Efficacy and Safety of Bortezomib，Lenalidomide Combined with Dexamethasone in the Treatment of Multiple Myeloma
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摘要:
目的 探讨硼替佐米、来那度胺联合地塞米松在多发性骨髓瘤（multiple myeloma，MM）患者中的有效率及治疗安全性。 方法 选择2021年9月至2022年9月曲靖市第一人民医院血液科94例多发性骨髓瘤患者为对象，采用随机数字表法分为2组。对照组（n = 47）采用硼替佐米联合地塞米松治疗，观察组（n = 47）联合来那度胺治疗，1个疗程为3周，共治疗6个疗程，记录2组有效率、血液生化指标、免疫水平、疾病负荷情况及不良反应。 结果 疗程结束后，观察组有效率高于对照组，差异有统计学意义（P < 0.05）；2组疗程结束后，观察组骨髓浆细胞、血M蛋白量血液生化指标低于对照组，差异有统计学意义（P < 0.05），BAP、OPG及LDH高于对照组，差异有统计学意义（P < 0.05）；观察组疗程后 CD3+、CD4+、CD4+/CD8+高于对照组，CD8+低于对照组，差异有统计学意义（P < 0.05）；2组疗程结束后骨髓浆细胞百分比、M蛋白水平、自由轻链水平得到降低；观察组骨髓浆细胞百分比、M蛋白水平、自由轻链水平均低于对照组，差异有统计学意义（P < 0.05）；2组用药过程中骨髓抑制、指尖麻木、脱发、肾损伤及胃肠道反应发生率，差异无统计学意义（P > 0.05）。 结论 硼替佐米、来那度胺结合地塞米松连续治疗6个疗程，用于多发性骨髓瘤患者中能可提高治疗的有效率，且改善其血液生化指标，提高CD3+、CD4+、CD4+/CD8+水平，且药物安全系数明显提升，值得推广应用。 Abstract:Objective To investigate the therapeutic efficacy and safety of bortezomib and lenalidomide combined with dexamethasone in patients with Multiple Myeloma （MM）. Methods A total of 94 patients with multiple myeloma in the Hematology Department of the First People’s Hospital of Qujing City from September 2021 to September 2022 were selected and divided into 2 groups by random number table method. The control group （n = 47 cases） was treated with bortezomib combined with dexamethasone, and the observation group （n = 47 cases） bortezomib, dexamethasone and lenalidomide. One course of treatment lasted for 3 weeks, and a total of 6 courses of treatment were conducted. The effective rate, blood biochemical indexes, immune level, disease load and adverse reactions of the two groups were compared. Results After treatment, the effective rate of observation group was higher than that of control group, the difference was statistically significant （P < 0.05）. After treatment, bone marrow plasma cells and blood M protein levels in the observation group were lower than those in the control group, and the difference was statistically significant （P < 0.05）. BAP, OPG and LDH in observation group were higher than those in control group, and the differences were statistically significant （P < 0.05）. CD3+, CD4+, CD4+/CD8+ in observation group were higher than those in control group, and CD8+ were lower than those in control group, the difference was statistically significant （P < 0.05）. The percentage of bone marrow plasma cells, the level of M protein and the level of free light chain were decreased in 2 groups. There was no significant difference in the incidence of bone marrow suppression, fingertip numbness, alopecia, kidney damage and gastrointestinal reaction between 2 groups （P > 0.05）. Conclusion Bortezomib, lenalidomide combined with dexamethasone for 6 consecutive courses of treatment can improve the treatment efficiency of multiple myeloma patients, improve their blood biochemical indexes, increase the levels of CD3+, CD4+, CD4+/CD8+, and significantly improve the drug safety factor, worthy of promotion and application. -
Key words:
- Bortezomib /
- Lenalidomide /
- Dexamethasone /
- Multiple myeloma /
- Efficacy rate /
- Immune level /
- Safety
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表 1 2组有效率比较[n（%）]
Table 1. Comparison of effective rates between the two groups [n（%）]
组别 n CR PR MR PD 有效率 观察组 47 3（6.38） 31（65.96） 10（21.28） 3（6.38） 34（72.34） 对照组 47 0（0.00） 23（48.94） 14（29.79） 10（21.28） 23（48.94） χ2 / - - - - 5.393 P / - - - - 0.020# 与对照组比较，#P < 0.05。 
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表 2 2组生化指标比较（
$ \bar{x} \pm s $ ）Table 2. Comparison of biochemical indicators between the two groups （
$ \bar{x} \pm s $ ）组别 骨髓浆细胞（%） 血M蛋白（g/L） BAP（μg/L） OPG（pg/mL） LDH（U/L） 观察组（n = 47） 治疗前 35.29 ± 5.62 38.63 ± 5.39 4.32 ± 0.79 178.46 ± 8.78 174.34 ± 9.43 疗程后 15.32 ± 2.38#* 25.16 ± 4.51#* 12.69 ± 1.63#* 199.69 ± 12.63#* 385.45 ± 26.32#* 对照组（n = 47） 治疗前 35.61 ± 5.64 38.65 ± 5.41 4.35 ± 0.82 178.74 ± 8.95 174.52 ± 9.54 疗程后 23.29 ± 3.59* 30.42 ± 4.89* 8.54 ± 1.32* 185.34 ± 10.29* 214.69 ± 22.41* 与对照组比较，#P < 0.05；与治疗前比较，*P < 0.05。
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表 3 2组免疫水平比较（
$ \bar{x} \pm s $ ）Table 3. Comparison of immune levels between the two groups （
$ \bar{x} \pm s $ ）组别 时间点 CD3+ CD4+ CD8+ CD4+/CD8+ 观察组（n = 47） 治疗前 45.92 ± 6.49 47.41 ± 7.21 25.56 ± 5.42 1.85 ± 0.41 疗程结束后 40.69 ± 5.14#* 42.56 ± 6.34#* 28.62 ± 6.71#* 1.49 ± 0.29#* 对照组（n = 47） 治疗前 45.95 ± 6.52 47.43 ± 7.26 25.58 ± 5.44 1.85 ± 0.43 疗程结束后 34.38 ± 4.58* 38.32 ± 5.82* 32.69 ± 6.75* 1.17 ± 0.17* 与对照组比较，#P < 0.05；与治疗前比较，*P < 0.05。
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表 4 2组疾病负荷比较（
$ \bar{x} \pm s $ ）Table 4. Comparison of disease burden between the two groups （
$ \bar x \pm s$ ）组别 n 骨髓浆细胞百分比（%） M蛋白 自由轻链（mg/L） 治疗前 疗程结束后 治疗前 疗程结束后 治疗前 疗程结束后 观察组 47 25.29 ± 4.31 12.19 ± 2.04# 51.94 ± 5.61 22.15 ± 3.14# 278.43 ± 12.59 152.15 ± 8.51# 对照组 47 25.31 ± 4.33 20.15 ± 3.35# 51.96 ± 5.64 33.61 ± 4.69# 279.51 ± 12.62 194.68 ± 10.29# T/χ2 / 1.201 6.619 0.458 7.439 0.095 13.239 P / 0.329 0.001 0.541 0.001 0.518 0.001 与治疗前比较，#P < 0.05。
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表 5 2组安全性比较[n（%）]
Table 5. Comparison of safty between the two groups [n （%）]
组别 n 肾损伤 胃肠道反应 脱发 骨髓抑制 指尖麻木 发生率 观察组 47 1（2.13） 3（6.38） 0（0.00） 0（0.00） 1（2.13） 5（10.64） 对照组 47 3（6.38） 4（8.51） 3（6.38） 1（2.13） 2（4.26） 13（27.66） χ2 / − − − − − 4.398 P / − − − − − 0.036# 与对照组比较，#P < 0.05。
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