摘要
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 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)].
基金
Supported by Research Foundation of Chinese Medicine Program of Zhejiang Province(No.2015ZA211)
National Major Project for the Innovative New Drugs of"the 13th Five-Year Plan"(No.2016ZX09101071)。
