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诃子对慢性稳定型心绞痛的疗效:一项比较诃子与单硝酸异山梨酯的双盲、安慰剂对照、交叉研究。

Efficacy of Terminalia arjuna in chronic stable angina: a double-blind, placebo-controlled, crossover study comparing Terminalia arjuna with isosorbide mononitrate.

作者信息

Bharani Anil, Ganguli Arunangshu, Mathur L K, Jamra Yogendra, Raman P G

机构信息

Department of Medicine, MGM Medical College and MY Hospital, Indore, MP.

出版信息

Indian Heart J. 2002 Mar-Apr;54(2):170-5.

PMID:12086380
Abstract

BACKGROUND

Terminalia arjuna, an Indian medicinal plant, has been reported to have beneficial effects in patients with ischemic heart disease in a number of small, open studies. The need for a double-blind, randomized, placebo-controlled study with adequate sample size has long been felt. The bark extract (IPC-53) contains acids (arjunic acid, terminic acid), glycosides (arjunetin arjunosides I-IV), strong antioxidants (flavones, tannins, oligomeric proanthocyanidins), minerals. etc. and exhibits antifailure and anti-ischemic properties.

METHODS AND RESULTS

Fifty-eight males with chronic stable angina (NYHA class II-III) with evidence of provocable ischemia on treadmill exercise test received Terminalia arjuna (500 mg 8 hourly), isosorbide mononitrate (40 mg/daily) or a matching placebo for one week each, separated by a wash-out period of at least three days in a randomized, double-blind, crossover design. They underwent clinical, biochemical and treadmill exercise evaluation at the end of each therapy which were compared during the three therapy periods. Terminalia arjuna therapy was associated with significant decrease in the frequency of angina and need for isosorbide dinitrate (5.69+/-6.91 mg/week v. 18.22+/-9.29 mg/week during placebo therapy, p<0.005). The treadmill exercise test parameters improved significantly during therapy with Terminalia arjuna compared to those with placebo. The total duration of exercise increased (6.14+/-2.51 min v. 4.76+/-2.38 min, p<0.005), maximal ST depression during the longest equivalent stages of submaximal exercise decreased (1.41+/-0.55 mm v. 2.21+/-0.56 mm, p<0.005), time to recovery decreased (6.49+/-2.37 min v. 9.27+/-3.39 min, p<0.005) and higher double products were achieved (25.75+/-4.81x10(3) v. 23.11+/-4.83x10(3), p<0.005) during Terminalia arjuna therapy. Similar improvements in clinical and treadmill exercise test parameters were observed with isosorbide mononitrate compared to placebo therapy. No significant differences were observed in clinical or treadmill exercise test parameters when Terminalia arjuna and isosorbide mononitrate therapies were compared. No significant untoward effects were reported during Terminalia arjuna therapy.

CONCLUSIONS

Terminalia arjuna bark extract, 500 mg 8 hourly, given to patients with stable angina with provocable ischemia on treadmill exercise, led to improvement in clinical and treadmill exercise parameters as compared to placebo therapy. These benefits were similar to those observed with isosorbide mononitrate (40 mg/day) therapy and the extract was well tolerated. Limitations of this study include applicability of the results to only men with chronic stable angina but not necessarily to women, as they were not studied.

摘要

背景

诃子是一种印度药用植物,在一些小型开放性研究中,据报道对缺血性心脏病患者有有益作用。长期以来一直认为需要进行一项样本量充足的双盲、随机、安慰剂对照研究。树皮提取物(IPC - 53)含有酸类(诃子酸、诃子次酸)、糖苷(诃子素、诃子苷I - IV)、强抗氧化剂(黄酮类、单宁、低聚原花青素)、矿物质等,并具有抗心力衰竭和抗缺血特性。

方法与结果

58名患有慢性稳定型心绞痛(纽约心脏协会II - III级)且在平板运动试验中有可诱发缺血证据的男性患者,接受诃子(每8小时500毫克)、单硝酸异山梨酯(每日40毫克)或匹配的安慰剂治疗,每种治疗为期一周,采用随机、双盲、交叉设计,各治疗期之间有至少三天的洗脱期。在每种治疗结束时进行临床、生化及平板运动评估,并在三个治疗期内进行比较。诃子治疗使心绞痛发作频率及硝酸异山梨酯的使用需求显著降低(安慰剂治疗期间为18.22±9.29毫克/周,诃子治疗期间为5.69±6.91毫克/周,p<0.005)。与安慰剂治疗相比,诃子治疗期间平板运动试验参数有显著改善。运动总时长增加(分别为6.14±2.51分钟和4.76±2.38分钟,p<0.005),次极量运动最长等效阶段的最大ST段压低减少(分别为1.41±0.55毫米和2.21±0.56毫米,p<0.005),恢复时间缩短(分别为6.49±2.37分钟和9.27±3.39分钟,p<0.005),诃子治疗期间达到的双倍乘积更高(分别为25.75±4.81×10³和23.11±4.83×10³,p<0.005)。与安慰剂治疗相比,单硝酸异山梨酯治疗在临床及平板运动试验参数方面也有类似改善。诃子与单硝酸异山梨酯治疗在临床或平板运动试验参数上无显著差异。诃子治疗期间未报告明显不良反应。

结论

对于平板运动试验中有可诱发缺血的稳定型心绞痛患者,每8小时给予500毫克诃子树皮提取物,与安慰剂治疗相比,可改善临床及平板运动参数。这些益处与单硝酸异山梨酯(每日40毫克)治疗所观察到的相似,且提取物耐受性良好。本研究的局限性包括结果仅适用于患有慢性稳定型心绞痛的男性,不一定适用于女性,因为未对女性进行研究。

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