摘要目的:探讨扶正培元方辅助改良VAD方案对多发性骨髓瘤(multiple myeloma, MM)患者M蛋白、骨髓瘤细胞及免疫功能的影响。方法:将符合入选标准的2017年1月-2019年5月96例MM患者按随机数字表法分为2组，每组48例。对照组给予改良VAD方案(长春新碱+阿霉素+地塞米松)治疗，观察组在对照组基础上给予扶正培元方辅助治疗。2组均治疗3个周期。分别于治疗前后进行中医证候评分，采用VAS量表对骨痛程度进行量化评分，采用氧化酶法检测SCr，采用氰酸盐法检测HbAlc，以紫外吸收分光光度法测定血钙水平，以免疫扩散电泳法测定M蛋白水平；行骨髓穿刺制作骨髓涂片测定骨髓瘤细胞水平。采用ELISA法测定血清IL-2、γ-干扰素、IL-4、IL-10水平。观察治疗期间的毒副作用，评价临床疗效。结果:观察组总有效率为81.3%(39/48)、对照组为62.5%(30/48)，2组比较差异有统计学意义( χ2=4.174， P=0.041)。治疗第1、3个周期，观察组中医证候积分( t值分别为4.674、13.328)、骨痛评分( t值分别为4.505、11.398)均低于对照组( P<0.01)；观察组SCr( t值分别为4.452、10.039)、血钙( t值分别为4.578、4.155)水平均低于对照组( P<0.01)；HbAlc( t值分别为5.290、8.871)水平高于对照组( P<0.01)；M蛋白( t值分别为11.145、33.812)、骨髓瘤细胞( t值分别为6.415、19.731)水平均低于对照组( P<0.01)；血清IL-2( t值分别为4.922、8.789)、γ-干扰素( t值分别为5.610、8.886)水平均高于对照组( P<0.01)；IL-4( t值分别为4.709、6.784)、IL-10( t值分别为5.287、12.823)水平均低于对照组( P<0.01)。治疗期间，观察组毒副作用发生率为41.7%(20/48)、对照组为62.5%(30/48)，2组比较差异有统计学意义( χ2=4.174， P=0.041)。 结论:扶正培元方辅助改良VAD方案可有效缓解MM患者的临床症状，减轻骨痛程度，促进骨髓瘤细胞减少，提高患者免疫功能及化疗耐受性。

abstractsObjective:To investigate the effect of Fuzheng-Peiyuan recipe assisted modified VAD program on M protein, myeloma cells and immune function in patients with multiple myeloma (MM). Methods:A total of 96 patients with MM from January 2017 to May 2019 in our hospital were selected as the research objects, and they were divided into two groups according to the random number table method, with 48 patients in each group. The control group was given a modified VAD regimen (vincristine + adriamycin + dexamethasone), and the observation group was given Fuzheng-Peiyuan recipe as an auxiliary VAD regimen. Both groups were treated for 3 cycles. The clinical efficacy, TCM syndrome score, bone pain score, blood creatinine, hemoglobin, blood calcium, M protein, myeloma cells, immune function [Interleukin-2 (IL-2), Interferon-gamma (INF-γ), Interleukin-4 (IL-4), Interleukin-10 (IL-10)] levels and adverse reactions of the two groups were recorded and compared before and after treatment. Results:The total effective rate of the observation group was 81.3% (39/48), and the control group was 62.5% (30/48). The difference between the two groups was statistically significant ( χ2=4.174, P=0.041). The scores of TCM syndromes ( t=4.674, 13.328) and bone pain scores ( t=4.505, 11.398) in the observation group were significantly lower than those in the control group ( P<0.01) at 1 and 3 cycles after treatment; SCr ( t=4.452, 10.039), blood calcium ( t=4.578, 4.155) in the observation group were significantly lower than those in the control group ( P<0.01); HbAlc levels ( t=5.290, 8.871) in the observation group was significantly higher than that of the control group ( P<0.01); M protein ( t=11.145, 33.812), myeloma cells ( t=6.415, 19.731) in the observation group were significantly lower than those in the control group ( P<0.01); serum IL-2 ( t=4.922, 8.789), INF-γ ( t=5.610, 8.886) in the observation group were significantly higher than those in the control group ( P<0.01); IL-4 ( t=4.709, 6.784), IL-10 ( t=5.287, 12.823) in the observation group were significantly lower than those in the control group ( P<0.01). During the treatment, the incidence of adverse reactions in the observation group was 41.7% (20/48) and that in the control group was 62.5% (30/48). The difference between the two groups was statistically significant ( χ2=4.174, P=0.041). Conclusion:Fuzheng-Peiyuan recipe assisted in improving the VAD regimen in the treatment of MM has a significant clinical effect, which can relieve the clinical symptoms of patients and reduce the degree of bone pain, and promote the reduction of myeloma cells in patients, improve their immune function, and improve the tolerance of chemotherapy.