Li Chang-Sheng, Ji Ye, Zhang Wan-Ping, Fu Li-Ping
Second Ward of Oncology Department,Nanyang City Center Hospital, Nanyang 473009, Henan Province, China.
Second Department of Oncology,Nanyang City Center Hospital, Nanyang 473009, Henan Province, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2018 Jun;26(3):836-841. doi: 10.7534/j.issn.1009-2137.2018.03.034.
To study the clinical efficacy and safety of dexamethasone of different doses combined with bortezomib and thalidomide for treatment of primary multiple myeloma.
Ninety-six patients with multiple myeloma from January 2013 to January 2014 were randomly divided into group A (high-dose dexamethasone + bortezomib + thalidomide, 32 cases), group B (low-dose dexamethasone + bortezomib + thalidomide, 32 cases) and group C (placebo + bortezomib + thalidomide, 32 cases). The clinical efficacy and safety of patients was compared among 3 groups.
The overall remission rate (ORR) in group A and B was significantly higher than that in group C (P<0.05), but the ORR was not significant difference between group A and group B (P>0.05). After treatment, the KPS and RNS score in 3 groups were significantly higher and lower than those before treatment, respectively; the KPS score in group A and B was significantly higher than that in group C (P<0.05), the RNS score in group A and B was significantly lower C (P<0.05). After treatment, the positive expression rates of CD38, CD56 and CD138 as well as small residual lesion (SRL) positive rate in 3 grops were significantly lower than those before treatment, but the positive expression rate of CD19 was significantly higher that before treatment; the positive expression rates of CD38, CD56 and CD138 as well as SRL positive rate in group A and B were significantly lower thant those in group C, while the positive expression rate of CD19 was significantly higher that in group C (P<0.05), but the positive expression rates of CD19, CD38, CD56 and CD138 as well as SRL positive rate were not significantly different between group A and B (P>0.05). The incidence of fatigue, rash, peripheral neuropathy, anlmia, granulocyte deficiance and so on in group B and C was significantly lower than that in group A(P<0.05), but the difference in group B and C was not significant (P>0.05).
The therapeutic efficacy of different doses of dexamethasone combined with bortezomib and thalidomide for patients with multiple myeloma is similar, can obviously enhance remission rate, prolong the survival time, promote life quality, but the incidence of adverse reactions in low dose dexamethason rigemen is significantly reduced, and the safety is better.
研究不同剂量地塞米松联合硼替佐米及沙利度胺治疗原发性多发性骨髓瘤的临床疗效及安全性。
选取2013年1月至2014年1月的96例多发性骨髓瘤患者，随机分为A组（高剂量地塞米松+硼替佐米+沙利度胺，32例）、B组（低剂量地塞米松+硼替佐米+沙利度胺，32例）和C组（安慰剂+硼替佐米+沙利度胺，32例）。比较3组患者的临床疗效及安全性。
A组和B组的总缓解率（ORR）显著高于C组（P<0.05），但A组和B组的ORR差异无统计学意义（P>0.05）。治疗后，3组患者的KPS和RNS评分分别显著高于和低于治疗前；A组和B组的KPS评分显著高于C组（P<0.05），A组和B组的RNS评分显著低于C组（P<0.05）。治疗后，3组患者的CD38、CD56和CD138阳性表达率以及微小残留病灶（SRL）阳性率均显著低于治疗前，但CD19阳性表达率显著高于治疗前；A组和B组的CD38、CD56和CD138阳性表达率以及SRL阳性率均显著低于C组，而CD19阳性表达率显著高于C组（P<0.05），但A组和B组的CD19、CD38、CD56和CD138阳性表达率以及SRL阳性率差异无统计学意义（P>0.05）。B组和C组疲劳、皮疹、周围神经病变、贫血、粒细胞缺乏等的发生率显著低于A组（P<0.05）；但B组和C组差异无统计学意义（P>0.05）。
不同剂量地塞米松联合硼替佐米及沙利度胺治疗多发性骨髓瘤患者的疗效相似，均可明显提高缓解率，延长生存时间，改善生活质量，但低剂量地塞米松方案的不良反应发生率显著降低，安全性更好。
