Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou, 450046, China.
Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, 450046, China.
Front Med. 2022 Oct;16(5):736-744. doi: 10.1007/s11684-021-0870-5. Epub 2022 Apr 22.
Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P < 0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI -27.87 to -9.74; P < 0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI -1.08 to -0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI -7.07 to -0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI -4.40 to -1.12; P < 0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.
针对尘肺病，目前缺乏有效的治疗选择。中医（TCM）在尘肺病的治疗中具有良好的前景。对中医证候的初步研究可以评估中医的临床疗效和安全性，并为进一步的临床研究奠定基础。一项为期 24 周的双盲、随机、安慰剂对照试验中，96 例尘肺病患者被随机分为对照组和治疗组。两组均进行对症治疗。治疗组采用中医辨证治疗，对照组采用安慰剂。主要结局指标为 6 分钟步行距离（6MWD）和圣乔治呼吸问卷（SGRQ）评分。次要结局指标为改良英国医学研究委员会呼吸困难量表（mMRC）、慢性阻塞性肺疾病评估测试（CAT）、医院焦虑抑郁量表（HADS）和肺功能。96 例尘肺病患者中仅 83 例完成了研究。主要结局方面，与对照组相比，治疗组的 6MWD 明显增加（407.90 m 比 499.51 m；95%置信区间（CI）47.25 至 135.97；P<0.001），SGRQ 总分也明显改善（44.48 比 25.67；95%CI-27.87 至-9.74；P<0.001）。治疗组的 mMRC 评分（1.4 比 0.74；95%CI-1.08 至-0.23；P=0.003）、CAT 评分（18.40 比 14.65；95%CI-7.07 至-0.43；P=0.027）和总症状评分（7.90 比 5.14；95%CI-4.40 至-1.12；P<0.001）也明显优于对照组。未发生严重不良事件。本研究表明，中医辨证论治对尘肺病患者的运动耐力和生活质量有良好的影响。
