Keshavarz Sedigheh, Reisi Mohsen, Keivanfar Majid, Rabbani Faezeh, Sabzghabaee Ali Mohammad
Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Pediatric Pulmonology, Imam Hossein Children's Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Pharm Pract. 2025 Mar 11;13(3):72-77. doi: 10.4103/jrpp.jrpp_54_24. eCollection 2024 Jul-Sep.
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.
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) level of more than 50% and no history of underlying cardiovascular and renal diseases.
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.
The indicators of FEV, FVC, FEV/FVC, , 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.
本研究调查了在囊性纤维化（CF）治疗方案中添加口服N-乙酰半胱氨酸（NAC）补充剂与添加安慰剂相比的疗效。它还研究了6至18岁轻度至中度肺部受累患者的生活质量和呼吸指标。
本临床试验是一项随机、准实验性的先导性附加疗法，用安慰剂对照3个月。病例组每天口服3次200毫克NAC。相比之下，对照组以同样的方式服用安慰剂。从2021年秋季到2022年夏季，最终检查了38名转诊至伊玛目侯赛因儿童医院诊所的CF患者。他们临床稳定，第一秒用力呼气量（FEV）水平超过50%，且无潜在心血管和肾脏疾病史。
两组之间的差异不显著。在安慰剂组中，关键指标保持不变，而NAC组的CF问卷修订评分有所改善，但其他指标无明显变化。总体而言，两组之间的用力肺活量（FVC）比较无差异。
病例组的FEV、FVC、FEV/FVC指标及生活质量与安慰剂组无显著差异，该药物与安慰剂之间未观察到显著差异。
