桃红四物汤加减联合VP方案治疗难治性多发性骨髓瘤临床观察

Clinical Observation on Modified Taohong Siwu Decoction Combined with VP Regimen in Treatment of Patients with Refractory Multiple Myeloma

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 curative effect of modified Taohong Siwu Decoction combined with VP regimen in refractory multiple myeloma（ MM）. Methods： Forty-one patients with recurrent/refractory MM in the department of hematology of our hospitalwere included in the study. According to the random number table method,the patients were divided into the observation group（ 21 cases） and the control group（ 20 cases）. The control group was treated with VP regimen（ V： bortezomib for injection,P： dexamethasone） for intervention（ V： injected at 1. 3mg/m^2,administrated on thest,4th,8thand 11 thday. 21 d was a course of treatment; P： 15 mg intravenous injection,administrated on the 1st,2nd,4th,5th,8th,9th,11 thand 12thday）. The observation group was given modified Taohong Siwu Decoction for intervention.After 2 courses of treatment,the curative effects of western medicine and TCM syndrome were compared between the two groups. The direct pathological indexes（ osteoclasts,osteoblasts,plasma cell ratio） and indirect pathological indexes（ neutrophils,platelet count,erythrocyte sedimentation rate,blood urea nitrogen,blood calcium,hemoglobin） were compared between the two groups before and after treatment to analyze the curative effect of integrated Chinese and Western medicine and possible therapeutic mechanism of Taohong Siwu Decoction. Results： In the observation group,the total effective rate of western medicine and TCM syndrome（ 90. 47%,90. 47%） was significantly higher than those in the control group（ 65%,55%）（ P〈0. 05）. The ratios of osteoclasts and plasma cells in the observation group after treatment[（ 0. 17 ± 0. 05）/mm^2,（ 4. 69 ± 2. 06） %] were significantly higher than those in the control group and those before treatment（ P〈0. 05）. Osteoblasts in the observation group after treatment（ 1. 31 ± 0. 42）/mm^2 was significantly higher than that in the control group（ P〈0. 05）. In the observation group after treatment,neutrophils,platelet count and hemoglobin [（ 2. 79 ± 1. 02） × 109/L,（ 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 in ESR,blood calciumor blood urea nitrogen between the two groups after treatment（ P〉0. 05）. The total incidence of adverse reactions in the observation group（ 42. 86%） was lower than that in the control group（ 65%）,but the difference was not statistically significant（ P〉0. 05）. Conclusions： Modified Taohong Siwu Decoction combined with western medicine in the treatment of refractory MM has obvious synergistic effect. The mechanism may be related to blood-activating drugs in the prescription which can improve levels of platelet,hemoglobin and white blood cells. Meanwhile,it can reduce the side effects of chemotherapy.The long-term curative effect and control of recurrence need to be further studied.