标题：盐酸氨溴索联合泼尼松治疗特发性肺间质纤维化急性加重期患者的疗效及安全性研究

      作者：石德龙，张烈，李永鹏    中国人民解放军空军第九八六医院呼吸内科，陕西 西安 710054

      卷次： 2023年34卷22期

      【摘要】 目的 探究盐酸氨溴索联合泼尼松治疗特发性肺间质纤维化急性加重期(AE-IPF)患者的临床疗效及安全性。方法 回顾性分析2018年6月至2021年11月于中国人民解放军空军第九八六医院呼吸内科治疗的114例AE-IPF患者的临床资料，其中55例采用泼尼松治疗者纳入对照组，59例采用盐酸氨溴索联合泼尼松治疗者纳入研究组。比较两组患者治疗2个月后的临床疗效，以及治疗前后的血气指标[动脉血氧饱和度(SaO2)、动脉血氧分压(PaO2)、动脉血二氧化碳分压(PaCO2)]、炎症因子[转化生长因子(TGF-β1)、白细胞介素 4 (IL-4)、白细胞介素 13(IL-13)]、肺纤维化指标[透明质酸(HA)、Ⅲ型前胶原肽(PC-Ⅲ)、层黏连蛋白(LN)]水平，并统计两组患者治疗期间的不良反应发生情况。结果 治疗2个月后，研究组患者的临床治疗总有效率为88.1%，明显高于对照组的70.9%，差异有统计学意义(P<0.05)；治疗2个月后，两组患者的PaO2、SaO2水平较治疗前明显升高，且研究组分别为(75.49±4.14) mmHg、(92.51±3.56)%，明显高于对照组的(75.49±4.14) mmHg、(90.77±3.38)%，PaCO2为(38.69±3.11) mmHg，明显低于对照组的(40.32±3.18) mmHg，差异均有统计学意义(P<0.05)；治疗 2个月后，两组患者的 IL-4、TGF-β1、IL-13水平均较治疗前明显降低，研究组分别为(4.95±1.02) ng/mL、(143.65±6.30) pg/mL、(87.49±5.94) mg/mL，明显低于对照组的(5.51±1.09) ng/mL、(151.27±7.18) pg/mL、(90.78±6.03) mg/mL，差异均有统计学意义(P<0.05)；治疗两个月后，两组患者的HA、LN、PC-Ⅲ水平均较治疗前明显降低，研究组分别为(89.43±7.20) μg/L、(90.68±8.33) μg/L、(70.53±6.19) mg/L，明显低于对照组的(93.15±7.32) μg/L、(95.47±8.59) μg/L、(74.17±6.36) mg/L，差异均有统计学意义(P<0.05)；治疗期间，研究组患者的不良反应总发生率为 5.1%，略低于对照组的 9.1%，但差异无统计学意义(P>0.05)。结论 盐酸氨溴索联合泼尼松可有效提高AE-IPF患者临床疗效，降低患者炎症反应水平，减缓患者肺纤维化进程，对患者血气指标的改善具有积极影响，且具有较好的安全性。
      【关键词】 特发性肺间质纤维化；急性加重期；盐酸氨溴索；泼尼松；血气指标；不良反应
      【中图分类号】 R563 【文献标识码】 A 【文章编号】 1003—6350（2023）22—3228—05

Efficacy and safety of ambroxol hydrochloride combined with prednisone in the treatment of patients with acuteexacerbation of idiopathic pulmonary fibrosis.
SHI De-long, ZHANG Lie, LI Yong-peng. Department of RespiratoryMedicine, the 986th Hospital of the People's Liberation Army Air Force, Xi'an 710054, Shaanxi, CHINA
【Abstract】 Objective To explore the clinical efficacy and safety of ambroxol hydrochloride combined with pred-nisone in the treatment of patients with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). Methods Theclinical data of 114 patients with AE-IPF who were treated in Department of Respiratory Medicine, the 986th Hospitalof the People's Liberation Army Air Force from June 2018 to November 2021 were retrospectively analyzed. Amongthem, 55 patients treated with prednisone were enrolled as control group, and 59 patients treated with ambroxol hydro-chloride combined with prednisone were included in study group. The clinical efficacy after 2 months of treatment, aswell as blood gas indicators [arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), arterial partialpressure of carbon dioxide (PaCO2)], inflammatory factors [transforming growth factor (TGF-β1), interleukin-4 (IL-4),interleukin-13 (IL-13)] and pulmonary fibrosis indicators [hyaluronic acid (HA), type procollagen Ⅲ peptide (PC-Ⅲ),laminin (LN)] before and after treatment were compared between the two groups. The occurrence of adverse reactionsbetween the two groups during treatment were statistically analyzed. Results After 2 months of treatment, the total ef-fective rate of clinical treatment was 88.1% in the study group, which was significantly higher than 70.9% in the con-trol group (P<0.05). After 2 months of treatment, the levels of PaO2 and SaO2 in the two groups were significantly high-er than those before treatment, and the levels of two indicators in the study group were (75.49 ± 4.14) mmHg and(92.51±3.56)%, significantly higher than (75.49±4.14) mmHg and (90.77±3.38)% in the control group, while the level ofPaCO2 was (38.69±3.11) mmHg, significantly lower than (40.32±3.18) mmHg in the control group (P<0.05). After 2months of treatment, the levels of IL-4, TGF-β1, and IL-13 in the two groups were significantly lower than those beforetreatment, and the levels of above indicators in the study group were (4.95±1.02) ng/mL, (143.65±6.30) pg/mL, and(87.49±5.94) mg/mL, significantly lower than (5.51±1.09) ng/mL, (151.27±7.18) pg/mL and (90.78±6.03) mg/mL in thecontrol group (P<0.05). After two months of treatment, the levels of HA, LN, and PC-Ⅲ in the two groups were signifi-cantly lower than those before treatment, and the levels of above indicators in the study group were (89.43±7.20) μg/L,(90.68±8.33) μg/L, and (70.53±6.19) mg/L, significantly lower than (93.15±7.32) μg/L, (95.47±8.59) μg/L, and (74.17±6.36) mg/L in the control group (P<0.05). During the treatment, the total incidence of adverse reactions in the studygroup was 5.1%, which was slightly lower than 9.1% in the control group, but the difference was not statistically signifi-cant (P>0.05). Conclusion Ambroxol hydrochloride combined with prednisone can effectively enhance the clinical ef-ficacy of patients with AE-IPF, reduce the inflammatory reaction level, and slow down the process of pulmonary fibro-sis, which has a positive impact on the improvements of blood gas indicators and has good safety.
      【Key words】 Idiopathic pulmonary fibrosis; Acute exacerbation; Ambroxol hydrochloride; Prednisone; Bloodgas indicators; Adverse reactions