A comparative study on efficacy of different dilutions of phenylephrine and tropicamide combination eye drops on pupil dilatation

Background: In ophthalmology (OPD), cycloplegics or mydriatics were needed for doing correct refraction and evaluation of fundus on a daily basis. Aims and Objectives: The objectives of this study were to compare the clinical efficacy and systemic side effects of different dilutions of phenylephrine and tropicamide combinations drops on pupil dilatation and to measure and compare pulse rate and blood pressure before and after giving the drug. Materials and Methods: The present study is a hospital-based interventional study conducted among patients attending to OPD of Regional Eye hospital, Visakhapatnam during April 2012–August 2012. Eighty-one patients randomly allocated to two groups (41 patients in Group 1 and 40 patients in Group 2). Dilution of phenylephrine 5% and Tropicamide 0.8% mixture was applied to patients of Group A in both eyes and dilution of phenylephrine 2.5% and Tropicamide 0.4% mixture was applied to Group B patients in both eyes. Pupil diameter and pulse rate BP were measured and compared. Results: Mean age of Group 1 patients was 55.39 ± 11.47 and Group 2 was 49.95 ± 13.71. Among 36 males, 50% in Group 1 and 50% in Group 2 and among 45 females 51.1% in Group 1 and 48.9% in Group 2. Among both Group 1 and Group 2 patients, both left and right pupil size was significantly increased after application of dilutions, but there was more increase in the pupil size among Group 1 patients compared to Group 2 patients 15 min after and 30 min after application of drug. Conclusions: The combination of 0.8% tropicamide and 5% phenylephrine was effective compared to alternate application of 0.4% tropicamide and 2.5% phenylephrine for rapid and sustainable pupil dilatation for indirect ophthalmoscopy.

Current management of upper lid ptosis: a web-based international survey of oculoplastic surgeons / Tratamento atual da ptose da pálpebra superior: estudo internacional baseado em questionário eletrônico envolvendo cirurgiões oculoplásticos

ABSTRACT Purpose: This study aimed to evaluate the current practice patterns for assessing and managing upper lid ptosis among members of the Latin American and Spanish societies of Ophthalmic Plastic and Reconstructive Surgery. Methods: An e-mail was sent to invite members of both societies to participate in this anonymous web-based survey. The survey collected data on surgeons' demographics and four other sections: upper lid ptosis preoperative evaluation, surgical preferences, postoperative management, and complications. The frequency and proportions of the responses were then statistically analyzed. Results: The survey was responded by 354 experienced oculoplastic surgeons, 47.7% of whom generally performed more than 20 upper lid ptosis surgeries annually. Of those respondents, 244 (68.9%) routinely check for dry eye preoperatively. Less than half of the respondents (47.4%) perform the phenylephrine test for congenital or acquired ptosis. Mild upper lid ptosis was reported to be usually corrected with conjunctival mullerectomy (43.6%). Severe upper lid ptosis was reported to be usually corrected with frontalis surgery (57%), followed by anterior levator resection, mainly supramaximal resection (17.5%). In cases of severe congenital ptosis, the main reason for surgery was to alleviate the risk of amblyopia (37.3%). An anterior approach was reported to be usually (63.3%) used to manage involutional ptosis associated with dermatochalasis. Common complications comprised undercorrection after levator resection (40%) or frontalis suspension (27.5%). Conclusions: This study reports the current practice patterns among Spanish and Latin American oculoplastic surgeons in upper lid ptosis diagnosis and treatment. Surgeons can use this study data to compare disease management with their colleagues.

RESUMO Objetivo: Avaliar a prática e tratamento da ptose da pálpebra superior por membros das sociedades latino-ame­ricanas e espanhola de Cirurgia Plástica Ocular. Métodos: Os membros das referidas sociedades foram convidados por e-mail para responder a um questionário eletrônico garantindo o anonimato. O questionário constou de dados demográficos do cirurgião e outras quatro seções: avaliação pré-operatória da ptose da pálpebra superior, preferências cirúrgicas, conduta pós-operatória e complicações. Estatística descritiva foi utilizada para análise da frequência e proporções percentuais. Resultados: Trezentos e cinquenta e quatro experientes cirurgiões oculoplásticos dos quais 47,7% realizam mais de 20 cirurgias de ptose da pálpebra superior por ano responderam ao questionário. Na avaliação pré-operatória, 68,9% realizam testes para olho seco, mas o teste da fenilefrina é feito por menos da metade dos entrevistados (47,4%). A ptose da pálpebra superior leve geralmente é corrigida por conjuntivo-mullerectomia (43,6%), a ptose da pálpebra superior grave por cirurgia do músculo frontal (57%) ou ressecção da aponeurose do levantador via anterior, principalmente usando a supramáxima (17,5%). O principal motivo para operar a ptose congênita grave é o risco de ambliopia (37,3%). A ptose involucional associada à dermatocálase costuma ser corrigida pela via anterior (63,3%). Hipocorreção é complicação comum após a ressecção da aponeurose do levantador (40%) ou suspensão ao frontal (27,5%). Conclusões: As práticas atuais dos cirurgiões oculoplásticos espanhóis e latino-americanos para diagnóstico e tratamento de ptose da pálpebra superior foram relatadas. Os dados apresentados podem ser usados para comparar a abordagem dos cirurgiões com a de seus pares.

Effect of pupil dilation on intraocular pressure in preterm and term infants / O efeito da dilatação da pupila na pressão intraocular em bebês pré-termo e a termo

ABSTRACT Purpose: To evaluate the effect of pupil dilation on intraocular pressure in preterm and term newborns. Methods: This prospective study involved 55 eyes of 28 preterm infants and 38 eyes of 20 term infants. The infants were divided into two groups according to their gestational ages at birth as follows: preterm group, <37 weeks and term group, ≥37 weeks. Pupil dilation was attained with tropicamide 0.5% and phenylephrine 2.5%. Intraocular pressure measurements were performed with Icare PRO (Icare Finland Oy, Helsinki, Finland) before and after pupil dilation. A paired t test was used to compare the measurements before and after pupil dilation. Results: The mean intraocular pressure change was -1.04 ± 3.03 mmHg (6.20/-11.40 mmHg) in the preterm group and -0.39 ± 2.81 mmHg (4.60/-9.70 mmHg) in the term group. A statistically significant difference in intraocular pressure was observed only in the preterm group after pupil dilation (p=0.01). Conclusion: An unexpected alteration in intraocular pressure in newborns may occur after pupil dilation, especially in preterm infants.

RESUMO Objetivo: Avaliar o efeito da dilatação da pupila sobre a pressão intraocular em recém-nascidos pré-termo e a termo. Métodos: Este estudo prospectivo envolveu 55 olhos de 28 bebês pré-termo e 38 olhos de 20 bebês a termo. Os bebês foram divididos em dois grupos, pré-termo e a termo, de acordo com a idade gestacional ao nascimento: grupo pré-termo <37 semanas; grupo a termo ≥37 semanas. A dilatação da pupila foi feita com tropicamida 0,5% e fenilefrina 2,5%. As medições da pressão intraocular foram realizadas com Icare PRO (Icare Finland Oy, Helsinki, Finlândia) antes e depois da dilatação da pupila. O teste t pareado foi usado para comparar as medidas antes e depois da dilatação da pupila. Resultados: A alteração média da pressão intraocular foi de -1,04 ± 3,03 mmHg (+6,20/-11,40 mmHg) no grupo pré-termo e -0,39 ± 2,81 mmHg (+4,60/-9,70 mmHg) no grupo a termo. Uma diferença estatisticamente significativa na pressão intraocular foi observada apenas no grupo pré-termo após a dilatação da pupila (p=0,01). Conclusão: Após a dilatação da pupila, pode ocorrer alteração inesperada da pressão intraocular em recém-nascidos, principalmente em bebês pré-termo.

Effects of pre-injection of pressors on pressor response and bispectral index of patients receiving lower abdominal surgery under total intravenous anesthesia

Surgery in the lower abdomen can cause many adverse reactions in nervous system, metabolic and endocrine systems. Conventional intravenous anesthesia applied for lower abdominal surgery can cause the drop in blood pressure leading to hypoperfusion of vital organs. Hence, an ideal anesthesia state is required to make patients unconscious, unaware and have no postoperative memory during anesthesia. In this study, we investigated the effects of pre-injection of different pressors on the pressor response and bispectral index (BIS) of patients receiving lower abdominal surgery under total intravenous anesthesia. For this, 300 patients undergoing lower abdominal surgery under total intravenous anesthesia were divided into normal saline (Gr. A), ephedrine (Gr. B) and phenylephrine groups (Gr. C) (n=100). Hemodynamics indices were recorded before anesthesia induction (T0) and 1, 3, 5, 7 and 9 min after drug injection (T1-T5, respectively). We observed the following reactions and recorded. BIS values at T0-T5 as well as the time points when the values rose to 65, 75, 85 and 95 and those for respiratory recovery, consciousness recovery and extubation after stopping target-controlled infusion were recorded. Compared with Gr. A, Gr. B had significantly higher systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and cardiac output (CO) at T1-T5 (P <0.05), and Gr. C had higher SBP, DBP, MAP and lower HR (P <0.05). Adverse reactions viz., intraoperative hypotension, hypertension, postoperative bradycardia, tachycardia, nausea and vomiting were also observed. The incidence rates of hypotension and total adverse reactions in groups B and C were significantly lower than those of Gr. A (P <0.05). Group B had significantly higher BIS values at T1-T5 than those of Gr. A (P <0.05). The time when BIS values recovered to 65 and 75 in group B was significantly shorter than that of Gr. A (P <0.05). Pre-injection of ephedrine and phenylephrine to patients undergoing lower abdominal surgery under total intravenous anesthesia elevated the blood pressure and reduced the incidence rate of adverse reactions without affecting the recovery time.

Safety & Efficacy of a Fixed Dose Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1mg) [Flucold Drops] in the Treatment of Common Cold and Flu Syndrome in Children : Postmarketing Surveillance Study

Background :The common cold and flu syndrome primarily affects the upper respiratory tract, along with a low fever and some systemic symptoms such as sore throat, cough, nasal decongestion, headache, and so on. Several clinical studies have shown that combining analgesics, antihistaminics, and decongestants provides better symptom relief in the common cold. The current post-marketing surveillance study was designed to look into the safety and efficacy of commercially available Flucold Drops in the Indian population. Methodology :A current prospective, single arm, multicenter, post-marketing clinical study included 224 subjects, 220 of whom completed the study. All patients were given Flucold Drops for three days and then monitored for the next six days. During the study, the incidence of adverse events (AE) and serious adverse events (SAE) was assessed. The efficacy of the Flucold Drops was evaluated using VAS score changes from the beginning to the end of the treatment. The product’s safety was also evaluated using blood biomarkers such as haemoglobin, platelet count, SGOT, SGPT, and creatinine level. Results : Results show the reduction in symptomatic score of common cold and flu syndrome observed after 2rd follow-up visit (0.202+0.325 to 0.139+0.231). During the study, no intervention-related adverse events were observed. Furthermore, no Serious Adverse Events (SAE) were observed in the study or follow-up period. The study found no changes in the levels of blood biomarkers (haemoglobin, platelets, SGOT, SGPT, and creatinine). Conclusions : Flucold Drops are safe and effective in the treatment of common cold and flu syndrome in Children and infants.

Aging-associated prostate smooth muscle hypercontractility in rats

Abstract Benign prostatic hyperplasia (BPH) is a multifactorial disease, highly associated with aging and characterized by increased prostate smooth muscle (PSM) contractility. Animal models have been employed to explore the aging-associated PSM hypercontractility; however, studies have focused in old animals, neglecting the initial alterations in early ages. The determination of prostatic dysfunctions onset is crucial to understand the BPH pathophysiology and to propose new BPH treatments. Considering that PSM contractility in 10-month-old rats has already been explored, the aim of the present study was to characterize the PSM contractility in younger rats. Male Wistar control (3.5-month-old), 6- and 8-month-old rats were used. Concentration-response curves to phenylephrine and electrical-field stimulation (EFS) were conducted in prostate from all groups. For the first time, we showed that 6- and 8-month-old rats exhibit PSM hypercontractility. The increased prostate contractility to phenylephrine starts around at 6-month-old, worsening during the aging. The 8-month-old rats exhibited hypercontractility to phenylephrine and EFS compared to the control and 6-month-old groups. Reduced phenylephrine potency was observed in 8-month-old rats, indicating an increased age-dependent prostate sensibility to this agonist. Collectively, our findings support the use of 6- and 8-month-old aged rats as new models to explore prostate hypercontractility in BPH.

Cardioprotective solutions exposure for 1 hour in hypoxia and low temperatures affects vascular reactivity differently

Abstract Introduction: Heart preservation benefits cardiac performance after operations decreasing morbidity but the contribution of the vascular reactivity has been neglected. Objective: We evaluated whether cardioprotective solutions, Krebs-Henseleit (KH), Bretschneider-HTK (BHTK), St. Thomas No. 1 (STH-1), and Celsior (CEL), affect vascular reactivity. Methods: Aortic rings from Wistar rats were used in two protocols. First, the rings were exposed to BHTK, STH-1 or CEL for 1 hour of hypoxia at 37 °C. Second, the rings were exposed to 10 °C or 20 °C for 1 hour under hypoxia. After treatment, the rings were immersed in KH at 37 °C, endothelial integrity was tested and concentration-response curves to phenylephrine were performed. Results: In the first protocol, the solutions did not damage the endothelium; CEL and BHTK reduced KCl-induced contractions but not STH-1; only CEL and BHTK reduced vascular reactivity; there was a positive correlation between Rmax and KCl concentration. At 20 °C, 1 hour under hypoxia, the solutions produced similar KCl-induced contractions without endothelial damage. CEL, BHTK and STH-1 decreased vascular reactivity. At 10 °C, STH-1 increased reactivity but CEL and BHTK decreased. After 1 hour under hypoxia in CEL or BHTK solutions, reactivity was similar at different temperatures. At 20 °C, endothelial damage after exposure to STH-1 produced more vasoconstriction than CEL and BHTK. However, at 10 °C, endothelial damage after CEL and BHTK exposure elicited more vasoconstriction while STH-1 showed a small vasoconstrictor response, suggesting endothelial damage. Conclusion: STH-1 decreased reactivity at 20 °C and increased at 10 °C. CEL promoted greater endothelial modulation at 10 °C than at 20 °C, while STH-1 promoted higher modulation at 20 °C than at 10 °C. Vascular tone was reduced by CEL and BHTK exposure, also depending on the KCl concentration.

The effect of epinephrine for the treatment of spinal-hypotension: comparison with norepinephrine and phenylephrine, clinical trial / O efeito de epinefrina, norepinefrina e fenilefrina no tratamento da hipotensão pós-raquianestesia: estudo clínico comparativo

Abstract Background and objectives: Limited data are present on safety and efficiency of epinephrine for the prophylaxis and treatment of spinal-hypotension. This study was conducted to compare the effect of epinephrine with norepinephrine and phenylephrine on the treatment of spinal-hypotension and ephedrine requirement during cesarean delivery. Methods: One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited. They were allocated randomly to receive norepinephrine 5 µg.mL−1 (n = 40), epinephrine 5 µg.mL−1 (n = 40), phenylephrine 100 µg.mL−1 (n = 40) or 0.9% saline infusions (n = 40) immediately after induction of spinal anesthesia. Whenever systolic blood pressure drops to less than 80% of baseline, 5 mg of intravenous ephedrine was administered as rescue vasopressor. The incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects were recorded. Results: There was no statistically significant difference in incidence of maternal hypotension between groups. The number of patients requiring ephedrine was significantly greater in group saline than in group phenylephrine (p< 0.001). However, it was similar between phenylephrine, norepinephrine, and epinephrine groups. The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p= 0.001). Conclusion: There is no statistically significant difference in incidence of hypotension and ephedrine consumption during spinal anesthesia for cesarean delivery with the use of epinephrine when compared to norepinephrine or phenylephrine. Epinephrine can be considered an alternative agent for management of spinal hypotension.

Resumo Justificativa e objetivos: Existem dados limitados sobre segurança e eficiência da epinefrina na profilaxia e tratamento da hipotensão arterial associada à raquianestesia. O presente estudo foi realizado para comparar o efeito da epinefrina com norepinefrina e fenilefrina no tratamento da hipotensão após raquianestesia e necessidade de efedrina durante o parto cesáreo. Método: Foram recrutadas 160 parturientes com gestações não complicadas, submetidas a cesariana eletiva sob raquianestesia. Elas foram alocadas aleatoriamente para receber norepinefrina 5 µg.mL-1 (n = 40), epinefrina 5 µg.mL-1 (n = 40), fenilefrina 100 µg.mL-1 (n = 40) ou infusão de solução fisiológica NaCl a 0,9% (n = 40) imediatamente após a indução da raquianestesia. Sempre que houvesse redução da pressão arterial sistólica para valor inferior a 80% da linha de base, 5 mg de efedrina iv eram administrados como vasopressor de resgate. A incidência de hipotensão, o número total de episódios de hipotensão, o número de pacientes que necessitaram de efedrina, o consumo médio de efedrina e os efeitos colaterais foram registrados. Resultados: Não houve diferença estatisticamente significante na incidência de hipotensão materna entre os grupos. O número de pacientes que necessitaram de efedrina foi significantemente maior no grupo solução fisiológica do que no grupo fenilefrina (p< 0,001). No entanto, foi semelhante entre os grupos fenilefrina, norepinefrina e epinefrina. O consumo médio de efedrina foi significantemente maior no grupo solução fisiológica do que nos grupos norepinefrina, epinefrina e fenilefrina (p = 0,001). Conclusão: Não houve diferença estatisticamente significante na incidência de hipotensão e consumo de efedrina durante raquianestesia para parto cesáreo com uso de epinefrina quando comparada à norepinefrina ou fenilefrina. A epinefrina pode ser considerada como agente alternativo para o tratamento da hipotensão após raquianestesia.

Evaluation of the bioequivalence of two formulations containing the combination of 400 mg of acetaminophen (paracetamol), 4 mg of phenylephrine and 4 mg of chlorpheniramine in capsules: open-label, three-way crossover study, partially replicated in healthy volunteers of both sexes

This study was carried out in order to compare the relative bioavailability of two different formulations containing 400 mg of acetaminophen + 4 mg of phenylephrine hydrochloride + 4 mg of chlorpheniramine maleate, Test formulation (Cimegripe®) and Reference formulation (Resfenol®) in 84 healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 3-way and partially replicated. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical methods using the ultra-performance liquid chromatography coupled to tandem mass spectrometry. The Cmax, Tmax, AUC0-t, AUC0-inf, T1/2 and Kel pharmacokinetic parameters were calculated from these obtained concentrations. The 90% confidence intervals were constructed for the ratio reference/test from the geometric average of the Cmax and AUC parameters which were comprised between 80% and 125%. Only the Cmax parameter of the phenylephrine was applied the scaled average bioequivalence due to the intraindividual coefficient of variation > 30% obtained, thus extending the acceptance limits of the interval. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable

A prospective observational study involving three fixed infusion regimens of phenylephrine for hemodynamic support during spinal anaesthesia for caesarian delivery

Background: Spinal anaesthesia used in caesarian section is associated with hypotension which can have maternal and fetal side effects. To determine the efficacy and ideal dosing of Phenylephrine in attenuating the hypotensive episodes during caesarean section under spinal anaesthesia.Methods: 100 patients were allocated to four groups, placebo group (PE 0) and 3 fixed phenylephrine infusion regimens, phenylephrine 25 μg/min-1 (PE 25), phenylephrine 50 μg/min-1 (PE 50), and phenylephrine 75 μg/min-1 (PE 75). Blood pressure, heart rate were noted among primary variables and fetal parameters like umbilical blood pH and lactate were recorded as secondary parameters.Results: There was a significant reduction in heart rate with increasing the infusion dosage of phenylephrine, with a mean of 86.8 beats/min at the end of procedure in placebo group and 69.4 beats/min in 75 μg group (p value <0.001). There was significant statistical difference among systolic blood pressure in the four groups after 7 min of the procedure and p-value of <0.05 with better attenuation of hypotension in infusion groups as compared to placebo. Similarly there was significant statistical difference in diastolic blood pressure among the four groups after 8 min of the procedure with p values <0.05.Conclusions: Prophylactic phenylephrine infusions reduced the incidence and severity of maternal pre-delivery hypotension. Among the fixed rate phenylephrine infusion regimens investigated, infusion rates of 50 μg/min-1 were associated with greater maternal hemodynamic stability compared with 25 and 75 μg/min-1, with minimal side effects and intervention.

Comparison of commonly used vasopressors for treating hypotension after spinal anaesthesia in elective lower abdominal surgery: a randomized, observational, case-control study

Background: During caesarean section hypotension due to spinal block is secondary to the sympathetic blockade and aorto-caval compression by the uterus. It can have important consequences for the mother and may affect neonatal outcome. The present study was aimed to compare intravenous bolus doses of phenylephrine and ephedrine to treat maternal hypotension during spinal block for elective caesarean section.Methods: After fulfilling the inclusion criteria, 100 parturient were randomly allocated into two groups of fifty each. For spinal anesthesia lumber puncture was done and 12.5mg, 0.5% hyperbaric bupivacaine was given intra-thecally. In this observational study, patients who developed hypotension under spinal anesthesia were selected for the study. According to their group, patients received either ephedrine 6mg (Group E) or phenylephrine 75µg (Group P) as vasopressor. During the study, number of vasopressor boluses, hemodynamic response and time taken to recover from hypotension was noted.Results: Ephedrine and phenylephrine were used in the mean doses of 6.72±1.97mg and 91.5±31.38µg respectively. In 88% parturient single bolus dose of ephedrine was effective in treating hypotension while phenylephrine was effective in 78% parturient. There was no significant difference observed in total number of boluses used. No significant difference was seen in mean systolic blood pressure, mean diastolic blood pressure and mean arterial pressure over a given period of time in Group E and Group P. Mean systolic BP was less than 20% when compared to baseline in both the groups at different time intervals. In Group P the mean heart rate was significantly lower as compared to the Group E (p<0.05).Conclusions: Intravenous phenylephrine and ephedrine are both similar in performance in treating hypotension after spinal anesthesia for elective caesarean section and the hypotensive control offered is comparable.

Ephedrine versus phenylephrine: effects on fetal acid-base status during spinal anesthesia for elective cesarean delivery

Background: During elective caesarean sections, post-spinal hypotension is a common problem. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The objective of this study was to compare and evaluate the effects of ephedrine and phenylephrine on the fetal outcome when used in the treatment of maternal hypotension during spinal block in elective caesarean section.Methods: After fulfilling the inclusion criteria, hundred patients were enrolled in this study and were randomly allocated into two groups of fifty each. According to their group, patients received either ephedrine 6 mg (group E) or phenylephrine 75µg (group P) as vasopressor. For spinal anaesthesia lumber puncture was done in sitting position and 12.5mg, 0.5% hyperbaric bupivacaine was given intra-thecally to every patient. Throughout surgery, maternal and neonatal complications were controlled and recorded. During the study, Apgar scores on the 1st and 5th minutes, and blood gases of the umbilical cord blood were evaluated.Results: Ephedrine and phenylephrine were used in the mean doses of 6.72±1.97mg and 91.5±31.38µg respectively. There was no significant difference observed in total number of boluses used in treating post-spinal hypotension. The difference in the first- and fifth-minute Apgar scores was statistically insignificant between the group E and group P. There was a statistically significant difference observed in SaO2 and base excess in arterial gas sample between two studied groups. Similarly, a significant difference was observed in PCO2 of umbilical venous sample between two studied groups. However, none of the neonates had the true fetal acidosis.Conclusions: Intravenous phenylephrine 75µg and ephedrine 6 mg offer a comparable hypotensive control without any significant complication for mother or her fetus in elective caesarean section.

Efficacy and Safety of a Fixed Dose Combination of Paracetamol, Chlorpheniramine Maleate, Phenylephrine and Caffeine in Treatment of Common Cold: A Phase IV, Open-Labelled, Multi-Centric Study

Common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. It also leads to reduction in subjective alertness and impaired psychomotor functioning. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyeretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Addition of caffeine enhances alertness and psychomotor functioning. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold. Methods: This was a phase IV, open-labelled, multicentric study in 262 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study. Results: There was reduction in mean TSS from 7.67 (day 1) to 3.78 (day 3) and 0.66 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 59.16 % patients had complete relief from the symptoms at the end of study. Out of 262 patients, 46 i.e. 17.56% experienced adverse event. Sedation and drowsiness (12.21%) was the most common adverse event seen in patients. Conclusion: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, Phenylephrine and Caffeine is safe and effective in the treatment of common cold.

Study of Safety and Efficacy for the Combination of Chlorpheniramine maleate and Phenylephrine in Infants suffering from Allergic Rhinitis and Associated Symptoms

Introduction: The epidemiological data suggest that thereis alarming rise in the prevalence of allergic rhinitis. It oftengoes intractable in small children. A combination of nasaldecongestant and antihistaminic drug is preferred over thevarious aetiologies associated with allergic rhinitis. Studyobjective was to evaluate the efficacy and safety for thecombination of Chlorpheniramine maleate and Phenylephrinein patients of allergic rhinitis and associated symptoms.Material and Methods: Total 215 patients were enrolledout of which 177 patients completed the study and efficacyassessment was made by reduction in TSS and four pointLikert-Type scales. Safety assessment was made by analysingthe adverse events during clinical trial.Results: There was significant reduction in TSS from 5.677(baseline) to 2.711 (day 3) and 0.542 (day 5). At day 3 andday 5 there was reduction of 52.23% and 90.44% as comparedto baseline. Nearly all the patients had > 50% reduction insymptom score at all visits and majority of patients hadcomplete relief from the symptom.Conclusion: A combination of Phenylephrine andChlorpheniramine maleate was found to be efficacious as wellas safe in the treatment of allergic rhinitis.

Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold.

Late cardiac perconditioning by phenylephrine in an isolated rat heart model is mediated by mitochondrial potassium channels

The present study was designed to investigate the effect of early and late administration of phenylephrine during ischemia against regional ischemia-reperfusion injuries in an isolated rat heart model. All animals were randomly divided into experimental groups: (I) IR (Ischemic/ reperfusion): the hearts underwent 35 min of regional ischemia followed by 60 min of reperfusion; (II) 5HD-IR-0: the hearts were perfused for 5 min with 5HD (5-hydroxydecanoate, specific mKATP channel blocker, 100 µM) at the onset of regional ischemia; (III) 5HD-IR-20: the hearts were perfused for 5 min with 5HD 20 min after regional ischemia; (IV) PE-IR-10: the hearts were perfused for 5 min with phenylephrine 10 min after regional ischemia; (V) PE-IR-30: the hearts were perfused for 5 min with phenylephrine (100 µM) 30 min after regional ischemia; (VI) PE-5HD-IR-10 group: the hearts were perfused for 5 min with 5HD at the onset of regional ischemia after which phenylephrine was administrated as in group IV; and (VII) PE-5HD-IR-30: the hearts were perfused for 5 min with 5HD 20 min after the ischemia and then phenylephrine was administrated as in group V. The hemodynamic parameters were recorded throughout the experiment. Ischemia-induced arrhythmias, myocardial infarct size (IS), creatin kinase-MB isoenzyme (CK-MB), plasma lactate dehydrogenase (LDH) activities, and coronary blood flow (CBF) were measured in all animals. Perfusion of phenylephrine 30 min after the regional ischemia curtailed the myocardial infarct size, reduced CK-MB, and improved cardiac function and CBF. Administration of 5HD 30 min after the ischemia abolished cardioprotective effects of phenylephrine in the late phase. These results suggest the involvement of mKATP in the mechanism of phenylephrine-induced late preconditioning.

Heat shock protein 22 reduces phenylephrine-induced cardiomyocytes hypertrophy / 中华急诊医学杂志

Objective To investigate the effect of Hsp22 on phenylephrine-induced cardiomyocytes hypertrophy.Methods Primary rat myocardial cells were isolated and cultured in Department of Cardiology,the First Affiliated Hospital of Zhengzhou University.Cells were divided into four groups randomly:Control group,model group,treatment group with 1 μg/mL Hsp22,and treatment group with 10 μg/mL Hsp22.Phenylephrine stimuli was used to induce cardiomyocytes hypertrophy model.Cell viability was measured by 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay.Cardiomyocytes surface area was evaluated by α-actin immunofluorescence staining.Reverse transcription-polymerase chain reaction (RT-PCR) was used to detect the transcription level of hypertrophic markers.Reactive oxygen species level was detected by 2',7'-Dichlorodihydrofluorescein diacetate (DCFH-DA) fluorescent probe.Apoptosis was detected by TUNEL staining.Signal pathway protein expression was detected by Western blot.SPSS 13.0 was used for statistical analysis.Data were expressed as mean + standard deviation.All data were analyzed by one-way ANOVA between groups.Comparisons between two groups were performed using LSD-t test.A P＜0.05 was considered statistically significant.Results Different concentrations of Hsp22 had no effect on cardiomyocytes viability (F=6.622;P＞0.05).Phenylephrine stimulation significantly increased cardiomyocytes area (t=10.80;P＜0.05),increased the transcription level of hypertrophy markers atrial natriuretic peptide (t=37.72;P＜0.05),type B natriuretic peptide (t=16.85;P＜0.05),and myosin heavy chain beta (t=41.53;P＜0.05).Different concentrations of Hsp22 significantly reduced cardiomyocytes area (PE+ 1 μg/mL Hsp22 t=4.018;P＜0.05;PE+10 μg/mL Hsp22 t=10.80;P＜0.05),reduced the transcription level of hypertrophic markers atrial natriuretic peptide (PE+1 μg/mL Hsp22 t=27.12,P＜0.05;PE+10 μg/mL Hsp22 t=37.72,P＜0.05),type B natriuretic peptide (PE+1 μg/mL Hsp22 t=4.82,P＜0.05;PE+10 μg/mL Hsp22 t=12.74,P＜0.05),and myosin heavy chain beta (PE+1 μg/mL Hsp22 t=23.68,P＜0.05;PE+10 μg/mL Hsp22 t=30.54,P＜0.05).Westem blot showed that Hsp22 increased the activation of AMP-activated protein kinase α (PE+1 μg/mL Hsp22 t=5.89,P＜0.05;PE+10 μg/mL Hsp22 t=5.88,P＜0.05),reduced mTOR phosphorylation level (PE+1 μg/mL Hsp22 t=16.80,P＜0.05;PE+10.μg/mL Hsp22 t=20.46,P＜0.05).Conclusions Hsp22 inhibits cardiomyocytes hypertrophy by activating AMP-activated protein kinase α.Hsp22 may become a potential anti-hypertrophic drug.

Comparison of IV bolus phenylephrine, ephedrine and mephentermine for maintenance of hemodynamic status and its effect on fetal outcome during spinal anesthesia in cesarean section

Background: Maternal hypotension during spinal anesthesia for cesarean section is a persistent problem which can result in adverse maternal and fetal outcome. Aim: Aim of this study was to compare the efficacy of IV bolus phenylephrine, ephedrine and mephentermine for the maintenance of hemodynamic status and its effect on fetal outcome during spinal anesthesia in cesarean section. Materials and Methods: We did prospective randomized double blind study in 60 patients. They were undergoing elective cesarean section under spinal anesthesia and who developed hypotension after subarachnoid block. The patients were randomly divided into three groups of 20 each. Phenylephrine Group (Group P) received Inj. Phenylephrine 100 mcg IV, Group E received Inj. Ephedrine 6 mg IV and Group M received Inj. Mephentermine 6 mg IV bolus. Whenever hypotension occurred, patients received the study drug. After administration of drugs and their consistence Sneha Dokania, Renu Gurung, Ambuj Jain. Comparison of IV bolus phenylephrine, ephedrine and mephentermine for maintenance of hemodynamic status and its effect on fetal outcome during spinal anesthesia in cesarean section. IAIM, 2019; 6(9): 28-36. Page 29 maintenance till end of 60 minutes. Patients were compared with respect to age, weight, duration of surgery, Systolic BP, Diastolic BP, Mean Arterial Pressure and Heart Rate. Results: The rise of systolic, diastolic and mean arterial pressure in Group P was significantly high for first 4min of bolus dose as compared to Group E & Group M (P<0.05). APGAR scores were ≥7 in all the three groups. Conclusion: It was concluded that IV bolus Mephentermine is as effective as Phenylephrine and Ephedrine in maintenance of arterial blood pressure during spinal anesthesia in cesarean section with good neonatal outcome.

Effect of α1-adrenergic signaling pathway on doxorubicin-induced apoptosis in cardiomyocytes / 上海交通大学学报（医学版）

Objective • To investigate the effects of α1-adrenergic receptor agonist phenylephrine (Phe) and antagonist prazosin (Pra) on cardiomyocyte apoptosis induced by doxorubicin (DOX). Methods • H9C2 cardiomyocytes were divided into 4 groups. Except for the control group incubated with medium alone, all other groups were treated with 1.8 μmol/L DOX. For agonist group and antagonist group, 0.1 mmol/L Phe and 10 μmol/L Pra were added respectively in DOX-treated cells. After culture for 24 h, flow cytometry and TUNEL assay were performed to detect the apoptosis rate. Western blotting was used to detect the expression of cleaved caspase 3. Real-time PCR was used to detect the expression of anti- and pro-apoptotic Bcl-2 family genes. CCK-8 assay was used to detect the cell viability. Results • The DOX-induced apoptosis was inhibited by Phe with decreased apoptosis rate of H9C2 and decreased expression of cleaved caspase 3, but promoted by Pra. Increased expression of Bcl-2 and Bcl-w and decreasedexpression of Bax and Bad at mRNA levels were found in agonist group in comparison with the cells treated with DOX alone; while decreased expression of Bcl-2 and Bcl-w and increased expression of Bax and Bad were found in antagonist group. The cell viability after 24 h of treatment with agonist was higher than cells treated with DOX alone, but no signifiant difference was found in cell viability between antagonist group and DOX group. Conclusion • α1-Adrenergic signaling pathway may be involved in endogenous myocardial protection in the process of cardiomyocyte apoptosis induced by DOX.

A Study Of Prophylactic Phenylephrine Infusion For Preventing Hypotension During Spinal Anaesthesia For Cesarean Section

BACKGROUND: Hypotension after spinal anaesthesia for Caesarean section still remains a common complication. Various methods have been recommended for prevention and treatment of this problem. However, despite crystalloid or colloid preloading, hypotension remains a common problem. Vasopressors are required to treat the spinal induced hypotension among most of these patients. Studies involving bolus phenylephrine are in plenty but studies pertaining to prophylactic phenylephrine infusion are sparse.