Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial

Background: Community acquired pneumonia (CAP) is a common cause of childhood morbidity, attributed to every 1 in 500 hospitalization of children under the age of 5 years. While science made therapeutic advancements to battle CAP, the pathogens too have acquired resistance to many drugs. In this fight for dominance, Ampicillin plus Gentamicin and 3rd Gen Cephalosporins are nowadays the cornerstone of treatment. However, their efficacy varies in different parts of the world owing to differing levels of drug resistance. Objective: To compare the effect of Ampicillin and Gentamicin vs. third generation cephalosporin in treatment of severe community acquired pneumonia. Methodology: This Randomized Controlled Trial was conducted at the Dept. of Pediatrics (Ziauddin University Hospital) upon a sample of 74 patients (in two equal groups) of either gender, aged 2 months to 5 years, presenting with CAP. After taking written informed consent, data was recorded onto a pre-structured questionnaire containing inquiries pertaining to basic biodata, sociodemographic details, presenting complaints, immunization status of the pneumococcal and HIB vaccine, laboratory values, and treatment outcome. Results: The mean age of the sample stood at 15 months (SD ± 3) with a majority of the sample comprising of male children (52.7%). The mean weight stood at 8.7 kg (SD ± 0.9) and the mean height was recorded to be 74.2 cm (SD ± 11). The commonest symptoms included fever, fast breathing, chest in-drawing and added sounds. It was revealed that both treatments achieved successful treatment outcomes in all patients with no mortality. The resolution of symptoms however varied with faster resolution observed in the Cephalosporin group. Conclusion: After careful consideration, it can be concluded that 3rd generation cephalosporins is more efficacious at treatment of CAP with significantly faster resolution of disease symptoms.

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Marked Reduction in 28-Day Mortality among Elderly Patients with Severe Community-Acquired Pneumonia: Post Hoc Analysis of XueBiJing Injection Randomized Controlled Trial

10.21203/rs.3.rs-16216/v1 ◽

2020 ◽

Author(s):

Yan Liu ◽

Chi Zhang ◽

Chengyu Li ◽

Chunxue Bai ◽

Hongcai Shang

Keyword(s):

Elderly Patients ◽

Controlled Trial ◽

Total Duration ◽

Community Acquired Pneumonia ◽

Post Hoc Analysis ◽

Improved Outcomes ◽

Severe Community Acquired Pneumonia ◽

Favorable Safety ◽

Post Hoc ◽

Case Mortality

Abstract Background There were a few studies on the case mortality of severe community-acquired pneumonia (CAP) in elderly people. Improved outcomes with XueBiJing (XBJ) Injection versus placebo have been shown in overall trial populations. We investigated the efficacy and safety of XBJ versus placebo in subjects with severe CAP stratified by age (<65 and ≥ 65 years). Methods This post hoc analysis of a large randomized trial compared data from elder and nonelderly patients with XBJ, 100 ml, q12h, or a visually indistinguishable placebo for 5-7 days. Results Among subjects ≥65 years (n=291), 23 (16.0%) XBJ recipients and 41 (27.9%) placebo recipients ( P =0.014) died within 28 days. Among subjects <65 years (n=360), XBJ still had lower mortality (XBJ 15.6% verse placebo 22.8%; P =0.082), without significantly statistical difference. Total duration of ICU stay and the time of mechanical ventilation were similar in both groups ( P > 0.05). XBJ also had a favorable safety profile, with no clinically relevant differences between two groups. The overall incidence of adverse events was similar in both groups. Conclusions XBJ was safe and effective for reduction in 28-day mortality among elderly patients with severe CAP. Additional trials involving elderly patients are needed to further confirm the present results.

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