Hematopoietic Stem Cell Transplantation, Hemorrhagic Cystitis, Moxibustion, Prevention
Conditions
Brief summary
This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.
Interventions
OTHERMoxibustion
The experimental group received moxibustion of Zhongji, Guanyuan, and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation, while treated conventionally.
The control group received conventional symptomatic treatment.
Sponsors
Yi Zhang
The First People's Hospital of Yunnan
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF); 2. Age: 14-60 years; 3. Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;
Exclusion criteria
1. refuse to participate in this clinical study; 2. The corresponding skin at the moxibustion site is broken or sensitive; 3. allo-HSCT pretreated with the RIC program;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| highest pain score in HC patients within 100 days of transplantation | 100 days | highest pain score in HC patients within 100 days of transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Pain Score (WPS) in HC within 100 days post-transplant | 100 days | Weighted Pain Score (WPS) is a method used to assess the overall pain burden by considering both the intensity and the duration of pain. Steps to Calculate WPS: Record Pain Intensity : Measure the patient's pain at various time points during the study or treatment. Determine Time Intervals : Record the duration for which the pain was experienced at each time point. Assign Weights : Weights are typically assigned based on the clinical significance of the time period. For example, if a patient experiences severe pain for a prolonged period, that period would have a higher weight. Calculate the WPS: Multiply the pain intensity by the duration and the weight for each time period, and sum all these values to get the total WPS. |
| incidence of HC within 100 days post-transplant | 100 days | — |
| Granulocyte implantation rate | 100 days | — |
| Platelet implantation rate | 100 days | — |
| Incidence of acute graft-versus-host disease | 100 days | — |
| Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation | 100 days | — |
| Infection | 100 days | — |
| No relapse mortality, NRM | 100 days | — |
Countries
China
Outcome results
None listed