Suarez-Almazor M E, Belseck E, Shea B, Homik J, Wells G, Tugwell P
Health Services Research, Veterans Affairs Medical Center, Mailbox Station 152, 2002 Holcombe Blvd, Houston, Texas 77024 USA.
Cochrane Database Syst Rev. 2000;2000(2):CD000959. doi: 10.1002/14651858.CD000959.
To estimate the short-term efficacy and toxicity of antimalarials for the treatment of rheumatoid arthritis (RA).
We searched the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, Medline and Embase up to and including July 1997. We also carried out a handsearch of the reference lists of the trials retrieved from the electronic search.
All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing antimalarials against placebo in patients with RA DATA COLLECTION AND ANALYSIS: Data abstraction was carried out independently by two reviewers. The same two reviewers using Jadad's scale (Jadad 1995) assessed the methodological quality of the RCTs and CCTs. Rheumatoid arthritis outcome measures were extracted from the publications for the 6-month endpoint. The pooled analysis was performed using standardized mean differences for joint counts, pain and global assessments. Weighted mean differences were used for erythrocyte sedimentation rate (ESR). Toxicity was evaluated with pooled odds ratios for withdrawals. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout.
We found four trials, with 300 patients randomized to hydrochloroquine and 292 to placebo. Only trials evaluating hydroxychloroquine could be pooled in the analysis. A statistically significant benefit was observed when hydroxychloroquine was compared to placebo. The standardized mean differences for the various outcome measures ranged from -0.33 to -0. 52, and were statistically significant. Statistically significant differences were also observed for ESR. Overall withdrawals and withdrawals due to lack of efficacy were significantly more frequent in the placebo group. No differences were observed in withdrawals due to toxicity.
REVIEWER'S CONCLUSIONS: Hydroxychloroquine appears to be efficacious for the treatment of RA. Its overall effect appears to be moderate, but its low toxicity profile should be considered when treating patients with RA.
评估抗疟药治疗类风湿关节炎（RA）的短期疗效和毒性。
我们检索了Cochrane肌肉骨骼组试验注册库、Cochrane对照试验注册库、截至1997年7月（含该月）的Medline和Embase。我们还对手检从电子检索中获取的试验的参考文献列表进行了检索。
所有比较抗疟药与安慰剂治疗RA患者的随机对照试验（RCT）和对照临床试验（CCT）。数据收集与分析：由两名审阅者独立进行数据提取。同样由这两名审阅者使用Jadad量表（Jadad，1995年）评估RCT和CCT的方法学质量。从出版物中提取6个月终点时的类风湿关节炎结局指标。采用标准化均数差对关节计数、疼痛和整体评估进行汇总分析。红细胞沉降率（ESR）采用加权均数差。采用汇总比值比评估撤药毒性。采用卡方检验评估各试验间的异质性。全程使用固定效应模型。
我们发现四项试验，300例患者随机分配至羟氯喹组，292例患者随机分配至安慰剂组。分析中仅纳入了评估羟氯喹的试验。与安慰剂相比，观察到羟氯喹具有统计学显著益处。各项结局指标的标准化均数差在-0.33至-0.52之间，具有统计学显著性。ESR也观察到统计学显著差异。总体撤药率及因疗效不佳导致的撤药率在安慰剂组显著更高。因毒性导致的撤药率未观察到差异。
羟氯喹似乎对RA治疗有效。其总体效果似乎中等，但在治疗RA患者时应考虑其低毒性特征。
