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Randomized Controlled Trial
. 2022 Jan;28(1):20-27.
doi: 10.1007/s11655-021-3283-z. Epub 2021 Apr 10.

Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study

Zhi-Yong Jiang  1 , Fang-Quan Yu  1 , Rui-Lan Gao  2 , Yue-Min Kuang  1 , Yan Zhu  1 , Yue-Hua Chen  3 , Lin-Jie Li  4 , Gui-Fang Ouyang  5 , Jing Hu  6 , Xiao-Long Wu  7
Affiliations
Randomized Controlled Trial

Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study

Zhi-Yong Jiang et al. Chin J Integr Med. 2022 Jan.

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 (P<0.05). The mild abdominal distention was observed in 1 cases 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)].

Keywords: Pai-Neng-Da Capsule; chronic aplastic anemia; clinical study; panaxadiol saponins component.

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References

    1. Wen WW, Sun X, Zhuang HF, Lin XJ, Zheng ZY, Gao RL, et al. Effects of panaxadiol saponins component as a new Chinese patent medicine on proliferation, differentiation and corresponding gene expression profile of megakaryocytes. Chin J Integr Med 2016;22:28–35. - DOI
    1. Zheng ZY, Yu XL, Dai TY, Yin LM, Zhao YN, Xu M, et al. Panaxdiol Saponins component promotes hematopoiesis and modulates T lymphocyte dysregulation in aplastic anemia model mice. Chin J Integr Med 2019;25:902–910. - DOI
    1. Zhu Y, Kuang YM, Gao RL, Jiang ZY, Huang L, Tong YJ, et al. Clinical observation on the improvement of quality of life in patients with chronic aplastic anemia by Pai-Neng-Da Capsule. Zhejiang J Integr Tradit Chin West Med (Chin) 2016;26:124–126.
    1. Kuang YM, Zhu Y, Gao RL, Hu J, Jiang ZY, Huang L, et al. Clinical study of Pai-Neng-Da Capsule in the treatment of chronic aplastic anemia. Chin J Integr Med 2016;22:124–129. - DOI
    1. Zhang ZN, Shen T, eds. Standard for diagnosis and therapeutic efficacy evaluation of hematopathy. 3th ed. Beijing: Publishing House of Science; 2007:19–23.

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