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A Pharmacovigilance Study of Covishield in a Tertiary Care Teaching Hospital in Tamil Nadu 泰米尔纳德邦三级护理教学医院Covishield的药物警戒研究
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_63_21
T. Goldlin, S. Kalyanaraman, M. Ravichandran, J. Ramya
Objective: To study the adverse events following immunization (AEFI) with Covishield, a coronavirus disease– 2019 (COVID-19) vaccine. Materials and Methods: A prospective observational study was conducted among 422 Covishield vaccinees based on the inclusion and exclusion criteria after the institutional ethics committee approval. They were followed up at the end of 1 and 2 weeks following the first dose of Covishield vaccine, and the details of adverse events were collected. AEFIs were classified using system organ classification, World Health Organization-Uppsala Monitoring Center (WHO-UMC) causality assessment, AEFI causality assessment, and Modified Hartwig Severity Scale. Various classifications of AEFI were analyzed using descriptive statistics. ANOVA and independent t-test were used for age group and gender comparison of the duration and number of AEFI, respectively. Results: Around 625 AEFIs were reported by 422 vaccinees. Majority of the vaccinees (62.8%) developed adverse events on the day of vaccination. The mean duration of AEFI was 2.52 ± 0.871 days. On WHO-UMC causality assessment, 98.08% were found to be probable, 1.12% possible, and 0.8% unclassifiable. AEFI causality assessment revealed 98.88% vaccine product-related reactions and 1.12% anxiety-related reactions. Regarding the severity, 83.52% of AEFIs were mild and 16.32% were moderate. On comparison of mean duration of AEFI (P = 0.298) and mean number of AEFI (P = 0.569) between different age groups, no statistical significance was observed. Conclusion: The majority of AEFIs reported in this study were mild to moderate in severity for a short duration. The protection offered against the deadly disease and its complication potentially outweighs the mild AEFIs or inconvenience caused by them. Hence, covid-19 vaccination is an important tool to break the pandemic chain.
目的:研究2019冠状病毒病(新冠肺炎)疫苗Covishield免疫(AEFI)后的不良事件。材料和方法:在机构伦理委员会批准后,根据纳入和排除标准,对422名Covishield疫苗接种者进行了前瞻性观察性研究。他们在接种第一剂Covishield疫苗后的1周和2周结束时进行了随访,并收集了不良事件的详细信息。使用系统器官分类、世界卫生组织-ppsala监测中心(WHO-UMC)因果关系评估、AEFI因果关系评估和改良Hartwig严重程度量表对AEFI进行分类。使用描述性统计分析了AEFI的各种分类。ANOVA和独立t检验分别用于年龄组和性别的AEFI持续时间和数量比较。结果:422名接种者报告了约625例AEFI。大多数接种者(62.8%)在接种当天出现不良事件。AEFI的平均持续时间为2.52±0.871天。在WHO-UMC因果关系评估中,98.08%是可能的,1.12%是可能,0.8%是不可分类的。AEFI因果关系评估显示98.88%的疫苗产品相关反应和1.12%的焦虑相关反应。就严重程度而言,83.52%的AEFI为轻度,16.32%为中度。在比较不同年龄组之间的平均AEFI持续时间(P=0.298)和平均AEFI数量(P=0.569)时,没有观察到统计学意义。结论:本研究中报告的大多数AEFI的严重程度为轻度至中度,持续时间短。针对这种致命疾病及其并发症提供的保护可能超过轻度AEFI或由此带来的不便。因此,新冠肺炎疫苗接种是打破疫情链的重要工具。
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引用次数: 8
Vancomycin-Induced Neutropenia with Fever 万古霉素所致嗜中性粒细胞减少伴发热
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_84_21
S. Swain, Mouna B Manjunath, P. Sethi
Vancomycin is a glycopeptide antibiotics acts by inhibiting cell well and is used for the treatment of resistant Gram-positive bacteria. Vancomycin-induced fever with neutropenia is not commonly encountered in our clinical practice, it can lead to diagnostic dilemmas during the course of management. We report the case of a 43-year-old female with infective endocarditis of the aortic valve, who was started empirically on vancomycin and ceftriaxone. She later developed fever with neutropenia following 2 weeks of intravenous antibiotics. This was attributed to the rare adverse effect of vancomycin, after further investigating and ruling out all other possible etiologies. After discontinuing vancomycin, the symptoms resolved rapidly. Although the exact mechanism of the fever and neutropenia is not known, many researchers believe it to be immune mediated.
万古霉素是一种糖肽类抗生素,通过抑制细胞发挥良好的作用,用于治疗耐药革兰氏阳性菌。万古霉素引起的发热伴中性粒细胞减少症在临床上并不常见,它在治疗过程中会导致诊断困境。我们报告的情况下,43岁的女性感染性心内膜炎的主动脉瓣,谁是开始经验万古霉素和头孢曲松。静脉注射抗生素2周后,患者出现发热伴中性粒细胞减少。在进一步调查并排除所有其他可能的病因后,这归因于万古霉素罕见的不良反应。停用万古霉素后,症状迅速消失。虽然发热和中性粒细胞减少的确切机制尚不清楚,但许多研究人员认为这是免疫介导的。
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引用次数: 0
Aceclofenac-Induced Drug Reaction with Eosinophilia and Systemic Symptoms Syndrome 乙酰氯芬酸诱导的嗜酸性粒细胞增多和全身症状综合征的药物反应
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_80_21
S. Sah, B. Shakya, Atiqulla Shariff, M. Babu, Subramanian Ramaswamy, M. Ramesh, P. Niharika, S. N. Dhurappanavar
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a rare but severe and potentially life-threatening systemic clinical condition. We report a case of a 44-year-old female, who developed DRESS syndrome after taking two doses of aceclofenac, paracetamol, and thiocolchicoside fixed-dose combination. The patient presented with maculopapular rashes, itching, fever, pedal edema, swelling of the face and lips, difficulty in swallowing, loose stools, and vomiting for 4 days following drug intake. Laboratory and histopathological investigations supported the diagnosis following RegiSCAR criteria. The DRESS syndrome in this patient was definite as per Naranjo's adverse drug reaction probability scale. The patient was adequately managed using systemic corticosteroids, antibiotics, and intravenous fluids. Aceclofenac is the most likely causative agent of DRESS syndrome in this patient. Early detection and withdrawal of the suspected drug along with adequate supportive treatment are the mainstay of management.
药物反应伴嗜酸性粒细胞增多和全身症状(DRESS)综合征是一种罕见但严重且可能危及生命的全身临床疾病。我们报告一例44岁女性,在服用两剂醋氯芬酸、扑热息痛和硫代秋糖苷固定剂量组合后出现DRESS综合征。患者用药后4天出现黄斑丘疹、瘙痒、发热、足部水肿、面部和嘴唇肿胀、吞咽困难、便稀、呕吐。实验室和组织病理学调查支持符合RegiSCAR标准的诊断。根据Naranjo的药物不良反应概率量表确定该患者的DRESS综合征。对患者进行了充分的管理,使用全身皮质类固醇、抗生素和静脉输液。在该患者中,乙酰氯芬酸是最可能引起DRESS综合征的药物。早期发现和停用可疑药物以及适当的支持治疗是管理的主要内容。
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引用次数: 2
Paradoxical Reaction in Lymph Node Tuberculosis Presented as Shoulder Osteomyelitis 淋巴结结核的矛盾反应表现为肩关节骨髓炎
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_61_21
VP Lakshmi, B. Abhinandh, A. Kunoor, T. Mohan, A. Sugunan, Jerry Jose
Paradoxical reactions (PRs) can be viewed as an abnormal immune response toward the anti-tubercular treatment (ATT). It is characterized by clinical worsening of the patient's symptoms and signs following an initial improvement despite definitive treatment with ATT. Tubercular lymphadenitis is the most common extrapulmonary manifestation seen under PR. Other sites of involvement include the pleura, central nervous system, bones, and muscle. Although some paradoxical events may not require any intervention, studies have shown to have good outcomes using glucocorticoid therapy. This case reports a PR that involves tubercular lymphadenitis and osteomyelitis, which showed marked improvement of patient ailment following a 1-month course of oral steroid.
矛盾反应(PRs)可视为抗结核治疗(ATT)的一种异常免疫反应。其特点是患者在接受ATT明确治疗后,症状和体征在最初改善后出现临床恶化。结核性淋巴结炎是PR患者最常见的肺外表现。其他受累部位包括胸膜、中枢神经系统、骨骼和肌肉。虽然一些矛盾的事件可能不需要任何干预,但研究表明使用糖皮质激素治疗有良好的结果。本病例报告了一例涉及结核性淋巴结炎和骨髓炎的PR,患者在口服类固醇治疗1个月后病情明显改善。
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引用次数: 1
Anaphylactic Reaction Following Injection Cefotaxime Sodium 注射用头孢噻肟钠后的过敏反应
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_60_21
Bharat Satish Krishnan, Kavita M. Jaiswal, S. Dudhgaonkar, Latesh B. Raghute
This is a case study of anaphylactic reaction to cefotaxime sodium in a 23-year-old female who underwent a lower segment cesarean section under spinal anesthesia. Cefotaxime sodium, an antibiotic belonging to the class of cephalosporins, was administered intravenously postoperatively for prevention of infection. The patient complained of breathlessness, swelling around both eyes, and pruritus and urticarial rash over her abdomen, legs, and forehead. The case was successfully managed by withholding the medication and treatment of symptoms. According to the WHO-Uppsala Monitoring Centre causality assessment scale, a probable causal relationship between the suspected drug (cefotaxime sodium) and anaphylactic reaction was made. The severity was found to be moderate (Level 3). Although cefotaxime has well established place in surgical prophylaxis, this case study emphasizes on constant observation and meticulous follow-up of patients receiving it in clinical practice as there is possibility of an adverse drug reaction (ADR) which can be life-threatening. Such happenings can add to challenges faced by the treating physician in the present COVID-19 era. Recognizing ADR helps reduce morbidity and mortality. Reporting ADR helps in documentation and education of healthcare professionals.
这是一例23岁女性在脊柱麻醉下接受下段剖宫产时对头孢噻肟钠过敏反应的病例研究。头孢噻肟钠是头孢菌素类抗生素,术后静脉注射预防感染。患者抱怨呼吸困难,双眼周围肿胀,腹部、腿部和前额瘙痒和荨麻疹。该病例通过扣留药物和症状治疗成功控制。根据世界卫生组织-尤普萨拉监测中心因果关系评估量表,对可疑药物(头孢噻肟钠)与过敏反应之间可能存在的因果关系进行了分析。严重程度为中度(3级)。尽管头孢噻肟在外科预防中有着良好的地位,但本病例研究强调在临床实践中对接受头孢噻肟治疗的患者进行持续观察和细致随访,因为可能会出现危及生命的药物不良反应(ADR)。这种情况可能会增加治疗医生在当前新冠肺炎时代面临的挑战。认识ADR有助于降低发病率和死亡率。报告ADR有助于记录和教育医疗保健专业人员。
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引用次数: 1
A Single-Center, Observational, Retrospective Cost-Effective Analysis of Treating Inadequately Controlled Type 2 Diabetes Mellitus by Addition of DPP4 Inhibitors Versus Intensified Treatment with Conventional Drugs 一项单中心、观察性、回顾性的成本效益分析:添加DPP4抑制剂与强化常规药物治疗控制不充分的2型糖尿病
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_22_21
Akshata Kalyani, Sachin Kuchya, >Prashant Punekar
Objective: To compare the cost effectiveness and achievement of glycemic goals in patients inadequately controlled by conventional drugs receiving either intensified treatment or DPP4 inhibitor as an add on. It shall help us to identify a preferred choice of treatment. Materials and Methods: As per study protocol, 52 patients with inadequately controlled type 2 diabetes mellitus (DM) were included in the study. They received either intensified treatment or add-on with DPP4 inhibitor. Glycated hemoglobin (HbA1c), fasting blood sugar (FBS), postprandial blood sugar (PPBS), adverse drug reactions, and their cost were calculated for the next 6 months of therapy. Results: Add on therapy with DPP4 inhibitor showed a greater achievement of glycemic goals. Target HbA1c was achieved by 58.6% (P < 0.0001) versus 40% (P < 0.05), FBS was achieved by 78.50% (P < 0.0001) versus 50% (P < 0.16), and PPBS was achieved by 63.6% (P < 0.0001) versus 42.8% (P < 0.03) in the add-on with DPP4 inhibitor versus intensified treatment group. No hypoglycemic episodes were documented in both the groups. Add-on with DPP4 inhibitor cost (×5.13) as compared to intensified treatment. Conclusions: Add-on with DPP4 inhibitor therapy achieved glycemic goals in greater proportion of patients as compared to treatment intensification but at 5 times the cost of therapy. Since the patent restrictions for DPP4 inhibitors such as vildagliptin and teneligliptin are over, the cost of therapy has come down. Hence their benefits should be extended to a greater proportion of patients with inadequately controlled type 2 DM.
目的:比较常规药物控制不充分的患者接受强化治疗或加用DPP4抑制剂治疗的成本-效果和血糖目标的实现情况。它将帮助我们确定一种首选的治疗方法。材料与方法:根据研究方案,纳入52例控制不充分的2型糖尿病(DM)患者。他们接受强化治疗或附加DPP4抑制剂。计算治疗后6个月的糖化血红蛋白(HbA1c)、空腹血糖(FBS)、餐后血糖(PPBS)、药物不良反应及其成本。结果:加用DPP4抑制剂治疗能更好地达到降糖目标。靶糖化血红蛋白(HbA1c)分别为58.6% (P < 0.0001)和40% (P < 0.05), FBS分别为78.50% (P < 0.0001)和50% (P < 0.16), PPBS分别为63.6% (P < 0.0001)和42.8% (P < 0.03)。两组均未发生低血糖事件。与强化治疗相比,添加DPP4抑制剂的成本(×5.13)。结论:与强化治疗相比,DPP4抑制剂治疗在更大比例的患者中达到了血糖目标,但治疗成本是强化治疗的5倍。由于DPP4抑制剂(如维格列汀和替尼格列汀)的专利限制已经结束,治疗成本已经下降。因此,它们的益处应该扩大到更大比例的控制不充分的2型糖尿病患者。
{"title":"A Single-Center, Observational, Retrospective Cost-Effective Analysis of Treating Inadequately Controlled Type 2 Diabetes Mellitus by Addition of DPP4 Inhibitors Versus Intensified Treatment with Conventional Drugs","authors":"Akshata Kalyani, Sachin Kuchya, >Prashant Punekar","doi":"10.4103/jpp.jpp_22_21","DOIUrl":"https://doi.org/10.4103/jpp.jpp_22_21","url":null,"abstract":"Objective: To compare the cost effectiveness and achievement of glycemic goals in patients inadequately controlled by conventional drugs receiving either intensified treatment or DPP4 inhibitor as an add on. It shall help us to identify a preferred choice of treatment. Materials and Methods: As per study protocol, 52 patients with inadequately controlled type 2 diabetes mellitus (DM) were included in the study. They received either intensified treatment or add-on with DPP4 inhibitor. Glycated hemoglobin (HbA1c), fasting blood sugar (FBS), postprandial blood sugar (PPBS), adverse drug reactions, and their cost were calculated for the next 6 months of therapy. Results: Add on therapy with DPP4 inhibitor showed a greater achievement of glycemic goals. Target HbA1c was achieved by 58.6% (P < 0.0001) versus 40% (P < 0.05), FBS was achieved by 78.50% (P < 0.0001) versus 50% (P < 0.16), and PPBS was achieved by 63.6% (P < 0.0001) versus 42.8% (P < 0.03) in the add-on with DPP4 inhibitor versus intensified treatment group. No hypoglycemic episodes were documented in both the groups. Add-on with DPP4 inhibitor cost (×5.13) as compared to intensified treatment. Conclusions: Add-on with DPP4 inhibitor therapy achieved glycemic goals in greater proportion of patients as compared to treatment intensification but at 5 times the cost of therapy. Since the patent restrictions for DPP4 inhibitors such as vildagliptin and teneligliptin are over, the cost of therapy has come down. Hence their benefits should be extended to a greater proportion of patients with inadequately controlled type 2 DM.","PeriodicalId":16761,"journal":{"name":"Journal of Pharmacology & Pharmacotherapeutics","volume":null,"pages":null},"PeriodicalIF":0.2,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44091506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2-Deoxy-D-Glucose: A Ray of Hope in COVID Pandemic 2-脱氧-D-葡萄糖:新冠肺炎疫情中的一线希望
IF 0.2 Q4 Medicine Pub Date : 2021-07-01 DOI: 10.4103/jpp.jpp_69_21
Priyotosh Banerjee, I. Sarma, D. Sekhar, D. K. Brahma, Melambha Surong
Coronavirus disease-19 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 is a respiratory tract infection that has already made a huge negative impact in global health situation. Transmission mainly occurs through droplets, and the virus is highly contagious. Mainly symptomatic treatments are given at present with some drugs for serious patients with unproven efficacy and safety. In this context, Institute of Nuclear Medicine and Allied Sciences, a research laboratory of Defence Research and Development Organization in collaboration with Dr. Reddy's Laboratories, Hyderabad, has introduced a new medicine named 2-Deoxy-d-glucose (2-DG) (which has been previously tried in cancer) for the treatment of seriously ill COVID patients with a target to reduce the oxygen demand. Clinical trials showed evidence that 2-DG effectively reduces oxygen requirement in seriously ill patients, and real-time polymerase chain reaction conversion is also faster. Recently, 2-DG is approved for the use in critically ill patients by the Drug Controller General of India in May 2021. The introduction of 2-DG brings a new hope in reducing the mortality in COVID patients.
冠状病毒病-19(新冠肺炎)由严重急性呼吸综合征引起的大流行冠状病毒2是一种呼吸道感染,已经对全球卫生形势产生了巨大的负面影响。传播主要通过飞沫传播,病毒具有高度传染性。目前主要是对症治疗,一些药物用于严重患者,其疗效和安全性尚未得到证实。在此背景下,国防研究与发展组织的研究实验室核医学与联合科学研究所与海得拉巴Reddy博士实验室合作,推出了一种名为2-脱氧-d-葡萄糖(2-DG)的新药(此前已在癌症中试用),用于治疗重症COVID患者,目的是减少氧气需求。临床试验表明,2-DG可以有效降低重症患者的氧气需求,实时聚合酶链式反应的转化也更快。最近,印度药品监督管理总局于2021年5月批准2-DG用于危重患者。2-DG的引入为降低新冠肺炎患者的死亡率带来了新的希望。
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引用次数: 0
Vitamin D3 Attenuates Type 3 Diabetic-Associated Cognitive Deficits in Rats through Regulating Neurotrophins and Enhancing Cholinergic Transmission Pathway 维生素D3通过调节神经营养素和增强胆碱能传递途径减轻大鼠3型糖尿病相关认知缺陷
IF 0.2 Q4 Medicine Pub Date : 2021-04-01 DOI: 10.4103/jpp.jpp_20_21
Yahya A. Al-Zahrani, Maimoon Sattar, Sameer Al-harthi, Ayed A Alkatheeri, Yahya Mohammed Al-Zahrani
Objective: To examine the protective effect of Vitamin D3 against Type 3 diabetes-induced cognitive dysfunction in rats. Materials and Methods: Type 3 diabetes was induced by a high-fat diet plus streptozotocin in rats. Rats were divided into seven groups: negative control, positive control, Vitamin D3 groups (100, 500 and 1000 IU/kg/day), Vitamin D3 plus rivastigmine, and rivastigmine monotherapy. A radial arm maze test was used to assess cognitive function. Levels of acetylcholinesterase (AChE), dopamine (DA), nerve growth factor, neurotrophin-3 (NT-3), and glial cell line-derived neurotrophic factor (GDNF) in the hippocampus were estimated by the enzyme-linked immunosorbent assay kits. Results: Chronic treatment with Vitamin D3 significantly (P < 0.05) and dose dependently alleviated cognitive deficits, with enhancing cholinergic transmission pathway activity through attenuated hippocampal AChE and increased DA level (P < 0.001). Moreover, Vitamin D3 significantly increased (P < 0.001) neurotrophin levels as an underlying mechanism for the resulted improvement. Conclusion: Vitamin D3 plus rivastigmine (combined group) is better than Vitamin D (100 and 500 mg/kg/day) for improvement of AChE, DA, NT-3, and GDNF levels. Vitamin D (500 and 1000 IU/kg/day) was effective as a combined group in terms of the behavioral test.
目的:探讨维生素D3对3型糖尿病大鼠认知功能障碍的保护作用。材料与方法:采用高脂饮食加链脲佐菌素诱导大鼠3型糖尿病。将大鼠分为阴性对照组、阳性对照组、维生素D3组(100、500、1000 IU/kg/d)、维生素D3联合利瓦斯汀明和利瓦斯汀明单药治疗7组。采用桡臂迷宫测试评估认知功能。采用酶联免疫吸附法测定海马组织中乙酰胆碱酯酶(AChE)、多巴胺(DA)、神经生长因子、神经营养因子-3 (NT-3)和胶质细胞系源性神经营养因子(GDNF)的水平。结果:长期服用维生素D3可显著(P < 0.05)且剂量依赖性地缓解认知功能障碍,通过减弱海马AChE和增加DA水平增强胆碱能传递通路活性(P < 0.001)。此外,维生素D3显著增加(P < 0.001)神经营养因子水平,这是结果改善的潜在机制。结论:维生素D3联合利瓦斯丁明(联合组)改善AChE、DA、NT-3、GDNF水平的效果优于维生素D(100、500 mg/kg/ D)。在行为测试中,维生素D(500和1000 IU/kg/天)作为联合组是有效的。
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引用次数: 2
Assessment of Potential Drug - Drug Interaction among the Patients Receiving Cancer Chemotherapy: A Cross-sectional Study 癌症化疗患者潜在药物相互作用的评估:一项跨部门研究
IF 0.2 Q4 Medicine Pub Date : 2021-04-01 DOI: 10.4103/jpp.jpp_16_21
K. Venkatesh, Swathi Acharya, R. Holla
Objectives: To identify and assess the various potential drug-drug interactions (pDDIs) among the patients receiving cancer chemotherapy, using the database from Lexicomp® Solutions with the ultimate goal of raising awareness among clinicians for safe medication usage. Materials and Methods: It is a prospective, cross-sectional study engaged at a tertiary care hospital in South India. Data regarding clinically prescribed drugs were obtained from the patients admitted to the oncology unit of a tertiary care hospital within the time frame of 6 months (June 2018 to December 2018). Frequency and clinical relevance, the onset, and Severity of pDDIs were assessed using the database from Lexicomp® Solutions version 4.1.2. Data were analyzed using the descriptive statistics. Statistical significance was analyzed using the Mann–Whitney and Chi-square tests. Pearson's correlation coefficient was used to identify the correlation between the incidence of drug-drug interactions with age, the number of drugs prescribed, and the type of cancer. Results: A total of 895 pDDIs were seen, including 261 with chemotherapeutic drugs and 634 with supportive medication. It was observed that around 14.18% of cyclophosphamide showing interaction with Ondansetron among chemotherapeutic drugs, whereas 9.14% of lithium presenting interaction with Ondansetron among supportive therapy. A statistically significant higher interaction was noted among supportive medications provided when compared to anticancer drugs (P = 0.001). Conclusions: The majority of pDDIs observed among the patients receiving chemotherapy with supportive medications as compared to anticancer chemotherapy. There is an urgent need for special safety measures to monitor and prevent drug interactions in the oncology unit.
目的:使用Lexicomp®Solutions的数据库,识别和评估接受癌症化疗的患者中各种潜在的药物相互作用(pDDI),最终目的是提高临床医生对安全用药的认识。材料和方法:这是一项前瞻性的横断面研究,在南印度的一家三级护理医院进行。在6个月(2018年6月至2018年12月)的时间范围内,从一家三级护理医院肿瘤科入院的患者那里获得了有关临床处方药的数据。使用Lexicomp®Solutions 4.1.2版的数据库评估pDDI的频率和临床相关性、发病率和严重程度。使用描述性统计对数据进行分析。使用Mann-Whitney和卡方检验对统计学显著性进行分析。皮尔逊相关系数用于确定药物与药物相互作用的发生率与年龄、处方药物数量和癌症类型之间的相关性。结果:共发现895个pDDI,其中261个使用化疗药物,634个使用支持药物。据观察,在化疗药物中,约14.18%的环磷酰胺表现出与昂丹司琼的相互作用,而在支持性治疗中,9.14%的锂表现出与昂丹西酮的相互作用。与抗癌药物相比,所提供的支持性药物之间的相互作用具有统计学意义(P=0.001)。结论:与抗癌化疗相比,在接受支持性药物化疗的患者中观察到大多数pDDI。迫切需要采取特殊的安全措施来监测和预防肿瘤科的药物相互作用。
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引用次数: 1
Role of Vitamin B Complex as an Add-on Therapy to Diclofenac in Patients with Primary Osteoarthritis of the Knee 维生素B复合物作为双氯芬酸辅助治疗原发性膝骨性关节炎的作用
IF 0.2 Q4 Medicine Pub Date : 2021-04-01 DOI: 10.4103/jpp.jpp_32_21
J. Kaur, S. Rani, A. Gulia, G. Bhutani, Sanjeev Kumar, Arvind Narwat
Objective: This study was conducted with the aim to evaluate the efficacy and safety of Vitamin B complex as an add-on therapy to diclofenac in patients with primary osteoarthritis (OA) of the knee. Materials and Methods: In this prospective, open-labeled, randomized, and comparative clinical study, a total of 130 patients of age >40 years with primary OA of knee attending orthopedics OPD were randomly allocated into two groups of 65 each, i.e., Group D and Group B. In Group D, patients received tablet diclofenac 75 mg and in Group B, patients received tablet Vitamin B complex along with diclofenac once daily for 4 weeks, respectively. Clinical assessment was done at baseline and at the end of 4 weeks and 8 weeks by the visual analog scale (VAS), WOMAC index, and Lequesne index. Results: During the intergroup comparison, it was found that Vitamin B complex as an add-on therapy to diclofenac produced statistically significant reduction in mean VAS pain score (P < 0.05). However, the difference in mean WOMAC index and Lequesne index was not statistically different at 4 and 8 weeks between the two groups (P > 0.05). Mild side effects were seen at 4 weeks, but no side effects persisted up to 8 weeks in both the groups. Conclusion: The present study suggested that Vitamin B complex as an add-on therapy was found to cause a significant reduction in pain score. It could be a promising drug in patients with OA to improve the analgesic effect, when combined can reduce the dose of diclofenac, thereby minimizing the side effects.
目的:本研究旨在评估维生素B复合物作为双氯芬酸辅助治疗原发性膝关节骨性关节炎(OA)的疗效和安全性。材料和方法:在这项前瞻性、开放标记、随机和比较的临床研究中,共有130名年龄>40岁的膝关节原发性OA患者被随机分为两组,每组65人,即D组和B组,患者分别接受片剂维生素B复合物和双氯芬酸,每天一次,持续4周。在基线以及4周和8周结束时,通过视觉模拟评分(VAS)、WOMAC指数和Lequesne指数进行临床评估。结果:在组间比较中,发现维生素B复合物作为双氯芬酸的附加治疗使平均VAS疼痛评分显著降低(P<0.05)。但两组在4周和8周时的平均WOMAC指数和Lequesne指数差异无统计学意义(P>0.05)。4周时出现轻度副作用,但两组患者均未出现持续8周的副作用。结论:本研究表明,维生素B复合物作为一种附加疗法可以显著降低疼痛评分。它可能是一种很有前途的改善OA患者镇痛效果的药物,当联合使用时可以减少双氯芬酸的剂量,从而最大限度地减少副作用。
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引用次数: 0
期刊
Journal of Pharmacology & Pharmacotherapeutics
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