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Para avaliar o papel da pregabalina na proteção das náuseas e vômitos induzidos pela quimioterapia, foi realizado um ensaio clínico de fase II, aleatorizado, duplamente cego, controlado por placebo, para investigar se a pregabalina poderia melhorar o controle completo das náuseas e vômitos (desfecho primário). Inscrevemos 82 pacientes virgens de quimioterapia, programados para receber quimioterapia moderadamente e altamente emetogênica. Todos os doentes receberam ondansetron 8mg por via intravenosa, dexametasona 10mg antes da quimioterapia no primeiro dia e, dexametasona 4 mg por via oral, b.d., nos dias dois e três. Os doentes foram distribuídos aleatoriamente para tomar pregabalina 75 mg ou placebo, bd, desde a noite anterior à quimioterapia até ao quinto dia. A resposta completa global não foi estatisticamente significativa entre os grupos (53,7 versus 48,8%, respetivamente, no grupo da pregabalina e no grupo de controlo (P=0,65)). Também não houve diferença estatística significativa durante a fase aguda (primeiras 24 horas) e a fase tardia (24-120h): 80,5% versus 82,9% (P=0,77), 53,7 versus 51,2% (P=0,82), respectivamente. Neste estudo não foi identificada ação da pregabalina na prevenção de náuseas e vômitos induzidos por quimioterapia. Número de registo no Clinicaltrial.gov: NCT04181346.
To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.
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Abstract Background Chronic low back pain (CLBP) is a global health problem, and gabapentin and pregabalin are often used in the treatment of patients without associated radiculopathy or neuropathy. Therefore, determining their efficacy and safety is of enormous value. Objective To examine the efficacy and safety of using gabapentin and pregabalin for CLBP without radiculopathy or neuropathy. Methods We performed a search on the CENTRAL, MEDLINE, EMBASE, LILACS, and Web of Science data bases for clinical trials, cohorts, and case-control studies that evaluated patients with CLBP without radiculopathy or neuropathy for at least eight weeks. The data were extracted and inserted into a previously-prepared Microsoft Excel spreadsheet; the outcomes were evaluated using the Cochrane RoB 2 tool, and the quality of evidence, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Results Of the 2,230 articles identified, only 5 were included, totaling 242 participants. In them, pregabalin was slightly less efficacious than amitriptyline, the combination of tramadol/acetaminophen, and celecoxib, and pregabalin added to celecoxib showed no benefit when compared to celecoxib alone (very low evidence for all). On the other hand, although one study with gabapentin did not support its use in a general sample of patients with low back pain, another found a reduction in the pain scale and improved mobility (moderate evidence). No serious adverse events were observed in any of the studies. Conclusion Quality information to support the use of pregabalin or gabapentin in the treatment of CLBP without radiculopathy or neuropathy is lacking, although results may suggest gabapentin as a viable option. More data is needed to fill this current gap in knowledge.
Resumo Antecedentes Dor lombar crônica (DLC) é um problema de saúde global, e a gabapentina e a pregabalina são frequentemente utilizadas no tratamento de pacientes sem radiculopatia ou neuropatia associada. Por isso, determinar sua eficácia e segurança é de enorme valor. Objetivo Examinar a eficácia e segurança do uso de gabapentina e pregabalina no tratamento da DLC sem radiculopatia ou neuropatia. Métodos Realizamos uma pesquisa nas bases de dados CENTRAL, MEDLINE, EMBASE, LILACS e Web of Science por ensaios clínicos, coortes e estudos de caso e controle que avaliassem pacientes com DLC sem radiculopatia ou neuropatia por pelo menos oito semanas. Os dados foram extraídos e inseridos em uma planilha previamente elaborada no programa Microsoft Excel; os desfechos foram avaliados com a ferramenta RoB 2 tool da Cochrane, e a qualidade das evidências, pelo sistema Grading of Recommendations Assessment, Development and Evaluation (GRADE). Resultados Dos 2.230 artigos identificados, apenas 5 foram incluídos, com um total de 242 participantes. Neles, a pregabalina foi ligeiramente menos eficaz do que a amitriptilina, a combinação de tramadol/acetaminofeno, e o celecoxibe, assim como a pregabalina adicionada ao celecoxibe não mostrou benefício em comparação ao uso isolado de celecoxibe (evidência muito baixa para todos). Quanto à gabapentina, embora um estudo não respalde seu uso para uma amostra geral de pacientes com lombalgia, outro encontrou redução na escala de dor e melhora da mobilidade (evidência moderada). Nenhum evento adverso grave foi observado nos estudos. Conclusão Há carência de informações de qualidade que sustentem o uso de pregabalina ou gabapentina no tratamento da DLC sem radiculopatia ou neuropatia, embora resultados possam sugerir que a gabapentina é uma opção viável. Mais dados são necessários para preencher essa atual lacuna no conhecimento.
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Background: Anxiety is a widespread disorder that approximately 18% of the population experience at some stage in their lives. Pain is a common stimulus that induces anxiety in both animals and human beings. Combination of drugs with good anti-anxiety and analgesic effect can be used for the treatment of chronic pain induced anxiety, post-operative, and procedure-related pain-induced anxiety. Aims and Objectives: The study was conducted to evaluate the anxiolytic activity of combination of gabapentin with tramadol, pregabalin with tramadol compared to standard fluoxetine, in elevated plus maze (EPM) and light-dark arena (LDA) models of anxiety in Wistar albino rats. Materials and Methods: Twenty-four male or female albino Wistar rats from Central Animal House, MRMC, Kalaburagi, were utilized. Fluoxetine 10 mg/kg, gabapentin 30 mg/kg, tramadol 30 mg/kg, and pregabalin 30 mg/kg were used. Eddy’s hot plate method used for inducing anxiety. EPM and LDA models were used to study the effect of drugs in reducing the pain and anxiety. Results: The present study showed that the exposure to hot plate induces pain, creates anxiety, and reduces locomotor and explorative activity among the rats when exposed to hot plate. There was reduction in anxiety after drug administration, in fluoxetine and gabapentin with tramadol groups with >75% increase in entry into the light chamber or open arm at least once or more during the time period of 5 min when compared to hot plate post-exposure readings. Whereas in pregabalin and tramadol group, it was observed that 25% increase in entry of rats into open arm at least once during the time period of 5 min and 25% decrease in entry of rats into light chamber as compared to those rats after exposure to hot plate. Conclusion: Our study has demonstrated that tramadol, pregabalin, and gabapentin have got analgesic as well as anti-anxiety effects in rats when given in combination. All these experimental data, together with the previous experimental studies and the results reported in this work, suggest that combination of these drugs could be more effective in treating anxiety-related disorders such as chronic pain, pain-induced anxiety, post-operative, and procedure-related pain-induced anxiety with minimal side effects. Further dose ranging studies and models might be necessary to better understand the effects of these drugs in combination.
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Objective To evaluate the short-term efficacy and quality of life of primary hepatocellular carcinoma patients after radiotherapy and pregabalin treatment for neuropathic pain with bone metastasis. Methods 32 patients with primary hepatocellular carcinoma bone metastases were treated with radiotherapy combined with pregabalin treatment.Then, we prospectively studied the analgesic efficacy for neuropathic pain and quality of life, used the brief pain inventory and douleur neuropathique 4 questionnaire (DN4) to evaluate pain at baseline, one and two months after radiotherapy, assessed pain response using the international consensus endpoint definition of bone metastasis, and used European Organization for Research and Treatment of Cancer Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30) and bone metastasis module (QLQ-BM22) for quality of life assessment. Results One and two months after radiotherapy, the average DN4 score of neuropathic pain decreased, and the objective pain relief rates were 62.8% and 68.6%, respectively.The physical, emotional, social, and role functional scores of EORTC QLQ-C30 functional scale significantly increased in the first month after radiotherapy.Symptom scale of pain (P=0.015), insomnia (P=0.035), and loss of appetite (P=0.022) improved, and fatigue was aggravated (P < 0.05).Two months after radiotherapy, the mean overall health score and all functional scale scores significantly increased than those at baseline.The scores of all symptom scales decreased, except fatigue, constipation, and financial difficulties (P < 0.05).In addition, pain responders showed significant improvement in emotional function (P=0.025) and physical function (P=0.029) in the functional scale and in pain (P=0.014) and fatigue (P=0.035) in the symptom scale.The QLQ-BM22 score showed that the painful sites (P=0.021) and pain characteristics (P=0.04) of the responders significantly improved compared with those of nonresponders two months after radiotherapy. Conclusion Radiotherapy combined with pregabalin can relieve neuropathic pain caused by bone metastasis from primary hepatocellular carcinoma and greatly improve the quality of life, particularly in pain responders.
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Introduction: Antiepileptics and antidepressant medications are known for managing neuropathic pain. We aim to compare the effects of pregabalin with low‑dose amitriptyline and gabapentin with low‑dose amitriptyline in managing neuropathic pain in cancer patients undergoing palliative care. Materials and Methods: We conducted our study on 160 cancer patients who were having neuropathic pain and were undergoingpalliative care treatment in our institute. It was a hospital‑based, randomized, tertiary cancer center‑based observational study. After taking approval from the institutional ethics committee and taking written informed consent from patients, the patients were divided into two groups and the effect of medicines on incidence of neuropathic pain was observed; the incidence of burning sensation and the incidence of adverse effects of medications were also analyzed. Statistical analysis was done using paired t‑test and SPSS version 20 software. Results: The onset of relief in pain was earlier in the pregabalin group as compared to the gabapentin group. There was more reduction in a burning sensation in the pregabalin group as compared to the gabapentin group. The incidence of headaches was the same in both groups. Nausea and vomiting were more in the pregabalin group but the overall difference in adverse effects was not statistically significant (P > 0.05) Conclusions: In the management of neuropathic pain in cancer patients who are undergoing palliative care, a combination of pregabalin with amitriptyline was found to be more effective in pain relief than gabapentin with amitriptyline.
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Background: Diabetes is a form of chronic illness requiring a collective treatment approach such as glycemic monitoring, self-management, education, and adequate support to prevent the occurrence of acute complications. One of the most frequently occurring complication in Type 2 diabetes has been diabetic peripheral neuropathy (DPN) or distal symmetrical polyneuropathy. Newer anticonvulsants such as Gabapentin and Pregabalin have been proven beneficial in patients with peripheral neuropathic pain. Aims and Objectives: The aim of the study was to compare the efficacy of Gabapentin and Pregabalin in relieving the pain in patients of DPN. Materials and Methods: This is an open label, randomized, multi-dose, two treatment, single-period, single-center, parallel study comparing Gabapentin and Pregabalin for efficacy in patients suffering with DPN using visual analog scale, daily sleep interference score, patient’s global impression of change, and clinician’s global impression of change. Results: One hundred patients were randomized into two groups and the treatment started as and when they reported to the hospital. Statistical analysis was done in SPSS version 23 and intent to treat principle is employed for analysis. Results were distributed in demographics and treatment comparison. Decreased sleep interference and global impression of change reported during first visit, in which participants under Pregabalin group had better improvement score comparing Gabapentin group alone was found statistically significant (P < 0.05). Conclusion: Our study revealed that Pregabalin is found to be more efficacious when compared to Gabapentin among Type 2 diabetes mellitus patients with painful peripheral neuropathy. Hence, we conclude that Pregabalin provided significant improvement in pain relief and other perspectives.
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Background: We assessed utilization patterns, profile of diagnoses, and fixed dose combination (FDC) with pregabalin in patients with various indications. Aims and Objectives: The aim of the study was to estimate the prevalence of pregabalin prescribing pattern among the patients attending the various outpatient departments (OPDs) of a tertiary care hospital at Trichy in South India. Materials and Methods: A hospital-based prospective observational study was planned and conducted over a period of 12 months. Patients who attended the various OPDs were included in the study. Prescriptions were collected from the respective consulting departments and pharmacy. Results: A total of 2490 patients prescription were analyzed. There was female preponderance (54.22%). Majority (45.74%) were in the age group of 51� years. General medicine was the highest (41.36%) visited patients. Neuropathic pain was the most prevalent disease condition among the various age group (57.67%), and predominant between 40 and 65 years (55.86%). Total of 12,220 drugs were prescribed, most frequently prescribed drugs belong to category of plain pregabalin 75 mg (53.37%) with female predominance, with maximum prescription from the medicine department (40%). Among the FDC, pregabalin 75 mg with nortriptyline 10 mg was the highest prescribed drug by the orthopedic department (41%). Extended release pregabalin 75 mg (13.04%) and low dose pregabalin 50 mg (2.19%) were also prescribed in our study. Conclusion: The prevalence of pregabalin prescription was maximum to neuropathic pain followed by radicular pain, trigeminal neuralgia, claudication, and herpetic neuralgia. Plain pregabalin 75 mg is preferred by most of the departments, few preferred extended release of 75 mg. Among the various FDC, pregabalin 75 mg with nortriptyline 10 mg and with methylcobalamine 750 mcg were prescribed by many departments.
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SUMMARY OBJECTIVES: This study aimed to investigate the effects of duloxetine and pregabalin primarily on pain and functional status in patients with knee osteoarthritis and secondarily on quality of life, depression, anxiety, and sleep disturbance. METHODS: A total of 66 patients with knee osteoarthritis were randomized to use duloxetine or pregabalin. Patients were evaluated by Visual Analog Scale, Neuropathic Pain Diagnostic Questionnaire, Western Ontario and McMaster University Osteoarthritis Index, Short Form-36, Beck Depression Inventory, Beck Anxiety Inventory, and Pittsburg Sleep Quality Index before the treatment and after 4 and 12 weeks of treatment. RESULTS: Improvements occurred in Visual Analog Scale, Neuropathic Pain Diagnostic Questionnaire, Western Ontario and McMaster University Osteoarthritis Index, Short Form-36 (with an exception of the mental health subgroup scores in duloxetine-treated group), Beck Depression Inventory, and Beck Anxiety Inventory scores in both groups from 4 weeks after baseline. Pittsburg Sleep Quality Index total scores and SF-36 mental health subgroup scores started to improve on the 4th and 12th weeks in pregabalin- and duloxetine-treated groups, respectively. CONCLUSION: Osteoarthritis pain, a complex outcome with nociceptive and neuropathic components, leads to central sensitization in a chronic phase. Using centrally acting drugs in the control of pain and associated symptoms would increase the probability of treatment success.
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ABSTRACT BACKGROUND AND OBJECTIVES: Mastectomy with lymphadenectomy is a surgery associated with moderate to severe pain in the immediate postoperatory. Several safe adjuvant drugs that provide good analgesia with few adverse effects have been researched. Pregabalin and magnesium sulfate are drugs that promote analgesia with few adverse effects. The objective of the present study was to evaluate the analgesic effect of pregabalin and magnesium sulfate in the postoperatory of mastectomy with axillary lymphadenectomy. METHODS: Double-blinded, randomized study involving 80 patients submitted to mastectomy with axillary lymphadenectomy under general anesthesia. The patients were distributed into 4 groups: Control (CG, did not receive the proposed adjuvant drug); Magnesium+Placebo (MG, received magnesium sulfate during anesthesia); Pregabalin+Magnesium (P+MG, received magnesium added to pregabalin 150 mg before and 12 h after surgery); and Pregabalin+Placebo (PG, received pregabalin). All patients completed the Self-Report Questionnaire 20 (SRQ-20) to screen for possible mental disorders and had their physical status monitored at 1 h, 12 h, and 24 h after surgery, through anamnesis, pain questionnaire, opioid consumption, and presence of complications and/or adverse events such as nausea, vomiting, and sleepiness. Randomization was performed using sealed opaque envelopes without the knowledge of the anesthesiologist (researcher) and the patient. RESULTS: For each group, twenty patients were randomized, which were analyzed at the end of the study. The number of patients presenting absent/mild pain in P+MG was significantly higher than in CG, MG and PG after one hour. After 12 hours, P+MG and PG had more patients with absent/mild pain than CG and MG. At 24 hours postoperatively, all patients in all evaluated groups had no moderate/severe pain. There was no diference in the frequency of patients presenting nausea or vomiting, nor in the scores of the sleep evaluation after surgery in the four groups. CONCLUSION: The combination of magnesium sulfate and pregabalin provided satisfactory analgesia in the first hour after mastectomy with axillary lymphadenectomy. Nevertheless, magnesium sulfate isolated presented no analgesic beneft for the patients, and pregabalin isolated was only slightly effective at the first hour after surgery.
RESUMO JUSTIFICATIVA E OBJETIVOS: Mastectomia com linfadenectomia é uma cirurgia que causa dor moderada ou intensa no pós-operatório imediato. Muitos fármacos adjuvantes, seguros, que promovem boa analgesia e com poucos efeitos adversos têm sido pesquisados. A pregabalina e o sulfato de magnésio são fármacos que promovem analgesia com poucos efeitos adversos. O objetivo deste estudo foi avaliar o efeito analgésico da pregabalina e do sulfato de magnésio no pós-operatório de mastectomia com linfadenectomia axilar. MÉTODOS: Estudo randomizado e duplo-cego envolvendo 80 pacientes submetidas à mastectomia com linfadenectomia axilar sob anestesia geral. As pacientes foram divididas em quatro grupos: Controle (GC, não receberam o fármaco adjuvante proposto); Magnésio+Placebo (GM, receberam sulfato de magnésio durante a anestesia); Pregabalina+Magnésio (GP+M, receberam magnésio adicionado a pregabalina 150 mg antes e 12 h após a cirurgia); e Pregabalina+Placebo (GP, receberam a pregabalina). Todas as pacientes responderam o Self-Report Questionnaire 20 (SRQ-20) para rastrear possível transtorno mental e foram seguidas, monitorando o estado físico 1h, 12h e 24h após a cirurgia, através de anamnese, questionário de dor, consumo de opioides e presença de complicações e/ou eventos adversos como náusea, vômito e sonolência. A randomização foi realizada por meio de envelopes opacos e selados sem o conhecimento do anestesiologista (pesquisador) e do paciente. RESULTADOS: Foram randomizadas 20 pacientes para cada grupo, as quais foram analisadas ao fim do estudo. O número de pacientes apresentando dor ausente/leve no GP+M foi significantemente maior que nos GC, GM e GP após uma hora. Após 12 horas, GP+M e GP apresentaram maior número de pacientes com dor ausente/leve que GC e GM. Em 24 horas do pós-operatório, todos os pacientes de todos os grupos avaliados não apresentaram dor moderada/severa. Não houve diferença na frequência de pacientes apresentando náusea ou vômito, nem nos escores da avaliação do sono após a cirurgia nos quatro grupos. CONCLUSÃO: A associação de sulfato de magnésio e pregabalina causa boa analgesia de mastectomia com linfadenectomia axilar na primeira hora do pós-operatório. No entanto, o uso isolado do sulfato de magnésio não trouxe benefício para analgesia nestas pacientes, assim como a pregabalina sozinha se mostrou pouco efetiva na primeira hora de avaliação.
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Abstract Pregabalin, a GABA analogue is used to treat epilepsy and neuropathic pain. The drug poses problems in analytical quantification when estimated at a shorter UV wavelength. The expensive and non-repetitive reported analytical methods necessitate the utility and development of an accurate, precise, repetitive, simple and highly sensitive colorimetric method for pregabalin in solution as well as sustained release mini matrices. Pregabalin (having primary amino group) was derivatized at alkaline pH of mixture with optimized ninhydrin solution at ambient temperature (25oC). The ninhydrin-pregabalin derivatized complex (Ruhemann's Purple) was analyzed for drug concentration at absorption maximum (λmax) of 570nm. The linearity was observed in the concentration range of 5-150 µg/mL with coefficient of correlation, 0.998. The developed analytical method was validated according to ICH guidelines and proved to be highly sensitive (LOD 0.917µg/mL, LOQ 3.055µg/mL), with good inter-day as well as intra-day accuracy and precision as 4.65% and 3.75%, respectively. The proposed method was proved to be a simple, sensitive, precise and accurate for the estimation of the minute concentrations of pregabalin in pure form and the developed formulations. Results verified that the proposed method could determine pregabalin at the ambient temperature without requiring high temperatures used in the existing methods. It was concluded that developed method was easier and more suitable for analysis of pregabalin in quality control of commercial preparations
Subject(s)
Temperature , Pregabalin/analogs & derivatives , Ninhydrin/analysis , Pharmaceutical Preparations/analysisABSTRACT
【Objective】 To explore the effects of platelet-rich plasma (PRP) injection combined with pregabalin on pain and knee function in knee osteoarthritis (KOA). 【Methods】 A total of 220 patients with KOA in our hospital, between June 2020 and April 2022, were enrolled and randomly divided into observation group (n=110) and the control (n=110). The observation group was given PRP injection combined with pregabalin, while control group was given sodium hyaluronate combined with pregabalin. The clinical curative effect, osteoarthritis index (WOMAC), pain level (VAS), knee function [Lysholm-Ⅱ scale, Rasmussen scale], levels of repair-promoting factors [transforming growth factor-β1 (TGF-β1), bone morphogenetic protein 4 (BMP4), insulin growth factor 1 (IGF-1)], inflammatory factors [interleukin-6 (IL-6), tumor necrosis factor α (TNF-α)], oxidative stress indexes [superoxide dismutase (SOD), nitric oxide (NO)] and blood routine [white blood cell count (WBC), platelet count (Plt)], and the occurrence of adverse reactions in the two groups were compared. 【Results】 The response rate of treatment was higher in observation group than control group [94.55% (104/110) vs 83.64% (92/110), P0.05). There was no significant difference in incidence of adverse reactions between the two groups (P>0.05). 【Conclusion】 PRP injection combined with pregabalin can effectively improve knee function, relieve pain, reduce levels of inflammatory factors and oxidative stress injury, and promote the expressions of repair-promoting factors in KOA patients.
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Objective:To explore the effect of pregabalin on sleep structure in rats with temporal lobe epilepsy induced by pilocarpine.Methods:Twelve adult SD rats (half male and half female) were injected intraperitoneally with pilocarpine to establish a chronic temporal lobe epilepsy model.According to the principle of gender matching, they were divided into model group and pregabalin group, with 6 rats in each group(half male and half female). Another 6 SD rats (half male and half female) were taken as the control group.The skull electrodes were placed in the brain areas of rats to monitor the cerebral electrical activity, then recorded the data after resting for 1 week.Rats in pregabalin group were intraperitoneally injected with 50 mg/kg pregabalin while the rats in model group and control group were intraperitoneally injected with equal volume of normal saline.Fifteen minutes later, video electroencephalogram(EEG) and electromyogram(EMG) of rats in each group were recorded.The recording time was from 10∶00 to 17∶00 for 2 consecutive days.The seizure frequency, EEG and EMG were obtained.SPSS 25.0 was used for data analysis, one-way ANOVA was used for multi group comparison, and Tukey test and Games-Howell test were used for further pairwise comparison.Results:(1)The frequency of seizures in the pregabalin group (0.0(0.0, 1.0)times) were significantly lower than that in the model group(2.5(1.0, 4.8)times)( Z=-3.0, P<0.05). (2)During the 7 h recording period, the analyzed data showed that there were significant differences in the sleep-wake transition frequency, slow-wave sleep(SWS) phase duration, rapid eye movement (REM) sleep phase duration, total SWS time, total REM time and total sleep time among the three groups( F=10.5, 4.1, 13.0, 7.8, 4.4, 9.3, all P<0.05). The frequency of sleep-wake transitions in the pregabalin group ((66.3±18.0) times) and the control group ((87.8±14.1) times) were less than that in the model group ((106.7±20.8) times) (both P<0.05). The duration of SWS phase ((11.2±4.0) min) in pregabalin group was significantly longer than that in model group ((5.9±1.8) min) ( P<0.05), while that in model group was shorter than that in control group ((7.7±1.2) min) ( P<0.05). The duration of REM phase in the model group ((1.9±0.4) min) was shorter than that in the control group ((2.5±0.4) min) ( P<0.05). There was no significant difference in the duration of REM phase between the pregabalin group and the model group ( P>0.05). Within 7 h of observation, the total SWS time ((296.5±37.1) min) and total sleep time ((338.4±33.3) min) in pregabalin group were longer than those in model group ((258.1±38.4) min, (288.9±41.0) min) (both P<0.05). The total REM time ((30.4±11.1) min) and total sleep time ((288.9±41.0) min) in the model group were significantly shorter than those in the control group ((50.2±8.5) min, (339.0±19.6) min) (both P<0.05). Conclusion:Pregabalin alone can reduce seizures and change the sleep structure disorder caused by epilepsy, which is mainly manifested in reducing the number of sleep-wake transitions, prolonging the duration of SWS, increasing sleep duration, increasing SWS and total sleep time and improving sleep quality.
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ABSTRACT Background: Many medical therapies have been tested to deal with urinary stent-related symptoms (USRS). Several preventive and pharmaceutical methods have been already used for better compatibility of stents. However, the existing evidence for pharmacological treatment is still controversial. This study aims to evaluate the effects of pregabalin, solifenacin, and combination therapy on ureteral double-J stent-related symptoms following ureteroscopy and transureteral lithotripsy (TUL). Materials and methods: In a randomized controlled clinical trial, from November 2017 to March 2019, 256 patients who underwent ureteroscopy were enrolled. Patients were randomly divided into four groups including: group A received pregabalin 75mg BID (twice daily), group B received solifenacin 5mg orally once daily, group C received combination of pregabalin and solifenacin and the group D (control) given no drugs. Results: One hundred and fifty-one (58.9%) males and 101 (41.1%) females were enrolled in this study with a mean age of 43.47±7 (p=0.32, p=0.67). USSQ domains score such as urinary symptoms, pain, general condition, work performance, sexual matters and additional problems were significantly differenced during second and fourth week of follow-up among study groups (p <0.0001). In Tukey's multiple comparison test, urinary symptoms (p=0.735), pain (p=0.954) and sexual matters (p=0.080) in second week and work performance in forth week in group B was not significantly better than group D. Only group C in all indexes of USSQ showed significantly beneficial effects over group D (p <0.0001). Conclusion: Combination therapy of pregabalin and solifenacin has a significant effect on stent-related symptoms and is preferred over monotherapy of the respected medications.
Subject(s)
Humans , Male , Female , Adult , Ureter , Stents/adverse effects , Solifenacin Succinate/therapeutic use , Quality of Life , Pregabalin/therapeutic use , Middle AgedABSTRACT
A Simple, rapid, specific, accurate, economical and precise UV spectrophotometric and RP-HPLC methods (inaccordance with ICH guidelines) were developed and validated for determination of Nortriptyline hydrochlorideand Pregabalin in tablet dosage form. The first method was based on Q - absorbance ratio, and absorbances ofboth drugs were determined at 239 nm (λmax of Nortriptyline Hydrochloride) and 235 nm (Iso-absorptive Point)when dissolved in methanol. It is found that Pregabalin does not have chromophoric group. To be UV-sensitive,it was compulsory to introduce chromophoric group in Pregabalin structure and make it UV-sensitive. This wasachieved by converting the primary amine group of Pregabalin through reaction with benzoyl chloride to formbenzoylated derivative of Pregabalin. Benzoylated Pregabalin was determined at 225 nm using UV-visiblespectrophotometer. The second method was based on RP-HPLC. The chromatographic separation was performedon an Inertsil ODS C18 column (250 x 4.6mmx 5 μm) with a mobile phase of 0.56 %w/v Sodium hexane sulphonicacid dissolved in water acetonitrile (50:50 %v/v, pH 4.5 adjusted with Glacial Acetic Acid) at flow rate of 1.0mL/min with DAD detection wavelength at 210 nm. Retention times of Nortriptyline Hydrochloride andPregabalin were 7.3894 min and 4.0506 min, respectively. Beer-Lambert’s law obeyed the concentration rangeof 2-12 μg/mL for Nortriptyline Hydrochloride and 10-60 μg/mL for Pregabalin. The results indicated that bothspectrophotometric and RP-HPLC methods were linear, accurate, precise and robust with RSD values less than0.2% and % recovery was within the standard limits (99 - 102%).
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ABSTRACT BACKGROUND AND OBJECTIVES: Opioids are drugs used to relieve pain, but may cause increased pain sensitivity, known as opioid-induced hyperalgesia, which adversely affects pain management. This study aimed to check if fentanyl, an opioid widely used in the clinical practice, produces hyperalgesia that can be attenuated by duloxetine, fluoxetine and pregabalin. METHODS: Thirty male Wistar rats were divided into six groups. The animals in group 1 received 1mL of 0.9% saline solution intraperitoneally (IP) and gavage; group 2 received fentanyl at a dose of 100µg.kg-1 IP and 0.9% saline solution per gavage; groups 3, 4 and 5 received fentanyl at the dose of 100µg.kg-1 IP, and gavage with duloxetine, 40mg.kg-1, fluoxetine, 40mg.kg-1 and pregabalin, 40mg.kg-1, respectively. Under general anesthesia with isoflurane, all animals were submitted to plantar surgical incision. The application of Von Frey filaments assessed hyperalgesia at the second hour, one, three, five and seven days after treatment. RESULTS: Two hours after the procedure, no differences were observed between G1 and G2, although G3, G4, and G5 showed less hyperalgesia. On day one and day three, a greater hyperalgesic effect was observed in G2 when compared to G1, G3, G4 and G5. On day five, there was a hyperalgesic effect on G2, and on day seven, there were no differences among the groups. CONCLUSION: The results suggest that fentanyl induces hyperalgesia and the efficacy of duloxetine, fluoxetine, and pregabalin in reducing it.
RESUMO JUSTIFICATIVA E OBJETIVOS: Opioides são fármacos utilizados para o alívio da dor, porém, podem causar aumento da sensibilidade dolorosa, denominada hiperalgesia induzida por opioides, que afeta negativamente o tratamento da dor. O objetivo deste estudo foi avaliar se o fentanil, opioide amplamente utilizado na prática clínica, produz hiperalgesia que pode ser atenuada pela duloxetina, fluoxetina e pregabalina. MÉTODOS: Trinta ratos Wistar machos, foram divididos em 6 grupos. No grupo 1, os animais receberam 1mL de solução fisiológica (SF) a 0,9% por via intraperitoneal (IP) e por gavagem; no grupo 2, fentanil na dose de 100µg.kg-1 IP e SF a 0,9% por gavagem; nos grupos 3, 4 e 5 os animais receberam fentanil na dose de 100µg.kg-1 IP e, por gavagem, receberam respectivamente duloxetina, 40mg.kg-1, fluoxetina, 40mg.kg-1 e pregabalina, 40mg.kg-1. A avaliação da hiperalgesia e sua atenuação foi feita pela aplicação de filamentos de Von Frey, na 2ª hora e nos dias 1, 3, 5 e 7, após o tratamento. RESULTADOS: Na 2ª hora pós-procedimento não foram observadas diferenças entre G1 e G2, entretanto, G3, G4 e G5 se mostraram com menor hiperalgesia. No 1º e 3º dias foi observado maior efeito hiperalgésico em G2 quando comparado com G1, G3, G4 e G5. No 5º dia foi observado efeito hiperalgésico no G2, e no 7º dia não houve diferenças entre os grupos. CONCLUSÃO: Os resultados sugerem que o fentanil induz hiperalgesia e eficácia da duloxetina, fluoxetina e pregabalina na sua redução.
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Objective: To develop an HPLC method for simultaneous determination of pregabalin, methylparaben and propylparaben in pregabalin oral solution. Methods: The analytical column was the CPACELL PAK C18 column(250 mm×4.6 mm, 5 μm). The mobile phase A was 25 mmol/L potassium dihydrogen phosphate solution(previously adjusted to pH 6.7 with concentrated ammonia)and the mobile phase B was methanol. Gradient elution was carried out at a flow rate of 1.0 ml/min. The detection wavelength was set at 210 nm for all analytes. The column temperature was maintained at 30℃, and the injection volume was 20 μl. Results: The linear ranges for pregabalin, methylparaben, propylparaben were 1000.45-4001.78, 65.21-260.84, and 8.17-32.68 μg/ml(all r≥0.9995), respectively. Their average recoveries were 100.17%(RSD=1.06%), 100.30%(RSD=0.56%), and 99.92%(RSD=0.28%)(n=9), respectively. Conclusion: The established HPLC method is simply operable, efficient, accurate and reproducible, which could be used for the quantitative determination of pregabalin and paraben preservatives in pregabalin oral solution.
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Objective: To evaluate the in vitro release degree, release mechanism and dose dumping of test tablet and reference tablet Lyrica® CR. The in vivo pharmacokinetics of the test tablet and the reference tablet were further investigated using the Beagle dog as a model. Methods: With Pfizer's pregabalin sustained-release tablets(Lyrica® CR)as the reference listed drug, the in vitro release behavior was evaluated using an automatic dissolution apparatus, and similarity factor(f2)method was used to analyze the in vitro release similarity between the reference tablet and the test tablet. The in vitro release equation was fitted to evaluate the drug release mechanism. Study was conducted on dose dumping of preparations based on the relevant guiding principles of the United States, Europe and China. Finally, the pharmacokinetic parameters of the test tablet and the reference tablet in Beagle dogs were compared. Results: The f2 of the test tablet and the reference tablet were more than 80 in all five release media, and there was no sudden release in the release medium containing ethanol. The pharmacokinetic parameters of the reference tablet and the test tablet were as follows: The Tmax was(6.00±2.19)and(4.00±2.19)h, the Cmax was(19.35±11.43)and(17.25±7.77)μg/ml, and the AUC0-t was(340.37± 220.66)and(281.65 ± 196.25)h•μg/ml for the reference tablet and the test tablet, respectively. Conclusion: In this study, the release curve of the test tablet was similar to that of the reference tablet in the five media. The drug was released slowly without sudden release, and the release mechanism in vitro was similar. There was no significant difference in pharmacokinetic parameters between the test tablet and the reference tablet in beagle dogs, and the relative bioavailability was more than 80%.
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@#To assess the efficacy and safety of pregabalin during short-term treatment in adults with neuropathic pain. We searched the PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and Clinical Trials databases. Twelve eligible articles were finally selected. Efficacy outcomes included change in Daily Pain Rating Scale score (DPRS; 0 = ‘no pain’ to 10 = ‘worst possible pain’) and sleep interference score (0 = ‘pain does not interfere with sleep’ to 10 = ‘completely interferes’). Safety was based on adverse events, serious adverse events (SAEs) and the incidence of treatment emergent adverse events (TEAEs) .The authors used the Cochrane Collaboration’s Risk of Bias Tool to assess the risk of bias in included trials. Review Manager 5.3 was used for all statistical analyses. Data from 12 articles including 3,169 patients (pregabalin, n = 1,677; placebo, n =1,492) were analyzed. Mean changes in the daily pain rating scale score [MD=-0.65, 95%CI(-0.88,-0.41), P<0.001] and daily sleep interference score in patients that received pregabalin were compared to those that received placebo [MD=-0.81, 95%CI(-1.16,-0.46), P<0.001]. The incidence of any TEAE was significantly increased in patients that received pregabalin [OR=1.70, 95%CI (1.44,2.01), P<0.001]. Serious adverse events (SAEs) rate in the pregabalin group was higher than the placebo group [OR=2.09, 95%CI (1.49,2.93), P<0.001], while there was no significant difference in the incidence rate of discontinuation [OR=1.29, 95%CI (0.79,2.11), P = 0.31]. Comparative results revealed pregabalin (150-600 mg/day) significantly reduced the symptoms of neuropathic pain in adults and its safety was acceptable
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Pregabalin can reduce the release of multiple neurotransmitters by acting on the voltagegated calcium channel of the nervous system.It is currently widely used in a variety of diseases,including neuropathic pain,generalized anxiety disorder,epilepsy and so on.In dermatology department,pregabalin also has a therapeutic effect on postherpetic neuralgia,prurigo nodularis,uremic pruritus,nerve-related pruritus and mentally relevant pruritus.
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We experienced a patient whose trigeminal neuralgia disappeared after treatment with keishikaryojutsubuto and maobushisaishinto. A 77-year-old man developed excruciating pain by a cold wave. The patient received Kampo medicine classified for treating coldness in addition to pregabalin. Ten days later, the patient was relieved of the excruciating pain. It was suggested that the synergistic effect between Kampo medicine and Pregabalin could relieve the pain.