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目的:评估PAD方案(硼替佐米+脂质体多柔比星+地塞米松)治疗初治多发性骨髓瘤(MM)的疗效和安全性。方法:初治MM 27例,均给予PAD方案为一线治疗:硼替佐米1.3mg/m2,静脉注射,第1、4、8、11天;脂质体多柔比星20mg,静脉滴注,第1、4、8天;地塞米松20~40mg/d,静脉滴注,第1、4、8、11天;每28d为1个周期。27例患者接受平均4(2~8)个疗程的治疗。观察其短期疗效和长期疗效,并判断其不良反应。结果:近期疗效观察:初始疗效的中位时间为2周,最佳疗效的中位时间为3个月。总反应率为89%,其中完全缓解14例(52%),非常好的部分缓解2例(7%),部分缓解8例(30%)。此外,疾病稳定3例(11%),疾病控制100%。长期疗效观察:中位随访49(7~96)个月,中位无进展生存时间24个月,中位生存时间50个月。患者3年、5年、7年的无疾病进展率分别为37.0%、17.3%和8.6%,3年、5年、7年的总生存率分别为51.9%、47.9%和47.9%。主要的不良反应为血液学毒性,中性粒细胞减少8例(30%),贫血5例(19%),血小板减少7例(26%)。非血液学毒性主要为胃肠道症状,便秘10例(37%),腹泻、恶心、黏膜炎分别为2例(7%);其次为周围神经病变,1/2级7例(26%),3级2例(7%)。4例(15%)出现手足综合征,4例(15%)出现乏力,2例(7%)肝功能异常,2例(7%)并发带状疱疹。结论:PAD方案对于初治MM总反应率高,起效快,不良反应较小,是一种安全、有效的治疗方法。其长期疗效显示,PAD方案能使MM获得最大程度的缓解,适当的维持治疗后近半数患者长期生存。
PURPOSE: To evaluate the efficacy and safety of the PAD regimen (bortezomib + liposomal doxorubicin + dexamethasone) in the treatment of newly diagnosed multiple myeloma (MM). Methods: 27 newly diagnosed MM patients were given first-line treatment of PAD regimen: bortezomib 1.3mg / m2 intravenous injection on day 1,4,8,11; liposomal doxorubicin 20mg, intravenous drip, 1, 4, 8 days; dexamethasone 20 ~ 40mg / d, intravenous drip, 1,4,8,11 days; every 28d for a cycle. Twenty-seven patients received an average of 4 (2 to 8) courses of treatment. Observe its short-term efficacy and long-term efficacy, and determine the adverse reactions. Results: The recent curative effect observation: The median time of initial curative effect is 2 weeks, and the median time of best curative effect is 3 months. The overall response rate was 89%, with complete remission in 14 (52%), very good partial remission in 2 (7%), and partial remission in 8 (30%). In addition, 3 were stable (11%) and disease control was 100%. Long-term efficacy of observation: median follow-up of 49 (7 to 96) months, the median progression-free survival time of 24 months, the median survival time of 50 months. The 3-year, 5-year and 7-year disease-free rates of patients were 37.0%, 17.3% and 8.6% respectively. The overall survival rates at 3, 5 and 7 years were 51.9%, 47.9% and 47.9%, respectively. The major adverse effects were hematologic toxicity, neutropenia in 8 patients (30%), anemia in 5 patients (19%) and thrombocytopenia in 7 patients (26%). Non-haematological toxicities were mainly gastrointestinal symptoms, constipation in 10 cases (37%), diarrhea, nausea and mucositis in 2 cases (7%), followed by peripheral neuropathy in 7 cases (26%) , Grade 3 in 2 cases (7%). Hand-foot syndrome occurred in 4 patients (15%), fatigue in 4 (15%), abnormal liver function in 2 (7%), and shingles in 2 (7%). Conclusion: The PAD regimen is a safe and effective treatment for patients with untreated MM with high overall response rate, fast onset of action and small adverse reactions. Its long-term efficacy shows that PAD regimen maximizes MM resolution and maintains nearly half of patients with long-term survival after adequate maintenance therapy.