The 23-valent pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis: a double-blinded, randomized, placebo-controlled trial

被引：26

作者：

Izumi, Yasumori ^{[1
]}

Akazawa, Manabu ^{[2
]}

Akeda, Yukihiro ^{[3
]}

Tohma, Shigeto ^{[1
]}

Hirano, Fuminori ^{[1
]}

Ideguchi, Haruko ^{[1
]}

Matsumura, Ryutaro ^{[1
]}

Miyamura, Tomoya ^{[1
]}

Mori, Shunsuke ^{[1
]}

Fukui, Takahiro ^{[1
]}

Iwanaga, Nozomi ^{[1
]}

Jiuchi, Yuka ^{[1
]}

Kozuru, Hideko ^{[1
]}

Tsutani, Hiroshi ^{[1
]}

Saisyo, Kouichirou ^{[1
]}

Sugiyama, Takao ^{[1
]}

Suenaga, Yasuo ^{[1
]}

Okada, Yasumasa ^{[1
]}

Katayama, Masao ^{[1
]}

Ichikawa, Kenji ^{[1
]}

Furukawa, Hiroshi ^{[1
]}

Kawakami, Kenji ^{[1
]}

Oishi, Kazunori ^{[4
]}

Migita, Kiyoshi ^{[1
,5
]}

机构：

[1] Japanese Natl Hosp Org NHO, Evidence Based Med Study Grp, Meguro Ku, Higashigaoka 2-5-23, Tokyo 1528621, Japan

[2] Meiji Pharmaceut Univ, Dept Publ Hlth & Epidemiol, Noshio 2-522-1, Tokyo 2048588, Japan

[3] Osaka Univ, Microbial Dis Res Inst, Yamadaoka 3-1, Suita, Osaka 5658563, Japan

[4] Natl Inst Infect Dis, Infect Dis Surveillance Ctr, Shinjuku Ku, Toyama 1-23-1, Tokyo 1628640, Japan

[5] Fukushima Med Univ, Dept Rheumatol, Hikarigaoka 1, Fukushima 9601295, Japan

来源：

ARTHRITIS RESEARCH & THERAPY | 2017年 / 19卷

关键词：

Interstitial lung disease; Pneumococcal polysaccharide vaccine; Pneumonia; Rheumatoid arthritis; COMMUNITY-ACQUIRED PNEUMONIA; LARGE OBSERVATIONAL COHORT; LUNG-DISEASE; STREPTOCOCCUS-PNEUMONIAE; SERIOUS INFECTION; RISK; METAANALYSIS; ADULTS; PREVENTION; MORTALITY;

D O I：

10.1186/s13075-016-1207-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: Pneumococcal pneumonia is the most frequent form of pneumonia. We herein assessed the effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in the prevention of pneumonia overall in rheumatoid arthritis (RA) patients at risk for infections. We hypothesized that PPSV23 vaccination is superior in preventing pneumococcal pneumonia compared with placebo in RA patients. Methods: A prospective, multicenter, double-blinded, randomized, placebo-controlled (1: 1) trial was conducted across departments of rheumatology in Japanese National Hospital Organization hospitals. RA patients (n = 900) who had been treated with biological or immunosuppressive agents were randomly assigned PPSV23 or placebo (sodium chloride). The primary endpoints were the incidences of all-cause pneumonia and pneumococcal pneumonia. The secondary endpoint was death from pneumococcal pneumonia, all-cause pneumonia, or other causes. Cox regression models were used to estimate the risk of pneumonia overall for the placebo group compared with the vaccine group. Results: Seventeen (3.7%) of 464 patients in the vaccine group and 15 (3.4%) of 436 patients in the placebo group developed pneumonia. There was no difference in the rates of pneumonia between the two study groups. The overall rate of pneumonia was 21.8 per 1000 person-years for patients with RA. The presence of interstitial pneumonia (hazard ratio: 3.601, 95% confidence interval: 1.547-8.380) was associated with an increased risk of pneumonia in RA patients. Conclusion: PPSV23 does not prevent against pneumonia overall in RA patients at relative risk for infections. Our results also confirm that the presence of interstitial lung disease is associated with pneumonia in Japanese patients with RA.

引用

页数：10

共 30 条

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