A Randomized Controlled Trial to Assess the Effects of Oral Alkali Therapy in Patients with Diabetic Kidney Disease

Background: To analyze the effects of oral alkali therapy on renal function, nutritional status and bone density in patients of diabetic kidney disease. Material & Methods: A randomized controlled trial was conducted on 60 patients of age>18 years with diabetic kidney disease who were not on dialysis and had plasma bicarbonate levels between 16 and 20 mmol/l. Patients were randomly divided into two groups: Test group (n=30) which received oral alkali therapy as sodium bicarbonate and control group (n=30) who did not receive oral alkali therapy. The patients were followed for 12 months to compare the improvement. Results: In comparison to controls, test group showed a significant improvement in the Hb (0.7 vs. 0.25, P =0.003), significantly less decrease in eGFR (-2.25 vs. -2.9, P=0.049), non-significant less increase in creatinine (-0.26 ± 0.4 vs. -0.43 ± 0.33, P=0.09), significant improvement in bicarbonate levels (7.5 vs. 1, p<0.0001), significant restoration of albumin (0.32 vs. 0.05, P<.0001), significant fall in iPTH levels (50 vs. 25, p=0.007) and ALP levels (32 vs. 12, p=0.015). Bone density (0.28 ± 0.17 vs. 0.01 ± 0.13, P<.0001) and clinical well-being VAS scores improved significantly among the cases (9.83 ± 5.65 vs. -1.67 ± 7.11, P<.0001). Conclusion: In conclusion, oral alkali therapy slows the rate of decline of renal function and the development of end stage renal disease in patients with advanced stages of CKD. This cheap and simple strategy, which is in line with current renal consensus documents, also improves the nutritional status of patients and bone density.

Comparación del efecto de omeprazol como monoterapia y su combinación con bicarbonato de sodio en el tratamiento de la pirosis moderada a severa: ensayo clínico controlado, aleatorizado y doble ciego / Comparison of the effect of omeprazole monotherapy and its combination with sodium bicarbonate in the treatment of moderate to severe heartburn: a double-blind, randomized controlled clinical trial

Heartburn occurs in 75% of patients with digestive discomfort of any origin and is one of the main symptoms of gastroesophageal reflux disease. Treatment focuses on lifestyle modification and symptomatology management with various drugs; when heartburn is moderate to severe, a proton pump inhibitor is more suitable. Omeprazole (OMZ) combined with sodium bicarbonate (BC) has demonstrated significant and sustained suppression of acid secretion. The objective was to compare the effect of sequential OMZ/BC therapy compared to OMZ monotherapy for the improvement of heartburn in Mexican individuals. The study was a double-blind, randomized, controlled, multicenter clinical study including 277 subjects with moderate to severe heartburn. Patients received 7 days of OMZ/BC and 7 days of OMZ (OMZ/BC7) or 14 days of OMZ (OMZ14). The primary endpoint was defined as the change in the number of days a week that the patient has heartburn, it was evaluated at 14 days. Both treatments reduced time (days) with heartburn by less than 4 days (OMZ14 3.9 vs. 4.2 days OMZ/BC7), as well as duration, number of events and intensity of heartburn. The treatments improved the quality of life, and the control of the symptoms. The proportion of adverse events was lower with OMZ/BC. The non-inferiority of OMZ/BC7 with respect to OMZ14 was verified.

La pirosis se presenta en el 75% de los pacientes con molestias digestivas de cualquier origen y es uno de los principales síntomas de la enfermedad por reflujo gastroesofágico. El tratamiento se enfoca en la modificación del estilo de vida y el manejo de la sintomatología con diversos fármacos; cuando la pirosis es moderada a severa, un inhibidor de la bomba de protones es más adecuado. El omeprazol (OMZ) combinado con bicarbonato de sodio (BC) ha demostrado supresión significativa y sostenida de la secreción ácida. El objetivo fue comparar el efecto de la terapia secuencial de OMZ/BC en comparación con el tratamiento continuo de OMZ para la mejoría de la pirosis en individuos mexicanos. Estudio clínico multicéntrico, doble ciego, controlado, aleatorizado que incluyó 277 sujetos con pirosis moderada a severa. Los pacientes recibieron 7 días de OMZ/BC y 7 días de OMZ (OMZ/BC7) o 14 días de OMZ (OMZ14). La variable primaria fue definida como el cambio del número de días a la semana que el paciente presenta pirosis, se evaluó a los 14 días. Ambos tratamientos redujeron los días con pirosis en menos 4 días (OMZ14 3,9 vs. 4,2 días OMZ/BC7), así como la duración, el número de eventos e intensidad de la pirosis. Los tratamientos mejoraron los indicadores de calidad de vida, y el control del padecimiento. La proporción de eventos adversos fue menor con OMZ/BC. Se comprobó la no-inferioridad de OMZ/BC7 respecto OMZ14.

Buffered 2% articaine in buccal infiltration of mandibular molars: a randomized triple-blind clinical trial

Abstract This crossover study aimed to compare the anesthetic effects of buffered 2% articaine with 1:200,000 epinephrine with that of non-buffered 4% articaine with 1:200,000 epinephrine. Forty-seven volunteers were administered two doses of anesthesia in the buccal region of the second mandibular molars in two sessions using 1.8 mL of different local anesthetic solutions. The onset time and duration of pulp anesthesia, soft tissue pressure pain threshold, and the score of pain on puncture and burning during injection were evaluated. The operator, volunteers, and statistician were blinded. There were no significant differences in the parameters: onset of soft tissue anesthesia (p = 0.80), duration of soft tissue anesthesia (p = 0.10), onset of pulpal anesthesia in the second (p = 0.28) and first molars (p = 0.45), duration of pulp anesthesia of the second (p = 0.60) and first molars (p = 0.30), pain during puncture (p = 0.82) and injection (p = 0.80). No significant adverse events were observed. Buffered 2% articaine with 1:200,000 epinephrine did not differ from non-buffered 4% articaine with 1:200,000 epinephrine considering anesthetic success, safety, onset, duration of anesthesia, and pain on injection.

¿Bicarbonato de sodio en terapia intensiva es útil o no?

La acidosis metabólica se ha convertido en un problema muy serio, tanto en las áreas críticas, como de medicina interna y emergencias, sobre todo por la innumerable cantidad de patologías que la presentan; que ha encaminado a muchos profesionales a usar el bicarbonato de Na (NaHCO3-), que definitivamente tiene un efecto en el ascenso del pH y el HCO3-, asociado a un sosiego inverosímil del profesional médico y probablemente a un escaso beneficio por parte de los pacientes; este estudio trata de explicar en forma concisa a la etiología de la acidosis metabólica y la real indicación de esta droga, que hasta el momento podría tener más perjuicios que beneficios.

Metabolic acidosis has become a very serious problem, both in critical areas, such as internal medicine and emergencies, especially due to the innumerable number of pathologies that present it; which has led many professionals to use Na bicarbonate (NaHCO3-), which definitely has an effect on the rise in pH and HCO3-, associated with an unlikely calmness of the medical professional and probably with little benefit on the part of the patients. patients; This study tries to concisely explain the etiology of metabolic acidosis and the real indication of this drug, which up to now could have more harm than good.

A prospective descriptive study on emergency medicines used most frequently from the emergency medicine packs at Universitas Academic Hospital and the associated financial loss of expired emergency medicines

Resuscitation trolleys with equipment and medicines for emergencies are required in all clinical areas in hospitals. Emergency medicines kept separately are more likely to expire than non-emergency medicines, as these are generally used less frequently. An updated list of essential emergency medicines was implemented in 2016 at an academic hospital in central South Africa. The aim of this study was to determine the frequency of both the use and the expiry, with associated financial losses, of the emergency medicines on this list. Methods: A prospective, descriptive study was conducted over a six-month period in 2019. Forms accompanying the emergency packs were returned to the pharmacy whenever packs expired or were opened. These forms were collected and the type and quantity of medicines either used or expired were recorded. Results: In total, 168 of the returned forms were included. The most frequently used emergency medicines were adrenaline, sodium bicarbonate and Ringer's lactate. Adrenaline use was recorded on 52.8% and 25% of the forms from the adult/paediatric and neonatal emergency packs, respectively. Medicines that were never used included: betamethasone, Darrow's half-strength solution and most of the neonatal pack medications. Neonatal emergency medicine packs were rarely used and the neonatal fluid packs were never used. The total cost of the expired medicines was R7 960.29 (US$569.41 at the time of the study). Adrenaline was the medication that expired most frequently but the greatest financial losses occurred from expired sodium bicarbonate. Conclusion: The total financial losses were low but can be reduced further. The contents of the emergency packs should be reviewed to possibly reduce the amount of items used infrequently. Also, the removal of those items not recommended in emergency care guidelines could be considered. Ensuring the policy was followed of returning unused medicines close to expiry and redistributing these to high-use areas would further reduce wastage

Simultaneous determination of 10 rhubarb anthraquinones and rhaponticin in Compound gentian and sodium bicarbonate tablets by UPLC / 中国药房

OBJECTIVE To establish a method for the simultaneous determination of 10 rhubarb anthraquinones in Compound gentian sodium bicarbonate tablets and the content of rhaponticin，which are the characteristic components of artifacts，and to use the method to evaluate the quality of compound preparation containing Rheum officinale. METHODS The ultra-performance liquid chromatography （UPLC） method was adopted to determine the contents of 10 rhubarb anthraquinones （aloe-emodin-8-O-glucoside， rheinic acid-8-O-β-D-glucoside，emodin-8-O-glucoside，chrysophanol-8-O-β-D-glucoside，emodin monomethyl ether-8-O-β-D-glucoside， aloe-emodin，rheinic acid，emodin，chrysophanol，emodin monomethyl ether） and rhaponticin in 40 batches of Compound gentian sodium bicarbonate tablets from 8 manufacturers. The determination was performed on the Agilent Eclipse Plus C18 column with a mobile phase consisted of acetonitrile-0.1% phosphoric acid solution （gradient elution） at a flow rate of 0.3 mL/min； the column temperature was set at 30 ℃ ，and the injection volume was 5 μL. Combining principal component analysis and cluster analysis to synthesize the results of content determination，the quality of samples from different manufacturers was evaluated. RESULTS All of above 11 components showed favorable linear relationships with peak areas in their respective mass concentration ranges （r≥0.999 3），with RSDs of precision，repeatability and stability 296261547@qq.com less than 3% （n＝6）； average sample recoveries ranged 96.82%-98.92% （RSD≤1.74%，n＝6）； their contents were 0971-8247794。E-mail：304436784@qq.com 0.011 7-0.252 0，0-0.323 3，0.131 3-1.236 6，0.081 1-1.056 2，0.015 2-0.189 8，0.001 8-0.152 3，0-0.255 2，0.001 9-0.223 4，0.054 3-0.303 0，0.022 7-0.172 2，0-2.835 9 mg/g，respectively. The cumulative variance contribution of the first three principal components was 95.533%； the 40 batches of samples can be clustered into 4 categories：samples from enterprises a and d were in a category of their own，samples from enterprises f，b，g and e were in a category，and samples from enterprises c and h were in a category. There were large differences in the content of rhubarb anthraquinone in the samples from 8 manufacturers，and rhaponticin was only detected in the sample from one enterprise. CONCLUSIONS Established UPLC method is stable and reliable； it can be used for the content determination of 10 rhubarb anthraquinones and rhaponticin in Compound gentian sodium bicarbonate tablets.

Effect of sodium bicarbonate Ringer′s solution on acute kidney injury following laparoscopic hepatectomy in elderly patients / 中华麻醉学杂志

Objective:To evaluate the effect of sodium bicarbonate Ringer′s solution on acute kidney injury(AKI) following laparoscopic hepatectomy in elderly patients.Methods:A total of 362 American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ elderly patients, aged 65-79 yr, with body mass index of 18-28 kg/m 2, scheduled for elective laparoscopic hepatectomy, were divided into 2 groups( n=181 each) using a random number table method: bicarbonate Ringer′s solution group(BR group) and lactated Ringer′s solution group(LR group). Bicarbonate Ringer′s solution and lactated Ringer′s solution were intravenously infused in BR group and LR group, respectively. All operations were performed under general anesthesia combined with abdominal fascia block, and the methods of controlled low central venous pressure and intermittent hepatic inflow occlusion were applied to reduce intraoperative bleeding. Radial artery blood samples were collected for blood gas analysis at 5 min before anesthesia induction(T 0), 20 min after occluding liver hilus(T 1), 10 min after hepatectomy and hemostasis(T 2), at the end of surgery(T 3) and at postanesthesia care unit discharge(T 4), and lactate value(Lac) was recorded. Blood samples from cubital vein were collected on admission to hospital(T A) and at 24(T 24) and 48 h after operation(T 48) for determination of serum creatinine(Cr) concentrations. Doppler-based renal resistive index(RRI) was measured at T A, T 4, T 24 and T 48. The incidence of AKI was calculated within 48 h after operation according to the Kidney Disease: Improving Global Outcomes criteria in 2012 for Cr concentration. Adverse reactions(such as nausea and vomiting) and complications(such as incision infection) within 48 h after operation were recorded. Results:Compared with the baseline at T 0, Lac concentrations were significantly increased at T 1-4 in both groups( P<0.01). Cr concentrations were significantly increased at T 24 and T 48, and RRI was increased at T 4, T 24 and T 48 than at T A in both groups( P<0.01). Compared with group LR, the incidence of AKI within 48 h after operation, Lac concentrations at T 3, 4, Cr concentrations at T 24 and T 48, and RRI at T 4, T 24 and T 48 were significantly decreased in group BR( P<0.05 or 0.01). There was no significant difference in the incidence of nausea, vomiting, incision infection, delirium, bile leakage and pulmonary infection within 48 h after operation among the two groups( P>0.05). Conclusions:Sodium bicarbonate Ringer′s solution can decrease the development of AKI following laparoscopic hepatectomy in elderly patients.

Bicarbonato de sodio intravenoso ¿Cuándo, cómo y por qué utilizarlo? / Intravenous sodium bicarbonate. When, how and why to use it?

Severe metabolic acidosis is defined by a pH < 7.2 with HCO3− < 8 mE- q/L in plasma. Its best treatment is to correct the underlying cause. However, acidemia produces multiple complications such as resistance to the action of catecholamines, pulmonary vasoconstriction, impaired cardiovascular function, hyperkalemia, immunological dysregulation, respiratory muscle fatigue, neurological impairment, cellular dysfunction, and finally, it contributes to multisystemic failure. Intravenous NaHCO3 buffers severe acidemia, preventing the associated damage and gains time while the causal disease is corrected. Its indication requires a risk-benefit assessment, considering its complications. These are hypernatremia, hypokalemia, ionic hypocalcemia, rebound alkalosis, and intracellular acidosis. For this reason, therapy must be "adapted" and administered judiciously. The patient will require monitoring with serial evaluation of the internal environment, especially arterial blood gases, plasma electrolytes, and ionized calcium. Isotonic solutions should be preferred instead of hypertonic bicarbonate. The development of hypernatremia must be prevented, calcium must be provided for hypocalcemia to improve cardiovascular function. Furthermore, in mechanically ventilated patients, a respiratory response similar to the one that would develop physiologically, must be established to be able to extract excess CO2 and thus avoid intracellular acidosis. It is possible to estimate the bicarbonate deficit, speed, and volume of its infusion. However, the calculations are only for reference. More important is to start intravenous NaHCO3 when needed, administer it judiciously, manage its side effects, and continue it to a safe goal. In this review we address all the necessary elements to consider in the administration of intravenous NaHCO3, highlighting why it is the best buffer for the management of severe metabolic acidosis.

Análise Bioquímica e Biomarcadores de Lesão e Fadiga em Atletas de Vôlei Suplementadas com Bicarbonato de Sódio / Biochemical Analysis and Injury and Fatigue Biomarkers in Volleyball Athletes Supplemented with Sodium Bicarbonate

Introdução: O objetivo do presente estudo foi analisar o potencial ergogênico e antifadiga da suplementação de bicarbonato em atletas de vôlei feminino durante sessão de treino de alta intensidade. Métodos: Realizou-se um ensaio clínico randomizado simples cego com 12 atletas profissionais de vôlei feminino, divididas em dois grupos experimentais: um controle e outro suplementado com 500ml de uma solução de bicarbonato de sódio 0,3-0,4mg/kg 90 minutos antes de um treinamento de alta intensidade, com duração de 60 minutos. Resultados: A análise estatística dos resultados mostra que houve diferença significativa entre o grupo suplementado e controle apenas na atividade da enzima creatina quinase (p=0,04) e na percepção subjetiva de esforço (p<0,001). Por outro lado, a atividade da enzima LDH e os níveis de glicose, lactato, proteína, albumina, triglicerídeos e TBARS não apresentaram diferenças significativas entre os dois grupos (p>0,05). A PSE medida pela escala de Borg adaptada não passou de cinco (de uma escala de 0 a 10) em nenhum dos grupos. Conclusão: Apesar de o bicarbonato ser um reconhecido agente de prevenção de fadiga, lesão e com efeitos ergogênicos para sessões de treinos extenuantes, sua suplementação nas condições propostas não mostrou benefícios, demonstrando que o tipo de protocolo de treino aplicado não justifica sua suplementação e que seu uso deve ser utilizado com cautela em razão de seus contraefeitos gastrintestinais.

Introduction: The aim of the present study was to analyze the ergogenic and antifatigue potential of bicarbonate supplementation in female volleyball athletes during a high intensity training session. Methods: A simple blind randomized clinical trial was conducted with 12 professional female volleyball athletes divided into two experimental groups: one control and the other supplemented with 500ml of 0.3-0.4mg / kg sodium bicarbonate solution 90 minutes before high-intensity training, lasting 60 minutes. Results: The statistical analysis of the results shows that there was a significant difference between the supplemented and the control group only in the activity of the enzyme creatine kinase (p = 0.04) and in the subjective perception of effort (p <0.001). On the other hand, the activity of the LDH enzyme and the levels of glucose, lactate, protein, albumin, triglycerides and TBARS did not present significant differences between the two groups (p> 0.05). The PSE measured by the adapted Borg scale did not exceed five (from a scale of 0 to 10) in any of the groups. Conclusion: Although bicarbonate is a recognized fatigue and injury prevention agent with ergogenic effects for strenuous training sessions, its supplementation under the proposed conditions did not show any benefits, demonstrating that the type of training protocol applied does not justify its supplementation and that its use should be used with caution because of its gastrointestinal counter-effects.

The ion partition detected in homeopathically manufactured medicine cuprum metallicum and controls

Homeopathy is highly controversial. The main reason for this is its use of very highly dilute medicines (high homeopathic potencies, HHP), diluted beyond the Avogadro/Loschmidt limit. Research using Nano Tracking Analysis has demonstrated the presence of particles in HHPs. This study aims to verify the results of a previous publication that identified the ionic composition of these particles in all dilutions. We used Scanning Electron Microscopy & Energy Dispersive X-Ray Spectroscopy (SEM-EDX) to examine dilutions of a commonly used homeopathic medicine, an insoluble metal, Cuprum metallicum, for the presence of particles (NPs). The homeopathic medicines tested were specially prepared according to the European pharmacopoeia standards. We compared the homeopathic dilutions/dynamizations of copper with simple dilutions and dynamized lactose controls. We observed an ionic diversity common to all preparations including HHPs but also significant differences in the relative quantity of each ion between manufacturing lines of homeopathic copper and lactose controls. The probability that the observed differences could have occurred chance alone (especially above Avogadro limit) can be rejected at p < 0.001. The essential component of these homeopathic medicines is sodium hydrogen carbonate, modulated by some other elements and by its quantity, size and shape. Homeopathic medicines made of Cuprum metallicum do contain material with a specific ionic composition even in HHPs diluted beyond the Avogadro/Loschmidt limit. This specificity can be attributed to the manufacturing process. This material demonstrates that the step-by-step process (dynamized or not) does not match the theoretical expectations of a dilution process. The starting material and dilution/dynamization method influences the nature of these NPs. Further measurements are needed on other raw materials using the same controls (solvent and simply diluted manufacturing lines) to support these findings. The role of sodium bicarbonate must be carefully studied in the future.

The Materiality of Homeopathic Medicines. DynHom Research Program

Homeopathy is controversial because using highly dilute medicines (high homeopathic potencies, HHP) beyond the Avogadro/Loschmidt limit. Previous publications [1,2] using NMR relaxation revealed the involvement of nanobubbles and/or nanoparticles and/or nanometric superstructures in high potentizations. Nano Tracking Analyse (NTA) demonstrated the presence of particles in HHPs [3,4]. WithSEM-EDX [5] we observed an ionic diversity common to all preparations including HHPs and significant differences in the relative quantity of each ion between different homeopathic manufacturing lines and controls. FTIR spectroscopy [6] shows that the molecular composition is that of carbonates, primarily sodium bicarbonate.Methods:To observe the materiality of homeopathic medicines a multidisciplinary approach is necessary. In collaboration with several universities,we canobserve these medications with NMR, NTA, SEM-EDX, FTIR, pH,and EPA. Results:The essential component of all already studied homeopathic medicines is sodium hydrogen carbonate modulated by some other elements in a specific quantity, size,and shape. The probability that the observed results could have occurred just by random chance can be rejected(significantlyabove the Avogadro limit) p < 0,001.Conclusions:The homeopathic medicines do contain material with a specific ionic composition even in HHPs diluted beyond the Avogadro/Loschmidt limit. This specificity can be attributed to the manufacturing process. These results demonstrate that the step-by-step process (dynamized or not) does not match the theoretical expectations in a dilution process. The starting material and dilution/dynamization method influencethe nature of these NPs. The role of carbonates and sodium bicarbonate must be carefully studied in the future. Its aqueous solution is alkaline in nature but itis an amphoteric compound, which means that the compound has both acidic as well as alkaline character. The reaction with acids results in sodium salts and carbonic acid and the reaction with the basic solution producescarbonates and water. Specific electric fields are indeed detectable.

Changes in blood during storage for transfusion

Introduction: Over the past 20 years, extensive research has been conducted on blood transfusion and the hazards arising from them, as well as on safest maximum storage duration for blood derivatives. Blood transfusion rates in patients with and-stage renal disease may have declined markedly after the discovery and use of erythropoietin in the mid-1980s, but is still remains a standard of care. Since several biochemical changes take place in stored blood, physicians should be alert when transfusing blood in end-stage renal disease patients, who are, theoretically at least, at higher risk of complications. Methods and Results: This study were designed to investigate changes in storer blood over time (every 10 days from 0 to 40 days). Changes in sodium, potassium, chloride, total calcium, lactate, pH, partial pressure of carbon dioxide, bicarbonate and hematocrit, as well as the degree of hemolysis, were recorded. The findings show a significant increase in potassium, lactate, partial pressure of carbon dioxide and hematocrit and a reduction in chloride, pH and bicarbonate. The serum levels of sodium initially increased (up to day 20) and then declined. Conclusions: In conclusion, stored blood undergoes significant changes, which can be life-threatening, especially + when the transfusions are massive or in patients with end-stage renal disease, who are more sensitive to significant K or acid overload.

Novel biopharmaceutical development investigations towards drug and formulation performance optimization

For a drug to excerpt pharmacological action after oral intake, it first needs to be released from the formulation, get into solution (dissolve), be absorbed, and reach the systemic circulation. Since only solubilized drugs can be absorbed, and thus have therapeutic effect, the understanding of the dissolution and drug release processes of a drug product is of primary importance. Such understanding allows a robust formulation development with an ideal in vivo performance. In order to meet set standards, the performance assessment of oral drug products, such as dissolution testing, often applies conditions that are not reflective of the in vivo environment. The use of non-physiologically relevant dissolution method during the drug product development phase can be misleading and give poor mechanistic understanding of the in vivo dissolution process. Hence, we hypothesized that applying physiologically relevant conditions to the dissolution test would result in more accurate in vivo predictability for a robust and precise development process. Since the buffering system in the intestinal lumen operates at low molarity values, phosphate buffer at low buffer capacity was used as a first approach to an in vivo relevant parameter. Furthermore, a biphasic system was used, that is, the low buffer capacity medium was paired with an organic layer (n-octanol) to mimic the concurrent drug absorption that happens with the in vivo dissolution. Both poorly and highly soluble drugs in immediate release formulations (ibuprofen and metronidazole, respectively) were tested in this set-up to assess the dissolution in the aqueous medium and the partitioning to the organic phase. Additionally, enteric coated formulations were tested in bicarbonate buffer at the in vivo reported molarities values to assess the impact of buffer species on drug dissolution. The evaluated parameters were the buffer system (bicarbonate buffer vs. phosphate buffer), buffer capacity and medium pH. In all approaches, dissolution was also carried out in compendial buffer for comparison purposes. Our results demonstrate that the USP-recommended dissolution method greatly lacked discriminatory power, whereas low buffer capacity media discriminated between manufacturing methods. The use of an absorptive phase in the biphasic dissolution test assisted in controlling the medium pH due to the drug removal from the aqueous medium. Hence, the applied noncompendial methods were more discriminative to drug formulation differences and manufacturing methods than conventional dissolution conditions. In this study, it was demonstrated how biphasic dissolution and a low buffer capacity can be used to assess drug product performance differences. This can be a valuable approach during the early stages of drug product development for investigating drug release with improved physiological relevance. Similarly, all the enteric coated formulations displayed a fast release in phosphate buffer and complied with the compendial performance specifications. On the other hand, they all had a much slower drug release in bicarbonate buffer and failed the USP acceptance criteria. Also, the nature of the drug (acid vs base) impacted the dissolution behavior in bicarbonate buffer. This study indicates that compendial dissolution test for enteric coated tablets lacks physiological relevance and it needs to be reevaluated. Thus, an in vivo relevant performance method for EC products is needed. Overall, the findings of this thesis comprehensively demonstrates that meaningful differences in performance and accordance to clinical reports were only obtained when physiological relevant conditions were applied. Hence, our results indicate that the central hypothesis was answered positively

Para que um medicamento exerça a ação farmacológica após a ingestão oral, ele primeiro precisa ser liberado da formulação, dissolver, ser absorvido e atingir a circulação sistêmica. Uma vez que apenas medicamentos solubilizados podem ser absorvidos e, assim, ter efeito terapêutico, a compreensão dos processos de dissolução e liberação de um medicamento é de extrema importância. Tal compreensão permite o desenvolvimento de uma formulação robusta com o desempenho in vivo ideal. Para atender aos padrões regulatórios previamente estabelecidos, a avaliação da performance de formulações orais, como por exemplo, o teste de dissolução, frequentemente aplica condições que não refletem o ambiente fisiológico. O uso de métodos de dissolução não fisiologicamente relevante durante a fase de desenvolvimento do medicamento pode gerar resultados equivocados sem uma compreensão mecanistica do processo de dissolução in vivo. Portanto, a hipótese desse trabalho é que a aplicação de condições fisiologicamente relevantes no teste de dissolução resultaria em uma predição mais precisa da dissolução in vivo para um processo de desenvolvimento robusto e preciso. Uma vez que o sistema tampão no lúmen intestinal possui baixa molaridade, o tampão fosfato com baixa capacidade tamponante foi usado como uma primeira abordagem como um meio de dissolução fisiologicamente relevante. Além disso, foi utilizado um sistema bifásico, ou seja, o meio de baixa capacidade tamponante combinado a uma fase orgânica (n-octanol) para imitar a absorção in vivo. Formulações de liberação imediata contendo fármacos de baixa e de alta solubilidade (ibuprofeno e metronidazol, respectivamente) foram testadas no sistema bifásico para avaliar a dissolução no meio aquoso e a partição para a fase orgânica. Ademais, formulações com revestimento entérico foram testadas em tampão bicarbonato nos valores de molaridades fisiológicos para avaliar o impacto da espécie tamponante na dissolução do fármaco. Os parâmetros avaliados foram o sistema tampão (tampão bicarbonato vs. tampão fosfato), capacidade tamponante e pH médio. Em todas as abordagens, a dissolução também foi realizada em tampão farmacopeico para fins de comparação. Nossos resultados demonstraram que o método de dissolução farmacopeico não foi discriminativo, enquanto o meio com menor capacidade tamponante diferenciou entre as formulações obtidas via granulação úmida ou compressão direta. Ademais, a utilização da fase orgânica no teste de dissolução bifásica auxiliou no controle do pH do meio aquoso. Portanto, os métodos não compendiais aplicados foram mais discriminativos do que as condições de dissolução convencionais. Neste estudo, foi demonstrado como a dissolução bifásica e uma baixa capacidade tamponante podem ser usadas para avaliar as diferenças na performance de formulações. Esta pode ser uma abordagem valiosa durante os estágios iniciais do desenvolvimento de medicamentos para investigar a liberação destes sob condições fisiologicamente relevantes. Da mesma forma, todas as formulações com revestimento entérico exibiram uma liberação rápida em tampão de fosfato e atenderam às especificações farmacopeicas. Entretanto, a liberação do fármaco foi muito mais lenta em tampão de bicarbonato e consequentemente não cumpriram com as especificações farmacopeicas. Além disso, a natureza do fármaco (ácido vs. base) impactou o comportamento de dissolução no tampão de bicarbonato. Este estudo indica que o teste de dissolução convencional para comprimidos de liberação retardada não possui relevância fisiológica e precisa ser reavaliado. Portanto, os resultados desta tese demonstram de forma abrangente que diferenças significativas na performance condizentes com relatórios clínicos foram obtidas apenas quando as condições fisiológicas relevantes foram aplicadas. Esses resultados indicam que a hipótese central foi respondida positivamente

Synergistic interaction of fluconazole/sodium bicarbonate on the inhibition of Candida glabrata phospholipase gene

Abstract Candida glabrata infections are responsible for deaths of people globally. Fluconazole is known to be less effective against C. glabrata, which developed many strategies to evade being destroyed by fluconazole. To achieve enhanced efficacy of fluconazole against C. glabrata, the interaction of fluconazole with sodium bicarbonate was investigated using the CLSI guidelines. The efficacy of fluconazole alone and in combination with sodium bicarbonate was evaluated using the time-kill and phospholipase production assays. Eventually, the expression of PLB was assessed using semi-quantitative RT-PCR to investigate the inhibitory properties of fluconazole alone and in combination with sodium bicarbonate against C. glabrata. The fluconazole/sodium bicarbonate combination displayed synergistic and antagonistic effects (FICI= 0.375-4.25). In C. glabrata ATCC, SN 152, and SN 164, the fluconazole/sodium bicarbonate combination exhibited a significant fungicidal activity (p< 0.05) but antagonistic effect in the case of SN 283. With exception of SN 283, a significant reduction was noted in phospholipase production in clinical isolates of C. glabrata treated with fluconazole/sodium bicarbonate combination. The PLB was down-regulated significantly by 0.168-0.515 fold in C. glabrata treated with fluconazole/sodium bicarbonate. The results suggested fluconazole/sodium bicarbonate to have a potential synergistic interaction in C. glabrata, and the underlying mechanism may be associated with phospholipase gene

Research progress on the role of bile salts in ischemic-type biliary lesion after liver transplantation / 器官移植

Ischemic-type biliary lesion (ITBL) refers to biliary tract injury caused by insufficient blood supply of hepatic artery, which is one of the main factors affecting the long-term survival and quality of life of liver transplant recipients. The incidence of ITBL is associated with cold and warm ischemia, acute and chronic rejection, cytomegalovirus infection and the bile effect, etc. The occurrence of ITBL is a complicated process involving with multiple factors and steps. The therapeutic option of ITBL is extremely limited. A large proportion of ITBL patients should undergo repeated liver transplantation. ITBL has become one of the most critical factors preventing further advancement of liver transplantation. Hence, it is of significance to strengthen prevention and explore more effective modalities. Recent studies have found that toxic injury of bile salts plays a central role in ITBL. Active regulation of bile components, regulation of bile acid-related receptor expression and blockage or activation of bile acid-related signaling pathways probably have potentials in the prevention and treatment of ITBL. In this article, the cytotoxicity of bile salts and the mechanism of bicarbonate umbrella in the incidence and progression of ITBL after liver transplantation were reviewed, aiming to provide reference for the diagnosis and treatment of ITBL.

Efficacy of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer: a multicenter clinical trial / 中华消化杂志

Objective:To evaluate the efficacy and safety of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer.Methods:This present study was a multicenter, randomized, double-blind, double-dummy, positive drug parallel controlled phase Ⅱ clinical trial. According to different indications, the trial was divided into gastric ulcer (GU) and duodenal ulcer (DU) studies. Patients were stratified-block randomly divided with a 1∶1 ratio into experimental group and control group. The patients in the experimental group were administrated with omeprazole and sodium bicarbonate suspension omeprazole (20 mg for DU or 40 mg for GU, and 1 680 mg sodium bicarbonate) once a day. The patients in the control group received omeprazole magnesium enteric-coated tablet20 mg for DU or 40 mg for GU once a day. The treatment period was 4 weeks for DU and 8 weeks for GU. The main efficacy indicator was ulcer healing rate under endoscopy. The time of pain disappearance and the total effective rate of clinical symptom relief were used as the secondary efficacy indicators, and the incidence of adverse reactions was used as the safety indicator. The data set included full analysis set (FAS), per-protocol set (PPS) and safety set (SS). Independent sample t test, Wilcoxon rank sum test, chi square test, Fisher exact test method and non-inferiority test were used for statistical analysis. Results:Two hundred and seventy two DU patients and 237 GU patients were included in the FAS, 247 DU patients and 201 GU patients were included in the PPS, and 272 DU patients and 235 GU patients were included in the SS. The results of FAS analysis showed that after 4 weeks treatment, the healing rate of DU under endoscopy in the experimental group was 91.91% (125/136) and that in the control group was 94.85% (129/136), and the difference was not statistically significant ( P>0.05). After 8 weeks treatment the healing rate of GU under endoscopy in the experimental group was 86.44% (102/118) and that in the control group was 87.39% (104/119), and the difference was not statistically significant ( P>0.05). The results of non-inferiority analysis showed the lower limit of 95% confidence interval of difference in effective rate between the two groups was over -10% (-8.84% for DU and -9.54% for GU), which indicated that the effective rate of experimental group was not inferior to that of the control group. The results of PPS analysis were consistent with the results of FAS. The results of FAS analysis showed the median time of abdominal pain disappearance of DU patients in the experimental group and the control group was both 6 d, and the difference was not statistically significant ( P>0.05). The median time of abdominal pain disappearance of GU patients in the experimental group and the control group was both 8 d, and the difference was not statistically significant ( P>0.05). After 4 weeks of treatment, the total effective rates of clinical symptom relief of DU of the trial group and the control group were 95.59% (130/136) and 97.79% (133/136), respectively, and the difference was not statistically significant ( P>0.05). After 8 weeks of treatment, the total effective rates of clinical symptom relief of GU of the experimental group and the control group were 95.76% (113/118) and 93.28% (111/119), respectively, and the difference was not statistically significant ( P>0.05). The results of SS analysis showed that the incidence of adverse reactions of DU patients in the trial group and the control group was 5.15% (7/136) and 2.21% (3/136), respectively, and the difference was not statistically significant ( P>0.05). The incidence of adverse reactions of GU patients in the experimental group and the control group was 12.71% (15/118) and 6.84% (8/117), respectively, and the difference was not statistically significant ( P>0.05). Conclusions:Omeprazole and sodium bicarbonate suspension is not inferior to omeprazole magnesium enteric-coated tablet in healing efficacy under endoscopy in peptic ulcer, and has a good safety.

Efectos del colutorio de bicarbonato de sodio sobre el pH salival y la microflora oral

Resumen La caries dental es una enfermedad infecciosa producida por bacterias, es una de las enfermedades crónicas con mayor prevalencia en la infancia, extendida por todo el mundo. Objetivo . Determinar el efecto del colutorio de bicarbonato de sodio (1,1%) sobre el pH salival y la microflora bucal. Materiales y métodos . Se realizó un estudio de tipo cuasi-experimental, longitudinal, prospectivo, que tuvo una muestra de 30 estudiantes de pre-clínicas de la escuela de odontología de la Universidad Nacional del Altiplano de Puno (Perú). de ambos sexos, divididos en tres grupos a quienes se indicó el uso de colutorios teniendo como principios activos: bicarbonato de sodio al 1,1%, clorhexidina al 0,12% y agua destilada respectivamente. Se recolectaron muestras de saliva pre y post enjuague, para evaluar el efecto sobre el pH salival y muestras de dorso de la lengua para evaluar la carga bacteriana oral. Para el análisis de datos se utilizó la prueba T de Student para muestras relacionadas, con el un nivel de significancia del 95%, en el programa SPSS Ver.17. Resultados . Se detecto que el efecto del buffer del bicarbonato de sodio después de su aplicación como colutorio, pasando de un pH de 6,47 a 7,97 mostrando diferencias significativas antes y después de su aplicación (p<0,05). Así también el crecimiento bacteriano después de la aplicación del bicarbonato de sodio, disminuyo en un 47,32% (p<0,05) evidenciando una efectividad antibacteriana. Conclusiones . Se encontró que el colutorio de bicarbonato de sodio tiene un efecto de manera significativa sobre estabilización del pH salival y una acción antimicrobiana sobre la microflora bucal, inhibiendo potencialmente a microorganismos cariogénicos.

Abstract Dental caries is an infectious disease produced by bacteria, it is one of the chronic diseases with the highest prevalence in childhood, spread throughout the world. Objective . To determine the effect of sodium bicarbonate mouthwash (1.1%) on salivary pH and oral microflora. Materials and methods . A prospective, longitudinal, quasi-experimental type study was carried out, which had a sample of 30 pre-clinic students from the dental school of the National University of the Altiplano de Puno (Peru), of both sexes. Divided into three groups to whom the use of mouthwashes was indicated having as active ingredients: 1.1% sodium bicarbonate, 0.12% chlorhexidine and distilled water respectively. Saliva samples were collected before and after rinsing, to evaluate the effect on salivary pH, and samples from the back of the tongue to evaluate the oral bacterial load. For data analysis, the student's t test was used for related samples, with a significance level of 95%, in the SPSS Ver.17 program. Results . It was detected that the effect of the sodium bicarbonate buffer after its application as mouthwash, going from a pH of 6.47 to 7.97 showing significant differences before and after its application (p <0.05). Likewise, bacterial growth after the application of sodium bicarbonate decreased by 47.32% (p <0.05), evidencing antibacterial effectiveness. Conclusions . It was found that sodium bicarbonate mouthwash has a significant effect on salivary pH stabilization and an antimicrobial action on oral microflora, potentially inhibiting cariogenic microorganisms.

Resumo A cárie dentária é uma doença infecciosa produzida por bactérias, é uma das doenças crônicas com maior prevalência na infância, disseminada em todo o mundo. Objetivo . Determinar o efeito do enxaguatório bucal com bicarbonato de sódio (1,1%) no pH salivar e na microflora oral. Materiais e métodos . Foi realizado um estudo prospectivo, longitudinal, quase experimental, que contou com uma amostra de 30 alunos pré-clínicos da Faculdade de Odontologia da Universidade Nacional do Altiplano de Puno (Peru), de ambos os sexos. em três grupos para os quais foi indicado o uso de enxaguatórios bucais tendo como princípios ativos: 1,1% de bicarbonato de sódio, 0,12% de clorexidina e água destilada respectivamente. Amostras de saliva foram coletadas antes e após o enxágue, para avaliar o efeito no pH salivar, e amostras do dorso da língua, para avaliar a carga bacteriana oral. Para a análise dos dados, foi utilizado o teste t de Student para amostras relacionadas, com nível de significância de 95%, no programa SPSS Ver.17. Resultados . Foi detectado que o efeito do tampão bicarbonato de sódio após sua aplicação como enxaguatório bucal, passando de um pH de 6,47 a 7,97 apresentando diferenças significativas antes e após sua aplicação (p <0,05). Da mesma forma, o crescimento bacteriano após a aplicação de bicarbonato de sódio diminuiu 47,32% (p <0,05), evidenciando eficácia antibacteriana. Conclusões. Verificou-se que o enxaguatório bucal com bicarbonato de sódio tem efeito significativo na estabilização do pH salivar e ação antimicrobiana na microflora oral, potencialmente inibindo microrganismos cariogênicos.

Use of bufferized dental anesthetics in dental surgery / Uso de anestésicos dentários bufferizados em cirurgia dentária / Uso de anestésicos dentales buferizados en cirugía oral

Abstract Introduction and objective: The addition of epinephrine to the anesthetic solution reduces the pH of the solution to a range between 2.9 and 4.4. The acidity of the anesthetic may delay onset and contribute to injection pain. Objective: to determine the intensity of pain during a mandibular third molar surgery after using buffered 4% articaine with epinephrine 1:100000 in the inferior alveolar nerve block with buccal infiltration. Materials and methods: an observational and descriptive clinical study was performed. The buffered solution was alkalinized with 8.4% sodium bicarbonate with a ratio of 9:1, using a hand-mixing methodology, the sample were patients who required a mandibular third molar surgery. After standardizing the anesthetic technique, it was used the inferior alveolar nerve block followed by buccal infiltration. Results: 32 patients (20 female - 62.5% and 12 male - 37.5%), with an average age of 21.12 years (mean ± standard deviation : 21.12 ± 3.61) were admitted to the study. When assessing the pain puncture and during the injection, 94% of patients classified it as mild pain according to VAS. When evaluating the latency period, the average time was less than two minutes and the perioral soft tissue anesthesia was 62%. Only a small percentage of patients required complementary anes thesia. Conclusion: buffered 4% of articaine with epinephrine in the in ferior alveolar nerve block with buccal infiltration significantly decreased onset time, injection pain and need for complementary anesthesia in third molar surgery.

Resumo Introdução e objetivo: A adição de adrenalina à solução anestésica reduz o pH da solução para uma faixa entre 2,9 e 4,4. A acidez do anestésico pode atrasar o início e contribuir para a dor da injeção. Determinar a inten sidade da dor durante uma cirurgia dos terceiros molares inferiores após o uso de articaína tamponada a 4% com adrenalina 1: 100000 no bloqueio do nervo alveolar inferior com infiltração bucal. Materiais e métodos: foi realizado um estudo clínico observacional e descritivo. A solução tamponada foi al calinizada com bicarbonato de sódio a 8,4% com uma proporção de 9: 1, utilizando uma metodologia de mistura manual; a amostra era de pacientes que necessitaram de uma cirurgia de terceiros molares inferiores. Após padronização da técnica anes tésica foi utilizada bloqueio do nervo alveolar inferior seguido de infiltração bucal. Resultados: 32 pacientes (20 mulheres - 62,5% e 12 homens - 37,5%), com idade média de 21,12 anos (média ± desvio padrão : 21,12 ± 3,61) foram admitidos no estudo. Ao avaliar a punção dolorosa e durante a injeção, 94% dos pacientes a classificaram como dor leve de acordo com a EVA. Ao avaliar o período de latência, o tempo médio foi inferior a dois minutos e a anestesia perioral dos tecidos moles foi de 62%. Apenas uma pequena porcentagem de pacientes necessitou de anestesia complementar. Conclusão: tamponar 4% de articaína com epinefrina no bloqueio do nervo alveolar inferior com infiltração bucal diminuiu significativamente o tempo de início, a dor da injeção e a necessidade de anestesia complementar em cirurgia de terceiros molares.

Resumen Introducción y objetivo: la adición de epinefrina a la solución anestésica reduce el pH en un rango entre 2.9 y 4.4. La acidez del anestésico puede retrasar el inicio del efecto anestésico y contribuir al dolor durante la inyección de la solución. deter minar la intensidad del dolor durante la cirugía de terceros molares mandibulares después de usar articaína al 4% con epinefrina 1:100000 buferizada, en el bloqueo del nervio alveolar inferior con infiltración bucal. Materiales y métodos: se realizó un estudio clínico observacional y descriptivo. La solución buferizada se alcalinizó con bicarbonato de sodio al 8,4% en una relación de 9:1, utilizando una técnica de mezcla manual, la muestra se obtuvo de pacientes que requerían cirugía del tercer molar mandibular. Después de estandarizar la técnica anestésica fue utilizado un bloqueo del nervio alveolar inferior seguido de una infiltración bucal. Resultados: 32 pacientes (20 mujeres - 62,5% y 12 hombres - 37,5%), con una edad promedio de 21.12 años (media ± desviación estándar : 21.12 ± 3.61) ingresaron al es tudio. Al evaluar el dolor durante la punción y durante la inyección de la solución anestésica, el 94% de los pacientes lo clasificaron como dolor leve según la EVA. Al evaluar el período de latencia, el tiempo promedio fue inferior a dos minutos y la anestesia perioral de tejidos blandos fue del 62%. Solo un pequeño porcentaje de pacientes requirió anestesia complementaria. Conclusión: El uso de 4% de articaína con epinefrina buferizada, en el bloqueo del nervio alveolar inferior con infiltración bucal disminuyó significativamente el tiempo de inicio, el dolor durante la inyección y la necesidad de anestesia complementaria en la cirugía de terceros molares.

Efficacy of bicarbonate Ringer′s solution applied in cardiopulmonary bypass in cardiac surgery / 中华麻醉学杂志

Objective:To evaluate the efficacy of bicarbonate Ringer′s solution applied in cardiopulmonary bypass (CPB) in cardiac surgery.Methods:Sixty patients of both sexes, aged 55-75 yr, undergoing cardiac valve replacement under CPB, were selected and randomly divided into compound electrolyte solution group (group A, n=30) and bicarbonate Ringer′s solution group (group B, n=30). Group A was primed with 1 500 ml compound electrolyte solution, group B was primed with 1 500 ml bicarbonate Ringer′s solution, and both groups were primed with 1 000 ml succinylated gelatin.Zero-balanced ultrafiltration was carried out during the rewarming stage.The replacement solution was compound electrolyte solution 2 000 ml in group A, and the replacement solution was bicarbonate Ringer′s solution 2 000 ml in group B. Sodium bicarbonate solution was continuously dripped into an intravenous blood storage tank during CPB, and the acid-base balance disorder was corrected according to the results of blood gas analysis.The peripheral venous blood samples or venous blood samples from the oxygenator were obtained for blood gas analysis before CPB, at 30 min of CPB, at 5 min after opening the ascending aorta for calcium supplementation, at the end of zero-balanced ultrafiltration, and at 5 min after termination of CPB.Venous blood samples were collected from the oxygenator before the start of zero-balanced ultrafiltration and at the end of zero-balanced ultrafiltration for determination of erythrocyte osmotic fragility and concentrations of 2, 3-diphosphoglycerate. Results:Compared with group A, PaCO 2, Ca 2+ and HCO 3-concentrations were significantly increased at 30 min of CPB and at the end of zero-balanced ultrafiltration ( P<0.05), and no significant change was found in pH value, BE, Glu, Lac, serum Na + , Cl - and K + concentrations, erythrocyte osmotic fragility and concentration of 2, 3-diphosphoglycerate in group B ( P>0.05). Conclusion:Bicarbonate Ringer′s solution can be safely and effectively used for CPB in cardiac surgery.

Lidocaína 2 % con adrenalina 1: 80000 alcalinizada con bicarbonato de sodio 8, 4 % en la anestesia dental / Lidocaine 2% with adrenaline 1: 80,000 alkalinized with sodium bicarbonate 8. 4 % in dental anesthesia

Introducción: La alcalinización de la lidocaína ha resultado ser exitosa en el bloqueo del nervio dentario inferior, sin embargo, existen resultados contradictorios respecto a su eficacia clínica. Objetivo: Determinar el efecto de la lidocaína 2 por ciento con adrenalina 1:80000 alcalinizada con bicarbonato de sodio al 8,4 % sobre el bloqueo del nervio dentario inferior. Material y métodos: Estudio experimental, prospectivo y longitudinal conformado por 50 pacientes de la Facultad de Odontología de la Universidad Nacional Mayor de San Marcos. Las siguientes soluciones fueron administradas para el bloqueo del nervio dentario inferior: lidocaína 2 por ciento con adrenalina 1:80000 alcalinizada con bicarbonato de sodio al 8,4 por ciento y lidocaína 2 por ciento con adrenalina 1:80000 no alcalinizada. Se evaluó la intensidad del dolor por la inyección, parámetros hemodinámicos y periodos anestésicos (tiempo de inicio de acción y duración del efecto anestésico). Resultados: Se evidenció una menor intensidad del dolor por la inyección en el grupo de lidocaína alcalinizada (19,16 ± 2,7) en comparación al grupo de lidocaína no alcalinizada (22,88 ± 4,2); p=0,02. Así mismo, el tiempo de inicio de acción fue menor en el grupo de lidocaína alcalinizada (105,72 ± 9,7s) en comparación con el grupo de lidocaína no alcalinizada (157,52 ± 12,1); p=0,002. Sin embargo, no se evidenciaron diferencias significativas en los parámetros hemodinámicos (p>0,05) y la duración del efecto anestésico (p=0,114). Conclusiones: La lidocaína 2 por ciento con adrenalina 1:80000 alcalinizada con bicarbonato de sodio al 8,4 por ciento sobre el bloqueo del nervio dentario inferior produce una disminución de la intensidad del dolor por la inyección y del tiempo de inicio de acción, en comparación con la formulación no alcalinizada. Sin embargo, no se evidencian diferencias en relación con los parámetros hemodinámicos ni a la duración del efecto anestésico(AU)

Introduction: The alkalinization of lidocaine has been successful in blocking the inferior dental nerve; however, there are contradictory results regarding its clinical efficacy. Objective: To determine the effect of 2 percent lidocaine with 1: 80,000 adrenaline alkalinized with 8.4 percent sodium bicarbonate on inferior dental nerve block. Material and methods: Experimental, prospective and longitudinal study that comprised 50 patients from the Dental School of the National University of San Marcos. The following solutions were administered for inferior dental nerve block: 2 percent lidocaine with epinephrine 1: 80,000 alkalinized with 8.4 percent sodium bicarbonate and 2 percent lidocaine with 1: 80,000 adrenaline not alkalinized. Pain intensity was evaluated by injection, hemodynamic parameters and anesthetic periods (time of onset of action and duration of the anesthetic effect). Results: There was a lower pain intensity due to injection in the alkalized lidocaine group (19.16 ± 2.7) compared to the non-alkalinized lidocaine group (22.88 ± 4.2); p=0.02. Likewise, the onset time of action was lower in the alkalized lidocaine group (105.72 ± 9.7) compared to the non-alkalinized lidocaine group (157.52 ± 12.1); p=0.002. However, no significant differences were found in the hemodynamic parameters (p>0.05) and the duration of the anesthetic effect (p=0.114). Conclusions: Lidocaine 2 percent with adrenaline 1: 80,000 alkalized with sodium bicarbonate at 8.4 percent on the block of the inferior dental nerve produces a decrease in pain intensity due to injection and the time of onset of action, compared to the non-alkalinized formulation. However, there are no differences in relation to the hemodynamic parameters or the duration of the anesthetic effect(AU)