Sedigheh Keshavarz, Mohsen Reisi, Majid Keivanfar, Faezeh Rabbani, Ali Mohammad Sabzghabaee
{"title":"在囊性纤维化治疗方案中添加口服N乙酰半胱氨酸补充剂的疗效:一项随机准实验试验。","authors":"Sedigheh Keshavarz, Mohsen Reisi, Majid Keivanfar, Faezeh Rabbani, Ali Mohammad Sabzghabaee","doi":"10.4103/jrpp.jrpp_54_24","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study investigated the efficacy of adding the oral N-acetyl cysteine (NAC) supplement to the cystic fibrosis (CF) treatment regimen compared to adding a placebo. It also studied the quality of life and respiratory indicators of patients aged 6-18 with mild-to-moderate pulmonary involvement.</p><p><strong>Methods: </strong>This clinical trial was a randomized, quasi-experimental pilot and add-on therapy controlled with a placebo for 3 months. The case group received 200 mg of oral NAC three times a day. In contrast, the control group had a placebo in the same way. From the 2021 fall to the summer of 2022, 38 CF patients referred to Imam Hossein Children's Hospital Clinic were finally examined. They were clinically stable with a forced expiratory volume in the first second (FEV<sub>1</sub>) level of more than 50% and no history of underlying cardiovascular and renal diseases.</p><p><strong>Findings: </strong>The differences between the groups were not significant. In the placebo group, key measures remained unchanged, whereas the NAC group had an improvement in the CF Questionnaire-Revised score but no notable changes in other indices. Overall, comparisons of forced vital capacity (FVC) between the groups showed no variation.</p><p><strong>Conclusion: </strong>The indicators of FEV<sub>1</sub>, FVC, FEV<sub>1</sub>/FVC, <i>forced expiratory flow between 25% and 75% of vital capacity</i>, and the quality of life of the case group were not significantly different from those of the placebo group, and no significant differences were observed between this medicine and placebo.</p>","PeriodicalId":17158,"journal":{"name":"Journal of Research in Pharmacy Practice","volume":"13 3","pages":"72-77"},"PeriodicalIF":0.8000,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12017402/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Adding Oral N acetyl Cysteine Supplement to the Cystic Fibrosis Treatment Regimen: A Randomized Quasi-Experimental Trial.\",\"authors\":\"Sedigheh Keshavarz, Mohsen Reisi, Majid Keivanfar, Faezeh Rabbani, Ali Mohammad Sabzghabaee\",\"doi\":\"10.4103/jrpp.jrpp_54_24\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study investigated the efficacy of adding the oral N-acetyl cysteine (NAC) supplement to the cystic fibrosis (CF) treatment regimen compared to adding a placebo. It also studied the quality of life and respiratory indicators of patients aged 6-18 with mild-to-moderate pulmonary involvement.</p><p><strong>Methods: </strong>This clinical trial was a randomized, quasi-experimental pilot and add-on therapy controlled with a placebo for 3 months. The case group received 200 mg of oral NAC three times a day. In contrast, the control group had a placebo in the same way. From the 2021 fall to the summer of 2022, 38 CF patients referred to Imam Hossein Children's Hospital Clinic were finally examined. They were clinically stable with a forced expiratory volume in the first second (FEV<sub>1</sub>) level of more than 50% and no history of underlying cardiovascular and renal diseases.</p><p><strong>Findings: </strong>The differences between the groups were not significant. In the placebo group, key measures remained unchanged, whereas the NAC group had an improvement in the CF Questionnaire-Revised score but no notable changes in other indices. Overall, comparisons of forced vital capacity (FVC) between the groups showed no variation.</p><p><strong>Conclusion: </strong>The indicators of FEV<sub>1</sub>, FVC, FEV<sub>1</sub>/FVC, <i>forced expiratory flow between 25% and 75% of vital capacity</i>, and the quality of life of the case group were not significantly different from those of the placebo group, and no significant differences were observed between this medicine and placebo.</p>\",\"PeriodicalId\":17158,\"journal\":{\"name\":\"Journal of Research in Pharmacy Practice\",\"volume\":\"13 3\",\"pages\":\"72-77\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2025-03-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12017402/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Research in Pharmacy Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/jrpp.jrpp_54_24\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Research in Pharmacy Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/jrpp.jrpp_54_24","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Efficacy of Adding Oral N acetyl Cysteine Supplement to the Cystic Fibrosis Treatment Regimen: A Randomized Quasi-Experimental Trial.
Objective: This study investigated the efficacy of adding the oral N-acetyl cysteine (NAC) supplement to the cystic fibrosis (CF) treatment regimen compared to adding a placebo. It also studied the quality of life and respiratory indicators of patients aged 6-18 with mild-to-moderate pulmonary involvement.
Methods: This clinical trial was a randomized, quasi-experimental pilot and add-on therapy controlled with a placebo for 3 months. The case group received 200 mg of oral NAC three times a day. In contrast, the control group had a placebo in the same way. From the 2021 fall to the summer of 2022, 38 CF patients referred to Imam Hossein Children's Hospital Clinic were finally examined. They were clinically stable with a forced expiratory volume in the first second (FEV1) level of more than 50% and no history of underlying cardiovascular and renal diseases.
Findings: The differences between the groups were not significant. In the placebo group, key measures remained unchanged, whereas the NAC group had an improvement in the CF Questionnaire-Revised score but no notable changes in other indices. Overall, comparisons of forced vital capacity (FVC) between the groups showed no variation.
Conclusion: The indicators of FEV1, FVC, FEV1/FVC, forced expiratory flow between 25% and 75% of vital capacity, and the quality of life of the case group were not significantly different from those of the placebo group, and no significant differences were observed between this medicine and placebo.
期刊介绍:
The main focus of the journal will be on evidence-based drug-related medical researches (with clinical pharmacists’ intervention or documentation), particularly in the Eastern Mediterranean region. However, a wide range of closely related issues will be also covered. These will include clinical studies in the field of pharmaceutical care, reporting adverse drug reactions and human medical toxicology, pharmaco-epidemiology and toxico-epidemiology (poisoning epidemiology), social aspects of pharmacy practice, pharmacy education and economic evaluations of treatment protocols (e.g. cost-effectiveness studies). Local reports of medication utilization studies at hospital or pharmacy levels will only be considered for peer-review process only if they have a new and useful message for the international pharmacy practice professionals and readers.