Acupoint Application Combined With Herbal Fumigation and Wash for Preventing Diarrhea-induced Perianal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation:A Single-Center, Randomized, Controlled, Open-Label Clinical Study

Diarrhea is one of the most common complications following hematopoietic stem cell transplantation (HSCT), with an incidence rate of 50%-70%. During HSCT, high-dose chemotherapy drugs can damage the intestinal mucosa, especially in allogeneic haploidentical hematopoietic stem cell transplantation, where the pre-treatment dosage is 5-10 times higher than that of conventional chemotherapy. This makes patients prone to chemotherapy-related diarrhea. Additionally, due to the patients' compromised immune systems, they are susceptible to other related types of diarrhea. Prolonged diarrhea can easily lead to damage to the perianal skin and intestinal mucosa, severely affecting the quality of life while increasing the risk of perianal infections. This, in turn, may trigger severe systemic infections, sepsis, organ failure, and ultimately transplant failure. Currently, the main causes of diarrhea are believed to include chemotherapy toxicity, infections, acute graft-versus-host disease (aGVHD), engraftment syndrome, and thrombotic microangiopathy. Chemotherapy-related diarrhea is most common in the early stages of transplantation, with an incidence rate of 78.5%, and a median onset time of -3 days (range: -9 to +10 days). The clinical manifestations of diarrhea are complex, and the mortality rate is high, with some studies reporting rates as high as 38.7%. Effectively preventing diarrhea is of great significance for improving patients' quality of life and prognosis.

In Western medicine, the management of diarrhea primarily focuses on symptom control, promoting mucosal repair, preventing secondary infections, and maintaining water and electrolyte balance. While these approaches have achieved certain clinical efficacy, they still have limitations, particularly in the prevention of diarrhea. Traditional Chinese medicine (TCM), characterized by its principles of "syndrome differentiation and treatment" and a "holistic approach," offers greater flexibility. With ongoing research, the efficacy of TCM in treating diarrhea has gradually become evident. Previous studies have shown that the mechanisms of TCM in alleviating diarrhea in chemotherapy patients include: increasing colonic cyclooxygenase-2 and prostaglandin B2 levels, reducing the movement of water and electrolytes into the intestinal lumen; promoting the production of serum IL-15, increasing cecal pH, reducing colonic β-glucuronidase activity, and protecting the structural integrity of the intestinal mucosa; promoting the secretion of intestinal IgA, increasing the content of vasoactive intestinal peptide, reducing pro-inflammatory factors such as IL-15, and regulating intestinal immune barrier function.

Herbal fumigation and external application are important components of TCM external therapies. Warm liquids can promote blood circulation, working synergistically with herbal medicine to unblock qi and blood, dredge meridians, and dispel cold and pain. High concentrations of active drug components act locally on the body, while also avoiding the metabolic burden on the liver and kidneys associated with oral administration of herbal medicine. With minimal side effects, these methods are worthy of clinical promotion. This study aims to explore the clinical application of herbal fumigation and acupoint application in preventing diarrhea in HSCT patients, with the goal of reducing the incidence of diarrhea and improving patients' quality of life and prognosis.

If the participant agree to participate in this study, he/she will be randomly assigned to either the intervention group or the control group, with an equal probability of being placed in either group. Each group will include 90 participants.

• Intervention Group: Starting 24 hours before pre-treatment, the participants will receive herbal fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 5 minutes. Additionally, starting 30 minutes after each meal, acupoint application will be performed on five acupoints: Shenque (CV8), Tianshu (ST25), and bilateral Zusanli (ST36). The application will last 4 hours per day.
• Control Group: Starting 24 hours before pre-treatment, the participants will receive povidone-iodine warm water fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 15 minutes.