双膦酸盐类药物治疗骨髓瘤骨病的临床研究  

Efficacy of bisphosphonates in reducing skeletal events in patients with multiple myeloma

作　　者：李斯丹[1] 徐燕[2] 安刚[2] 赵耀中[2] 邹德慧[2] 邱录贵[2] 王亚非[3] 

机构地区：[1]首都医科大学附属北京儿童医院血液肿瘤中心,100045 [2]中国医学科学院北京协和医学院血液学研究所血液病医院淋巴肿瘤中心 [3]天津医科大学附属肿瘤医院血液科

出　　处：《白血病．淋巴瘤》2012年第7期397-400,共4页Journal of Leukemia & Lymphoma

基　　金：卫生部临床重点学科建设项目（2010-2012）,天津市科技支撑计划重点项目（09ZCGYSF01000）,国家自然科学基金（81172255,81101794）

摘　　要：目的总结双瞵酸盐类药物对中国多发性骨髓瘤患者骨病的疗效及其意义。方法采用历史同期对照研究分析205例多发性骨髓瘤患者，比较应用双膦酸盐类药物组（简称用药组）和未用双膦酸盐类药物组（简称未用药组）患者骨骼事件的发生率、骨病改善的程度，并分析此类药物的应用对预后的影响。结果骨骼事件发生率用药组低于未用药组[38．9％（35／90）比54．8％（63／115）]（P〈0．01），用药组发生第1次骨事件时间及发生第1次病理性骨折的时间均明显长于未用药组[（34．7±3．2）个月比（27．5±3．2）个月，（47．2±3．6）个月比（42．7±5．0）个月1（均P〈0．05）。治疗6个周期后不同治疗组评价骨髓瘤骨病（MBD）的治疗反应，用药组有效＋显效者比例明显高于未用药组[80．0％（64／80）比48．7％（37／76）1（P〈0．001）；高钙血症治疗的有效率分别为100％（70／70）、98．3％（59／60），二者差异无统计学意义（19=0．278）。治疗6个周期后用药组骨痛缓解有效＋显效者的比例及ECOG评分≤2分者比例均显著高于未用药组[83．9％（73／87）比63．2％（55／87）（P=0．001）；80．0％（68／85）比53．5％（46／86）（P〈0．001）1。90例用药组中双膦酸盐类药物不良反应轻微，常见不良反应包括胃肠道反应3例（3．3％）、发热1例（1．1％）、皮疹2例（2．2％）。应用双膦酸盐不影响总体生存时间[（39．4±4．2）个月比（36．2±2．9）个月（P=0．580）]。结论双膦酸盐可有效降低骨骼事件的发生率，延长第1次骨骼事件及病理性骨折的发生时间，明显改善MBD治疗反应、ECOG评分，缓解骨骼疼痛，从而提高生存质量。双膦酸盐的应用不能延长患者的总体生存时间。Objective To review the efficacy of bisphosphonates in reducing skeletal events in patients with multiple myeloma. Methods Two hundred and five patients with newly diagnosed MM were enrolled in this retrospective study, with bisphosphonates or not. Skeletal-related events, therapeutic reaction of myeloma bone disease and patient survival were analyzed. Results The occurrence of skeletal-related events （SRE） per patient year （P〈0.01） and the time to first SRE （P〈0.05）were significantly lower in the treatment group than in the untreated group. After 6 cycles of treatment, a significant higher percentage of effective and marked effect patients were observed through X ray in the treatment group （80.0 %） compared to the untreated group （48.7 %）, P〈0.001. There was no overall significant difference in the level of serum calcium between the two groups （P=0.278）. After 6 cycles of treatment, the patients who received bisphosphonates had significant decreases in bone pain and lower ECOG score （ECOG≤2） compared to the untreated group （P〈0.05）. Bisphosphonates were tolerated well, and the common adverse reaction including gastrointestinal reaction （3 cases, 3.3 %）, fever （lcase, 1.1%） and skin rash （2 cases, 2.2 %）. There was no significant difference in overall survival between the two treatment groups, （P=0.580）. Conclusion Infusions of Bisphosphonates could reduce the occurrence of skeletal- related events （SRE）, prolong the time to first SRE and improve the quality of life of patients with muhiple myeloma. Bisphosphonates could not prolong survival time of myeloma patients.

关 键 词：多发性骨髓瘤 骨疾病 二膦酸盐类 预后 

分 类 号：R733.3[医药卫生—肿瘤]