PDF(Pubmed)
Abstract：
As face masks became mandatory in most countries during the COVID-19 pandemic, adverse effects require substantiated investigation.
A systematic review of 2,168 studies on adverse medical mask effects yielded 54 publications for synthesis and 37 studies for meta-analysis (on n = 8,641, m = 2,482, f = 6,159, age = 34.8 ± 12.5). The median trial duration was only 18 min (IQR = 50) for our comprehensive evaluation of mask induced physio-metabolic and clinical outcomes.
We found significant effects in both medical surgical and N95 masks, with a greater impact of the second. These effects included decreased SpO2 (overall Standard Mean Difference, SMD = -0.24, 95% CI = -0.38 to -0.11, p < 0.001) and minute ventilation (SMD = -0.72, 95% CI = -0.99 to -0.46, p < 0.001), simultaneous increased in blood-CO2 (SMD = +0.64, 95% CI = 0.31-0.96, p < 0.001), heart rate (N95: SMD = +0.22, 95% CI = 0.03-0.41, p = 0.02), systolic blood pressure (surgical: SMD = +0.21, 95% CI = 0.03-0.39, p = 0.02), skin temperature (overall SMD = +0.80 95% CI = 0.23-1.38, p = 0.006) and humidity (SMD +2.24, 95% CI = 1.32-3.17, p < 0.001). Effects on exertion (overall SMD = +0.9, surgical = +0.63, N95 = +1.19), discomfort (SMD = +1.16), dyspnoea (SMD = +1.46), heat (SMD = +0.70), and humidity (SMD = +0.9) were significant in n = 373 with a robust relationship to mask wearing (p < 0.006 to p < 0.001). Pooled symptom prevalence (n = 8,128) was significant for: headache (62%, p < 0.001), acne (38%, p < 0.001), skin irritation (36%, p < 0.001), dyspnoea (33%, p < 0.001), heat (26%, p < 0.001), itching (26%, p < 0.001), voice disorder (23%, p < 0.03), and dizziness (5%, p = 0.01).
Masks interfered with O2-uptake and CO2-release and compromised respiratory compensation. Though evaluated wearing durations are shorter than daily/prolonged use, outcomes independently validate mask-induced exhaustion-syndrome (MIES) and down-stream physio-metabolic disfunctions. MIES can have long-term clinical consequences, especially for vulnerable groups. So far, several mask related symptoms may have been misinterpreted as long COVID-19 symptoms. In any case, the possible MIES contrasts with the WHO definition of health.
Face mask side-effects must be assessed (risk-benefit) against the available evidence of their effectiveness against viral transmissions. In the absence of strong empirical evidence of effectiveness, mask wearing should not be mandated let alone enforced by law.
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021256694, identifier: PROSPERO 2021 CRD42021256694.
A systematic review of 2,168 studies on adverse medical mask effects yielded 54 publications for synthesis and 37 studies for meta-analysis (on n = 8,641, m = 2,482, f = 6,159, age = 34.8 ± 12.5). The median trial duration was only 18 min (IQR = 50) for our comprehensive evaluation of mask induced physio-metabolic and clinical outcomes.
We found significant effects in both medical surgical and N95 masks, with a greater impact of the second. These effects included decreased SpO2 (overall Standard Mean Difference, SMD = -0.24, 95% CI = -0.38 to -0.11, p < 0.001) and minute ventilation (SMD = -0.72, 95% CI = -0.99 to -0.46, p < 0.001), simultaneous increased in blood-CO2 (SMD = +0.64, 95% CI = 0.31-0.96, p < 0.001), heart rate (N95: SMD = +0.22, 95% CI = 0.03-0.41, p = 0.02), systolic blood pressure (surgical: SMD = +0.21, 95% CI = 0.03-0.39, p = 0.02), skin temperature (overall SMD = +0.80 95% CI = 0.23-1.38, p = 0.006) and humidity (SMD +2.24, 95% CI = 1.32-3.17, p < 0.001). Effects on exertion (overall SMD = +0.9, surgical = +0.63, N95 = +1.19), discomfort (SMD = +1.16), dyspnoea (SMD = +1.46), heat (SMD = +0.70), and humidity (SMD = +0.9) were significant in n = 373 with a robust relationship to mask wearing (p < 0.006 to p < 0.001). Pooled symptom prevalence (n = 8,128) was significant for: headache (62%, p < 0.001), acne (38%, p < 0.001), skin irritation (36%, p < 0.001), dyspnoea (33%, p < 0.001), heat (26%, p < 0.001), itching (26%, p < 0.001), voice disorder (23%, p < 0.03), and dizziness (5%, p = 0.01).
Masks interfered with O2-uptake and CO2-release and compromised respiratory compensation. Though evaluated wearing durations are shorter than daily/prolonged use, outcomes independently validate mask-induced exhaustion-syndrome (MIES) and down-stream physio-metabolic disfunctions. MIES can have long-term clinical consequences, especially for vulnerable groups. So far, several mask related symptoms may have been misinterpreted as long COVID-19 symptoms. In any case, the possible MIES contrasts with the WHO definition of health.
Face mask side-effects must be assessed (risk-benefit) against the available evidence of their effectiveness against viral transmissions. In the absence of strong empirical evidence of effectiveness, mask wearing should not be mandated let alone enforced by law.
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021256694, identifier: PROSPERO 2021 CRD42021256694.
摘要：
在COVID-19大流行期间，大多数国家都必须戴口罩，不良反应需要经过证实的调查。
对2,168项有关医疗面罩不良反应的研究进行了系统综述，得出了54项出版物用于合成，37项研究用于荟萃分析（n=8,641，m=2,482，f=6,159，年龄=34.8±12.5）。对于我们对面罩诱导的生理代谢和临床结果的综合评估，中位试验持续时间仅为18分钟（IQR=50）。
我们发现在医疗外科和N95口罩中都有显著的效果，第二个影响更大。这些影响包括降低SpO2(总体标准平均差，SMD=-0.24，95％CI=-0.38至-0.11，p<0.001）和分钟通气（SMD=-0.72，95％CI=-0.99至-0.46，p<0.001），血液CO2同时增加（SMD=+0.64，95%CI=0.31-0.96，p<0.001），心率（N95：SMD=+0.22，95%CI=0.03-0.41，p=0.02），收缩压（手术：SMD=+0.21，95%CI=0.03-0.39，p=0.02），皮肤温度(总SMD=+0.8095%CI=0.23-1.38,p=0.006)和湿度(SMD+2.24,95%CI=1.32-3.17,p<0.001)。对劳累的影响（整体SMD=+0.9，手术=+0.63，N95=+1.19），不适（SMD=+1.16），呼吸困难（SMD=+1.46），热量（SMD=+0.70），在n=373中，湿度（SMD=0.9）显着，与面罩佩戴之间存在牢固的关系（p<0.006至p<0.001）。汇总症状患病率（n=8,128）在以下方面显着：头痛（62％，p<0.001)，痤疮（38%，p<0.001)，皮肤刺激（36%，p<0.001)，呼吸困难（33%，p<0.001)，热量(26%，p<0.001)，瘙痒（26%，p<0.001)，语音障碍（23%，p<0.03),和头晕(5%，p=0.01)。
面罩干扰O2吸收和CO2释放并损害呼吸补偿。尽管评估的佩戴持续时间短于每日/长期使用，结果独立验证了面罩诱导的耗竭综合征(MIES)和下游生理代谢障碍.MIES可能会产生长期的临床后果，特别是弱势群体。到目前为止,一些与口罩相关的症状可能被误解为COVID-19长症状。无论如何,可能的MIES与世界卫生组织对健康的定义形成鲜明对比。
必须根据现有证据评估口罩的副作用（风险-收益），以证明其对病毒传播的有效性。在缺乏强有力的有效性经验证据的情况下，戴口罩不应强制，更不用说法律强制执行了。
https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42021256694，标识符：PROSPERO2021CRD42021256694。
对2,168项有关医疗面罩不良反应的研究进行了系统综述，得出了54项出版物用于合成，37项研究用于荟萃分析（n=8,641，m=2,482，f=6,159，年龄=34.8±12.5）。对于我们对面罩诱导的生理代谢和临床结果的综合评估，中位试验持续时间仅为18分钟（IQR=50）。
我们发现在医疗外科和N95口罩中都有显著的效果，第二个影响更大。这些影响包括降低SpO2(总体标准平均差，SMD=-0.24，95％CI=-0.38至-0.11，p<0.001）和分钟通气（SMD=-0.72，95％CI=-0.99至-0.46，p<0.001），血液CO2同时增加（SMD=+0.64，95%CI=0.31-0.96，p<0.001），心率（N95：SMD=+0.22，95%CI=0.03-0.41，p=0.02），收缩压（手术：SMD=+0.21，95%CI=0.03-0.39，p=0.02），皮肤温度(总SMD=+0.8095%CI=0.23-1.38,p=0.006)和湿度(SMD+2.24,95%CI=1.32-3.17,p<0.001)。对劳累的影响（整体SMD=+0.9，手术=+0.63，N95=+1.19），不适（SMD=+1.16），呼吸困难（SMD=+1.46），热量（SMD=+0.70），在n=373中，湿度（SMD=0.9）显着，与面罩佩戴之间存在牢固的关系（p<0.006至p<0.001）。汇总症状患病率（n=8,128）在以下方面显着：头痛（62％，p<0.001)，痤疮（38%，p<0.001)，皮肤刺激（36%，p<0.001)，呼吸困难（33%，p<0.001)，热量(26%，p<0.001)，瘙痒（26%，p<0.001)，语音障碍（23%，p<0.03),和头晕(5%，p=0.01)。
面罩干扰O2吸收和CO2释放并损害呼吸补偿。尽管评估的佩戴持续时间短于每日/长期使用，结果独立验证了面罩诱导的耗竭综合征(MIES)和下游生理代谢障碍.MIES可能会产生长期的临床后果，特别是弱势群体。到目前为止,一些与口罩相关的症状可能被误解为COVID-19长症状。无论如何,可能的MIES与世界卫生组织对健康的定义形成鲜明对比。
必须根据现有证据评估口罩的副作用（风险-收益），以证明其对病毒传播的有效性。在缺乏强有力的有效性经验证据的情况下，戴口罩不应强制，更不用说法律强制执行了。
https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42021256694，标识符：PROSPERO2021CRD42021256694。
