Hongri Xu1, Meng Li2, Chengxiang Wang3, Renyi Yin4, Jie Ma5, Mingzhe Wang6, Quan Ming Tan5, Liangduo Jiang5, Miao Cheng5, Xianhai Chen7, Lishan Zhang5, Huiping Su5, Ruifu Hao8, Yang Jiao8, Caihua Wang9, Hanlin Wei10, Cuiling Feng5, Hui Luo5, Chuanyun Ren5, Shaozhong Zhou5, Shengxian Wu11, Pingan Zhou8. 1. Emergency Department, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (BUCM), Beijing, China. 2. Respiratory Department, ShaanXi TCM Hospital, Xi'an, China. 3. Respiratory Department, Dongzhimen Hospital Affiliated to BUCM, Beijing, China; Respiratory Department, No. 4 Hospital Beijing, University of Chinese Medicine, Zaozhuang Hospital of TCM, China. Electronic address: wang601@vip.sina.com. 4. Respiratory Department, Wuhan No. 1 Hospital, Wuhan, China. 5. Respiratory Department, Dongzhimen Hospital Affiliated to BUCM, Beijing, China. 6. Nephrology Department, Dongzhimen Hospital Affiliated to BUCM, Beijing, China. 7. Respiratory Department, Shandong Hospital of TCM, Jinan, China. 8. Respiratory Department, Dongfang Hospital Affiliated to BUCM, Beijing, China. 9. Respiratory Department, Changzhou TCM Hospital, Changzhou, China. 10. Department of TCM, Air Force General Hospital, PLA, Beijing, China. 11. Clinical Research Center, Dongzhimen Hospital Affiliated to BUCM, Beijing, China.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of Fuzheng Jiedu Huayu Decoction (FJHD) in treating pneumonia in the elderly. METHODS: Adopting a multi-center, double-blind, parallel, randomized controlled trial, 284 elderly pneumonia patients were enrolled and randomly allocated to the standard treatment with FJHD (treatment group, TG) and the standard treatment with placebo group (control group, CG). Efficacy and safety was evaluated through mortality rate, curative rate, symptom improvement, chest X-ray (CXR) lesion absorption, arterial blood gas (ABG), peripheral blood leukocyte count (PBLC) and adverse events. RESULTS: There was no significant difference in mortality rate between both groups (P > 0.05). TG significantly enhanced the curative rate of a 2-week treatment course (P < 0.05). Compared with CG, TG significantly decreased the expectoration score during the first and second week of treatment (P < 0.05). During the first week, improvement in expectoration was conducive to airway patency. During the second week, wheezing, shortness of breath and other symptoms were also significantly improved. During the third week, body temperature was stable. TG improved lesion absorption with Pneumonia Severity Index (PSI) class II (P < 0.05) and SMART-COP score 1 (P < 0.05). TG significantly decreased the arterial carbon dioxide partial pressure after a 1-week treatment. There were no serious adverse events in TG. CONCLUSION: Standard anti-infection treatment with FJHD is a safe and reliable method of treating elderly patients with pneumonia, improving the curative effect after a 2-week treatment course, ameliorating expectoration and promoting the absorption of pneumonia lesions.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of Fuzheng Jiedu Huayu Decoction (FJHD) in treating pneumonia in the elderly. METHODS: Adopting a multi-center, double-blind, parallel, randomized controlled trial, 284 elderly pneumoniapatients were enrolled and randomly allocated to the standard treatment with FJHD (treatment group, TG) and the standard treatment with placebo group (control group, CG). Efficacy and safety was evaluated through mortality rate, curative rate, symptom improvement, chest X-ray (CXR) lesion absorption, arterial blood gas (ABG), peripheral blood leukocyte count (PBLC) and adverse events. RESULTS: There was no significant difference in mortality rate between both groups (P > 0.05). TG significantly enhanced the curative rate of a 2-week treatment course (P < 0.05). Compared with CG, TG significantly decreased the expectoration score during the first and second week of treatment (P < 0.05). During the first week, improvement in expectoration was conducive to airway patency. During the second week, wheezing, shortness of breath and other symptoms were also significantly improved. During the third week, body temperature was stable. TG improved lesion absorption with Pneumonia Severity Index (PSI) class II (P < 0.05) and SMART-COP score 1 (P < 0.05). TG significantly decreased the arterial carbon dioxide partial pressure after a 1-week treatment. There were no serious adverse events in TG. CONCLUSION: Standard anti-infection treatment with FJHD is a safe and reliable method of treating elderly patients with pneumonia, improving the curative effect after a 2-week treatment course, ameliorating expectoration and promoting the absorption of pneumonia lesions.