加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎的疗效观察  

Prophylactic effect of Jia Wei Jingui Shengqi Pill on haemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation

作　　者：刘慧霞 冯赟 赵初娴 邵珊 王椿 魏道林 LIU Hui-xia;FENG Yun;ZHAO Chu-xian;SHAO Shan;WANG Chun;WEI Dao-lin(Department of Bone Marrow Transplantation,Shanghai Zhaxin Integrated Traditional Chinese and Western Medicine Hospital,SHANGHAI 200435,China;Department of Gastroenterology,Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine,SHANGHAI 200080,China)

机构地区：[1]上海闸新中西医结合医院骨髓移植科,上海200435 [2]上海交通大学医学院附属第一人民医院消化科,上海200080

出　　处：《中国新药与临床杂志》2024年第9期680-685,共6页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的观察加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎(HC)的临床疗效。方法对2020年1月至2023年10月接受单倍型异基因造血干细胞移植的65例血液病患者进行前瞻性队列研究,31例接受加味金匮肾气丸(5 g,每日2次口服)为肾气丸组,不接受肾气丸的34例为对照组。比较2组患者HC的累积发生率、临床特征及尿病毒检出率。中位随访时间为277(65,624)d。结果肾气丸组HC累积发生率为(29±3)%,对照组为(53±3)%,肾气丸组显著低于对照组(P<0.01)。肾气丸组和对照组患者HC发生的中位时间分别为移植后26(20,32)d和37(25,45)d,持续的中位时间分别为13(10,24)d和16(14,53)d,组间无显著差异(P>0.05)。2组患者移植后尿液BK病毒(BKV)阳性率分别为42%和68%,肾气丸组显著低于对照组(P<0.05)。结论加味金匮肾气丸能够降低单倍型异基因造血干细胞移植后HC的累积发生率,可能与尿路BKV感染率降低有关。AIM To explore the clinical efficacy of Jia Wei Jingui Shengqi Pill(JWJSP)as a novel prophylaxis regimen for haemorrhagic cystitis(HC)in patients undergoing haploidentical hematopoietic stem cell transplantation.METHODS A prospective cohort analysis was conducted on 65 patients with hematological malignancies who underwent haploidentical hematopoietic stem cell transplantation from January 2020 to October 2023.Patients were divided into a JWJSP group(31 cases)and a control group(34 cases).The JWJSP group was administered JWJSP 5 g orally twice daily,while the control group received no specific prophylactic measures.The cumulative incidence of HC,clinical characteristics,and the positive rate of viruria in both groups were compared.The median follow-up duration was 277(65,624)days.RESULTS The cumulative incidence of HC in the JWJSP group was(29±3)%,significantly lower than that in the control group(53±3)%(P<0.01).There was no significant difference in the median onset time and duration of HC between the two groups(P>0.05).The median onset time of HC in the two groups of patients was 26(20,32)days and 37(25,45)days after transplantation,respectively,and the median duration was 13(10,24)days and 16(14,53)days,respectively,with no significant difference(P>0.05).The positive rate of BKV viruria in the JWJSP group after transplantation was 42%,significantly lower than that in the control group(68%)(P<0.05).CONCLUSION Prophylaxis with JWJSP may decrease the infection rate of BKV in urine and the overall incidence of HC in patients undergoing haploidentical hematopoietic stem cell transplantation.

关 键 词：加味金匮肾气丸 造血干细胞移植 单倍型 膀胱炎 

分 类 号：R256.1[医药卫生—中医内科学]