Retrospective Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. May 16, 2022; 10(14): 4425-4435
Published online May 16, 2022. doi: 10.12998/wjcc.v10.i14.4425
Hematopoiesis reconstitution and anti-tumor effectiveness of Pai-Neng-Da capsule in acute leukemia patients with haploidentical hematopoietic stem cell transplantation
Jiao-Jiao Yuan, Ying Lu, Jun-Jie Cao, Ren-Zhi Pei, Rui-Lan Gao
Jiao-Jiao Yuan, Ying Lu, Jun-Jie Cao, Ren-Zhi Pei, Department of Hematology, The Affiliated People’s Hospital of Ningbo University, Ningbo 315000, Zhejiang Province, China
Rui-Lan Gao, Institute of Hematology Research, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hang Zhou 310006, Zhejiang Province, China
Author contributions: Yuan JJ wrote the first draft of the manuscript; Lu Y critically reviewed and revised the manuscript; Cao JJ and Pei RZ collected and analyzed the clinical data; Gao RL designed the study and confirmed the statistical methods for the research; all the authors read and approved the final manuscript.
Supported by The Zhejiang Provincial Science and Technology Program of Traditional Chinese Medicine, No. 2017ZA129 and No. 2018ZA112.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Affiliated People’s Hospital of Ningbo University Institutional Review Board (Approval No.2017022).
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Rui-Lan Gao, PhD, Professor, Institute of Hematology Research, The First Affiliated Hospital of Zhejiang Chinese Medical University, No. 54 Youdian Road, Hang Zhou 310006, Zhejiang Province, China. gaorl2021@163.com
Received: August 19, 2021
Peer-review started: August 19, 2021
First decision: November 11, 2021
Revised: March 25, 2022
Article in press: March 25, 2022
Published online: May 16, 2022
Processing time: 267 Days and 1.5 Hours
Abstract
BACKGROUND

With the rapid development of haploidentical hematopoietic stem cell transplantation (haplo-HSCT), primary poor graft function (PGF) has become a life-threatening 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.

Keywords: Pai-Neng-Da capsule; Hematopoiesis reconstitution; Anti-tumor; Acute leukemia; Haploidentical hematopoietic stem cell transplantation; Effectiveness

Core Tip: New Chinese patent medicine Pai-Neng-Da (PND) Capsule exerts dual effect of promoting hematopoiesis recovery and regulating immunity. However, the efficacy of PND capsule in patients with haploidentical hematopoietic stem cell transplantation (haplo-HSCT) has not yet been reported. To the best of our knowledge, this is the first study that evaluated the effectiveness of PND capsule in acute leukemia (AL) patients following haplo-HSCT. Our study showed that PND capsule could promote hematopoietic function recovery, improve the therapeutic efficacy according to Chinese medical symptom scores, present anti-tumor effectiveness, and prolong the survival of AL patients who underwent haplo-HSCT.