Department of Hematology, Jinhua People's Hospital, Jinhua, Zhejiang Province, 321000, China.
Institute of Hematology Research, the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310006, China.
Chin J Integr Med. 2022 Jan;28(1):20-27. doi: 10.1007/s11655-021-3283-z. Epub 2021 Apr 10.
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).
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.
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.
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)].
评价参能达胶囊（，人参二醇组皂苷成分，PNDC）联合环孢素和雄激素治疗慢性再生障碍性贫血（CAA）患者的疗效和安全性。
将 79 例 CAA 患者按随机数字表法分为 2 组，PCA 组[43 例，口服 PNDC 320 mg/d 联合环孢素 5 mg/（kg·d）联合雄激素 80 mg/d]和 CA 组[36 例，口服环孢素 5 mg/（kg·d）联合雄激素 160 mg/d]。所有患者均治疗 24 周，共 6 个疗程，并进行随访。评估全血细胞计数、中医症状评分，观察尿常规、心电图、肝肾功能，进行安全性评价。根据实际临床表现，建立女性 CAA 患者雄激素治疗后男性化的准确程度评价的女性男性化评分量表。
根据血液病疗效评价标准，PCA 组有效率为 88.1%（37/42），CA 组为 77.8%（28/36），两组外周血白细胞（WBC）计数、血小板计数和血红蛋白浓度在治疗 6 个月后无显著差异。PCA 组女性患者的男性化评分明显低于 CA 组（P<0.05）。PCA 组 1 例出现轻度腹胀，CA 组 2 例肝功能异常，1 例肾功能异常。
PNDC 治疗 CAA 疗效确切，无明显副作用，可部分替代雄激素，降低男性化程度[在中国临床试验注册中心注册（ChicTR1900028153）]。
