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巴瑞替尼和托法替尼治疗类风湿关节炎患者的结果:来自常规临床实践的数据。

Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice.

机构信息

Servicio de Farmacia, Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain. Instituto de Investigación Sanitaria Galicia Sur, Fundación Biomédica Galicia Sur. Spain..

Servicio de Farmacia, Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain..

出版信息

Farm Hosp. 2021 Jun 1;45(4):165-169. doi: 10.7399/fh.11586.

DOI:10.7399/fh.11586
PMID:34218760
Abstract

OBJECTIVE

Main objective: Describe the effectiveness and safety of baricitinib and tofacitinib in patients diagnosed with rheumatoid arthritis in our hospital.

SECONDARY OBJECTIVE

Analyse whether there are  differences between the two drugs in routine clinical practice.

METHOD

Two-year retrospective study of patients diagnosed with  rheumatoid arthritis treated in our hospital with baricitinib and tofacitinib  for at least 6 months. Databases: Electronic medical record and outpatient medication dispensing software. Variables collected:  Demographic variables, poor prognosis factors, previous treatment,  duration of treatment, concomitant treatment, DAS28, number of swollen  and painful joints, pain visual analogy scale, treatment discontinuation,  and adverse reactions. Effectiveness evaluation: Decreases in the DAS28  scale, the number of swollen and painful joints, and the pain Visual  Analogy Scale at 6 months and 12 months after starting treatment. Safety evaluation: Detection of adverse reactions.

STATISTICAL ANALYSIS

Student t- test.

RESULTS

A total of 44 patients were evaluated. Of these, 20 (70%  women) received treatment with baricitinib and 24 (95.8% women)  received tofacitinib. Baricitinib reduced the DAS28 by 2.3 and 1.7 at 6  months and 12 months, respectively, and tofacitinib reduced the scale by 2 and 1.9 at 6 months and 12 months, respectively. Baricitinib reduced the  number of swollen and painful joints by 7 at both 6 months and 12  months, and tofacitinib reduced the number of swollen and painful joints  by 4 and 6 at 6 months and 12 months, respectively. Baricitinib reduced  the Visual Analogy Scale score by 7.8 and 6.8 at 6 months and 12 months, respectively, and tofacitinib reduced the score by 5 and 6 at 6 months and 12 months, respectively. Corticosteroid treatment was needed in 40% of patients treated with baricitinib and 62.5% of patients treated with  rofacitinib. Treatment was discontinued due to loss of effectiveness in 10% of patients receiving baricitinib and 25% of patients treated with  tofacitinib. Adverse reactions were experienced by 10% of patients treated with baricitinib and 12.5% of patients treated with tofacitinib. Adverse  reactions led to treatment discontinuation in only 1 patient in each group.  No statistically significant differences were observed between the two  drugs.

CONCLUSIONS

The results show that baricitinib and tofacitinib were  effective and safe in relation to all the variables analysed. Moreover, both drugs were similar in terms of effectiveness and safety for the  treatment of rheumatoid arthritis in real-world clinical practice.

摘要

目的

主要目的:描述巴瑞替尼和托法替布在我院诊断为类风湿关节炎患者中的疗效和安全性。

次要目的

分析这两种药物在常规临床实践中是否存在差异。

方法

对在我院接受巴瑞替尼和托法替布至少 6 个月治疗的类风湿关节炎患者进行为期两年的回顾性研究。数据库:电子病历和门诊配药软件。收集的变量:人口统计学变量、预后不良因素、既往治疗、治疗持续时间、伴随治疗、DAS28、肿胀和疼痛关节数、疼痛视觉类比量表、治疗终止和不良反应。疗效评估:治疗开始后 6 个月和 12 个月时 DAS28 量表、肿胀和疼痛关节数以及疼痛视觉类比量表的下降。安全性评估:检测不良反应。

统计分析

学生 t 检验。

结果

共评估了 44 例患者,其中 20 例(70%为女性)接受巴瑞替尼治疗,24 例(95.8%为女性)接受托法替布治疗。巴瑞替尼分别在 6 个月和 12 个月时将 DAS28 降低了 2.3 和 1.7,托法替布分别在 6 个月和 12 个月时将 DAS28 降低了 2 和 1.9。巴瑞替尼分别在 6 个月和 12 个月时将肿胀和疼痛关节数减少了 7 个,托法替布分别在 6 个月和 12 个月时将肿胀和疼痛关节数减少了 4 个和 6 个。巴瑞替尼分别在 6 个月和 12 个月时将视觉类比量表评分降低了 7.8 和 6.8,托法替布分别在 6 个月和 12 个月时将视觉类比量表评分降低了 5 和 6。巴瑞替尼治疗组有 40%的患者需要接受皮质类固醇治疗,托法替布治疗组有 62.5%的患者需要接受皮质类固醇治疗。巴瑞替尼治疗组有 10%的患者因疗效丧失而停止治疗,托法替布治疗组有 25%的患者因疗效丧失而停止治疗。巴瑞替尼治疗组有 10%的患者出现不良反应,托法替布治疗组有 12.5%的患者出现不良反应。两组各有 1 例患者因不良反应而停止治疗。两种药物之间未观察到统计学上的显著差异。

结论

结果表明,巴瑞替尼和托法替布在所有分析的变量方面均有效且安全。此外,在真实世界的临床实践中,这两种药物在治疗类风湿关节炎方面的疗效和安全性相似。

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