黄芪注射液联合地西他滨注射液治疗骨髓增生异常综合征的临床研究

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目的观察黄芪注射液联合地西他滨注射液在治疗骨髓增生异常综合征(MDS)上的临床疗效及安全性。方法将67例MDS患者按入院先后分为试验组38例和对照组29例。对照组予以静脉滴注25 mg·m~(-2)地西他滨注射液,每个疗程开始后第1~5 d进行滴注治疗,每日滴注时间为1 h,以4周为1个疗程,连续治疗4个疗程。试验组在对照组的基础上静脉滴注黄芪注射液30 mL。比较2组患者的临床疗效、白细胞计数、血小板计数、白细胞分化抗原34(CD34)和CD117水平以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为65.79%(25例/38例)和41.38%(12例/29例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的白细胞计数分别为(2.82±0.42)×10~9/L、(2.31±0.26)×10~9/L,血小板计数分别为(92.51±17.09)×10~9/L,(82.01±10.07)×10~9/L,CD34表达率分别为(7.91±1.88)%,(9.13±2.54)%,CD117表达率分别为(9.02±1.63)%,(10.01±1.53)%,差异均有统计学意义(均P<0.05)。试验组和对照组的中位生存期分别为(32.29±9.00),(27.17±10.53)月,中位无进展生存期分别为(22.91±6.61),(21.26±10.02)月,差异均有统计学意义(均P<0.05)。试验组发生恶心呕吐5例,发热3例;对照组发生恶心呕吐6例,发热5例,感染1例,肝肾损伤1例,试验组和对照组的药物不良反应发生率分别为21.05%(8例/38例)和44.83%(13例/29例),差异有统计学意义(P<0.05)。结论黄芪注射液联合地西他滨注射液能够有效促进髓系细胞的成熟和分化,临床疗效显著,安全性高。 Objective To observe the clinical efficacy and safety of astragalus injection combined with decitabine injection in the treatment of myelodysplastic syndrome (MDS). Methods Sixty-six MDS patients were divided into experimental group (n = 38) and control group (n = 29). The control group was given intravenous infusion of 25 mg · m ~ (-2) decitabine injection, each treatment began 1 to 5 d after instillation treatment, daily infusion time of 1 h, 4 weeks 1 course of treatment, continuous treatment 4 courses. The experimental group in the control group on the basis of intravenous infusion of Astragalus 30 mL. The clinical efficacy, white blood cell count, platelet count, leukocyte differentiation antigen 34 (CD34) and CD117 levels and the incidence of adverse drug reactions were compared between the two groups. Results After treatment, the total effective rate was 65.79% (25 cases / 38 cases) and 41.38% (12 cases / 29 cases) respectively, the difference was statistically significant (P <0.05). After treatment, the leukocyte counts of the experimental group and the control group were (2.82 ± 0.42) × 10 ~ 9 / L and (2.31 ± 0.26) × 10 ~ 9 / L respectively and the platelet counts were (92.51 ± 17.09) × 10 ~ 9 (7.91 ± 1.88)%, (9.13 ± 2.54)%, respectively. The expression rates of CD117 were (9.02 ± 1.63)% and (10.01 ± 1.53) / (82.01 ± 10.07) × 10-9 / )%, The differences were statistically significant (all P <0.05). The median survival time was (32.29 ± 9.00) and (27.17 ± 10.53) months respectively in the experimental and control groups, with a median progression-free survival of (22.91 ± 6.61) and (21.26 ± 10.02) months, respectively, with statistical differences Significance (both P <0.05). There were 5 cases of nausea and vomiting in the experimental group and 3 cases of fever. In the control group, nausea and vomiting occurred in 6 cases, fever in 5 cases, infection in 1 case and liver and kidney injury in 1 case. The adverse drug reaction rates in the experimental group and the control group were 21.05% 8 cases / 38 cases) and 44.83% (13 cases / 29 cases), the difference was statistically significant (P <0.05). Conclusion Astragalus injection combined with decitabine can effectively promote the maturation and differentiation of myeloid cells, with significant clinical effect and high safety.
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