尼达尼布治疗特发性肺纤维化92例对肺功能和肺纤维化指标的影响及不良反应分析

目的观察尼达尼布治疗特发性肺纤维化(IPF)的临床疗效及不良反应。方法收集2019年11月至2021年1月在南阳市第二人民医院呼吸内科接受治疗的IPF病人144例,年龄(67.8±7.2)岁,男性103例,女性41例,根据临床治疗情况病人分为对照组52例,治疗组92例。收集病人入院时的一般临床资料、肺功能指标和肺纤维化指标。比较治疗12周后和治疗24周后,两组病人的肺功能指标、肺纤维化指标和不良反应率。结果治疗前,对照组和观察组病人的年龄、性别、吸烟情况、病程、肺功能指标和肺纤维化指标之间均差异无统计学意义(P>0.05)。对照组治疗24周后最大肺活量占预计值百分比(FVC%)(61.5±4.8)%低于治疗前(65.9±6.0)%,一氧化碳弥散量占预计值百分比(DLCO%)(70.5±5.9)%低于治疗前(75.9±5.7)%,均P<0.05。观察组治疗24周后FVC%(54.7±3.8)%、FEV1%(50.7±3.9)%和DLCO%(59.6±6.0)%低于治疗前[(67.1±3.4)%、(66.8±4.6)%、(76.3±4.3)%],P<0.05。对照组治疗24周后Ⅳ型胶原(Ⅳ-C)(129.3±7.8)μg/L水平高于治疗前(124.3±5.6)μg/L,P<0.05。观察组治疗24周后Ⅲ型胶原(Ⅲ-C)(138.5±6.3)μg/L、Ⅳ-C(146.2±4.1)μg/L和透明质酸(HA)(164.3±8.0)μg/L的水平高于治疗前[(127.3±7.3)μg/L、(126.5±6.0)μg/L、(142.8±10.2)μg/L],均P<0.05。两组病人治疗后的不良反应发生率之间差异无统计学意义。结论尼达尼布可延缓特发性肺纤维化病人肺功能和肺纤维化的恶化,且治疗期间未增加不良反应率。

Effects of ninadab on NF-κB expression in lung tissue and PC Ⅲ level in bronchoalveolar lavage fluid induced by lipopolysaccharide-induced ARDS in rats

Objective: To observe effects of ninadab on NF-κB expression in lung tissue and PCⅢlevel in bronchoalveolar lavage fluid induced by lipopolysaccharide-induced ARDS in rats. Methods: Forty healthy SD rats were randomly divided into control group, group A, group B and group C, with 10 in each group. Rats in group A, group B and group C were successful in modeling. In control group, rats in group A were injected with saline only. Rats in group B were treated with nisinib at 7 days and rats in group C were treated with nisinib at 14 days. The expression of NF-κB in lung tissue, the level of β-EP in plasma and the level of PCⅢ in bronchoalveolar perfusion fluid. Results: There were significant differences in the expression of NF-κB positive cells and plasma β-EP among groups. Compared with the control group, the expression of NF-κB positive cells and plasma β-EP in group A, group B and group C were significantly higher than those in control group, Compared with group A, the expression of NF-κB positive cells and plasma β-EP in group B and group C were significantly lower than those in group A. Compared with group B, the expression of NF-κB positive cells and plasma β-EP in group C were significantly higher than those in group B. There was a significant difference between the 4 groups on the 7th, 14th and 28th days. Compared with the control group, PCⅢ levels in the 7th, 14th and 28th days in group A, group B and group C were significantly higher. Compared with group A, group B, group C, the content of PCⅢon the 7th day, the 14th day and the 28th day in group C was significantly higher. Conclusion:Nidanib on lipopolysaccharide-induced ARDS rats have a good protective effect, and its mechanism may be related to the reduction of NF-κB expression in bronchoalveolar perfusion solution PCⅢ level.

尼达尼布治疗特发性肺纤维化有效性和安全性系统评价

目的系统评价尼达尼布治疗特发性肺纤维化(IPF)的有效性与安全性。方法在The Cochrane Library、Embase、Medline等外文数据库及中国知网、万方等中文数据库进行文献检索,检索时间为建库至2019年1月。筛选文献条件为尼达尼布治疗特发性肺纤维化的随机对照试验(RCT),由两位研究人员独立进行文献筛选、数据提取和研究偏倚风险评价,使用RevMan5.3软件进行分析。结果共纳入4个随机对照研究,共计患者1249例。Meta分析结果显示:两组用力肺活量(FVC)下降超过10%的患者例数、圣乔治呼吸问卷(SGRQ)评分中的改善患者症状和活动能力差异有统计学意义(P<0.05),试验组优于对照组;在不良反应方面,虽然试验组在所有不良反应发生率及消化系统不良反应发生率上高于对照组,但是此类不良反应大多轻度、可逆,而在IPF进展、鼻咽炎、心脏功能紊乱方面和对照组差异无统计学意义(P>0.05)。结论尼达尼布治疗特发性肺纤维化疗效较好且耐受性较好。但由于纳入研究数量较少,该结论尚需大样本、高质量RCT进一步论证。

系统性硬化症的生物制剂治疗新进展

系统性硬化症(SSc)是一种难治性的结缔组织疾病,目前国内外尚无统一治疗方法,传统的治疗方案以抑制纤维化、调节免疫和改善微循环为主,但疗效欠佳。近年来,对于该病发病机制的认识取得了重大进展,靶向针对B淋巴细胞、T淋巴细胞、细胞因子(白细胞介素-6、白细胞介素-17)、肿瘤坏死因子-α、Ⅰ型干扰素、转化生长因子-β等的不同生物制剂,如利妥昔单抗、托珠单抗、尼达尼布,正在进行的临床试验的结果可能有助于指导未来SSc的治疗。

吡非尼酮联合尼达尼布治疗特发性肺纤维化患者的临床研究

目的观察吡非尼酮联合尼达尼布治疗特发性肺纤维化的疗效及肺功能的影响。方法将95例特发性肺纤维化患者随机分为对照组(47例)和试验组(48例)。对照组给予吡非尼酮,每次200 mg,每日3次,口服;试验组在对照组治疗的基础上,给予乙磺酸尼达尼布软胶囊,每次150 mg,每日2次,口服。2组均持续治疗12周。比较2组的临床疗效、第1秒用力呼气容积(FEV1)、用力肺活量(FVC)、一氧化碳弥散量占预计值的百分比(DLco%)及血清透明质酸(HA)、层粘连蛋白(LN)、涎液化糖链抗原-6(KL-6)水平。结果对照组和试验组的总有效率分别为77.27%和93.18%,差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FEV1分别为(73.63±5.49)%和(68.94±5.82)%,FVC分别为(2.91±0.43)和(2.53±0.46)L,DLco%分别为(50.65±10.32)%和(49.57±6.35)%,血清HA分别为(83.47±14.01)和(95.12±15.36)μg·L^(-1),LN分别为(96.52±14.47)和(115.24±16.35)μg·L^(-1),KL-6分别为(794.41±210.46)和(712.16±256.71)U·mL^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论吡非尼酮联合尼达尼布治疗特发性肺纤维化的疗效显著,可以改善肺功能和纤维化,安全性高。