Machado Márcio, Cruz Lorena Souza, Tannus Gabriela, Fonseca Marcelo
Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Toronto, Ontario, Canada.
Clin Ther. 2009 May;31(5):962-79. doi: 10.1016/j.clinthera.2009.05.009.
Complications from skeletal-related events (SREs) constitute a challenge in the care of patients with metastatic bone disease (MBD) that originated from any type of malignancy.
The purpose of this article was to compare the efficacy of clodronate, pamidronate, and zoledronate with that of placebo in reducing morbidity and overall mortality in cancer patients with MBD.
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched (from inception to January 2009) to retrieve randomized clinical trials that evaluated the bisphosphonates of interest. The search included articles published in English, French, Italian, Portugese, and Spanish. Patients with a definite (ie, biopsy-proven) diagnosis of MBD were included in the analysis. We extracted and combined data from studies that reported the number of patients with SREs and mortality data. A random-effects, meta-analytic model was applied in all calculations. The Jadad scale was used to assess the quality of study reporting.
The literature search identified 62 potential full-text studies; 44 of these studies were excluded and 18 were evaluated. The mean (SD) quality of reporting of the included studies was 57.8% (22.6%), or 2.89/5 (1.1/5). Each of the 3 drugs was found to be more effective than placebo in preventing all SREs in cancer patients with MBD. The relative risk of developing SREs was 0.70 (95% CI, 0.61-0.81; N = 1211) for zoledronate, 0.81 (95% CI, 0.73-0.91; N = 2251) for pamidronate, and 0.87 (95% CI, 0.75-1.00; N = 681) for clodronate. However, no clear advantage of one drug over the others was observed (CIs overlapped substantially). None of the bisphosphonates was more beneficial than placebo in reducing the number of deaths in the course of the trials (P = NS).
Clodronate, pamidronate, and zoled-ronate were associated with reductions in morbidity in cancer patients with MBD with regard to preventing SREs, but were not associated with a reduction in overall mortality.
骨相关事件（SREs）引发的并发症给源自任何类型恶性肿瘤的转移性骨病（MBD）患者的护理带来了挑战。
本文旨在比较氯膦酸盐、帕米膦酸盐和唑来膦酸盐与安慰剂在降低MBD癌症患者发病率和总死亡率方面的疗效。
检索MEDLINE、Embase和Cochrane对照试验中央注册库（从建库至2009年1月），以获取评估相关双膦酸盐的随机临床试验。检索范围包括以英文、法文、意大利文、葡萄牙文和西班牙文发表的文章。分析纳入确诊（即经活检证实）为MBD的患者。我们从报告SREs患者数量和死亡率数据的研究中提取并合并数据。所有计算均采用随机效应荟萃分析模型。使用Jadad量表评估研究报告的质量。
文献检索确定了62项潜在的全文研究；其中44项研究被排除，18项研究被评估。纳入研究的报告质量平均（标准差）为57.8%（22.6%），即2.89/5（1.1/5）。发现这三种药物在预防MBD癌症患者的所有SREs方面均比安慰剂更有效。唑来膦酸盐发生SREs的相对风险为0.70（95%CI，0.61 - 0.81；N = 1211），帕米膦酸盐为0.81（95%CI，0.73 - 0.91；N = 2251），氯膦酸盐为0.87（95%CI，0.75 - 1.00；N = 681）。然而，未观察到一种药物比其他药物有明显优势（置信区间有大量重叠）。在试验过程中，没有一种双膦酸盐在降低死亡人数方面比安慰剂更有益（P = 无统计学意义）。
氯膦酸盐、帕米膦酸盐和唑来膦酸盐在预防SREs方面可降低MBD癌症患者的发病率，但与总死亡率降低无关。
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