），变化百分比为7.35%。B组治疗前平均总胆固醇为234±3.822mg/dl，治疗后显著降至212.67±3.94mg/dl（P<0.001），变化百分比为9.11%。对照组C治疗前平均总胆固醇为242.7±5.563mg/dl，治疗后显著降至178.73±4.669mg/dl（P<0.001），变化百分比为26.3%。A组治疗后疲劳显著缓解20.72%（P<0.001），心悸缓解16.09%（P>0.5），呼吸困难缓解26.17%（P<0.001）。B组疲劳显著下降18.14%（P<0.01），心悸下降22.91%（P<0.01），呼吸困难下降20.46%（P<0.01）。C组治疗后疲劳无显著增加2.2%，心悸无显著下降10.22%，呼吸困难显著下降17.64%（P<0.001）。结果表明，受试药物在降低胆固醇水平的同时，安全有效地改善了高脂血症患者的临床状况。