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

doi:10.3877/cma.j.issn.1674-0785.2021.07.008

Abstract

Abstract:

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

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.

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URL: https://zhlcyszz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.1674-0785.2021.07.008

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References 19

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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

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

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

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

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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