Alum and metoclopramide synergistically enhance cellular and humoral immunity after immunization with heat-killed Salmonella typhimurium vaccine.

Typically, the killed form of microorganisms in combination with alum does not produce strong cellular immune responses. A recent investigation has indicated the role of dopamine D2 receptor antagonists like metoclopramide in reducing the polarization of immune responses toward Th2 immunity. This study was performed to evaluate the effects of a combination of alum and metoclopramide on the induction of cellular and humoral immunity in response to a heat-killed preparation ofSalmonella typhimurium(HKST). Wistar rats were immunized with the HKST vaccine alone or in combination with alum, metoclopramide, or the alum-metoclopramide mixture twice with a two-week interval. Fourteen days after the last vaccination, immune responses against S. typhimurium and the protective potential of the vaccines were assessed. The combination of alum and metoclopramide as an adjuvant augmented the potential of the HKST vaccine to enhance lymphocyte proliferation, delayed-type hypersensitivity reaction, and antibody titer. These results were concurrent with the polarization of immune response towards the Th1 response and improving protective immunity against S. typhimurium. Overall, the combination of alum and metoclopramide as an adjuvant synergistically enhanced cellular and humoral immunity after immunization with the HKST vaccine.

Influence of aluminum salts on COVID-19 infected patients

Background/aim: Based on the antiviral and antibacterial properties of aluminum salts, we aimed to find out the influence of aluminum salts on COVID-19 infected patients. Materials and methods: We performed an observational retrospective cohort study which includes the patients diagnosed as COVID-19 and received aluminum salts in addition to actual treatments during hospitalization as the treatment group (Alum Group). Patients who received standard COVID-19 treatment protocols in the Infectious Diseases Clinics were included as the Control Group. Clinical findings, laboratory parameters, length of stay, survival, radiological follow-up, intensive care and mechanical ventilation needs, the presence of comorbidity, polymerase chain reaction (PCR) tests, symptoms, symptom recovery times, hospital stay times, treatment protocols, and clinical presence of pneumonia were examined in all patients. Advanced chemical composition analyzes of existing aluminum salts were also performed. Results: A total of 109 patients, 54 in the alum group and 55 in the control group, were included in the study. None of the patients in the aluminum group developed side effects due to the intake of aluminum salt. Survival status was significantly different between the two groups as there were 5 loss in the Control Group and none in the Alum Group (P = 0.023). The symptom recovery time was significantly shorter in the Alum Group; 2 (1­3) vs. 1 (1­2) days, P = 0.003. According to the paired samples analyses of the comparison between hospitalization and discharge, CRP levels significantly drops in the Alum Group (from 54.09 to 27, P = 0.001) but not in the Control Group. The drop was significantly same for the lactate dehydrogenase (LDH) and procalcitonin levels with P = 0.001. Conclusion: It has been observed that aluminum salts have beneficial effects in COVID-19 infected cases. Considering the low systemic toxicity of intermittent oral intake of aluminum salts as food supplements and the fact that pandemic control is still not achieved, the use of aluminum salts is promising.

Protective effects of vitamin E on aluminium sulphate-induced testicular damage.

Male infertility can be caused by environmental factors, genetic defects, physiological and endocrine deficiencies and testicular pathologies. Aluminium (Al) can cause male infertility through a number of mechanisms. The aim of our study was thus to determine whether vitamin E (VitE) has protective effects on Al-induced testicular damage, which was determined according to sperm counts and morphology and using the terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) method. Thirty-four male Wistar rats (250-300 g) were randomly assigned to control (no procedures performed; n = 6) or 0.2 mL intraperitoneal injection group (n = 7 each; three times per week for 4 weeks): sham (distilled water), 10 mg/kg Al, 500 mg/kg VitE and 10 mg/kg Al plus 500 mg/kg VitE (Al + VitE). Sperm samples were evaluated for andrological parameters. The testes were examined by haematoxylin/eosin. The epithelial thickness and areas were calculated and Johnsen scores were determined for the germinal epithelium; the apoptotic indices were determined from TUNEL staining. For Al, the bonds between the germinal epithelial cells were broken in some tubules, and there were unidentified cells in the lumen of some tubules. For control, sham and VitE, normal morphology of the germinal epithelium was generally preserved. With Al + VitE, the full germinal epithelium cell series was maintained, with only mature sperm in the lumen. TUNEL-positive cells were significantly higher with Al compared to control and sham (p < 0.05). For Al + VitE, the number of apoptotic cells was reduced compared to Al alone and was therefore similar to control, sham and VitE (p > 0.05). Our findings show that Al caused testicular damage. VitE reduced the number of apoptotic cells during the damage caused by Al.

Laparoscopic rectal tumor surgery after administration of a new sclerosing therapy (aluminum potassium sulfate and tannic acid injection) for internal hemorrhoids: A report of three cases.

Aluminum potassium sulfate and tannic acid (ALTA) injection is a new sclerosing therapy for internal hemorrhoids that has been gaining widespread use. However, there have been few reports about rectal cancer after ALTA injection. We performed laparoscopic surgery for three patients who had underwent ALTA therapy 6 months or 1 year earlier: (i) a 51-year-old man with neuroendocrine tumor; (ii) a 44-year-old woman with rectal cancer; and (iii) 77-year-old man with rectal cancer. All three patients had sclerosis of the resected rectal wall stump, making transection of the rectum difficult. Histological examination of the specimens also showed an inflammatory reaction and/or fibrosis of the resection stump. Although laparoscopic low anterior resection was planned for all three patients, we had to construct a diverting stoma for two patients and could not perform sphincter-preserving surgery for the other. We must be well prepared for laparoscopic rectal surgeries after ALTA therapy, and these cases suggest sigmoidoscopy before ALTA therapy should be recommended.

Increased Susceptibility to Allergic Asthma with the Impairment of Respiratory Tolerance Caused by Psychological Stress.

BACKGROUND: Bronchial asthma is characterized by type 2 T helper (Th2) cell inflammation, essentially due to a breakdown of immune tolerance to harmless environmental allergens. Etiologically, experiences of psychological stress can be associated with a heightened prevalence of asthma. However, the mechanisms underlying stress-related asthma development are unclear. In this study, we examined whether psychological stress increases susceptibility to allergic asthma by downregulating immune tolerance. METHODS: Female BALB/c mice were sensitized with ovalbumin/alum, followed by ovalbumin inhalation. Ovalbumin inhalation induced immune tolerance before sensitization occurred. Some mice were exposed to restraint stress during tolerance induction or sensitization. Asthma development was evaluated by airway responsiveness, inflammation, cytokine expression, and IgE synthesis. Sensitization was evaluated by measuring proliferation and cytokine production by splenocytes. The effects of stress exposure on the numbers and functions of dendritic cells and regulatory T (Treg) cells in bronchial lymph nodes and spleens were evaluated. To investigate the role of endogenous glucocorticoid in inhibiting immune tolerance after stress exposure, we examined the effects of (i) a glucocorticoid-receptor antagonist administered prior to stress exposure, and (ii) exogenous gluco-corticoid (instead of stress exposure). RESULTS: Asthmatic responses and Th2-biased sensitization, which were suppressed in tolerized mice, re-emerged in tolerized mice stressed during tolerance induction in association with decreased tolerogenic dendritic and Treg cell numbers. The effects of stress exposure on tolerized mice were abolished by administering a glucocorticoid-receptor antagonist and reproduced by administering exogenous glucocorticoid without stress. CONCLUSIONS: Our findings suggested that psychological stress can potentially increase allergic asthma susceptibility by inhibiting immune tolerance.

Type III hypersensitivity reactions to a B cell epitope antigen are abrogated using a depot forming vaccine platform.

Peptide antigens are combined with an adjuvant in order to increase immunogenicity in vivo. The immunogenicity and safety of a RSV vaccine formulated in a novel oil-based platform, DepoVax™ (DPX), was compared to an alum formulation. A peptide B cell epitope derived from RSV small hydrophobic ectodomain (SHe) served as the antigen. Both vaccines induced SHe-specific antibodies after immunization of mice. A single dose of the DPX-based formulation resulted in anti-SHe titres for up to 20 weeks. Boosting with Alum-SHe, but not with DPX-SHe, led to unexpected clinical signs such as decreased activity, cyanosis and drop in body temperature in mice but not in rabbits. The severity of adverse reactions correlated with magnitude of SHe-specific IgG immune responses and decreased complement component 3 plasma levels, indicating a type III hypersensitivity reaction. By RP-HPLC analysis, we found that only 8-20% of the antigen was found to be adsorbed to alum in vitro, indicating that this antigen is likely released systemically upon injection in vivo. Clinical signs were not observed in rabbits, indicating the response correlates with peptide dose relative to size of animal. These results suggest that peptide antigens targeted to produce B cell mediated response may result in increased incidence of type III hypersensitivity reactions when delivered in non-depot forming vaccines. The DPX formulation induced strong antibody titres to the antigen without causing adverse events, likely due to the strength of the depot in vivo, and demonstrates the potential safety and immunogenicity of this platform for B cell peptide antigens.

Risk of continuous bladder irrigation in the monoplace hyperbaric chamber: a cautionary tale.

We previously published our method of performing continuous bladder irrigation (CBI) in a monoplace hyperbaric chamber [1]. This method entailed the use of an IV pump to infuse saline into the monoplace chamber. The specter of causing iatrogenic rupture of the bladder was raised following such a case, reported herein, of a woman with hemorrhagic radiation cystitis leading to cystectomy. Due to the danger of bladder rupture while providing CBI with a pump, we retract ourpreviously reported method and encourage the use of either a gravity-fed system or delay in hyperbaric oxygen therapy treatment until CBI is no longer necessary.

Liver injury after aluminum potassium sulfate and tannic acid treatment of hemorrhoids.

We are reporting a rare case of acute liver injury that developed after an internal hemorrhoid treatment with the aluminum potassium sulfate and tannic acid (ALTA) regimen. A 41-year-old man developed a fever and liver injury after undergoing internal hemorrhoid treatment with a submucosal injection of ALTA with lidocaine. The acute liver injury was classified clinically as hepatocellular and pathologically as cholestastic. We could not classify the mechanism of injury. High eosinophil and immunoglobulin E levels characterized the injury, and a drug lymphocyte stimulation test was negative on postoperative day 25. Fluid replacement for two weeks after hospitalization improved the liver injury. ALTA therapy involves injecting chemicals into the submucosa, from the rectum to the anus, and this is the first description of a case that developed a severe liver disorder after this treatment; hence, an analysis of future cases as they accumulate is desirable.

Palatal perforation and chemical ulcers of the tongue in a blind patient.

We report a unique case of a potassium aluminum sulfate oral dissolution leading to palatal chemical necrosis and extensive chemical ulcers on the tongue. The patient, a 47-year-old white, blind male, denied using cocaine or other illegal drugs that could cause such lesions. His self-medication started as a treatment for a traumatic ulcerative lesion on the hard palate. After palatal perforation, he started another self-medication routine, mixing corticoid cream and tandrilax tablets with a gauze obturator. Our treatment comprised the removal of all chemical factors, a surgical debridement, and a prosthetic obturator to resolve the communication. The 1-year follow-up showed no complications.

No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines.

Development of non-infectious subunit vaccines is hampered by a slow pipeline of new adjuvants to replace or enhance alum in part because expectations of safety are high. Transient vaccine side effects are not clinical priorities because they cause no lasting harm and vaccine development has appropriately been focused on avoidance of serious adverse events. As a result, surprisingly little is known about the extent to which side effects caused by a vaccine's reactogencicity are predictive of successful immunization outcomes. Recent clinical studies of pertussis and human papillomavirus vaccines adjuvanted with alum or the TLR4 agonist monophosphoryl lipid A can be used to advance understanding of the relationship between vaccine side effects and immunization outcomes.

Leukotriene receptor antagonist attenuated airway inflammation and hyperresponsiveness in a double-stranded RNA-induced asthma exacerbation model.

BACKGROUND: Viral infections are the most common triggers of asthma exacerbation, but the key molecules involved in this process have not been fully identified. Although cysteinyl leukotrienes (cysLTs) have been postulated as the key mediators, their precise roles remain largely unclear. To investigate the roles of cysLTs in virus-induced asthma exacerbation, we developed a murine model using a viral double-stranded RNA analog, polyinosinic-polycytidylic acid (poly I:C), and analyzed the effect of leukotriene receptor antagonist (LTRA) administration. METHODS: A/J mice were immunized with ovalbumin (OVA) + alum (days 0, 28, 42, and 49), followed by intranasal challenge with OVA (phase 1: days 50-52) and poly I:C (phase 2: days 53-55). Montelukast was administered during poly I:C challenge (phase 2) in the reliever model or throughout the OVA and poly I:C challenges (phases 1 and 2) in the controller model. Airway responsiveness to acetylcholine chloride was assessed, and bronchoalveolar lavage (BAL) was performed on day 56. RESULTS: Administration of poly I:C to OVA-sensitized and -challenged mice increased the number of eosinophils and levels of IL-13, IL-9, CCL3, and CXCL1 in BAL fluid (BALF) and tended to increase airway responsiveness. Montelukast significantly attenuated the poly I:C-induced increase in the number of eosinophils and levels of IL-13, IL-9, and CCL3 in BALF and airway hyperresponsiveness in both the reliever and controller models. CONCLUSIONS: This is the first report showing that LTRA functionally suppressed the pathophysiology of a virus-induced asthma exacerbation model, suggesting the importance of cysLTs as a potential treatment target.

Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation

ABSTRACT Introduction: Hemorrhagic cystitis (HC) represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regarding safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. Materials and Methods: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. Results: Median patient age was 76.5 years (IQR 69, 83). Pelvic radiation was the most common etiology for HC (n=38, 95%). Alum use decreased patient's transfusion requirement, with 82% (32/39) receiving a transfusion within 30 days before alum instillation (median 4 units) versus 59% (23/39) within 30 days after completing alum (median 3 units) (p=0.05). In total, 24 patients (60%) required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5), 13 patients (32.5%) remained without additional treatment for HC. Adverse effects were reported in 15 patients (38%), with bladder spasms representing the most common event (14/40; 35%). No clinical evidence of clinically significant systemic absorption was detected. Conclusion: Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC.

Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: A contemporary evaluation.

INTRODUCTION: Hemorrhagic cystitis (HC) represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regard¬ing safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. MATERIALS AND METHODS: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. RESULTS: Median patient age was 76.5 years (IQR 69, 83). Pelvic radiation was the most common etiology for HC (n=38, 95%). Alum use decreased patient's transfusion requirement, with 82% (32/39) receiving a transfusion within 30 days before alum instillation (median 4 units) versus 59% (23/39) within 30 days after completing alum (median 3 units) (p=0.05). In total, 24 patients (60%) required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5), 13 patients (32.5%) remained without additional treatment for HC. Adverse ef¬fects were reported in 15 patients (38%), with bladder spasms representing the most common event (14/40; 35%). No clinical evidence of clinically significant systemic absorption was detected. CONCLUSION: Intravesical alum therapy is well-tolerated, with resolution of HC in ap¬proximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC.

Salivary protein levels as a predictor of perceived astringency in model systems and solid foods.

Salivary protein difference value (SP D-value) is a quantitative measure of salivary protein replenishment, which reportedly relates to individual differences in perceived astringency. This in vitro measure is calculated as the difference in total salivary protein before (S1) and after (S2) stimulation with tannic acid, with a greater absolute value (S2-S1) indicating less protein replenishment. Others report that this measure predicts perceived astringency and liking of liquid model systems and beverages containing added polyphenols. Whether this relationship generalizes to astringent compounds other than polyphenols, or to solid foods is unknown. Here, the associations between SP D-values and perceived astringency and overall liking/disliking for alum and tannic acid (experiment 1) as well as solid chocolate-flavored compound coating with added tannic acid or grape seed extract (GSE) (experiment 2) were examined. In both experiments, participants (n=84 and 81, respectively) indicated perceived intensity of astringency, bitterness, sweetness, and sourness, and degree of liking of either aqueous solutions, or solid chocolate-flavored compound coating with added astringents. Data were analyzed via linear regression, and as discrete groups for comparison to prior work. Three discrete groups were formed based on first and third quartile splits of the SP D-value distribution: low (LR), medium (MR), and high responding (HR) individuals. In experiment 1, significantly higher mean astringency ratings were observed for the HR as compared to the LR/MR groups for alum and tannic acid, confirming and extending prior work. In experiment 2, significantly higher mean astringency ratings were also observed for HR as compared to LR groups in solid chocolate-flavored compound containing added tannic acid or GSE. Significant differences in liking were found between HR and LR groups for alum and tannic acid in water, but no significant differences in liking were observed for chocolate-flavored compound samples. A significant linear relationship between SP D-values and perceived astringency was observed for both alum and tannic acid (p's<0.001), although the variance explained was relatively low (R(2)=0.33 and 0.29, respectively). In the solid chocolate-flavored compound spiked with either tannic acid or GSE, the relationship was not significant (p=0.17 and 0.30; R(2)=0.03 and 0.02, respectively). Due to the weak associations overall, and the lack of significant differences in perception of astringency between the MR and LR groups, we conclude that SP D-values are not a strong predictor of astringency, especially in solid, high-fat foods. Additional research investigating alternative methods for quantifying individual differences in astringency, as well as exploring the underlying complexities of this percept appears warranted.

Citrus Tachibana Leaf Extract Mitigates Symptoms of Food Allergy by Inhibiting Th2-Associated Responses.

Although the incidence of food allergy continues to rise, there have been no effective therapeutic strategies. Citrus fruits contain a number of bioactive flavonoids with immune-regulatory functions. The objective of this study was to determine whether Citrus tachibana (fruit body with peel, leaves, and branch) can protect against the development of food allergy and the mechanism behind it, and to identify the active compound(s) responsible. We found that C. tachibana leaf extract (CLE) mitigated ovalbumin (OVA)-induced food allergy symptoms including increased rectal temperature, diarrhea, and anaphylaxis. This mitigation was likely due to CLE-mediated decreases in cytokine release from T-helper 2 cells (Th2 cells) in mesenteric lymph nodes. Moreover, higher levels of CLE attenuated systemic Th2 cell-mediated responses in mouse splenocytes sensitized with OVA+Alum. This was evidenced by CLE-mediated reductions in Th2 cytokine release, including interleukin (IL)-4, IL-5, and IL-13, but not the Th1 cytokines IL-12 and interferon (IFN)-γ, which was attributable to decreased gene expression levels. We also identified kaempferol as the most potent compound for reducing Th2-associated responses in splenocytes. The findings of this study suggest that CLE suppresses Th2-cell-mediated immune responses, contributing to alleviation of food allergy symptoms, and that kaempferol is a flavonoid with potential antiallergenic activity that targets Th2 cell-induced responses.

Fluorescent nanodiamonds as a relevant tag for the assessment of alum adjuvant particle biodisposition.

BACKGROUND: Aluminum oxyhydroxide (alum) is a crystalline compound widely used as an immunologic adjuvant of vaccines. Concerns linked to alum particles have emerged following recognition of their causative role in the so-called macrophagic myofasciitis (MMF) lesion in patients with myalgic encephalomyelitis, revealing an unexpectedly long-lasting biopersistence of alum within immune cells and a fundamental misconception of its biodisposition. Evidence that aluminum-coated particles phagocytozed in the injected muscle and its draining lymph nodes can disseminate within phagocytes throughout the body and slowly accumulate in the brain further suggested that alum safety should be evaluated in the long term. However, lack of specific staining makes difficult the assessment of low quantities of bona fide alum adjuvant particles in tissues. METHODS: We explored the feasibility of using fluorescent functionalized nanodiamonds (mfNDs) as a permanent label of alum (Alhydrogel(®)). mfNDs have a specific and perfectly photostable fluorescence based on the presence within the diamond lattice of nitrogen-vacancy centers (NV centers). As the NV center does not bleach, it allows the microspectrometric detection of mfNDs at very low levels and in the long-term. We thus developed fluorescent nanodiamonds functionalized by hyperbranched polyglycerol (mfNDs) allowing good coupling and stability of alum:mfNDs (AluDia) complexes. Specificities of AluDia complexes were comparable to the whole reference vaccine (anti-hepatitis B vaccine) in terms of particle size and zeta potential. RESULTS: In vivo, AluDia injection was followed by prompt phagocytosis and AluDia particles remained easily detectable by the specific signal of the fND particles in the injected muscle, draining lymph nodes, spleen, liver and brain. In vitro, mfNDs had low toxicity on THP-1 cells and AluDia showed cell toxicity similar to alum alone. Expectedly, AluDia elicited autophagy, and allowed highly specific detection of small amounts of alum in autophagosomes. CONCLUSIONS: The fluorescent nanodiamond technology is able to overcome the limitations of previously used organic fluorophores, thus appearing as a choice methodology for studying distribution, persistence and long-term neurotoxicity of alum adjuvants and beyond of other types of nanoparticles.

Racotumomab-alum vaccine for the treatment of non-small-cell lung cancer.

Racotumomab-alum vaccine is an anti-idiotypic vaccine able to mimic the tumor-associated antigen NeuGcGM3. Different Phase I clinical trials and compassionate use studies demonstrated its low toxicity and capacity to induce a strong anti-NeuGcGM3 response, able to bind and directly kill tumor cells expressing the antigen. A Phase II/III randomized double-blind clinical trial in advanced non-small cell lung cancer patients showed a significant improvement in overall survival and progression-free survival for racotumomab-alum versus placebo. Patients who developed anti-NeuGcGM3 antibodies capable of binding and killing NeuGcGM3 expressing tumor cells showed significantly longer median survival times. The impact of using racotumomab-alum as switch maintenance followed by second-line therapy is currently being explored in a new randomized, multinational Phase III study.

G Protein signaling modulator-3 inhibits the inflammasome activity of NLRP3.

Inflammasomes are multi-protein complexes that regulate maturation of the interleukin 1ß-related cytokines IL-1ß and IL-18 through activation of the cysteine proteinase caspase-1. NOD-like receptor family, pyrin domain containing 3 (NLRP3) protein is a key component of inflammasomes that assemble in response to a wide variety of endogenous and pathogen-derived danger signals. Activation of the NLRP3-inflammasome and subsequent secretion of IL-1ß is highly regulated by at least three processes: transcriptional activation of both NLRP3 and pro-IL-1ß genes, non-transcriptional priming of NLRP3, and final activation of NLRP3. NLRP3 is predominantly expressed in cells of the hematopoietic lineage. Using a yeast two-hybrid screen, we identified the hematopoietic-restricted protein, G protein signaling modulator-3 (GPSM3), as a NLRP3-interacting protein and a negative regulator of IL-1ß production triggered by NLRP3-dependent inflammasome activators. In monocytes, GPSM3 associates with the C-terminal leucine-rich repeat domain of NLRP3. Bone marrow-derived macrophages lacking GPSM3 expression exhibit an increase in NLRP3-dependent IL-1ß, but not TNF-α, secretion. Furthermore, GPSM3-null mice have enhanced serum and peritoneal IL-1ß production following Alum-induced peritonitis. Our findings suggest that GPSM3 acts as a direct negative regulator of NLRP3 function.

Serum aluminum levels in dialysis patients after sclerotherapy of internal hemorrhoids with aluminum potassium sulfate and tannic acid.

PURPOSE: Aluminum potassium sulfate and tannic acid (ALTA) is an effective sclerosing agent for internal hemorrhoids. However, it is contraindicated for patients with chronic renal failure on dialysis, because the aluminum in ALTA can cause aluminum encephalopathy when it is not excreted effectively. We conducted this study to measure the serum aluminum concentrations and observe for symptoms relating to aluminum encephalopathy in dialysis patients after ALTA therapy. METHODS: Ten dialysis patients underwent ALTA therapy for hemorrhoids. We measured their serum aluminum concentrations and observed them for possible symptoms of aluminum encephalopathy. RESULTS: The total injection volume of ALTA solution was 31 mL (24-37). The median serum aluminum concentration before ALTA therapy was 9 µg/L, which increased to 741, 377, and 103 µg/L, respectively, 1 h, 1 day, and 1 week after ALTA therapy. These levels decreased rapidly, to 33 µg/L by 1 month and 11 µg/L by 3 months after ALTA therapy. No patient suffered symptoms related to aluminum encephalopathy. CONCLUSIONS: Although the aluminum concentrations increased temporarily after ALTA therapy, dialysis patients with levels below 150 µg/L by 1 week and thereafter are considered to be at low risk of the development of aluminum encephalopathy.