毒结清口服液联合VAD方案治疗多发性骨髓瘤临床研究

发布时间：2018-05-12 08:46

  本文选题：多发性骨髓瘤 + 毒结清口服液　； 参考：《广西中医药大学》2017年硕士论文

【摘要】：目的:客观评价毒结清口服液联合VAD方案化疗治疗多发性骨髓瘤(multiple myeloma,MM)的临床疗效,并观察其安全性。方法:选取2014年10月01日至2016年06月30日在广西中医药大学第一附属医院血液科就诊的MM住院病人64例,西医符合2015年NCCN指南MM诊断标准,中医符合脾肾亏虚,毒瘀互结证的。采用随机数字表法随机分为治疗组(32例)和对照组(32例),治疗组:毒结清口服液(20ml/次,tid)联合VAD化疗,对照组:VAD化疗。4周为1疗程,共治疗4疗程后评价,观察两组病人治疗后的临床疗效、中医症候疗效,骨痛疗效,生活质量KPS评分,中医症候积分,骨髓浆细胞比例,β2-微球蛋白,乳酸脱氢酶,血钙,C反应蛋白,肾功能,血红蛋白及不良反应发生率。结果:研究共入组病例64例,治疗过程中脱落5例,最终纳入统计分析59例。其中,治疗组30例,对照组29例。(1)两组病人疗效比较:(1)总反应率(ORR):治疗组ORR为70%,对照组ORR为58.60%,两组ORR差别无统计学意义;等级资料经秩和检验,治疗组整体疗效优于对照组(P0.05);(2)中医症候疗效:治疗组总有效率为80%,对照组总有效率为58.60%,差别无统计学意义;等级资料经秩和检验,治疗组整体疗效优于对照组(P0.05);(3)生活质量:治疗组KPS评分总有效率为76.7%,对照组KPS评分总有效率为62.07%,两组总有效率差别无统计学意义;等级资料经秩和检验,治疗组整体疗效优于对照组(P0.05)。(2)两组实验结果比较:(1)两组病人治疗后骨髓浆细胞比例较前显著下降(P0.05),但组间疗效相似(P0.05);(2)两组病人治疗后HGB均升高,β2-MG、LDH、血钙、CRP、Scr、BUN均下降(P0.05),治疗组优于对照组(P0.05);(3)两组病人症候积分比较:两组病人治疗后骨痛、疲倦乏力、食少纳呆、形体消瘦、四肢麻木、耳鸣积分较前下降(P0.05),其中治疗组优于对照组(P0.05);(4)不良反应:对照组有10例,其中,恶心呕吐5例,肝功能损害2例,Ⅲ度以上骨髓抑制3例。发生率34.48%;治疗组有7例,其中,恶心呕吐3例,肝功能损害2例,Ⅲ度以上骨髓抑制2例。发生率为23.33%,组间比较无统计学差异(P0.05)。结论:毒结清口服液联合VAD化疗方案治疗MM,可提高临床疗效;降低血β2-MG、LHD、Scr、BUN、血钙及CRP水平,提高HGB水平。还可以有效改善患者骨痛等临床症状,提高病人生活质量。安全性好,不增加化疗毒副作用。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Duqing oral liquid combined with VAD regimen in the treatment of multiple myeloma with multiple myeloma. Methods: 64 cases of MM hospitalized in hematology department of the first affiliated Hospital of Guangxi University of traditional Chinese Medicine were selected from October 01, 2014 to June 30, 2016. Western medicine met the MM diagnostic criteria of 2015 NCCN guidelines, TCM accorded with deficiency of spleen and kidney, and syndrome of toxin and blood stasis. The treatment group (n = 32) and the control group (n = 32) were randomly divided into treatment group (n = 32) and control group (n = 32). The treatment group was treated with Duqingoral liquid 20 ml / time tid) and the control group was treated with VAD for 4 weeks. The clinical effect, TCM symptom effect, bone pain effect, quality of life (QOL) score, TCM symptom score, bone marrow plasmacyte ratio, 尾 2-microglobulin, lactate dehydrogenase, serum calcium C-reactive protein, renal function were observed in both groups. Incidence of hemoglobin and adverse reactions. Results: 64 cases were included in the study, 5 cases dropped out during the course of treatment, and 59 cases were included in the statistical analysis. There were 30 cases in the treatment group and 29 cases in the control group. The total response rate of the two groups was: ORR was 70 in the treatment group and ORR was 58.60 in the control group. There was no significant difference in ORR between the two groups. The total effective rate of the treatment group was 80, the total effective rate of the control group was 58.60, the difference was not statistically significant. The overall curative effect of the treatment group was better than that of the control group (P 0.05): the total effective rate of the KPS score in the treatment group was 76.70.The total effective rate of the control group was 62.07, the difference of the total effective rate between the two groups was not statistically significant, and the rank data were tested by rank sum test. The overall curative effect of the treatment group was better than that of the control group (P0.05n. 2) the results of the two groups were compared with that of the control group (P 0.05) the ratio of bone marrow plasma cells in the two groups decreased significantly after treatment, but the curative effect was similar between the two groups (P 0.05). After treatment, the HGB of the two groups was increased, and the levels of 尾 _ 2-MGG LDH and serum calcium CRPG-Scr-BUN were all decreased (P0.05). Comparison of symptom score between the two groups: bone pain was found in the two groups after treatment. Fatigue and fatigue, eating little, wasting, limb numbness, tinnitus score decreased P0.05G, the treatment group was superior to the control group (P0.05 / 4) adverse reactions: in the control group, there were 10 cases, including 5 cases of nausea and vomiting, 2 cases of liver function damage. There were 3 cases of bone marrow suppression above degree 鈪，

本文编号：1877943