Pharmacotherapy for Behcet's syndrome

  • Review
  • Intervention

Authors


Abstract

Background

Behcet's syndrome is a multisystemic disorder presenting with recurrent oral and genital ulcerations as well as ocular involvement. Treatment of Behcet's syndrome is symptomatic and empirical.

Objectives

To determine the effects of available pharmacological interventions in treating the different clinical features of Behcet's syndrome.

Search methods

We searched the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, and Medline up to January 1998. The computer search was complemented by a hand search of all bibliographic references from the reference lists of included trials. Principal investigators were contacted to seek unpublished literature. All languages were included.

Selection criteria

Studies were eligible if they fulfilled all of the four following criteria:
1. Randomized controlled trials, single or double-blind;
2. Participants were patients with Behcet's Syndrome as defined by the International Study Group, 1990 (Int Study Group 1990);
3. Interventions included any pharmacological therapy compared to placebo or some other pharmacological intervention for the treatment of Behcet's syndrome.
4. Outcome measures included active ocular inflammatory processes, arthritis, mucocutaneous manifestations (oral ulcer, genital ulcer, erythema nodosum), laboratory changes and major events such as adverse effects and death.

Data collection and analysis

The 32 potentially relevant references were assessed by two independent reviewers (MA, AS) according to the inclusion criteria. Ten trials fit the inclusion criteria and were included in this review. From the 10 included trials, data were independently extracted by the same two observers and cross checked. The quality of the included trials was assessed independently by two observers (MA, AS) using a validated scale (Jadad 1996).

For dichotomous measures, the treatment effect for each trial was calculated using a fixed effect model [Peto model (Petitti 1994)]. The weighted mean differences were based, if available, on end-of-trial results. The analysis was conducted separately for each different intervention. Since the trials could not be pooled it was not possible to carry out a sensitivity analysis by quality scores or a subgroup analysis by drug dosages. Because of this lack of comparability across trials and the small number of trials, we could not conduct a heterogeneity test or a funnel plot.

Main results

Ten trials and 679 patients were included. There is insufficient evidence either to support or to refute some of the classic treatments for Behcet's syndrome, including colchicine, cyclophosphamide and steroids for eye involvement, azapropazone and colchicine for arthritis and acyclovir, colchicine and topical interpheron for aphthas. The results confirm the protective effects of cyclosporine and azathioprine for eye involvement and benzathine-penicillin for arthritis.

Authors' conclusions

We conclude that further randomized, placebo-controlled, double-blind trials should be carried out to compare cyclosporine, azathioprine and benzathine-penicillin versus placebo in order to make the results generalizable and comparable.

摘要

背景

貝塞特氏症候群(Behcet's syndrome) 的藥物療法

Behcet's syndrome 是一種多系統性的疾病,呈現的症狀為口腔與生殖器出現反覆的潰瘍,眼睛也會出現同樣的症狀。Behcet's syndrome 的治療是一種根據經驗與症狀的支持性療法。

目標

為了決定可使用之藥物在Behcet's syndrome 不同臨床表徵的治療效果。

搜尋策略

我們搜尋了 the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, and Medline 追朔至1998年1月。並利用參考書目的索引來加強搜尋.主要研究者未發表的論文也被徵詢引用. 所有的語言皆納入搜尋範圍內。

選擇標準

如果符合下列四種標準,研究視為合格 :1.隨機對照實驗,單盲或雙盲實驗 2. Behcet's Syndrome患者的診斷是依據 International Study Group, 1990 (Int Study Group 1990) 3.介入性處置為所有藥物治療與安慰劑或其他治療Behcet's syndrome的藥物的比較 4.預後的評估為眼球的活動性發炎進展,關節炎,皮下黏膜的表現 (口腔潰瘍,生殖器潰瘍,紅斑節結),實驗室數據改變和重大不良之事件發展和死亡。

資料收集與分析

32件與此可能相關論文由兩位獨立作者根據收案標準評估。10樣合乎收案標準的試驗包含在此項回顧研究當中 。從此10樣的收案試驗中由同樣兩位作者交叉與比對資料的收集。試驗品質由兩位作者獨立評估,使用了驗證過的測量表(Jadad 1996). For dichotomous measures每項試驗的治療效果使用 fixed effect model 來計算. 如果可以的話,在實驗結束的結果 會統計根據 weighted mean differences 分別分析每個不同的治療.如果試驗無法被合併分析,我們便無法利用實質的分數或次模組分析方式來進行分析.因為此種試驗缺乏可比較性且統計數量較少,我們無法建立 heterogeneity test or a funnel plot.

主要結論

10種試驗包括了679位患者,無足夠的證據來支持或反駁傳統Behcet's syndrome的治療方式,包括了使用秋水仙素, cyclophosphamide和使用類固醇治療被侵犯的眼睛azapropazone and colchicine 用來治療關節炎acyclovir, colchicine and topical interpheron 用來治療口腔部份。結果驗證了cyclosporine and azathioprine對被侵犯的眼睛以及benzathinepenicillin 對關節炎兩者具有保護的效果。

作者結論

我們的結論認為需要更進一步的隨機試驗,安慰劑控制,及雙盲實驗,才能更有效比較出cyclosporine, azathioprine 和benzathinepenicillin對安慰劑的結果,也能更有效的做出歸納與比較。

翻譯人

本摘要由林口長庚醫院陳威志翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

無總結

Plain language summary

Pharmacotherapy for Behcet's syndrome

Behcet's syndrome is a multisystemic disorder presenting with recurrent oral and genital ulcerations as well as ocular involvement. Treatment of Behcet's syndrome is symptomatic and empirical.

Ten trials and 679 patients were included. There is insufficient evidence either to support or to refute some of the classic treatments for Behcet's syndrome, including colchicine, cyclophosphamide and steroids for eye involvement, azapropazone and colchicine for arthritis and acyclovir, colchicine and topical interpheron for aphthas. The results confirm the protective effects of cyclosporine and azathioprine for eye involvement and benzathine-penicillin for arthritis.

We conclude that further randomized, placebo-controlled, double-blind trials should be carried out to compare cyclosporine, azathioprine and benzathine-penicillin versus placebo in order to make the results generalizable and comparable.

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