Efficacy and Safety of rhTPO Combined with High-dose Short-cycle Dexamethasone Regimen in Treatment of ANa-positive Adult Immune Thrombocytopenia
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摘要:
目的 探讨重组人血小板生成素(recombinant human thrombopoietin,rhTPO)联合大剂量短周期地塞米松(hexadecadrol,HDD)方案治疗抗核抗体(anti-nuclear antibody,ANA)阳性成人免疫性血小板减少症(immune thrombocytopenia,ITP)的有效性及安全性。 方法 选取2020年8月至2021年12月曲靖市第一人民医院确诊的66例ANA阳性成人免疫性血小板减少症患者,运用随机数字表法对患者实行分组,分为单纯HDD组(n = 22例)、单纯rhTPO组(n = 22例)和联合组(n = 22例)。单纯HDD组采用大剂量短周期地塞米松(HDD)治疗,单纯rhTPO组采用rhTPO治疗,联合组采用HDD和rhTPO联合治疗。对比3组患者治疗前后肝肾相关指标、血小板计数、临床疗效包括总有效率、复发率、血小板计数达有效标准时间和不良反应。 结果 联合组患者治疗总有效率明显高于单纯HDD组和单纯rhTPO组(P < 0.05);联合组血小板计数高于单纯HDD组和单纯rhTPO组,血小板计数有效时间短于单纯HDD组和单纯rhTPO组(P < 0.05),3组血小板输注率差异无统计学意义(P > 0.05);3组总不良反应发生率差异无统计学意义(P > 0.05);3组治疗前后ALT、AST、BUM、Scr水平差异无统计学意义(P > 0.05);与治疗前相比较,3组治疗后的ALT、AST、BUM、Scr水平差异无统计学意义(P > 0.05);疗程结束后,随访3组患者治疗后的复发率差异无统计学意义(P > 0.05)。 结论 采用rhTPO联合大剂量短周期HDD治疗能明显提高ANA阳性成人ITP的临床疗效,增加血小板数量,安全性良好。 Abstract:Objective To investigate the combination of recombinant human thrombopoietin (rhTPO) combined with high-dose short-cycle dexamethasone (hexadecadrol, HDD) regimen in the treatment of anti-nuclear antibody (ANA) positive adults with immune thrombocytopenia (immune thrombocytopenia, ITP) efficacy and safety. Methods A total of 66 adult patients with ANA-positive immune thrombocytopenia diagnosed in Qujing First People's Hospital from August 2020 to December 2021 were selected and divided into HDD alone group (n = 22), rhTPO alone group (n = 22) and combination group (n = 22) by random number table method. The HDD alone group was treated with high-dose short-cycle dexamethasone (HDD), the rhTPO alone group was treated with rhTPO, and the combination group was treated with HDD and rhTPO. The liver and kidney-related indexes, platelet count, clinical efficacy including total effective rate, recurrence rate, time to effective standard of platelet count and adverse reactions were compared between the three groups before and after treatment. Results The total effective rate of the combination group was significantly higher than that of HDD alone group and rhTPO alone group (P < 0.05). The platelet count of combination group was higher than that of HDD alone group and rhTPO alone group, and the effective time of platelet count was shorter than that of HDD alone group and rhTPO alone group (P < 0.05). There was no significant difference in platelet transfusion rate among the three groups (P > 0.05). There was no significant difference in the incidence of total adverse reactions among the three groups (P > 0.05). There were no significant differences in ALT, AST, BUM and Scr levels among the three groups before and after treatment (P > 0.05). Compared with before treatment, there were no significant differences in ALT, AST, BUM and Scr levels among the three groups after treatment (P > 0.05). After the course of treatment, there was no significant difference in the recurrence rate among the three groups (P > 0.05). Conclusion The use of rhTPO combined with high-dose short-cycle HDD therapy can significantly improve the clinical efficacy of ANA-positive adult ITP, increase the number of platelets, and has good safety. -
Key words:
- Thrombopoietin /
- Dexamethasone /
- Immune thrombocytopenia /
- Antinuclear antibodies
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表 1 3组患者临床总有效率比较[n(%)]
Table 1. Comparison of clinical total effective rate among three groups of patients [n(%)]
组别 n 显效 有效 无效 总有效率 单纯HDD组 22 5(22.73) 8(36.36) 9(40.91) 13(59.09) 单纯rhTPO组 22 6(27.27) 7(31.82) 9(40.91) 13(59.09) 联合组 22 13(59.09) 7(31.82) 2(9.09) 20(90.91) χ2 − − − − 7.030 P − − − − 0.030* *P < 0.05。 表 2 3组患者的血小板相关指标比较[(
$\bar x \pm s $ )/n(%)]Table 2. Comparison of platelet-related indicators between the three groups [(
$\bar x \pm s $ )/n(%)]组别 n 血小板计数(×109/L) 血小板计数达有效时间(d) 血小板输注率 治疗前 治疗后 单纯HDD组 22 35.16 ± 7.34 108.15 ± 12.09 9.45 ± 1.73 12(54.55) 单纯rhTPO组 22 36.28 ± 6.16 115.34 ± 13.26 8.27 ± 1.32 13(59.09) 联合组 22 37.28 ± 6.57 132.63 ± 16.24 6.13 ± 1.25 9(40.91) t/χ2 − 0.550 17.839 29.683 1.577 P − 0.582 0.001* 0.001* 0.454 *P < 0.05。 表 3 3组患者不良反应总发生率比[n(%)]
Table 3. Comparison of the total incidence of adverse reactions in the three groups of patients [n(%)]
组别 n 血压升高 血糖升高 水钠潴留 继发感染 总不良反应发生率 单纯HDD组 22 2(9.09) 0(0.00) 2(9.09) 1(4.55) 5(22.73) 单纯rhTPO 22 1(4.55) 2(9.09) 1(4.55) 2(9.09) 6(27.27) 联合组 22 1(4.55) 2(9.09) 1(4.55) 2(9.09) 6(27.27) χ2 − − − − − 0.158 P − − − − − 0.924 表 4 3组患者肝肾损害情况比较(
$\bar x \pm s $ )Table 4. Comparison of liver and kidney damage between the three groups (
$\bar x \pm s $ )指标 时间 联合组(n = 22) 单纯HDD组(n = 22) 单纯rhTPO组(n = 22) F P ALT(U/L) 治疗前 24.25 ± 3.40 25.19 ± 2.85 24.16 ± 2.57 0.817 0.446 治疗后 23.72 ± 3.18 24.62 ± 3.15 23.45 ± 2.53 0.937 0.397 AST(U/L) 治疗前 22.48 ± 2.54 22.51 ± 3.07 22.69 ± 2.65 0.037 0.964 治疗后 21.69 ± 2.43 21.76 ± 2.37 21.15 ± 2.03 0.470 0.627 BUM(mmol/L) 治疗前 4.13 ± 1.23 3.92 ± 1.55 3.46 ± 1.02 1.564 0.217 治疗后 4.62 ± 0.78 4.47 ± 0.69 4.71 ± 0.54 0.705 0.498 Scr(μmol/L) 治疗前 80.29 ± 7.34 81.14 ± 7.08 80.82 ± 7.11 0.079 0.924 治疗后 78.85 ± 8.27 80.31 ± 8.56 79.54 ± 8.14 0.169 0.845 -
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