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中华临床医师杂志(电子版)

中华临床医师杂志(电子版) ›› 2021, Vol. 15 ›› Issue (07) : 520 -525. doi: 10.3877/cma.j.issn.1674-0785.2021.07.008

临床研究

定清片联合健脾补肾活血解毒方治疗骨髓增生异常综合征的临床研究
浦月红1,†(), 陆嘉惠2, 曾庆3, 王婕3   
  1. 1. 200437 上海，上海中医药大学附属岳阳中西医结合医院急诊医学科
    2. 200071 上海，上海中医药大学附属市中医医院血液科
    3. 200437 上海，上海中医药大学附属岳阳中西医结合医院血液科
  • 收稿日期:2021-04-27 出版日期:2021-07-15
  • 通信作者: 浦月红

Clinical efficacy and safety of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation in treatment of myelodysplastic syndrome

Yuehong Pu1,†(), Jiahui Lu2, Qing Zeng3, Jie Wang3   

  1. 1. Department of Emergency Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China
    2. Department of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
    3. Department of Hematology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China
  • Received:2021-04-27 Published:2021-07-15
  • Corresponding author: Yuehong Pu
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浦月红, 陆嘉惠, 曾庆, 王婕. 定清片联合健脾补肾活血解毒方治疗骨髓增生异常综合征的临床研究[J]. 中华临床医师杂志(电子版), 2021, 15(07): 520-525.

Yuehong Pu, Jiahui Lu, Qing Zeng, Jie Wang. Clinical efficacy and safety of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation in treatment of myelodysplastic syndrome[J]. Chinese Journal of Clinicians(Electronic Edition), 2021, 15(07): 520-525.

目的

观察定清片联合健脾补肾活血解毒方治疗骨髓增生异常综合征的临床效果及安全性。

方法

收集2012年5月至2013年4月在上海中医药大学附属岳阳中西医结合医院诊断骨髓增生异常综合征及中医辨证属脾肾亏虚、瘀毒内蕴证患者60例，随机进入治疗组和对照组，各30例。对照组采用十一酸睾酮或沙利度胺或环孢素等西医基础治疗，结合健脾补肾活血解毒方，必要时结合DA（柔红霉素+阿糖胞苷）或CAG（阿糖胞苷+阿克拉霉素+粒细胞集落刺激因子）化疗方案治疗；治疗组采用定清片联合健脾补肾活血解毒方治疗。2组分别予以3个月药物治疗，比较患者西医、中医疗效及不良反应情况。

结果

西医疗效观察，治疗组部分缓解8例，进步11例，无效11例，总有效率为63.4%；对照组部分缓解12例，进步10例，无效8例，总有效率为73.2%；2组总有效率差异无统计学意义（P＞0.05）。在中医证候疗效方面，治疗组显著3例，有效17例，无效9例，加重1例，总有效率为66.7%；对照组无显著病例，有效7例，无效15例，加重8例，总有效率为11.7%；治疗组总有效率显著高于对照组（P＜0.05）。在安全性评价中，治疗组患者肝肾功能异常发生率低于对照组，差异有统计学意义（6.7% vs 30.0%，P＜0.05）。

结论

定清片联合健脾补肾活血解毒方与西医常规治疗联合治疗方案治疗骨髓增生异常综合征的临床疗效相当，但中医证候疗效方面定清片联合治疗方案明显更优。2种治疗方法均具有一定的安全保障，但定清片联合健脾补肾活血解毒方治疗的安全性更优。

关键词: 骨髓增生异常综合征, 定清片, 健脾补肾活血解毒方, 临床疗效, 安全性
Objective

To observe the clinical efficacy and safety of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation in the treatment of myelodysplastic syndrome (MDS).

Methods

Sixty patients with MDS and TCM syndrome of spleen and kidney deficiency, stasis and toxin internal accumulation diagnosed at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from May 2012 to April 2013 were selected and randomly divided into a treatment group and a control group, with 30 cases in each group. The patients in the control group were treated with Testosterone Undecanoate, Thalidomide, or Cyclosporine, combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation, or combined with DA or CAG chemotherapy if necessary. Patients in the treatment group were treated with Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation. After 3 months of medication, the clinical efficacy of TCM and Western medicine, and the adverse reactions of the two groups were compared.

Results

In terms of the efficacy for Western medicine, in the treatment group there were 8 cases of partial remission, 11 cases of disease improvement, and 11 cases of ineffectiveness, with an effective rate of 63.4%; in the control group, there were 12 cases of partial remission, 10 cases of disease improvement, and 8 cases of ineffectiveness, with an effective rate of 73.2%. The effective rate did not differed statistically between the two groups (P＞0.05). In terms of the efficacy for TCM syndrome, in the treatment group, there were 3 cases of remarkable improvement, 17 cases of improvement, 9 cases of ineffectiveness, and 1 case of aggravation, with a total effective rate of 66.7%; in the control group, there was no case of remarkable improvement, 7 cases of improvement, 15 cases of ineffectiveness, and 8 case of aggravation, with a total effective rate of 11.7%. The total effective rate of the treatment group was statistically significant higher than that of the control group (P＜0.05). The incidence of abnormal liver and kidney function in the treatment group was significantly lower than that of the control group (6.7% vs 30.0%, P＜0.05).

Conclusion

The clinical efficacy of Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation in the treatment of MDS is equivalent to that of conventional Western medicine combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation, but the curative effect on TCM syndrome is obviously better. Although the two treatments are both safe, Dingqing Tablets combined with Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation for MDS treatment has a better safety profile.

Key words: Myelodysplastic syndrome, Dingqing Tablets, Prescription of Invigorating Spleen and Kidney, Detoxification and Vigoration of Blood Circulation, Clinical efficacy, Safety
表1 2组骨髓增生异常综合征患者西医疗效比较
组别 例数 部分缓解（例） 进步（例） 无效（例） 总有效率（%）
治疗组 30 8 11 11 63.4
对照组 30 12 10 8 73.2
χ2值 4.541
P值 0.073
表2 2组骨髓增生异常综合征患者中医疗效比较
组别 例数 显效（例） 有效（例） 无效（例） 加重（例） 总有效率（%）
治疗组 30 3 17 9 1 66.7
对照组 30 0 7 15 8 11.7
χ2值 13.247
P值 0.021
表3 骨髓增生异常综合征患者死亡情况汇总
序号 性别 诊断 确诊日期（年-月） 死亡日期（年-月-日） 死亡年龄 死亡原因
病例1 男 MDS-RAEB-2 2011-09 2015-01-08 73岁 急性呼吸窘迫综合征、重症肺炎、MDS
病例2 女 MDS-RCMD 2011-05 2015-02-16 56岁 休克、下肢皮肤感染、MDS
病例3 男 MDS-RA 1999-04 2015-04-18 65岁 肺部感染、呼吸衰竭、MDS
MDS-RCMD 2006-12
MDS-RAEB-1 2015-01
病例4 男 MDS-RAEB-1 2012-05 2015-05-07 80岁 肺部感染、MDS
MDS-RCMD 2014-02
病例5 男 MDS-RCMD 2012-09 2016-08-27 44岁 AML（MDS转化）伴骨髓纤维化、肺部感染、局部脾梗死
MDS-RAEB-2 2014-04
AML 2016-03
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