一项评估特立帕肽与抗吸收药物治疗严重骨质疏松症患者背痛情况的观察性研究：印度亚组分析。

An observational study to assess back pain in patients with severe osteoporosis treated with teriparatide versus antiresorptives: An Indian subpopulation analysis.

作者信息

Chhabra Harvinder, Malhotra Rajesh, Marwah Sunil, Dave Bharat, See Kyoungah, Sohal Simrat, Gurbuz Sirel

机构信息

Medical Director and Chief of Spine Services, Indian Spinal Injuries Centre, All India Institute of Medical Sciences, New Delhi, India.

Consultant Orthopedic Surgeon, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):483-90. doi: 10.4103/2230-8210.159039.

DOI:10.4103/2230-8210.159039

PMID:26180763

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4481654/

Abstract

BACKGROUND

One year, prospective, observational study in an Indian subpopulation to assess back pain in patients with severe osteoporosis treated with teriparatide or antiresorptives in a clinical setting.

MATERIALS AND METHODS

One hundred and nineteen teriparatide-naοve Indian men and postmenopausal women (mean age 68.0 years) with previous osteoporotic vertebral fracture participated. Patients were assessed at baseline, 6-and 12-months to evaluate relative risk (RR) of new/worsening back pain using the Back Pain Questionnaire. The incidence of back pain and changes in back pain severity were assessed using the visual analog scale (VAS); Health outcomes were assessed using the euroquol-5 dimensions (EQ-5D) questionnaire. All tests were conducted with a two-sided alpha of 0.05.

RESULTS

Of 562 overall patients, 57, 60, and 2 Indian patients received teriparatide, antiresorptive, or teriparatide and antiresorptive, respectively. Baseline disease characteristics were slightly worse for antiresorptive-treated patients, whereas teriparatide-treated patients were older with more comorbidities. At 6-months, the incidence of new/worsening back pain was 5.3% for teriparatide-treated patients versus 4.4% for antiresorptive-treated patients (RR: 1.00, 95% confidence interval: 0.68, 1.48); the incidence of severe back pain was 0% versus 12.5% (P = 0.017); in these treatment groups, respectively. Mean VAS change scores (mean ± standard deviation [SD]) were - 1.9 ± 1.73 versus - 1.4 ± 1.77, and mean EQ-5D change scores were 4.2 ± 27.20 versus 9.9 ± 26.23 at 6-months. At 6 months, more teriparatide-treated patients felt better (89% vs. 61%; P = 0.001) and were at least very satisfied with their treatment (30% vs. 9%; P = 0.011).

CONCLUSION

Teriparatide-treated Indian patients had similar new/worsening back pain risk and minimal risk of severe back pain compared with antiresorptive-treated patients at 6-months.

摘要

背景

在印度亚人群中进行了一项为期一年的前瞻性观察性研究，以评估在临床环境中接受特立帕肽或抗吸收药物治疗的严重骨质疏松症患者的背痛情况。

材料与方法

119名既往未使用过特立帕肽的印度男性和绝经后女性（平均年龄68.0岁），均有骨质疏松性椎体骨折病史，参与了本研究。在基线、6个月和12个月时对患者进行评估，使用背痛问卷评估新发/加重背痛的相对风险（RR）。使用视觉模拟量表（VAS）评估背痛的发生率和背痛严重程度的变化；使用欧洲五维健康量表（EQ-5D）问卷评估健康结局。所有检验的双侧α水平均为0.05。

结果

在562名总体患者中，分别有57名、60名和2名印度患者接受了特立帕肽、抗吸收药物或特立帕肽与抗吸收药物联合治疗。接受抗吸收药物治疗的患者基线疾病特征略差，而接受特立帕肽治疗的患者年龄较大，合并症较多。在6个月时，接受特立帕肽治疗的患者新发/加重背痛的发生率为5.3%，而接受抗吸收药物治疗的患者为4.4%（RR：1.00，95%置信区间：0.68，1.48）；严重背痛的发生率分别为0%和12.5%（P = 0.017）。在这些治疗组中，6个月时VAS平均变化评分（平均值±标准差[SD]）分别为-1.9±1.73和-1.4±1.77，EQ-5D平均变化评分分别为4.2±27.20和9.9±26.23。在6个月时，更多接受特立帕肽治疗的患者感觉好转（89%对61%；P = 0.001），并且至少对其治疗非常满意（30%对9%；P = 0.011）。