[H15（锯叶乳香树脂提取物，“香脂”）对慢性多关节炎既定药物治疗是否是一种有用的补充？一项双盲试点研究的结果]

[Is H15 (resin extract of Boswellia serrata, "incense") a useful supplement to established drug therapy of chronic polyarthritis? Results of a double-blind pilot study].

作者信息

Sander O, Herborn G, Rau R

机构信息

Rheumatologische Klinik, Evangelisches Fachkrankenhaus Ratingen.

出版信息

Z Rheumatol. 1998 Feb;57(1):11-6. doi: 10.1007/s003930050051.

DOI:10.1007/s003930050051

PMID:9566100

Abstract

BACKGROUND

Leukotrienes and prostaglandines are important mediators of inflammation. While prostaglandine synthesis can be influenced by NSAIDs therapeutical approaches to the 5-lipoxygenase pathway are rare. Resinous extracts of Boswellia serrata (H15, indish incense), known from traditional ayurvedic medicine, decrease leukotriene synthesis in vitro. Case reports suggest a clinical role for that drug.

METHODS

Outpatients with active RA have been enrolled into a multicenter controlled trial. Patients received 9 tablets of active drug (3600 mg) or placebo daily in addition to their previous therapy. Doses of NSAIDs could be adjusted on demand. Efficacy parameters, Ritchies Index for swelling and pain, ESR, CRP, pain on VAS and NSAID dose were documented at baseline and 6 and 12 weeks after initiation. Mean values and medians were calculated to compare the groups for significant or clinically relevant change from baseline or difference between both groups at any time point of observation.

RESULTS

A total of 78 patients were recruited in 4 centers, the data have been published in abstract form. Only 37 patients (verum 18, placebo 19), enrolled in Ratingen were available for detailed efficacy and safety analysis. All evaluations in these patients were performed by one investigator (G.H.). There was no subjective, clinical or laboratory parameter showing a significant or clinically relevant change from baseline or difference between both groups at any time point of observation. The mean NSAID dose reduction reached levels of 5.8% (H15) and 3.1% (placebo). One patient in each group showed a good response in all parameters but 4 patients in each group worsened. The others showed no alteration of their disease.

CONCLUSION

Treatment with H15 showed no measurable efficacy. Controlled studies including a greater patient population are necessary to confirm or reject our results.

摘要

背景

白三烯和前列腺素是炎症的重要介质。虽然前列腺素的合成可受非甾体抗炎药影响，但针对5-脂氧合酶途径的治疗方法却很少见。锯叶乳香（H15，印度香）的树脂提取物在传统阿育吠陀医学中为人所知，它在体外可减少白三烯的合成。病例报告提示了该药物的临床作用。

方法

活动性类风湿关节炎门诊患者被纳入一项多中心对照试验。患者在原有治疗基础上，每天服用9片活性药物（3600毫克）或安慰剂。非甾体抗炎药的剂量可根据需要调整。在基线以及开始治疗后6周和12周记录疗效参数、肿胀和疼痛的里奇指数、红细胞沉降率、C反应蛋白、视觉模拟评分法的疼痛评分以及非甾体抗炎药剂量。计算平均值和中位数，以比较两组在任何观察时间点相对于基线的显著或临床相关变化，或两组之间的差异。

结果

4个中心共招募了78名患者，数据已以摘要形式发表。只有在拉廷根登记的37名患者（试验组18名，安慰剂组19名）可用于详细的疗效和安全性分析。这些患者的所有评估均由一名研究者（G.H.）进行。在任何观察时间点，没有主观、临床或实验室参数显示相对于基线有显著或临床相关变化，或两组之间有差异。非甾体抗炎药平均剂量降低幅度分别为5.8%（H15）和3.1%（安慰剂）。每组各有1名患者在所有参数上显示出良好反应，但每组各有4名患者病情恶化。其他患者病情未出现变化。