接種四價人乳頭瘤病毒疫苗不會增加自主神經功能障礙症候群的風險

接種四價人乳頭瘤病毒疫苗不會增加自主神經功能障礙症候群的風險

作者：

小柯機器人

發布時間：2020/9/8 21:23:36

丹麥史坦頓血清研究所Anders Hviid團隊分析了女性四價人乳頭瘤病毒疫苗接種與自主神經功能障礙症候群之間的相關性。2020年9月2日，《英國醫學雜誌》發表了該成果。

為了評估四價人乳頭瘤病毒疫苗接種與自主神經功能障礙症候群（如慢性疲勞症候群、複雜區域疼痛症候群和體位直立性心動過速症候群）之間的相關性，研究組進行了一項以人群為基礎的自我控制病例系列研究。

研究組使用丹麥全國登記的ICD-10（國際疾病分類修訂10版）診斷代碼來確定人乳頭瘤病毒疫苗接種和自主神經功能障礙信息，2007-2016年間，出生在丹麥的1375737名10-44歲的女性參與者中有869名患有自主神經功能障礙症候群。研究組比較了接種四價人乳頭瘤病毒疫苗和未接種的女性參與者間經年齡和季節校正後的自主神經功能障礙症候群的發生率。

研究組共進行了10581902人年的隨訪，確定了869例具有自主神經功能障礙綜合症的女性參與者，其中136例為慢性疲勞綜合症，535例為複雜區域疼痛綜合症，198例為體位直立性心動過速綜合症。與未接種者相比，接種四價人乳頭瘤病毒疫苗後在365天危險期內所有自主神經功能障礙症候群的發生率未顯著增加，且風險期內慢性疲勞症候群、複雜區域疼痛症候群或體位直立性心動過速症候群等單獨症候群的發生率亦未顯著增加。

研究結果表明，與接種疫苗密切相關的不良事件可能純粹是偶然發生的，四價人乳頭瘤病毒疫苗接種與慢性疲勞症候群、複雜區域疼痛症候群或體位直立性心動過速症候群之間不存在因果關係。

附：英文原文

Title: Association between quadrivalent human papillomavirus vaccination and selected syndromes with autonomic dysfunction in Danish females: population based, self-controlled, case series analysis

Author: Anders Hviid, Nicklas M Thorsen, Palle Valentiner-Branth, Morten Frisch, Kre Mlbak

Issue&Volume: 2020/09/02

Abstract:

Objective To evaluate the association between quadrivalent human papillomavirus vaccination and syndromes with autonomic dysfunction, such as chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome.

Design Population-based self-controlled case series.

Setting Information on human papillomavirus vaccinations and selected syndromes with autonomic dysfunction (chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome) identified using ICD-10 (international classification of diseases, revision 10) diagnostic codes from Danish nationwide registers.

Participants 869 patients with autonomic dysfunction syndromes from a cohort of 1375737 Danish born female participants aged 10 to 44 years during 2007-16.

Main outcome measures Self-controlled case series rate ratios (95% confidence intervals) of the composite outcome of chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome, adjusted for age and season, comparing female participants vaccinated and unvaccinated with the quadrivalent human papillomavirus vaccine. Chronic fatigue syndrome, complex regional pain syndrome, and postural orthostatic tachycardia syndrome were also considered separately in secondary analyses.

Results During 10581902 person years of follow-up, 869 female participants with syndromes of autonomic dysfunction (136 with chronic fatigue syndrome, 535 with complex regional pain syndrome, and 198 with postural orthostatic tachycardia syndrome) were identified. Quadrivalent human papillomavirus vaccination did not statistically significantly increase the rate of a composite outcome of all syndromes with autonomic dysfunction in a 365 day risk period following vaccination (rate ratio 0.99, 95% confidence interval 0.74 to 1.32) or the rate of any individual syndrome in the risk period (chronic fatigue syndrome (0.38, 0.13 to 1.09), complex regional pain syndrome (1.31, 0.91 to 1.90), or postural orthostatic tachycardia syndrome (0.86, 0.48 to 1.54)).

Conclusions When vaccination is introduced, adverse events could occur in close temporal relation to the vaccine purely by chance. These results do not support a causal association between quadrivalent human papillomavirus vaccination and chronic fatigue syndrome, complex regional pain syndrome, or postural orthostatic tachycardia syndrome, either individually or as a composite outcome. An increased risk of up to 32% cannot be formally excluded, but the statistical power of the study suggests that a larger increase in the rate of any syndrome associated with vaccination is unlikely.

DOI: 10.1136/bmj.m2930

Source: https://www.bmj.com/content/370/bmj.m2930