尼达尼布联合汉防己甲素治疗结缔组织病相关肺间质纤维化患者的临床研究  

Clinical trial of nintedanib combined with tetrandrine in the treatment of patients with connective tissue disease-related pulmonary interstitial fibrosis

作　　者：杨东明 聂建军[1] 任蔚 张瑞 龚本尚 许东风[1] YANG Dong-ming;NIE Jian-jun;REN Wei;ZHANG Rui;GONG Ben-shang;XU Dong-feng(Department of Respiratory and Critical CareMedicine,TheFirstAt ffiliated Hospital of Nanyang Medical College,Nanyang 473000,Henan Province,China)

机构地区：[1]南阳医学高等专科学校第一附属医院呼吸与危重症医学科,河南南阳473000

出　　处：《中国临床药理学杂志》2024年第19期2781-2785,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察乙磺酸尼达尼布软胶囊联合汉防己甲素片对结缔组织病相关肺间质纤维化患者肺功能和呼吸困难症状的影响。方法将结缔组织病相关肺间质纤维化患者按队列法分为试验组和对照组。对照组根据患者情况给予糖皮质激素、免疫抑制药等基础治疗;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100 mg,bid,口服+汉防己甲素片每次40 mg,tid,口服。2组患者均治疗3个月。比较2组患者的临床疗效、呼吸困难严重程度[改良英国医学研究委员会呼吸困难量表(mMRC)及圣乔治呼吸问卷(SGRQ)]、肺功能指标、肺纤维化积分及血气分析指标,并评价安全性。结果试验组和对照组均分别纳入42例。治疗后,试验组和对照组的总有效率分别为92.86%(39例/42例)和76.19%(32例/42例),在统计学上差异有统计意义(P<0.05)。治疗后,试验组和对照组的mMRC评分分别为(1.43±0.27)和(1.69±0.31)分,SGRQ评分分别为(46.51±4.39)和(51.08±4.76)分,第1秒用力呼气容积分别为(64.96±6.55)%和(58.67±5.01)%,纤维化积分分别为(1.12±0.14)和(1.26±0.18)分,动脉血氧分压分别为(80.31±7.03)和(75.02±6.94)mmHg,试验组的上述指标与对照组比较,在统计学上差异均有统计意义(均P<0.05)。试验组未出现药物不良反应,对照组药物不良反应主要有胃肠道不适,试验组和对照组的总药物不良反应发生率分别为0和2.38%,在统计学上差异无统计学意义(P>0.05)。结论乙磺酸尼达尼布软胶囊联合汉防己甲素片治疗较基础治疗更能改善结缔组织病相关肺间质纤维化患者肺纤维化程度及呼吸困难程度、延缓患者肺功能下降。Objective To observe the influence of nintedanib ethanesulfonate soft capsules combined with tetrandrine tablets on pulmonary function and dyspnea symptoms in patients with connective tissue disease-related pulmonary interstitial fibrosis.Methods Patients with connective tissue disease-related pulmonary interstitial fibrosis were divided into treatment group and control group by cohort method.The control group was given basic treatment such as glucocorticoids and immunosuppressants according to the patient's condition;the treatment group was given ethanesulfonate nintedanib soft capsules(100 mg,bid)and tetrandrine tablets(40 mg,tid)on the basis of the control group,and the treatment course was 3 months.The clinical efficacy,severity of dyspnea[modified British Medical Research Council Dyspnea Scale(mMRC)and St.George's Respiratory Questionnaire(SGRQ)],pulmonary function indicators,pulmonary fibrosis score,and blood gas analysis indicators were compared between the two groups,and the safety was assessed.Results A total of 42 cases were included in the treatment group and the control group,respectively.The total effective rates of the treatment group and the control group were 92.86%(39 cases/42 cases)and 76.19%(32 cases/42 cases)respectively(P<0.05).After treatment,the mMRC scores of the treatment group and the control group were(1.43±0.27)and(1.69±0.31)points;the SGRQ scores were(46.51±4.39)and(51.08±4.76)points;the forced expiratory volume in one second(FEV,)values were(64.96±6.55)%and(58.67±5.01)%;the fibrosis scores were(1.12±0.14)and(1.26±0.18)points;the partial pressure of arterial oxygen values were(80.31±7.03)and(75.02±6.94)mmHg.The above indexes of the treatment group were compared with those of the control group,and the differences were statistically significant(all P<0.05).There were no adverse drug reactions in the treatment group,and the main adverse drug reactions in the control group were gastrointestinal discomfort.The total incidence rates of adverse drug reactions in the treatment group

关 键 词：乙磺酸尼达尼布软胶囊 汉防己甲素片 结缔组织病相关肺间质纤维化 肺功能 呼吸困难症状 

分 类 号：R974[医药卫生—药品]