BACKGROUND With the rapid development of haploidentical hematopoietic stem cell transplantation(haplo-HSCT),primary poor graft function(PGF)has become a lifethreatening complication.Effective therapies for PGF are inc...BACKGROUND With the rapid development of haploidentical hematopoietic stem cell transplantation(haplo-HSCT),primary poor graft function(PGF)has become a lifethreatening complication.Effective therapies for PGF are inconclusive.New Chinese patent medicine Pai-Neng-Da(PND)Capsule exerts dual effect in promoting hematopoiesis recovery and regulating immunity.Still,the application of PND capsule in hematopoietic stem cell transplantation,especially in the haplo-HSCT setting,has not yet been reported.AIM To evaluate the role of PND capsule in acute leukemia patients with haplo-HSCT.METHODS We retrospectively collected data of acute leukemia patients who underwent haplo-HSCT at the Affiliated People’s Hospital of Ningbo University between April 1,2015 and June 30,2020.Twenty-nine consecutive patients received oral PND capsule from the sixth day to the first month after haplo-HSCT were included in the PND group.In addition,31 patients who did not receive PND capsule during haplo-HSCT were included in the non-PND group.Subsequently,we compared the therapeutic efficacy according to the western medical evaluation indexes and Chinese medical symptom scores,and the survival between the PND group and the non-PND group,using the chi-square test,Fisher’s exact test,and the Kaplan-Meier method.RESULTS The duration of platelet engraftment was shorter in the PND group than in the non-PND group(P=0.039).The PND group received a lower frequency of red blood cells and platelet transfusions than the non-PND group(P=0.033 and P=0.035,respectively).In addition,PND capsule marginally reduced the rate of PGF(P=0.027)and relapse(P=0.043).After 33(range,4-106)months of follow-up,the 3-year relapse-free survival(P=0.046)and progression-free survival(P=0.049)were improved in the PND group than in the non-PND group.Also,the therapeutic efficacy of the PND group according to Chinese medical symptom scores was significantly better than that of the non-PND group(P=0.022).Moreover,the adverse events caused by PND capsule were mild.Nevertheless,there were no significant differences in the duration of neutrophil engraftment,the risk of infection within 100 days after haplo-HSCT,the acute graft-versus-host disease,or the 3-year overall survival between the two groups.CONCLUSION PND capsule could promote hematopoiesis reconstitution,improve the therapeutic efficacy of Chinese medical symptom scores,present anti-tumor effectiveness,and prolong the survival of acute leukemia patients with haplo-HSCT.展开更多
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 ...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)].展开更多
基金Supported by The Zhejiang Provincial Science and Technology Program of Traditional Chinese Medicine,No.2017ZA129 and No.2018ZA112.
文摘BACKGROUND With the rapid development of haploidentical hematopoietic stem cell transplantation(haplo-HSCT),primary poor graft function(PGF)has become a lifethreatening complication.Effective therapies for PGF are inconclusive.New Chinese patent medicine Pai-Neng-Da(PND)Capsule exerts dual effect in promoting hematopoiesis recovery and regulating immunity.Still,the application of PND capsule in hematopoietic stem cell transplantation,especially in the haplo-HSCT setting,has not yet been reported.AIM To evaluate the role of PND capsule in acute leukemia patients with haplo-HSCT.METHODS We retrospectively collected data of acute leukemia patients who underwent haplo-HSCT at the Affiliated People’s Hospital of Ningbo University between April 1,2015 and June 30,2020.Twenty-nine consecutive patients received oral PND capsule from the sixth day to the first month after haplo-HSCT were included in the PND group.In addition,31 patients who did not receive PND capsule during haplo-HSCT were included in the non-PND group.Subsequently,we compared the therapeutic efficacy according to the western medical evaluation indexes and Chinese medical symptom scores,and the survival between the PND group and the non-PND group,using the chi-square test,Fisher’s exact test,and the Kaplan-Meier method.RESULTS The duration of platelet engraftment was shorter in the PND group than in the non-PND group(P=0.039).The PND group received a lower frequency of red blood cells and platelet transfusions than the non-PND group(P=0.033 and P=0.035,respectively).In addition,PND capsule marginally reduced the rate of PGF(P=0.027)and relapse(P=0.043).After 33(range,4-106)months of follow-up,the 3-year relapse-free survival(P=0.046)and progression-free survival(P=0.049)were improved in the PND group than in the non-PND group.Also,the therapeutic efficacy of the PND group according to Chinese medical symptom scores was significantly better than that of the non-PND group(P=0.022).Moreover,the adverse events caused by PND capsule were mild.Nevertheless,there were no significant differences in the duration of neutrophil engraftment,the risk of infection within 100 days after haplo-HSCT,the acute graft-versus-host disease,or the 3-year overall survival between the two groups.CONCLUSION PND capsule could promote hematopoiesis reconstitution,improve the therapeutic efficacy of Chinese medical symptom scores,present anti-tumor effectiveness,and prolong the survival of acute leukemia patients with haplo-HSCT.
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)。
文摘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)].
