派能达胶囊部分替代雄激素治疗慢性再生障碍性贫血的多中心临床研究

Zhi-yong JIANG; Fang-quan YU; Rui-lan GAO; Yue-min KUANG; Yan ZHU; Yue-hua CHEN; Lin-jie LI; Gui-fang OUYANG; Jing HU; Xiao-long WU

doi:10.1007/s11655-021-3283-z

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派能达胶囊部分替代雄激素治疗慢性再生障碍性贫血的多中心临床研究

Original Article | Updated：2022-03-18

- 派能达胶囊部分替代雄激素治疗慢性再生障碍性贫血的多中心临床研究
- Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule for Replacing Androgen Partially: A Clinical Multicenter Study
- Chinese Journal of Integrative Medicine 2022年28卷第1期页码：20-27
- Affiliations：
  
  1.Department of Hematology, Jinhua People's Hospital,Jinhua (321000), Zhejiang Province, China
  2.Institute of Hematology Research, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou (310006), China
  3.Department of Hematology, the Second of Shaoxing Hospital,Shaoxing (312000), Zhejiang Province, China
  4.Department of Hematology, Lishui Central Hospital, Lishui (323000),Zhejiang Province, China
  5.Department of Hematology, First Hospital of Ningbo, Ningbo (315010), Zhejiang Province, China
  6.Department of Clinical Medicine, Medical College, Jinhua Polytechnic, Jinhua (321000), Zhejiang Province, China
- Author bio：
  
  Prof. GAO Rui-lan, E-mail: gaoruilan@126.com
- Funds：
  
  Research Foundation of Chinese Medicine Program of Zhejiang Province(2015ZA211);National Major Project for the Innovative New Drugs of "the 13th Five-year Plan"(2016ZX09101071)
- DOI：10.1007/s11655-021-3283-z
  中图分类号：
- 纸质出版日期：2022-01-01，
  
  网络出版日期：2021-04-10，
  
  录用日期：2020-06-17
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Zhi-yong JIANG, Fang-quan YU, Rui-lan GAO, 等. 派能达胶囊部分替代雄激素治疗慢性再生障碍性贫血的多中心临床研究[J]. Chinese Journal of Integrative Medicine, 2022,28(1):20-27.

Zhi-yong JIANG, Fang-quan YU, Rui-lan GAO, et al. Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule for Replacing Androgen Partially: A Clinical Multicenter Study[J]. Chinese Journal of Integrative Medicine, 2022,28(1):20-27.
Zhi-yong JIANG, Fang-quan YU, Rui-lan GAO, 等. 派能达胶囊部分替代雄激素治疗慢性再生障碍性贫血的多中心临床研究[J]. Chinese Journal of Integrative Medicine, 2022,28(1):20-27. DOI： 10.1007/s11655-021-3283-z.

Zhi-yong JIANG, Fang-quan YU, Rui-lan GAO, et al. Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule for Replacing Androgen Partially: A Clinical Multicenter Study[J]. Chinese Journal of Integrative Medicine, 2022,28(1):20-27. DOI： 10.1007/s11655-021-3283-z.

摘要

目的:

评估派能达胶囊(人参二醇皂苷成分

简称PNDC)结合环孢素和雄激素治疗慢性再生障碍性贫血(CAA)患者的有效性和安全性.

方法:

将79例CAA患者按照随机数字表法分为观察组[43例

口服派能达胶囊 320 mg/d +环孢素5 mg/(kg•d) + 雄激素 80 mg/d]和对照组[36例

口服环孢素5 mg/(kg•d) + 雄激素 160 mg/d]. 所有患者均接受24周共6个疗程的治疗和随访

以血常规、中医症状评分为疗效评价指标

尿常规、心电图与肝肾功能作为安全评价指标. 并根据临床表现设立女性雄性化评分量表

评价雄激素治疗后女性CAA患者雄性化程度.

结果:

根据血液病疗效评价标准

观察组治疗有效率为88.1% (37/42)

对照组有效率为77.8%(28/36). 治疗6个月后

两组患者外周血白细胞计数、血小板计数、血红蛋白浓度比较

差异无统计学意义(

0.05). 观察组女性患者雄性化评分明显低于对照组(

0.05). 观察组出现轻度腹胀1例; 对照组出现肝功能异常2例

肾功能异常1例.

结论:

派能达胶囊治疗CAA有一定疗效

未见明显副作用

可部分替代雄激素

降低女性CAA患者雄性化程度[中国临床试验注册号(ChicTR1900028153)].

Abstract

Objective:

To evaluate the efficacy and safety of Pai-Neng-Da Capsule (panaxadiol saponins component

PNDC) in combination with the cyclosporine and androgen for patients with chronic aplastic anemia (CAA).

Methods:

A total of 79 CAA patients was randomly divided into 2 groups by a random number table

including PCA group [43 cases

orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg•d) plus andriol 80 mg/d] and CA group [36 cases

orally cyclosporine 5 mg/(kg•d) plus andriol 160 mg/d]. All patients were treated and followed-up for 6 treatment courses over 24 weeks. The complete blood counts

score of Chinese medical (CM) symptoms were assessed and urine routine

electrocardiogram

hepatic and renal function were observed for safety evaluation. Female masculinization rating scale was established according to the actual clinical manifestations to evaluate the accurate degree of masculinization in female CAA patients treated by andriol.

Results:

The effective rates were 88.1% (37/42) in the PCA group and 77.8% (28/36) in the CA group based on the standard for the therapeutic efficacy evaluation of hematopathy. There was no significant difference in the white blood cell (WBC) counts

platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment. The masculinization score of female patient in the PCA group was significantly lower than the CA group (

0.05). The mild abdominal distention was observed in 1 case in the PCA group. In CA group

the abnormalities in the hepatic function developed in 2 cases and the renal disfunction was found in 1 case.

Conclusion:

The PNDC possesses certain curative effects in the treatment of CAA without obvious side-effects and can partially replace andriol thereby to reduce the degree of masculinization [Registried at Chinese Clinical Trial Registry (ChicTR1900028153)].

关键词

Keywords

chronic aplastic anemiaPai-Neng-Da Capsulepanaxadiol saponins componentclinical study

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Panaxdiol Saponins Component Promotes Hematopoiesis and Modulates T Lymphocyte Dysregulation in Aplastic Anemia Model Mice