摘要
目的系统评价双膦酸盐类药物治疗多发性骨髓瘤的效果和安全性。方法采用Cochrane系统评价方法,检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库、中国期刊全文数据库等数据库,由两名评价者共同纳入符合标准的研究,采用Cochrane系统评价手册4.2.7中RCT的质量评价标准评价研究的方法学质量后,对同质研究进行Meta分析。结果共纳入11个RCT,研究地点均在国外,研究质量均较高,各试验间具有基线可比性。Meta分析结果显示:双膦酸盐类药物有助于预防病理性脊柱骨折[OR=0.59,95%CI(0.45,0.78),P=0.000-2]和缓解疼痛[OR=0.59,95%CI(0.46,0.76),P=0.000-05],但在缓解疼痛方面,由于数据临床异质性较大,需谨慎对待这一结论。同时,在病死率[OR=0.98,95%CI(0.82,1.18),P=0.85]及高钙血症[OR=0.76,95%CI(0.56,1.03),P=0.07]方面与安慰剂组无差异。结论在治疗多发性骨髓瘤中加入双膦酸盐类药物可降低病理性脊柱骨折和疼痛,但无益于病死率及高钙血症的改善。
Objective To evaluate the effcacy of bisphosphonates in treating patients with Multiple Myeloma. Methods The databases including The Cochrane Library, PubMed, EMBASE, CBM, and CNKI were searched. Quality assessment and data extraction were conducted by two reviewers independently, and disagreement, if any, was resolved by discussion. Meta-analyses were performed for homogeneous studies. Results Eleven RCTs were included, all of which came from abroad. The methodological quality of the included studies was good. The baseline data of each trial were com-parable. Meta-analyses showed that, the pooled analysis of the published evidence demonstrated the beneficial effect of bi-sphosphonates on prevention of pathological vertebral fractures (OR=0.59, 95%CI 0.45 to 0.78, P=0.000-1) and on relieving pain (OR=0.59, 95%CI 0.46 to 0.76, P=0.000-05). However, the analysis of the effect of bisphosphonates on pain was based on clinically heterogeneous data which must be interpreted with caution. Meanwhile, there was no significant effect of bisphosphonates on mortality (OR=0.99, 95%CI 0.88 to 1.12, P=0.9) and hypercalcemia (OR=0.76, 95%CI 0.56 to 1.03, P=0.07). Conclusions Adding bisphosphonates to the treatment of myeloma can reduce pathological vertebral fractures and pain, but is not helpful to mortality and hypercalcemia.
出处
《中国循证医学杂志》
CSCD
2010年第10期1188-1193,共6页
Chinese Journal of Evidence-based Medicine
关键词
双膦酸盐类
多发性骨髓瘤
系统评价
随机对照试验
Bisphosphonates
Multiple myeloma
Systematic review
Randomized controlled trial