首页|华蟾素联合沙利度胺/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的回顾性临床研究

华蟾素联合沙利度胺/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的回顾性临床研究

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目的 观察华蟾素片联合沙利度胺/地塞米松(TD)方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的疗效及安全性.方法 回顾性分析2015年6月1日至2019年7月31日江苏省中医院收治的50例新诊断多发性骨髓瘤痰瘀痹阻型患者的临床资料,根据治疗方案分为对照组(含硼替佐米/地塞米松方案)27例和观察组(华蟾素片联合TD方案)23例.两组患者均治疗2或3个疗程.主要结局指标为患者治疗后临床缓解情况(包括总缓解率、深度缓解率),患者 1年、2年总生存率,不良反应.次要结局指标为治疗前后骨髓浆细胞比例,血红蛋白、血清β2-微球蛋白、乳酸脱氢酶、血肌酐、血尿素氮水平及骨痛积分、卡氏(KPS)评分.结果 治疗后观察组和对照组总缓解率分别为69.57%(16/23)及70.37%(19/27),深度缓解率分别为56.52%(13/23)及55.56%(15/27),两组比较差异均无统计学意义(P>0.05).观察组和对照组1年总生存率分别为90.9%和92.4%,2年总生存率分别为81.8%和80.9%,组间差异均无统计学意义(P>0.05).治疗过程中,两组均未发生肾功能损伤.观察组周围神经损伤发生率为8.70%(2例),低于对照组的48.15%(13例),两组比较差异有统计学意义(P<0.01).与治疗前比较,两组患者治疗后骨髓浆细胞比例、β2-微球蛋白水平、血肌酐水平、骨痛评分降低,血红蛋白水平、KPS评分升高(P<0.05或P<0.01).两组治疗后比较,观察组治疗后骨痛评分低于对照组,KPS评分高于对照组(P<0.05).结论 华蟾素片联合TD方案与含硼替佐米/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者疗效相当,但华蟾素片联合TD方案在减轻患者疼痛、提高生活质量方面优于含硼替佐米/地塞米松方案,且安全性更好.
Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction:A Retrospective Study
Objective To investigate the efficacy and safety of cinobufagin tablets combined with thalidomide/dexamethasone(TD)regimen in the treatment of newly diagnosed multiple myeloma(NDMM)with phlegm and stasis obstruction.Methods The clinical data of 50 patients with NDMM of phlegm and stasis obstruction who were hospi-talized at the Jiangsu Province Hospital of Chinese Medicine from June 1st,2015 to July 31th,2019 were retrospec-tively analyzed,and they were divided into a control group(bortezomib/dexamethasone-containing regimen,27 cases)and an observation group(cinobufagin tablets combined with TD regimen,23 cases).The clinical efficacy and safety were compared between the two groups after two or three courses of treatment.The primary outcomes were clini-cal remission rate including overall response rate and deep remission rate,one-year and two-year overall survival rate,and adverse effects.The secondary outcomes were the proportion of plasma cells in bone marrow,hemoglo-bin,β2-microglobulin,lactate dehydrogenase,serum creatinine,blood urea nitrogen,bone pain score,and KPS func-tional status score(KPS score)before and after treatment.Results In terms of clinical efficacy,there was no statistically significant difference(P>0.05)in the overall response rate[the observation group 69.57%(16/23)vs the control group 70.37%(19/27)]and deep remission rate[the observation group 56.52%(13/23)vs the control group 55.56%(15/27)]between groups after the treatment.The one-year overall survival rates of the observation group and the control group were 90.9%and 92.4%,and the two-year overall survival rates were 81.8%and 80.9%respectively,with no statistically significant differences between groups(P>O.05).During the treatment,no renal function injury occurred in both groups.The incidence of peripheral nerve injury in the observation group was 8.70%,which was lower than 48.15%in the control group(P<0.01).After the treatment,the proportion of myeloma plasma cells,β2-microglobulin,serum creatinine level,and bone pain score decreased,while the hemoglobin level and KPS score increased in both groups(P<0.05 or P<0.01).Compared between groups after treatment,the bone pain score of the observation group was lower than that of the control group,while the KPS score was higher than that of the control group(P<0.05).Conclusion The clinical efficacy of cinobufagin tablets combined with TD in the treatment of NDMM is equivalent to bortezomib/dexamethasone-containing regimen,but the former is more helpful in relieving the pain and improving the quality of life,and has better safety.

multiple myelomaphlegm and stasis obstructioncinobufaginthalidomidebortezomibclinical remissionsurvival rateadverse effects

张玮光、丁海花、陈碧清、孔祥图、代兴斌、徐祖琼、杨箐、刘细细、黎陈铖、胡中晓、朱学军

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南京中医药大学附属医院,江苏省南京市秦淮区汉中路155号,210029

南京中医药大学第一临床医学院

南京市浦口区中医院

多发性骨髓瘤 痰瘀痹阻 华蟾素 沙利度胺 硼替佐米 临床缓解 生存率 不良反应

国家自然科学基金江苏省中医药科技发展计划项目江苏省研究生科研创新计划江苏高校中医学优势学科建设工程

81673771ZT202106KYCX23_2122035062005001

2024

中医杂志
中华中医药学会 中国中医科学院

中医杂志

CSTPCD北大核心
影响因子:1.464
ISSN:1001-1668
年,卷(期):2024.65(1)
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