Evaluation on clinical efficacy of Fuzheng Jiedu Huayu Decoction combined with antibiotics in the treatment of pneumonia in the elderly – A multi-center, double-blind, parallel, randomized controlled trial

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.

Introduction

Pneumonia is one of the most common infectious diseases and a frequent cause of hospitalization among the elderly. The use of antibiotics has improved the treatment efficacy. However, antibiotics have not significantly reduce the mortality rate of elderly patients with pneumonia in recent years. With the widespread and irrational use of antibiotics, drug resistance of bacteria is becoming a serious problem, which has increased the difficulty in treatment of pneumonia. According to a systematic review of 23 clinical studies on 22,753 patients of CAP from 1999 to 2009, the average mortality rate was 7.4%.¹ In the elderly, pneumonia is an important contributing factor of death. According to literature reports, the incidence rate of pneumonia in the elderly over 65 years old was 1.6%,which over 75 years old was 11.6%, and the average mortality rate was 30–60%. In a study, A total of 447,670 hospitalized patients over 50 years old with CAP or pneumococcus pneumonia were studied, and the mortality rate was 17%.² Hospital acquired pneumonia (HAP) patients have a greater risk of death. The mortality rate of patients with ventilator associated pneumonia (VAP) was 25–50%.³ The clinical manifestations of pneumonia in the elderly are atypical,¹⁰ because of their low immune function, weak resistance to disease and underlying comorbidities. Their poor nutritional status makes them susceptible to severe homeostatic imbalances and sepsis, which can eventually lead to organ failure or even death.

Pneumonia in the elderly can be diagnosed and treated with reference to “wind-warm lung-heat disease” with “deficiency of vital energy with toxin and blood stasis” as the basic pathomechanism.⁴ Preliminary clinical studies have confirmed that the syndrome distribution for drug-resistant pneumonia in the elderly is closely related to the causative microbe, and usually manifests as phlegm-heat obstructing lung in the TCM⁴ Meanwhile, it was also found that some Chinese medicinals similar to FJHD could inhibit the expression of proinflammatory cytokines, such as TNF-α, IL-6 and IFN-γ in influenza virus FM1-induced murine lung, and promote the expression of anti-inflammatory cytokine IL-10. Thus, it can inhibit immunoinflammatory damage caused by the pathogenic microbial infection, and promote the repair of inflammatory damage, which may shorten the course of pneumonia in the elderly.⁵ We sought to evaluate the efficacy and safety of FJHD based on this understanding and popularize its clinical application in elderly patients with pneumonia.