干扰素联合MP方案治疗多发性骨髓瘤的随机对照研究

A Randomized Control Study for the Treatment of Multiple Myeloma Using MP Regimen Combined with Interferon-α

目的 :探讨MP方案 (马法兰和强的松 )联合α-干扰素治疗多发性骨髓瘤的临床疗效、感染发生情况和对患者生存期的影响。方法 :用随机对照研究的方法 ,将 4 3例多发性骨髓瘤患者分为两组 :研究组 (干扰素组 ) 2 0例采用MP方案化疗加α-干扰素治疗 ;对照组 2 3例则只用MP方案化疗。连续治疗 6～ 12个月后作临床疗效评价 ;对照组 2 3例则只用MP方案化疗。连续治疗 6～ 12个月后作临床疗效评价 ;治疗期间观察两组患者感染发生情况 ;追踪随访两组患者 1年、 3年生存率。结果 :干扰素组完全缓解 10 % (2 /2 0 )、部分缓解 30 % (6 /2 0 )、进步 4 0 % (8/2 0 )、无效 2 0 % (4 /2 0 ) ;对照组完全缓解 8 7% (2 /2 3)、部分缓解 2 1 7% (5 /2 3)、进步39 1% (9/2 3)、无效 30 4 % (7/2 3) (P >0 0 5 )。干扰素组共化疗 2 14例次 ,发生感染 18例次、占 8 4 % ,无 1例败血症 ;对照组共化疗 2 38例次 ,感染 4 2例次、占 17 6 % ,2例次表现为败血症 (P <0 0 5 )。干扰素组 1年和3年生存率分别为 90 %及 6 0 % ,而对照组 1年和 3年生存率分别为 82 6 %及 5 2 2 % (P >0 0 5 )。结论 :MP方案联合α -干扰素治疗多发性骨髓瘤的临床疗效不比单用MP方案化疗好 ,它对患者生存率影响不明显 ,但能有效减少患者感染率。

Objective:To investigate the clinical effectacy,infection occurencl and survival of patients with multiple myeloma(MM)treated with MP regimen(melphalan and prednisone)plus interferon-α.Method:a randomized control study was applied.43 patients with MM were divided into 2 groups.One group was the research group(interferon group)in which 20 cases were treated with MP regimen combined with interferon-α.The remaining 23 cases in the control group were administered MP regimen only.All cases were evaluated for effectiveness,infectious rate and were followed up to observe 1-year and 3-year survival rates after consecutive 6～12 months treatments.Results:The complete remission rate,partial remission rate,improvement rate and no response rate in the research group were 10%(2/20),30%(6/20),40%(8/20)and 20%(4/20)respectively,while the corresponding rates in the control group were 8.7%(2/23),21.7%(5/23),39.1%(9/23)and 30.4%(7/23)(P>0.05).The total cycles of chemotherapy in the interferon group were 214 and the infectious rate was 8.4%(18/214),no case occurred septicaemia.The total cycles of chemotherapy in the control group were 238,the infectious rate was 17.6%(42/238),2 cases occurred septicaemia(P<0.05).The 1-year and 3-year survival rates in interferon groups were 90% and 60% separately while in control group were 82.6% and 52.2% respertively(P>0.05).Conclusions:The clinical effectiveness of MP regimen combined with interferon-α was no better than that of MP regimen only,and the difference of survival rates between these two groups was not significant,but MP regimen combined with interferon-α may reduce infection rate.