OBJECTIVE: We aimed to compare the efficacy and safety of 1.8% SPHNSI and 0.9% commercial isotonic nasal saline irrigation (0.9% CINSI) in patients with AR.
METHODS: A randomised, single-blinded, placebo-controlled trial was performed as a pilot study. Seventy-eight patients with AR were included. Each patient was randomised to nasal irrigation with 80 mL of either 1.8% SPHNSI or 0.9% CINSI twice-daily for 4 weeks. Randomised codes were generated using a computer and a block of 4 procedure. The primary outcome was improvement of quality of life scores in Thai patients with allergic rhinoconjunctivitis (Rcq-36). Secondary outcomes were clinical symptoms using total nasal symptom scores (TNSS) and adverse events. All outcomes were assessed by blinded assessors at baseline, week 2, and week 4.
RESULTS: At week 4, nasal irrigation with 1.8% SPHNSI had significantly improved the Rcq-36 score (54% versus 50%; p < 0.032) and congestion symptom score (96% versus 84%; p < 0.018) compared to nasal irrigation with 0.9% CINSI. Adverse events were comparable for both groups at week 4.
CONCLUSIONS: This pilot study indicates that regular use of 1.8% SPHNSI in AR patients for 4 weeks is safe and has superior efficacy to 0.9% CINSI for alleviating congestion and improving quality of life scores.
SETTING: A sample of 1419 Malaysian community pharmacies with resident pharmacists.
METHOD: A cross-sectional nationwide survey using a self-completed mailing questionnaire.
MAIN OUTCOME MEASURE: Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence.
RESULTS: Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia.
CONCLUSION: The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.
OBJECTIVE: From the considerable amount of clinical narrative text, natural language processing (NLP) researchers have developed methods for extracting ADEs and their related attributes. This work presents a systematic review of current methods.
METHODOLOGY: Two biomedical databases have been searched from June 2022 until December 2023 for relevant publications regarding this review, namely the databases PubMed and Medline. Similarly, we searched the multi-disciplinary databases IEEE Xplore, Scopus, ScienceDirect, and the ACL Anthology. We adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement guidelines and recommendations for reporting systematic reviews in conducting this review. Initially, we obtained 5,537 articles from the search results from the various databases between 2015 and 2023. Based on predefined inclusion and exclusion criteria for article selection, 100 publications have undergone full-text review, of which we consider 82 for our analysis.
RESULTS: We determined the general pattern for extracting ADEs from clinical notes, with named entity recognition (NER) and relation extraction (RE) being the dual tasks considered. Researchers that tackled both NER and RE simultaneously have approached ADE extraction as a "pipeline extraction" problem (n = 22), as a "joint task extraction" problem (n = 7), and as a "multi-task learning" problem (n = 6), while others have tackled only NER (n = 27) or RE (n = 20). We further grouped the reviews based on the approaches for data extraction, namely rule-based (n = 8), machine learning (n = 11), deep learning (n = 32), comparison of two or more approaches (n = 11), hybrid (n = 12) and large language models (n = 8). The most used datasets are MADE 1.0, TAC 2017 and n2c2 2018.
CONCLUSION: Extracting ADEs is crucial, especially for pharmacovigilance studies and patient medications. This survey showcases advances in ADE extraction research, approaches, datasets, and state-of-the-art performance in them. Challenges and future research directions are highlighted. We hope this review will guide researchers in gaining background knowledge and developing more innovative ways to address the challenges.
OBJECTIVE: The aim of this systematic review and meta-analysis is to compare the effectiveness of amiodarone, dexmedetomidine and magnesium in preventing JET following congenital heart surgery.
METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement, where 11 electronic databases were searched from date of inception to August 2020. The incidence of JET was calculated with the relative risk of 95% confidence interval (CI). Quality assessment of the included studies was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.
RESULTS: Eleven studies met the predetermined inclusion criteria and were included in this meta-analysis. Amiodarone, dexmedetomidine and magnesium significantly reduced the incidence of postoperative JET [Amiodarone: risk ratio 0.34; I2= 0%; Z=3.66 (P=0.0002); 95% CI 0.19-0.60. Dexmedetomidine: risk ratio 0.34; I2= 0%; Z=4.77 (P<0.00001); 95% CI 0.21-0.52. Magnesium: risk ratio 0.50; I2= 24%; Z=5.08 (P<0.00001); 95% CI 0.39-0.66].
CONCLUSION: All three drugs show promise in reducing the incidence of JET. Our systematic review found that dexmedetomidine is better in reducing the length of ICU stays as well as mortality. In addition, dexmedetomidine also has the least pronounced side effects among the three. However, it should be noted that this conclusion was derived from studies with small sample sizes. Therefore, dexmedetomidine may be considered as the drug of choice for preventing JET.
OBJECTIVE: To study the association between plasma AAG level and non-haematological AEs of docetaxel in Malaysian breast cancer patients of three major ethnic groups (Malays, Chinese and Indians).
MATERIALS AND METHODS: One hundred and twenty Malaysian breast cancer patients receiving docetaxel as single agent chemotherapy were investigated for AAG plasma level using enzyme-linked immunosorbent assay technique. Toxicity assessment was determined using Common Terminology Criteria of Adverse Events v4.0. The association between AAG and toxicity were then established.
RESULTS: There was interethnic variation of plasma AAG level; it was 182 ± 85 mg/dl in Chinese, 237 ± 94 mg/dl in Malays and 240 ± 83 mg/dl in Indians. It was found that low plasma levels of AAG were significantly associated with oral mucositis and rash.
CONCLUSIONS: This study proposes plasma AAG as a potential predictive biomarker of docetaxel non-haematological AEs namely oral mucositis and rash.
MATERIALS AND METHODS: A total of 110 Malaysian breast cancer patients were enrolled in the present study, and their blood samples were investigated for different single nucleotide polymorphisms using polymerase chain reaction restriction fragment length polymorphism. AEs were evaluated using the Common Terminology Criteria for Adverse Events, version 4.0.
RESULTS: Fatigue, nausea, oral mucositis, and vomiting were the most common nonhematologic AEs. Rash was associated with heterozygous and mutant genotypes of ABCB1 3435C>T (P < .05). Moreover, patients carrying the GG genotype of ABCB1 2677G>A/T reported more fatigue than those carrying the heterozygous genotype GA (P < .05). The presence of ABCB1 3435-T, ABCC2 3972-C, ABCC2 1249-G, and ABCB1 2677-G alleles was significantly associated with nausea and oral mucositis. The coexistence of ABCB1 3435-C, ABCC2 3972-C, ABCC2 1249-G, and ABCB1 2677-A was significantly associated with vomiting (P < .05).
CONCLUSION: The prevalence of nonhematologic AEs in breast cancer patients treated with docetaxel has been relatively high. The variant allele of ABCB1 3435C>T polymorphism could be a potential predictive biomarker of docetaxel-induced rash, and homozygous wild-type ABCB1 2677G>A/T might predict for a greater risk of fatigue. In addition, the concurrent presence of specific alleles could be predictive of vomiting, nausea, and oral mucositis.