Clinical trial of nintedanib combined with tetrandrine in the treatment of patients with connective tissue disease-related pulmonary interstitial fibrosis
10.13699/j.cnki.1001-6821.2024.19.005
- VernacularTitle: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
- Author:
Dong-Ming YANG
1
;
Jian-Jun NIE
;
Wei REN
;
Rui ZHANG
;
Ben-Shang GONG
;
Dong-Feng XU
Author Information
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
- Keywords:
nintedanib ethanesulfonate soft capsule;
tetrandrine tablet;
connective tissue disease-related pulmonary interstitial fibrosis;
pulmonary function;
dyspnea symptoms
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(19):2781-2785
- CountryChina
- Language:Chinese
-
Abstract:
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(FEV1)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 and the control group were 0 and 2.38％,respectively(P＞0.05).Conclusion Compared with basic treatment,nintedanib ethanesulfonate soft capsules combined with tetrandrine tablets can better improve the pulmonary fibrosis degree and dyspnea degree in patients with connective tissue disease-related pulmonary interstitial fibrosis,and delay the decline of pulmonary function of patients.
