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目的:研究桃红四物汤加减联合VP方案治疗难治性多发性骨髓瘤(MM)临床疗效。方法:将医院血液科41例复发/难治性多发性骨髓瘤患者纳入研究样本,以随机数表法分为观察组(21例)和对照组(20例),对照组给予VP方案(V:注射用硼替佐米,P:地塞米松)干预,V:1.3 mg/m~2推注,于1、4、8、11 d给药,21 d/疗程;P:15 mg静注,1、2、4、5、8、9、11、12 d给药。观察组另给予桃红四物汤加减干预,2疗程后比较两组西医疗效、中医证候疗效,并比较两组治疗前后直接病理指标(破骨细胞、成骨细胞、浆细胞比率)及间接病理指标(中性粒细胞、血小板计数、血沉、血尿素氮、血钙、血红蛋白)的差异,以分析中西联合治疗的疗效及桃红四物汤可能的治疗机制。结果:观察组西医有效率、中医证候总有效率均为90.47%,与对照组65%、55%比较显著较高(P<0.05)。观察组治疗后破骨细胞及浆细胞比率分别为(0.17±0.05)个/mm~2、(4.69±2.06)%与对照组及治疗前比较显著较低(P<0.05),观察组成骨细胞治疗后为(1.31±0.42)个/mm~2与对照组比较显著较高(P<0.05);观察组治疗后中性粒细胞、血小板计数、血红蛋白分别为(2.79±1.02)×10~9/L、(42.16±9.15)×10~9/L、(91.74±11.32)g/L与对照组比较显著较高(P<0.05),两组血沉、血钙、血尿素氮治疗后比较均无统计学意义(P>0.05);观察组总不良反应发生率42.86%与对照组65%比较较低,但差异无统计意义(P>0.05)。结论:桃红四物汤加减联合西药治疗难治性多发性骨髓瘤具有显著增效作用,其机制可能与方内多味活血药物可提高血小板、血红蛋白以及白细胞水平相关,同时可减少化疗不良反应,远期疗效及对复发的控制有待进一步研究。
Objective: To study the clinical efficacy of Taohong Siwu Decoction combined with VP regimen in treatment of refractory multiple myeloma (MM). Methods: Forty-one patients with relapsed / refractory multiple myeloma in the department of hematology were enrolled in the study sample. The patients were divided into observation group (21 cases) and control group (20 cases) by random number table. The control group received VP regimen : Injection of bortezomib, P: dexamethasone) intervention, V: 1.3 mg / m ~ 2 bolus administered at 1, 4, 8, 11 d for 21 d / 1,2,4,5,8,9,11,12 d dosing. The observation group was given another addition and subtraction of Taohongsiwu Decoction. After two courses of treatment, the curative effect of TCM and TCM syndrome were compared between the two groups. The direct pathological indexes (osteoclast, osteoblast and plasma cell ratio) and indirect pathology (Neutrophil, platelet count, erythrocyte sedimentation rate, blood urea nitrogen, serum calcium, hemoglobin) in order to analyze the curative effect of combined Chinese and western medicine and the possible therapeutic mechanism of Taohong Siwu Decoction. Results: The total effective rate of TCM and TCM syndrome in observation group were 90.47%, which was significantly higher than 65% and 55% in control group (P <0.05). The ratio of osteoclasts and plasma cells in the observation group after treatment was (0.17 ± 0.05) / mm ~ 2, (4.69 ± 2.06)%, which were significantly lower than those in the control group and before treatment (P <0.05) (1.31 ± 0.42) / mm ~ 2 after treatment was significantly higher than that of the control group (P <0.05). The neutrophil count, platelet count and hemoglobin in the observation group were (2.79 ± 1.02) × 10 ~ 9 (42.16 ± 9.15) × 10 ~ 9 / L, (91.74 ± 11.32) g / L were significantly higher than those in the control group (P <0.05) There was no significant difference between the two groups (P> 0.05). The total incidence of adverse reactions in the observation group was 42.86% compared with 65% in the control group, but the difference was not statistically significant (P> 0.05). Conclusion: The addition and subtraction of Taohongsiwu Decoction combined with Western medicine has significant synergistic effect on the treatment of refractory multiple myeloma. The mechanism may be related to the increase of platelets, hemoglobin and leukocyte level by multi-flavor and blood-activating drugs in the prescription, meanwhile, it can reduce the adverse reactions of chemotherapy, Long-term efficacy and control of recurrence need further study.