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大剂量乙酰半胱氨酸联合汉防己甲素治疗尘肺病的随机对照临床试验
引用本文:晏丽,彭莹,贺炜,叶绿素,夏安莉. 大剂量乙酰半胱氨酸联合汉防己甲素治疗尘肺病的随机对照临床试验[J]. 职业卫生与应急救援, 2021, 39(5): 524-528. DOI: 10.16369/j.oher.issn.1007-1326.2021.05.009
作者姓名:晏丽  彭莹  贺炜  叶绿素  夏安莉
作者单位:重庆市职业病防治院, 重庆 400060
基金项目:重庆市科卫联合医学科研项目2018QNXM036
摘    要:  目的  评价大剂量乙酰半胱氨酸联合汉防己甲素治疗尘肺病的临床疗效和安全性。
  方法  将尘肺病患者随机分为对照组(n=57)和试验组(n=57)。对照组:给予对症支持治疗,发生呼吸系统感染时,给予抗感染治疗。试验组:在对照组的基础上给予口服乙酰半胱氨酸泡腾片及汉防己甲素片治疗,疗程24周。
  结果  治疗24周后试验组有咳嗽、咳痰、气促、胸痛等症状的患者比例明显低于对照组(P < 0.05)。治疗12周及24周后,对照组患者第一秒用力呼气量(FEV1)、第一秒用力呼气量占用力肺活量的百分比(FEV1/FVC)、用力肺活量(FVC)均较治疗前下降(P < 0.05),试验组患者FEV1、FEV1/FVC及FVC较治疗前无变化(P > 0.05),表明试验组疗效好于对照组,差异有统计学意义(P < 0.05)。在不同治疗期内,试验组新发呼吸系统感染率均低于对照组(P < 0.05)。试验组有1例患者出现皮肤色素沉着,不良反应率为1.75%。
  结论  大剂量乙酰半胱氨酸联合汉防己甲素可有效改善尘肺病患者临床症状,维持肺通气功能,减少新发呼吸系统感染率,不良反应少,为一种安全有效的治疗措施,值得临床推广使用。


关 键 词:乙酰半胱氨酸   汉防己甲素   尘肺病   随机临床试验
收稿时间:2021-05-26

A randomized controlled clinical trial of large-dose acetylcysteine combined with tetrandrine in treatment of pneumoconiosis
Abstract:  Objective  To evaluate the clinical effectiveness and safety of large-dose acetylcysteine combined with tetrandrine in treatment of pneumoconiosis.  Methods  Patients with pneumoconiosis were randomly divided into the control group (n=57) and the experimental group (n=57). The control group was given the conventional therapy, anti-infection treatment if needed. The experimental group was treated with acetylcysteine combined with tetrandrine for 24 weeks, on the basis of conventional therapy.  Results  After treatment, the ratios of patients with cough, sputum expectoration, shortness of breath and chest pain in the experimental group were significantly lower than those in the control group(P < 0.05). After 12 weeks and 24 weeks of treatment, the forced expiratory volume in the first second (FEV1), the forced vital capacity(FVC) and FEV1/FVC ratios of the patients in control group were decreased compared with those at pre-treatment stage(P < 0.05), while the FEV1, FEV1/FVC and FVC of the patients in experimental group showed no significant change(P > 0.05). The curative effect of the experimental group was better than that in the control group(P < 0.05). After 24 weeks of treatment, the carbon monoxide diffusion function(DLco) in the experimental group was higher than that in the control group(P < 0.05). The ratio of new respiratory infections in the experimental group was significantly lower than that in the control group(P < 0.05). One patient in the experimental group had skin pigmentation, and the adverse reaction ratio was 1.75%.  Conclusions  large-dose acetylcysteine combined with tetrandrine could effectively improve the clinical symptoms of patients with pneumoconiosis, maintain lung ventilation and diffusion, reduce respiratory infections, and have fewer adverse reactions. This safe and effective treatment measures are worthy of clinical application.
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