AP-Bio®（KalmCold®）用于单纯性上呼吸道病毒感染（普通感冒）患者的疗效和安全性——一项III期、双盲、平行组、随机安慰剂对照试验。

Efficacy and safety of AP-Bio®(KalmCold®) in participants with uncomplicated upper respiratory tract viral infection (common cold) - A phase III, double-blind, parallel group, randomized placebo-controlled trial.

作者信息

Raj Jeffrey Pradeep, Maurya Miteshkumar Rajaram, Nair Nayana, Marfatia Hetal, Hadaye Rujuta, Gogtay Nithya Jaideep

机构信息

Department of Clinical Pharmacology, Seth GS Medical College & King Edward Memorial Hospital, Mumbai 400012, Maharashtra, India.

出版信息

Complement Ther Med. 2023 May;73:102934. doi: 10.1016/j.ctim.2023.102934. Epub 2023 Feb 24.

DOI:10.1016/j.ctim.2023.102934

PMID:36842634

Abstract

INTRODUCTION

Kalmegh (Andrographis paniculata) is commonly used for treating uncomplicated Upper Respiratory Tract Infection (URTI) in complementary and alternative system of medicine. AP-Bio®(KalmCold®) is a standardized extract derived from the leaves of A. paniculata. This study was proposed to evaluate its efficacy using validated scales and objective measures.

METHODS

Participants were randomized in a ratio of 1:1:1 to receive either AP-Bio® 200 mg/day, AP-Bio® 400 mg/day or placebo for 7 days. The primary outcome measure was Wisconsin Upper Respiratory Symptom Survey (WURSS-21) score. The secondary outcome measures were nasal mucous weight, nasal muco-ciliary clearance function and Interleukin-8 in nasal wash, as well as safety and tolerability.

RESULTS

A total of n = 331 participants were screened and N = 300 participants were enrolled. The absolute WURSS-21 global score [mean (Standard Deviation - SD)] in the AP-Bio® 400 mg group [5.70 (5.31)] was less than the AP-Bio® 200 mg group [5.81 (4.83)] on Day-3. However, it was much higher in the placebo group [9.55 (14.27)]. AP-Bio® 400 mg group (Mean Difference - MD [Standard Error - SE] = -3.85 [1.52]; 95% CI = -6.85, - 0.85; adjusted p = 0.034) and 200 mg group (MD [SE] = -3.74 [1.51]; 95% CI = -6.73, - 0.76; adjusted p = 0.038) had significantly lower score than placebo. Similarly, on Day-3, the change in global score from baseline was significantly better in the AP-Bio® 400 mg group (MD [SE] = -3.91; [1.82] 95% CI = -7.50, - 0.32; adjusted p = 0.038) and AP-Bio® 200 mg group (MD [SE] = -3.84 [1.97]; 95% CI = -7.72, - 0.04; adjusted p = 0.044) in comparison to the placebo group. Nasal mucous weight, tissue paper counts used, and interleukin-8 showed a trend towards AP-Bio® groups having a favourable outcome when compared with placebo but did not reach statistical significance due to a small sample size. None of the study participants complained of any adverse physical symptoms. However, incident eosinophilia was noted in n = 20 participants on day 3. (n = 6 in AP-Bio® 200 mg group, n = 7 in Ap-Bio® 400 mg group and n = 13 in placebo group; p = 0.181).

CONCLUSIONS

Participants in both the AP-Bio® dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.

摘要

引言

穿心莲（Andrographis paniculata）在补充和替代医学体系中常用于治疗单纯性上呼吸道感染（URTI）。AP-Bio®（KalmCold®）是一种从穿心莲叶中提取的标准化提取物。本研究旨在使用经过验证的量表和客观指标评估其疗效。

方法

参与者按1:1:1的比例随机分组，分别接受200毫克/天的AP-Bio®、400毫克/天的AP-Bio®或安慰剂，为期7天。主要结局指标是威斯康星上呼吸道症状调查（WURSS-21）评分。次要结局指标包括鼻黏液重量、鼻黏液纤毛清除功能、鼻洗液中的白细胞介素-8，以及安全性和耐受性。

结果

共筛查了n = 331名参与者，纳入了N = 300名参与者。在第3天，AP-Bio® 400毫克组的WURSS-21总体绝对评分[均值（标准差-SD）]为[5.70（5.31）]，低于AP-Bio® 200毫克组[5.81（4.83）]。然而，安慰剂组的评分[9.55（14.27）]要高得多。AP-Bio® 400毫克组（平均差值-MD[标准误-SE]= -3.85[1.52]；95%置信区间= -6.85，-0.85；校正p = 0.034）和200毫克组（MD[SE]= -3.74[1.51]；95%置信区间= -6.73，-0.76；校正p = 0.038）的评分显著低于安慰剂组。同样，在第3天，与安慰剂组相比，AP-Bio® 400毫克组（MD[SE]= -3.91；[1.82] 95%置信区间= -7.50，-0.32；校正p = 0.038）和AP-Bio® 200毫克组（MD[SE]= -3.84[1.97]；95%置信区间= -7.72，-0.04；校正p = 0.044）的总体评分从基线的变化明显更好。与安慰剂组相比，AP-Bio®组的鼻黏液重量、使用的纸巾数量和白细胞介素-8显示出有良好结局的趋势，但由于样本量小，未达到统计学意义。没有研究参与者抱怨任何不良身体症状。然而，在第3天，n = 20名参与者出现了嗜酸性粒细胞增多症（AP-Bio® 200毫克组n = 6，AP-Bio® 400毫克组n = 7，安慰剂组n = 13；p = 0.181）。