AGB-Pharma AB, Lund, Sweden.
Enzymatica AB, Lund, Sweden.
PLoS One. 2023 Jan 18;18(1):e0279204. doi: 10.1371/journal.pone.0279204. eCollection 2023.
Previous clinical and in vitro investigations have supported the efficacy of a glycerol throat spray containing cold-adapted cod trypsin (ColdZyme) against respiratory viruses causing the common cold bycreating a protective mucosal barrier shown to deactivate common cold virus in vitro and decrease pharyngeal rhinovirus load.
This was a double-blind, randomized, parallel-group, placebo-controlled study conducted at 10 German sites to evaluate the efficacy of the medical device ColdZyme, a glycerol mouth spray containing cold-adapted cod trypsin for a naturally occurring common cold versus placebo spray. Adults experiencing a minimum of three common colds during the previous year, but otherwise healthy, were enrolled to begin treatment with the mouth spray or placebo six times daily at first sign of a common cold. Jackson's symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) quality of life (QoL) domain and a sore throat scale were recorded daily by subjects, as well as any use of allowed rescue treatment. Between January and April 2019, 701 subjects were enrolled and randomly assigned to the ColdZyme group (n = 351) or the placebo group (n = 350). Of the 701 subjects, 438 (62.5%) subjects developed symptoms typical of common cold, and all 438 started study treatment (n = 220 in the ColdZyme group and n = 218 in the placebo group). The demographic profile of the treatment groups were comparable with 68.1% female and almost all subjects being Caucasian (98.4%). The age ranged between 18 and 70 years with a mean age of 41.3 (±14.4) years. There were no differences between the groups in primary and major secondary endpoints, however, the assessment using the WURSS-21 QoL domain and Jackson score suggests a slightly faster recovery with ColdZyme as symptoms and complaints affecting the quality of life were shortened by about 1 day. The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold. A positive difference between treatment groups was also seen for the subjects' assessments of global efficacy of the investigational product A robust safety profile for ColdZyme was demonstrated throughout the study.
The safety and tolerability of ColdZyme have been confirmed in a large study population and further establishes evidence of a faster recovery from common cold symptoms. Early self-diagnosis and early use of ColdZyme mouth spray is a safe alternative for treatment of naturally occurring colds.
先前的临床和体外研究支持了含有冷适应鳕鱼胰蛋白酶（ColdZyme）的甘油喉咙喷雾治疗引起普通感冒的呼吸道病毒的疗效，通过形成一种保护性粘膜屏障，该屏障已被证明可在体外使普通感冒病毒失活，并减少咽部鼻病毒载量。
这是一项在德国 10 个地点进行的双盲、随机、平行组、安慰剂对照研究，旨在评估医疗设备 ColdZyme 的疗效，即含有冷适应鳕鱼胰蛋白酶的甘油口腔喷雾用于治疗自然发生的普通感冒与安慰剂喷雾相比。至少在过去一年中经历了三次普通感冒但身体健康的成年人被招募，一旦出现普通感冒症状，他们将开始每天使用口腔喷雾或安慰剂六次。研究对象每天记录杰克逊症状量表和 9 项威斯康星州上呼吸道症状调查-21 量表（WURSS-21）生活质量（QoL）量表和咽喉痛量表，以及任何允许的急救治疗的使用情况。2019 年 1 月至 4 月期间，共有 701 名受试者入组并随机分配到 ColdZyme 组（n = 351）或安慰剂组（n = 350）。在 701 名受试者中，有 438 名（62.5%）出现了普通感冒的典型症状，所有 438 名受试者均开始接受研究治疗（ColdZyme 组 220 名，安慰剂组 218 名）。治疗组的人口统计学特征相似，其中 68.1%为女性，几乎所有受试者均为白种人（98.4%）。年龄在 18 至 70 岁之间，平均年龄为 41.3（±14.4）岁。主要和次要终点之间无差异，但使用 WURSS-21 QoL 量表和 Jackson 评分进行评估表明，ColdZyme 的恢复速度略快，因为影响生活质量的症状和不适缩短了约 1 天。普通感冒的第五天，ColdZyme 的疗效差异更为明显。研究产品的总体疗效评估也显示出治疗组之间的差异，ColdZyme 的安全性和耐受性已在大量研究人群中得到证实，并进一步证明了从普通感冒症状中更快恢复的证据。早期自我诊断和早期使用 ColdZyme 口腔喷雾是治疗自然发生的感冒的一种安全替代方法。
