International Journal of Basic & Clinical Pharmacology

Permanent URI for this collection

https://imsear.searo.who.int/handle/123456789/149644

Chief Editor: Dr. Bhaven Kataria

Print ISSN: 2319-2003 (Print)

Frequency: 6 issues a year

Language: English

Open Access Peer-reviewed journal

Web site: https://www.ijbcp.com/index.php

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Now showing 1 - 20 of 1928

Antipsychotics - a key line treatment for various psychotic symptoms
(Medip Academy, 2024-08) Kaur, D.
‘Psychosis’ is the state of mental disorder characterized by loss of contact with reality followed by delusions, hallucinations, disorganised thoughts etc. which mainly occurs because of the imbalance of neurotransmitters like dopamine, serotonin or glutamate. About 5-8% of people suffer from mental disorders in the whole world. In the earlier time it was difficult to treat such psychotic patients. So, when antipsychotics came in the market the treatment of such serious mental conditions became possible. Mainly two categories of antipsychotics are prescribed, out of which second generation are commonly prescribed because of their less adverse effects.
Unveiling supply chain efficiency: exploring ABC-VED analysis studies on drug inventory management in India
(Medip Academy, 2024-08) Meena, D. K.; Mathaiyan, J.
About one-third of annual hospital budget is spent on buying materials and supplies including medicines. In any health facility, be it small health center or a big teaching institution, drugs forms an essential and indispensable element. Non-availability of drugs particularly in the developing countries is due to lack of proper material management. A poor management in a public pharmaceutical supply can result in wastage or blockade of financial resources, irrational utilization of drugs, shortage or overage of essential drugs, increased holding cost, and reduction in flexibility and decline in quality of health care services. Adaptation of a scientific approach of inventory management in healthcare manages all the issues regarding stocking of pharmaceutical items, ensuring safety, stability, efficacy, availability and maintenance of quality of drugs to provide better healthcare services. This review will focus on inventory management and its importance with special emphasis on always better control-vital, essential, desirable (ABC-VED) analysis technique on essential medicine concept and report of various research studies conducted on ABC-VED analysis in different parts of country.
Antifungal activity testing of curry leaf ethanol extract on the growth of Pityrosporum ovale and Candida albicans fungus
(Medip Academy, 2024-02) Purnama Sari, U.; Reveny, J.; Morin Sinaga, S.
Background: The curry leaf is an Indonesian plant commonly utilized as a spice. Curry leaves are abundant in secondary metabolites, which endow this plant with numerous advantages, including antibacterial and antifungal properties, as well as the ability to reduce blood sugar levels and blood pressure. The objective of this study is to assess the efficacy of an ethanol extract derived from curry leaves in suppressing the proliferation of Pityrosporum ovale and Candida albicans fungus. Methods: The symbiotic properties and phytochemical composition of curry leaf simplisia were examined. The antifungal efficacy of the ethanol extract derived from curry leaves was evaluated against Pityrosporum ovale and Candida albicans using the disc diffusion method. Calculate the precise values of the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC). Results: The simplisia of curry leaf fulfills the criteria for simplisia characterization. Curry leaves possess a variety of secondary metabolite chemicals, including alkaloids, flavonoids, tannins, saponins, glycosides, steroids, and triterpenoids. The activity against the inhibition of fungal growth of Pityrosporum ovale and Candida albicans can suppress fungal growth with inhibition zone diameters measuring 6.93±0.15 mm and 7.27±0.47 mm, respectively. The minimum lethal concentration of leaf ethanol extract for Pityrosporum ovale fungi is 8.75%, resulting in a decrease of 98.25%. For Candida albicans fungi, the minimum lethal concentration is 12.5%, resulting in a reduction of 98.37%. Conclusions: The ethanol extract derived from curry leaves has the ability to hinder the proliferation of Pityrosporum ovale and Candida albicans fungus.
Artificial intelligence-driven patient monitoring for adverse event detection in clinical trials
(Medip Academy, 2024-08) Vampana, S. B.; Jayanthi, E. S. S.; Mary, D. A.; Sriniketh, C.
Artificial intelligence (AI) keeps an eye on people in clinical studies to find out when bad things happen. This is a big way that AI is changing healthcare. It goes into a lot of detail about how AI has changed this field and stresses how important it is to use complicated formulas, always keep an eye on things, and follow the rules. These days, we have tools like deep learning frameworks, controlled and unsupervised learning models, and others that help us find bad things faster and more accurately. Tracking in real time is possible with early warning systems and constant data analysis. It helps make sure the experiment is done right and puts the safety of the people being tested first. AI-driven tracking systems can only work in an honest and reliable way if they follow the rules set by regulatory bodies such as the FDA and the EMA. The fact that AI has the ability to change the way medical research is done today, with benefits like making it faster and more accurate, makes its problems even more important. The report comes to the conclusion that more research, better teamwork, and a wider use of AI technologies are needed to make it more reliable to find bad events in clinical studies over time.
Pharmacological effect of walnuts consumption on metabolic syndrome: a current view
(Medip Academy, 2024-08) Ofor, C. C.; Ohanme, E. O.; Nwakelu, B. N.; Ofornakara, U.; Aja, D. O.; Shu, E. N.; Ghasi, S. I.
Cardiovascular disease (CVD) is the leading cause of death worldwide (WHO, 2017). In addition to the global and national morbidity and mortality burdens of the disease, it imposes a substantial economic burden on society. The American heart association predicts that by 2035, 45% of Americans will suffer from CVD with costs expected to reach $1.1 trillion annually. Clinical trials have demonstrated that a nut-containing diet low in saturated fat and cholesterol, while high in poly and monounsaturated fatty acids has a beneficial effect on plasma lipids and lipoproteins when compared with either a low fat or average American diet. Other bioactive compounds present in walnuts, including micronutrients, fiber, and phytochemicals, may also contribute to their cardio protective effect by reducing inflammation, improving vascular reactivity, and lowering oxidative stress. It has been demonstrated that the consumption of walnuts resulted in significant reduction in body mass index (BMI), percentage of body fat, increased lean body mass and an increased amount of water in the body. A large population cohort study also demonstrated a marked reduction in body weight and other anthropometric parameters in people on regular consumption of walnuts.
Septic shock diagnosis and its treatment
(Medip Academy, 2024-08) Reshi, M. R.; Nabi, N.; Muzaffar, M.; Anees, S.; Yusuf, N.; Qasim, A.; Naqvi, M.
In critical care, sepsis continues to be a major cause of mortality. The pathogenic, diagnostic, and therapeutic panorama of sepsis is no longer restricted to the critical care unit: many patients who enter treatment through other doors, both inside and outside the hospital, develop severe illness. Next, administer fluids and broad-spectrum antibiotics after taking the proper cultures. Step up the treatment to include monitoring urine output, blood gases for base excess, lactate, haemoglobin, and glucose if the situation does not get better within the following six hours. These will dictate how bicarbonate, insulin, fluids, transfusions, and vasopressors are managed. The patient should be sent to intensive care if the hypotension doesn't improve (septic shock). Sepsis can now be treated with methods that have produced better results with other illnesses. New medicines have been created as a result of a better understanding of the biology of severe sepsis and septic shock, placing a strong emphasis on early detection and aggressive treatment. The major priorities continue to be prevention through screening, preventing cross infection, and prudent antibiotic usage.
Enhancing patient safety: leveraging artificial intelligence-powered electronic medical records for effective drug-drug interaction nudge in real-world prescribing practices
(Medip Academy, 2024-08) Jayanthy, G.; Majumdar, A.; Kaloo, S.; Shah, S.
Background: Concurrent prescriptions of various medications may lead to unfavorable and unanticipated potential drug-drug interactions. Hence, the elimination of drug-drug interactions is a key aspect of delivering a coherent treatment regime. In response to this concern, HealthPlix, one of India's largest AI-powered electronic medical record providers, introduced a drug-drug interaction nudge feature in June 2022, providing a proactive solution for physicians to address potential interactions between incompatible drugs. This study aimed to elucidate the role of electronic medical records in identifying and managing drug interactions and the advantages of interaction nudges for doctors in prescribing appropriate medications. Methods: An observational retrospective study was conducted using data obtained from HealthPlix, containing two or more drugs, written for patients older than 18 years. Results: In an average of 1.9 million patient visits analyzed, the interaction visits were observed to be 1.2 million. An average of 185,745 interactions were observed during the study period. For all observed interactions, an average of 72,383 molecules were removed. These results provide insights into the efficiency of HealthPlix in abrogating interactions and illustrate the tangible benefits of nudges in modifying prescription practices. Conclusions: The above results illustrate the effectiveness of drug-drug interaction nudges as a clinical decision support tool integrated into HealthPlix, marking a significant advancement in Indian healthcare. This unique feature contributes to reducing the frequency of potent drug interactions, showcasing its potential to enhance patient safety and improve the quality of healthcare delivery.
Antibiotic utilization profile in surgical ward at secondary government hospital
(Medip Academy, 2024-02) Marchiella, R.; Khairunnisa, K.; Wiryanto, W.
Background: This study aimed to determine the profile of the antibiotic utilization in defined daily dose (DDD) units and DU 90% at surgical ward of secondary government hospital in Indonesia within six months period of study. Methods: A retrospective cross-sectional study was conducted over six months on surgical ward patients prescribed with at least one oral or parenteral antibiotic during hospitalization. Data were collected from pharmacy dispensing data and evaluated using World Health Organization (WHO) DDD. Antibiotics DDD were analysed using DU 90% segmentation in order to know the 90 percent cumulative of antibiotic consumption in surgical ward. WHO prescribing indicators were used to examine the antibiotic prescribing pattern in DU 90% segment. Results: Out of 319 antibiotic prescribed to surgical ward patients, 219 prescriptions were belonging to DU 90% segment including ceftriaxone (38.94%), moxifloxacin (16.41%), fosfomycin (14.06%), metronidazole (12.43%), and gentamicin (7.69%) in decreasing fashioned. Of the five groups of antibiotics belong to DU90%, ceftriaxone was the highest in DDD (272.5). The average number of antibiotic prescribed to patients were 1.64±0.92. The percentage of antibiotic prescribed by its generic name as well the prescribing of antibiotic from National list of essential medicines were 70.79% and 72.51%, respectively (optimal value 100%). Conclusions: Our findings on using drug utilization 90% and prescribing indicators are practical for assessing the most widely used antibiotics in ward or hospital setting and to evaluate the quality of prescribing pattern. The antibiotic utilization profile in this study can be used to provide comparative data between hospital and beneficial for future policy making to improve prescribing practice.
Evaluation of knowledge, attitude and practices of second year MBBS students about over the counter drugs
(Medip Academy, 2024-08) Sharma, A.; Chincholkar, A.; Sawant, A.
Background: The utilization of over-the-counter (OTC) drugs among medical students during academic exams has raised concerns about health risks and potential implications. This cross-sectional study aimed to estimate the prevalence of OTC drug utilization among medical students. Methods: A cross-sectional study was conducted using pre-validated questionnaire. The data obtained was tabulated, analysed and the results were calculated in percentages.150 students had participated in this study of which 100 were selected by simple random sampling. Results: The use of OTC drugs was common amongst undergraduate students. Majority of students (92%) who participated in the study had used OTC drugs at some point in their life. Commonly used OTCs were antacids (73%) and the most common indications for use of OTCs was cough and cold (92%). 87% of students preferred OTC drugs due to ease and convenience while 44% preferred OTC drugs due to lack of time to consult the doctor. Doctors (32.3%) followed by family and friends; textbook/journals were found to be the most common source of information on OTC drugs. Conclusions: A tendency to choose self-medication over doctor’s consultation by most of the undergraduate medical students was consistently seen in the present study. This unrestrained use of OTC drugs certainly possesses several health risks. Awareness should be created among undergraduate medical students to restrict the use of OTC drugs and efforts should be undertaken to increase the sale of drugs without prescription.
Antihypertensive drug prescription patterns and their impact on blood pressure outcomes in a tertiary care teaching hospital
(Medip Academy, 2024-08) Kedare, R. K.; Pujari, A. J.; Hivale, N.; Kharat, R.
Background: The guidelines from the Joint National Committee (JNC-8) emphasize the importance of rapid blood pressure (BP) control to reduce morbidity and mortality. The success of hypertension treatment depends on various factors, with irrational prescription being strongly linked to poor BP control. This study aimed to evaluate the patterns of antihypertensive drug prescriptions among patients in a tertiary care teaching hospital. Methods: A hospital-based observational study was conducted in 2018, including all hypertensive patients on medication. Their prescription patterns were analyzed. Results: The study analyzed prescriptions from 240 hypertensive patients. The mean ages for male and female patients were 56.68±15.32 and 62.29±12.65 years, respectively. Physicians commonly prescribed monotherapy (34.60%) followed by two-drug (18.40%), three-drug (11.80%), and four-drug combinations (3.00%). The most frequent two-drug combination was ACE inhibitors + diuretics (4.40%), followed by angiotensin receptor blockers (ARBs) + diuretics (3.60%) and calcium channel blockers (CCBs) + ACE inhibitors (2.60%). Adherence to JNC 8 guidelines was 19.3% for pre-hypertension, 88.70% for stage 1 hypertension, and 73.29% for stage 2 hypertension. Conclusions: Monotherapies were the most commonly prescribed regimens. Twice-daily dosing and monthly appointments were associated with lower incidences of uncontrolled BP. However, complete adherence to standard guidelines was not observed in all cases, especially in patients with comorbid conditions.
Assessment of efficacy and safety of clindamycin with nicotinamide in mild to moderate acne vulgaris: a prospective study
(Medip Academy, 2024-08) A T, Priyanka; Mamatha, K. R.; Yuvarani, R.; Yamini, K.
Background: Acne vulgaris is a very common skin disease that is usually treated with topical products, systemic medications, or a combination of both. Acne vulgaris affects approximately 9% of the population worldwide causing permanent physical scarring, negatively affects the quality of life and self-image, and has been associated with increased rates of anxiety, depression, and suicidal ideation. Methods: This was a prospective study conducted at BMCRI including thirty-five subjects who were diagnosed with mild to moderate acne vulgaris. Patients were treated with topical clindamycin 1% with nicotinamide 4%. Efficacy was assessed by mean change in acne severity index (ASI) and total lesion count (TLC) from baseline and at the end of 4, 8 and 12 weeks. Safety was assessed by adverse events reported. Results: There was statistically significant improvement noted at the end of each visit. Baseline ASI was 88.05±4.02 and end of 12 weeks was 14.17±2.7. Baseline TLC was 30.17±1.33 and at the end of 12 weeks was 4.25±0.99. Both the ASI and TLC results were statistically significant at the end of fourth, eighth and twelfth-week p value <0.0001. Conclusions: Combination topical formulations are the most broadly used treatment regimen for Acne vulgaris to target one or more steps in the pathogenesis of acne. From the results of the present study the participants on combination of clindamycin with nicotinamide had a significant improvement in acne lesions at end of 12th week of topical application and were satisfied with the therapy with no major adverse effects.
Assessment of antimicrobial activity of Meliponula ferrugica in pathogenic wound samples
(Medip Academy, 2024-08) Rajayan, J. S.; Rangasamy, N.; Narayan, N. L.; George, V. H. M.; Rajendran, K.
Background: Honey is a naturally occurring sweet material that bees make from nectar from flowers, secretions from plant parts, or excretions from plants that suck insects from plant parts. Honey’s antibacterial and antifungal qualities are widely known, and it has been used to heal burns, surgical wounds, and decubitus ulcers. Honey instantly sterilizes wounds affected by Staphylococcus aureus. The honey’s ability to fight bacteria can be ascertained by the nectar’s origin. Many antibiotic resistances among the bacteria that cause infections in humans have directly evolved as a result of the use of antibiotics in clinical practice. Methods: This study found that Bergey’s manual of determinative bacteriology can be used to identify Pseudomonas aeruginosa and Staphylococcus aureus. According to the study’s findings, honey has a capacity to neutralise Pseudomonas aeruginosa and Staphylococcus aureus that have been isolated from infected wounds. Honey’s antibacterial characteristics account for a significant portion of its antibacterial activity. Results: Staphylococcus aureus and Pseudomonas aeruginosa were both susceptible to the antibacterial activity of the honey sample. Pseudomonas aeruginosa exhibited lower activity compared to Staphylococcus aureus. Conclusions: The results of this investigation show that Bergey’s handbook of determinative bacteriology can be used to identify Staphylococcus aureus and Pseudomonas aeruginosa. According to the study’s findings, honey has the ability to neutralise Pseudomonas aeruginosa and Staphylococcus aureus that have been isolated from infected wounds.
Comparative study of efficacy and safety of pregabalin and gabapentin for treatment of neuropathic pain in oral cavity cancer patients: a comparative, randomized and prospective study
(Medip Academy, 2024-08) Saji, S.; Singhal, Y.; Pingoliya, S. K.
Background: Pain in patients with oral cancers can limit the normal functioning and quality of life. Neuropathic pain raises the anxiety and depression levels, increases the morbidity and decreases the efficiency to work. Neuropathic pain is frequently diagnosed as a complication of cancer pain due to direct invasion of nerves, plexus or compression, and side effect of chemotherapy, radiation injury or surgery. Methods: A total of 60 patients were divided randomly into two groups based on treatment: group P (pregabalin) and group G (gabapentin). The intensity of pain was measured using visual analog scale (VAS) and DN4 questionnaire (Douleur Neuropathique 4) was used to evaluate neuropathic component. Changes in pain score and neuropathic component was assessed at 2nd and 4th week of follow up. Data was collected and analysed using SPSS 20.0 software at level of significance being p<0.05. Results: At baseline, the mean±SD of VAS score in group P was 7.20±0.79; in group G was 7.13±0.66. At 2nd week, the mean±SD of VAS score in group P was 4.5±0.91; in group G was 4.46±0.88. At 4th week, the mean±SD of VAS score in group P was 3.66±0.69; in group G was 3.83±0.85. At baseline, the mean±SD of DN4 score in group P was 7.13±0.80; in group G was 6.93±0.85. At 2nd week, the mean±SD of DN4 score in group P was 4.73±0.92; in group G was 4.46±0.82. At 4th week, the mean±SD of DN4 score in group P was 3.73±0.42; in group G was 3.93±0.62. Conclusions: Pregabalin was found to be more effective with lesser side effects than gabapentin
Knowledge, attitude and practice towards sunscreen use among undergraduate medical students in a tertiary care teaching hospital in south India: a cross-sectional study
(Medip Academy, 2024-08) Xaviar, S.; Natarajan, A.; Selvaraj, N.; Joseph, P.
Background: This study was done to evaluate the knowledge, attitude and practice (KAP) of medical undergraduate students toward the usage of sunscreen as protective measures against ultraviolet (UV) radiation. Methods: A cross-sectional survey was conducted among the undergraduate medical students in a tertiary care teaching hospital in South India. A pre-designed and validated questionnaire containing 13 questions was used to assess knowledge, attitude and practice. The filled KAP questionnaires were analyzed using descriptive statistics. Results: A total of 100 medical students participated in our study. The mean age of respondents was 19.9±0.73 years. Half of the study participants (50%) were aware of the association between long term sun exposure and skin cancer. Only 17.5% of students were aware of the correct quantity of sunscreen to be used for effective sun protection.65% of respondents did not apply the sunscreen product 30 minutes prior to sun exposure. Only 40% of students could name at least 1 ingredient in sunscreen. Reapplication rates were 39.1% among respondents. Conclusions: This study indicated that the awareness and level of knowledge of sunscreen use is not adequate among the medical personnel, thus requiring health education programs to emphasize the importance of regular and correct sunscreen use. It is imperative that the medical students are adequately informed regarding sunscreen benefits and skin cancer prevention as they form the future healthcare system.
A comparative study of intrathecal isobaric ropivacaine and hyperbaric bupivacaine for elective lower segment caesarean section
(Medip Academy, 2024-08) Ramarao, M.; Laxman Rao, K.; Santhi Sree, M.; Raghuvardhan, M.
Background: The study was to compare intrathecal isobaric ropivacaine and hyperbaric bupivacaine in terms of onset of sensory block, maximum height of sensory block, total sensory duration, onset of motor block, degree of motor block and duration of motor block, quality of anesthesia. Methods: The 100 cases of ASA II undergoing elective lower segment caesarean section were taken for the study and divided into two groups. Group B patients received 2 ml of hyperbaric bupivacaine intrathecally. Group R patients received 2ml of isobaric ropivacaine intrathecally. Patients were evaluated for onset and duration of sensory block, onset and duration of motor block, maximum height of sensory block, quality of anaesthesia, time to request for analgesia, hemodynamic parameters and side effects if any were studied. Results: There were no significant differences between the two groups in mean time to onset of sensory block. Maximum sensory height attained in group B ranged between T4 and T6, where as in group R, it ranged between T2 and T6 which was clinically and statistically highly significant (p<0.001). Total duration of sensory block in group B and in group R, which is not significant (p=0.068). Mean time onset of motor block was 4min in group B and 8 min in group R, (p<0.001). Duration of motor block was 155.20±14.95 min in group B and 94.10±8.31 min group R, which is clinically and statistically significant (p<0.001). Conclusions: Ropivacaine 15 mg (2 ml of 0.75% isobaric ropivacaine) provides comparable quality of sensory block but has slower onset and significantly shorter duration of motor block compared to bupivacaine.
A randomized, double-blind, parallel and placebo-controlled clinical study to evaluate the efficacy and safety of KaraCalm™: a dietary supplement to support sleep and manage stress
(Medip Academy, 2024-08) Gersappe, V.; Rajendran, K.; Layton, K.; Guan, B.; Gupta, A. K.; Venkateshwarlu, K.
Background: KaraCalm™ is a novel polyherbal formulation obtained from the combination of Valeriana officinalis extract, Passiflora incarnata extract, Ocimum sanctum extract, Ziziphus jujuba extract, Rosmarinus officinalis extract, and Nigella sativa extract. The objective of the present investigation was to assess the efficacy and safety of KaraCalm™ to manage stress and improve sleep in healthy subjects in a randomized, double-blind, placebo-controlled clinical study. Methods: A total of 60 healthy volunteers were randomized into two groups, with 30 subjects in the KaraCalm™ group and 30 in the placebo group. Participants were asked to take KaraCalm™ 500 mg or placebo once daily for 56 days. As primary outcomes, sleep analysis was performed by using Actiwatch, while stress level was evaluated with the Perceived Stress Scale (PSS) scores from baseline to the end of the study period. Serum cortisol, and hs-CRP from baseline to the end of the study period were assessed as secondary endpoints. Results: An increase in overall sleep quality was observed in the KaraCalm™ group compared to the placebo as measured by total sleep time, onset latency, wake after sleep onset minutes, and number of awakenings. There was also a reduction in PSS scores in the KaraCalm™ group from baseline to the end of the study, indicating reduced stress levels. A significant reduction in Serum cortisol and hs-C-reactive protein (CRP) levels in the KaraCalm™ group from baseline to the end of the study further supported the effectiveness of KaraCalm™ in reducing stress. There was no significant change in the safety analyses of the patients in the intervention group when assessed from the start of the study to the end. Conclusions: KaraCalm™ can be considered a safe and effective dietary herbal Supplement to reduce stress and improve sleep quality.
Cost analysis study of price variation among the various brands of proton pump inhibitors available in Benghazi-Libya
(Medip Academy, 2024-08) Mohamad, K. A.; Alhallouji, O. S.; Alabbar, I. H.; Alfitori, A. M.; Sharif, S. I.
Background: A large proportion of patients in developing countries have to pay out of pocket for their medications. The prices of different brands of the same medications vary considerably and may vary from one community pharmacy to another. This study was undertaken to evaluate the variation in costs of proton pump inhibitors (PPI) and histamine H2-receptor antagonists available in Libya. Methods: Prices of various brands of PPI and various formulations were collected from four community pharmacies in the city of Benghazi. Both cost ratio and percentage variation were calculated and compared for various brands of the same strength and number of tablets, capsules, injections, or syrups. Results: The highest cost ratio and percentage price variation were found with omeprazole 20 mg, followed by omeprazole 40 mg. Other significant cost variations (>100%) were seen with pantoprazole 40 mg, Downoprazol (omeprazole + sodium bicarbonate) 40 mg, and esomeprazole 40 mg. Ampoules of omeprazole, cimetidine, and ranitidine had cost ratios of 1:1.7, 1:1.7, and 1:1.8, and cost variation ratios of 71.4, 66.7, and 75, respectively. Variations in prices of PPI and histamine H2 antagonists from the same manufacturer between different community pharmacies were common. The highest percentage cost variation (100) was seen with omeprazole 20 mg. Conclusions: Due to political instability, the prices of all drugs are controlled by importing private companies and the owners of community pharmacies instead of governmental authorities, that leads to cost variations. Therefore, the health authorities exert strict control on pricing of medications.
Efficacy and safety of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in Indian paediatric patients with common cold: an active post-marketing surveillance study
(Medip Academy, 2024-08) Kiran, M. D.; Pawaskar, L. J.; Waghambare, P. D.; Singh, A. V.
Background: The common cold, mainly caused by viruses, brings discomfort to children with symptoms like sneezing, congestion, runny nose, and sore throat. As no specific antiviral treatments are available to relieve common cold symptoms, it is typically managed using decongestants, antihistamines, and antipyretics. This study aims to assess the safety and efficacy of a fixed-dose combination (FDC) of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in children aged 2 to 12 years with common cold. Methods: This non-randomized, open-label, non-comparative, active post-marketing surveillance (PMS) study was conducted across multiple centres in India, involving 417 patients. The study assessed efficacy using the total symptom score (TSS) scale over 5 days with visits on days 1, 3, and 5. Safety was evaluated based on adverse events reported by patients on days 3 and 5 of the trial. Results: Initially, 417 patients were enrolled in the active PMS, of which 309 completed the study. The mean TSS showed a notable decrease from 8.95 at visit 1 to 0.19 at visit 3, depicting a significant reduction i.e., 97.90% as compared to baseline. At visit 1, most patients (95.79%) exhibited severe symptoms, whereas by visit 3, 83.82% were symptom-free, with only 16.18% experiencing mild symptoms. Conclusions: This active PMS study examined the safety and efficacy of an FDC of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in treating common cold in children in India. The findings indicate a significant reduction in symptoms, with many patients becoming symptom-free by the third visit, demonstrating its efficacy and safety.
The impact of anti-tumor necrosis factor alpha drugs on lipid profile of patients with rheumatoid arthritis or seronegative spondyloarthropathy
(Medip Academy, 2024-02) Mohammadi-Kebar, Y.; Zandian, H.; Khazdooz, Z.
Background: Inflammatory arthritis is associated with abnormal levels of lipoprotein. The cause is considered to be inflammation. Recently, the use of biologic drugs in the treatment of inflammatory arthritis, especially rheumatoid arthritis (RA) and seronegative spondyloarthropathy, has increased. There are different results of the effect of these drugs on fat profile. Evaluate the impact of anti-tumor necrosis factor (TNF) alpha drugs on lipid profile of patients with RA or seronegative spondyloarthritis. Methods: In this cross-sectional descriptive study, 50 patients with rheumatoid arthritis or seronegative spondyloarthritis, who were candidates for TNF alpha treatment, were included in the study. After obtaining written consent, a checklist was completed for all patients including demographic information such as age, sex, height, weight, place of residence, level of education, type of disease, and lipid profile test results including total cholesterol, triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL) were recorded. Then the patients were treated and evaluated for fat profile after 3, 6, 9 months after receiving the relevant treatment regimen. The test results were recorded in checklists. After completing the study, the data were entered into the statistical package for the social sciences (SPSS) 24 software and analyzed. Results: The mean age of patients was 46.38±14.33 years. 54% of patients were female. 54% of patients had rheumatoid arthritis. 62% of patients were treated with Sinora. The results of this study showed that serum triglyceride levels increased during the study period and this increase was statistically significant but the trend of changes in serum cholesterol, HDL and LDL levels was not statistically significant. However, serum LDL levels measured in the ninth month increased significantly compared to the initial measurement. Conclusions: Results showed that there was a significant relationship between lipid profile changes and anti-TNF alpha consumption. Although decreased inflammation appears but other mechanisms may be involved in dyslipidemia.
Aframomum subsericeum and Aframomum alboviolaceum leaf essential oils exhibit testosterone antagonistic and oestrogen synergic effects in male Wistar rats: potential candidates for prostate cancer treatment
(Medip Academy, 2024-08) Chiara Nange, A.; Djiogue, S.; Bruno, Dupon, A. A.; Berlise, B. Y.; Kamga, K. S.; Dieudonné, N.
Background: Aframomum species are routinely used as spices in many traditional Cameroonian meals due to their sweet fragrance. Many species of the Aframomum species are also used to treat cancer, pain, arthritis, and stomach disorders. This work was performed to determine the chemical composition, antiandrogenic, and estrogenic properties of Aframomum subsericeum and Aframomum alboviolaceum leaf essential oils. Methods: The chemical components of A. subsericeum and A. alboviolaceum essential oils were identified by gas chromatography-mass spectroscopy. The anti-androgenic and estrogenic properties were investigated in vivo in physically and chemically castrated Wistar rats, respectively. Results: Fifteen compounds versus nine compounds were identified in A. subsericeum and A. alboviolaceum essential oils, respectively. The main compounds of Aframomum subsericeum were cyclohexene, 1-methyl-4-(1-methylethylidene) (10.03%), ?-terpine (12.22%), and myrtenyl acetate (8.52%), while those of Aframomum alboviolaceum were ?-terpinene (20.07%), caryophyllene (11.58%), myrtenyl acetate (7.22%), and (1R)2, 6, 6 trimethylbicyclo [3.1.1] hept-2-ene (6.97%). The results of the anti-androgenic test reveal that both A. subsericeum and A. alboviolaceum induced a significant decrease in androgen-dependent organs, especially the prostate and seminal vesicle, at doses of 200 mg/kg and 100 mg/kg. Interestingly, A. alboviolaceum showed oestrogen synergic effects on the above organs. Conclusions: So, this study reveals mainly the presence of diterpenoids in both A. subsericeum and A. alboviolaceum, which are potential candidates for prostate cancer treatment. The in vivo results show that Aframomum leaf essential has antiandrogenic and oestrogen synergic properties, suggesting that the oils could provide a safe natural drug for prostate cancer treatment.

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