抗白延年汤1号方联合预激化疗方案治疗中高危骨髓增生异常综合征临床研究

Clinical Study of Kangbai Yannian Tang No.1 Prescription Combined with Preexcitation Chemotherapy for High-risk Myelodysplastic Syndrome

目的:观察抗白延年汤1号方联合预激化疗方案治疗中高危骨髓增生异常综合征的血液学与中医证候疗效以及安全性。方法:将中高危骨髓增生异常综合征患者38例随机分对照组18例和联合组20例。对照组采用单纯预激化疗方案(地西他宾+CAG或HAG);联合组采用抗白延年汤1号方联合预激化疗方案。观察2组血液学指标变化、中医证候积分变化,并评估临床疗效。结果:2组治疗前外周血象比较,差异无统计学意义(P>0.05)。治疗后,2组各访问时点比较,差异无统计学意义(P>0.05)。2组治疗前原始细胞百分率比较,差异无统计学意义(P>0.05)。治疗后,2组各访问时点原始细胞百分率与治疗前比较,差异有统计学意义(P<0.05)。联合组治疗后8周、12周外周血原始细胞百分率与对照组比较下降(P<0.05);联合组治疗后8周、24周骨髓原始细胞百分率与对照组比较下降(P<0.05)。治疗前,2组病例中医证候积分比较,差异无统计学意义(P>0.05)。治疗后各访问时点,2组病例中医证候积分比较,差异有统计学意义(P<0.05)。联合组治疗后各访问时点,中医证候改善情况优于对照组(P<0.05)。2组疗效比较,经Mann-Whitney U检验,差异无统计学意义(P>0.05)。对照组、联合组死亡或转白率分别占22.22%、20.00%,2组比较,差异无统计学意义(P>0.05)。对照组、联合组无疾病进展生存率分别占77.77%、80.00%,2组比较,差异无统计学意义(P>0.05)。2组病例总生存天数与无疾病进展生存天数比较,差异无统计学意义(P>0.05)。2组安全性观察指标比较,差异无统计学意义(P>0.05)。结论:抗白延年汤1号方联合预激化疗方案能够改善中高危骨髓增生异常综合征患者临床证候,下调外周血、骨髓原始细胞百分率,可进行扩大病例的深入研究。

Objective:To observe the curative effect and safety of Kangbai Yannian tang No.1 prescription combined with preexcitation chemotherapy on hematology and Chinese medicine symptoms of patients with high-risk myelodysplastic syndrome.Methods:A total of 38 cases of patients with high-risk myelodysplastic syndrome were randomly divided into the control group and the combination group,18 and 20 cases in each group.The control group was treated with preexcitation chemotherapy(decitabine plus CAG or HAG),and the combination group was treated with Kangbai Yannian tang No.1 prescription combined with preexcitation chemotherapy.The changes in hematologic indexes and Chinese medicine syndrome scores in the two groups were observed,and the clinical effect was evaluated.Results:There was no significant difference being found in the comparison of peripheral hemogram before treatment between the two groups(P>0.05).After treatment,there was no significant difference being found in the comparison of peripheral hemogram at each time point between the two groups(P>0.05).Before treatment,no significant difference was found in the comparison of the percentage of initial cells between the two groups(P>0.05).The comparison of the percentage of initial cells at each time point in the two groups before and after treatment showed significance in the difference(P<0.05).The percentage of initial cells in the peripheral blood 8 and 12 weeks after treatment in the combination group was decreased when compared with that in the control group(P<0.05);the percentage of initial cells in the bone marrow 8 and 24 weeks after treatment in the combination group was decreased when compared with that in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparison of Chinese medicine syndrome scores between the two groups(P>0.05).After treatment,the comparison of Chinese medicine syndrome scores at each time point between the two groups showed significance in the difference(P<0.05).After treatment,the improvement of Chinese medicine syndromes at each time point in the combination group was better than that in the control group(P<0.05).The Mann-Whitney U test showed that there was no significant difference being found in the comparison of the curative effect between the two groups(P>0.05).The mortality or conversion rate was 22.22%in the control group and 20.00%in the combination group,there being no significance in the difference(P>0.05).The survival rate without any development of diseases was 77.77%in the control group and 80.00%in the combination group,there being no significance in the difference(P>0.05).Compared the total survival days and the survival days without any development of diseases between the two groups,there being no significance in the difference(P>0.05).There was no significant difference being found in the comparison of the observation indexes of safety between the two groups(P>0.05).Conclusion:The therapy of Kangbai Yannian tang No.1 prescription combined with preexcitation chemotherapy in treating patients with high-risk myelodysplastic syndrome can relieve their clinical syndrome,and downregulate the percentage of initial cells in peripheral blood and bone marrow.Further study of the cases can be carried out.