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印度糖尿病合并结核病患者中二甲双胍治疗对健康相关生活质量结局的影响:一项前瞻性研究。

Impact of metformin therapy on health-related quality of life outcomes in tuberculosis patients with diabetes mellitus in India: A prospective study.

机构信息

Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.

Department of Drug Safety and Pharmacovigilance, Syneos Health, Gurgaon, India.

出版信息

Int J Clin Pract. 2021 Apr;75(4):e13864. doi: 10.1111/ijcp.13864. Epub 2020 Dec 10.

Abstract

OBJECTIVE

To assess the impact of metformin use on health-related quality of life (HRQoL) in tuberculosis (TB) patients who are presented with type 2 diabetes mellitus (T2DM).

METHODOLOGY

In this community-based prospective study, TB patients attending Hakeem Abdul Hameed Centenary Hospital, New Delhi (India) and had comorbidity of T2DM between April 2018 and July 2019 were enrolled. Patients were divided into metformin users and metformin non-users on the basis of the presence of metformin in their routine as antidiabetic drug(s). HRQoL was determined using a validated TB-specific tool (Dhingra and Rajpal-12 scale ie, DR-12) consists of symptom and socio-psychological and exercise adaptation domains. The HRQoL scores were compared at pretreatment (1st visit), end of intensive phase (2nd visit) and end of treatment (3rd visit) between the two groups.

RESULTS

A total of 120 patients were enrolled, of which 24 were excluded as they did not respond at follow-up visits. Among the metformin users (n = 48) the mean age of patients was 47.56 years and 62.50% was males. Among the metformin non-users (n = 48), the mean age of patients was 49.02 years and 54.10% was males. The baseline characteristics were similar in both groups except for the substance used history (P = .025), literacy level (P = .048) and BMI (P = .028). Metformin users demonstrated significant improvement in symptom scores (2nd visit: P < .001; 3rd visit: P = .001) and socio-psychological and exercise adaptation scores (2nd visit: P < .0001; 3rd visit: P < .0001) as compared with metformin non-users at 2nd visit and 3rd visit. Overall, scores were also found to be significantly improved in metformin users (2nd visit: P < .001; 3rd visit: P = .001).

CONCLUSION

Metformin therapy exerted favourable effects on HRQoL in patients with TB and T2DM and can be recommended as an adjuvant antitubercular drug in TB patients with co-morbidity of T2DM, unless contraindicated.

摘要

目的

评估二甲双胍在患有 2 型糖尿病(T2DM)的结核病(TB)患者中的使用对健康相关生活质量(HRQoL)的影响。

方法

在这项基于社区的前瞻性研究中,招募了 2018 年 4 月至 2019 年 7 月在印度新德里 Hakeem Abdul Hameed 百年纪念医院就诊且患有 T2DM 合并症的 TB 患者。根据常规降糖药物中是否含有二甲双胍,将患者分为二甲双胍使用者和非使用者。使用经过验证的结核病专用工具(Dhingra 和 Rajpal-12 量表,即 DR-12)确定 HRQoL,该量表由症状和社会心理及运动适应领域组成。在两组患者中,比较治疗前(第 1 次就诊)、强化期结束时(第 2 次就诊)和治疗结束时(第 3 次就诊)的 HRQoL 评分。

结果

共纳入 120 例患者,其中 24 例因随访时未应答而被排除。在二甲双胍使用者(n=48)中,患者的平均年龄为 47.56 岁,62.50%为男性。在二甲双胍非使用者(n=48)中,患者的平均年龄为 49.02 岁,54.10%为男性。两组患者的基线特征相似,但药物使用史(P=0.025)、文化程度(P=0.048)和 BMI(P=0.028)存在差异。与二甲双胍非使用者相比,二甲双胍使用者的症状评分在第 2 次就诊时(P<0.001;第 3 次就诊时:P=0.001)和社会心理及运动适应评分在第 2 次就诊时(P<0.0001;第 3 次就诊时:P<0.0001)显著改善,第 2 次就诊和第 3 次就诊时也发现整体评分显著改善(第 2 次就诊:P<0.001;第 3 次就诊:P=0.001)。

结论

二甲双胍治疗对合并 T2DM 的结核病患者的 HRQoL 有积极影响,在没有禁忌证的情况下,可以作为合并 T2DM 的结核病患者的辅助抗结核药物进行推荐。

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