Department of Respiratory Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China.
Department of Neurology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China.
J Tradit Chin Med. 2020 Aug;40(4):674-682. doi: 10.19852/j.cnki.jtcm.2020.04.017.
To evaluate the effects of Qizhukangxian granules (QG) on idiopathic pulmonary fibrosis (IPF).
This is a randomized, double blind, placebo-controlled and multicenter clinical pilot trial. Six medical centers in Tianjin, China, participated in the study. A total of 120 IPF patients were enrolled and randomized into two groups, with 60 patients in each group. The treatment group was treated with QG, while the control group received a Qizhukangxian placebo. The pharmacological treatment lasted for 48 weeks from the enrollment date. The indexes of patients were recorded on the admission day and at the end of the 24th and 48th weeks. Data were analyzed to study the effects of QG; forced vital capacity, change in forced vital capacity and maximal 6-min walk test (6MWT) distance were the primary endpoints. Secondary endpoints were percentage of patients with episodes of acute exacerbation of IPF, pulmonary function, changes in pulse oxygen saturation during the 6MWT, dyspnea score, St. George's respiratory questionnaire score, arterial blood gas analyses and the total Traditional Chinese Medicine symptom pattern score.
After 24 weeks of treatment, QG showed greater efficacy than the placebo in certain parameters, including the dyspnea score, Traditional Chinese Medicine symptom pattern score and some indicators in the St. George's respiratory questionnaire score. Analysis of the indexes obtained from all patients at the end of the 48th week showed that the therapeutic effects in the treatment group were significantly better than those in the control group because remarkable differences were observed in most of the primary and secondary endpoints between the two groups, except for the maximal distance of the 6MWT and arterial blood gas analyses. No adverse reaction was observed in either group during the 48-week trial treatment period.
QG could effectively treat IPF patients by ameliorating pulmonary function, improving the quality of life and lowering the percentage of acute exacerbations.
评价芪苈强心胶囊治疗特发性肺纤维化（IPF）的疗效。
这是一项随机、双盲、安慰剂对照、多中心临床初步试验。中国天津的 6 家医疗中心参与了这项研究。共纳入 120 例 IPF 患者，随机分为两组，每组 60 例。治疗组给予芪苈强心胶囊治疗，对照组给予芪苈强心安慰剂。药物治疗从入组日期开始，持续 48 周。记录患者入院当天和第 24、48 周末的各项指标。分析数据以研究芪苈强心胶囊的疗效；用力肺活量、用力肺活量变化和最大 6 分钟步行试验（6MWT）距离为主要终点。次要终点为 IPF 急性加重发作的患者比例、肺功能、6MWT 期间脉搏血氧饱和度变化、呼吸困难评分、圣乔治呼吸问卷评分、动脉血气分析和总中医症状模式评分。
治疗 24 周后，芪苈强心胶囊在某些参数上的疗效优于安慰剂，包括呼吸困难评分、中医症状模式评分和圣乔治呼吸问卷评分中的一些指标。分析所有患者在第 48 周末的各项指标发现，治疗组的治疗效果明显优于对照组，因为两组的大部分主要和次要终点都存在显著差异，除了 6MWT 的最大距离和动脉血气分析。在 48 周的试验治疗期间，两组均未观察到不良反应。
芪苈强心胶囊可有效治疗 IPF 患者，改善肺功能，提高生活质量，降低急性加重的比例。
