Skeletal pain in postmenopausal women with osteoporosis: prevalence and course during raloxifene treatment in a prospective observational study of 6 months duration

ABSTRACT

Objective: To assess the prevalence of skeletal pain in postmenopausal women before the onset of raloxifene treatment and the further course of pain during treatment in a naturalistic setting.

Research design and methods: Prospective, uncontrolled, multicentre, 6‐month, observational study in Germany. Clinical, diagnostic and pain data were collected at baseline, 6 weeks and 6 months of raloxifene treatment from 3299 female outpatients with postmenopausal osteoporosis. Physicians assessed the presence or absence of back pain, joint pain and diffuse bone pain at each visit, perceived sleep quality and the use of analgesics. Patients assessed intensity and frequency of pain using a 100?mm visual analogue scale (VAS) and a 5‐point scale (from ‘rarely’ to ‘permanently’), respectively.

Results: At baseline, patients had mean (SD) age 67.6 (9.3) years, 89.4% were reported to have reduced bone mineral density, 39.8% had pre-existing fractures and 93.4% had skeletal pain (physician assessment): 85.1% had back pain, 41.8% joint pain and 32.5% diffuse bone pain. Median pain intensity on VAS was 66.0?mm. After 6 months of raloxifene treatment, the frequency and intensity of pain and use of analgesics for skeletal pain decreased consistently by approximately 50%. Pain frequency decreased in 58.2% and increased in 2.3% of patients. The median decrease in pain intensity from baseline to 6 months was 27.0?mm (46%). Patients’ subjective quality of sleep improved: the proportion of patients who were reported to sleep well increased from 21.3% at baseline to 46.7% at 6 months. The decrease in relative pain frequency was greatest with diffuse pain (67.6%) followed by joint pain (36.9%) and back pain (32.5%).

Conclusion: Raloxifene treatment in postmenopausal women with osteoporosis was associated with a marked reduction of skeletal pain and analgesic consumption and an improvement in subjective sleep quality. Further investigation in a randomised, placebo-controlled trial is warranted.     

Evaluation of health status in epilepsy using the EQ-5D questionnaire: a prospective,observational, 6-month study of adjunctive therapy with anti-epileptic drugs

ABSTRACT

Aims: The aims of this project were to evaluate the impact of adjunctive treatment with an anti-epileptic drug (AED) on the health status of people with epilepsy and to investigate how seizure frequency affects their health status.

Methods: Adult epilepsy patients, refractory to current treatment, were included in this prospective observational study. Patients commencing adjunctive therapy with one of five AEDs (topiramate, lamotrigine, gabapentin, clobazam, vigabatrin) were eligible for inclusion. The study took place at the outpatient clinics of the National Hospital for Neurology and Neurosurgery, Queen Square, London. Patients completed the EQ-5D, a generic health status measure, at baseline and again after 3 and 6 months. Information was also collected on medications and seizure frequency.

Results: In total, 125 patients entered the study and were followed up for 6 months. Patients treated with topiramate had a significant increase (?p < 0.05) in EQ-5D score from baseline, indicating an improvement in their health status whereas scores for lamotrigine, clobazam and gabapentin all showed a non-significant decline. When the data were analysed according to seizure frequency, only patients who became seizure-free on adjunctive treatment had a significant increase in their health status. The group who had a 50% reduction in seizure frequency did not have increased health status.

Conclusions: In summary, adjunctive treatment with topiramate significantly increased health status as measured by the EQ-5D. These data also suggest that achievement of seizure-freedom is the key to improving health status in this patient group.     

Physical performance and life quality in postmenopausal women supplemented with vitamin D: a two-year prospective study

Aim:

To investigate the effects of calcium and vitamin D supplementation on bone turnover marker levels, muscle strength and quality of life in postmenopausal Chinese women.

Methods:

A total of 485 healthy postmenopausal Chinese women (63.44±5.04 years) were enrolled in this open-label, 2-year, prospective, community-based trial. The participants were divided into group A, B, C, which were treated with calcium (600 mg/d) alone, calcium (600 mg/d) and cholecalciferol (800 IU/d) or calcium (600 mg/d) and calcitriol (0.25 μg/d), respectively, for 2 years. Serum levels of 25-hydroxyvitamin D, parathyroid hormone, β-CTX and P1NP were measured, and the muscle strength and quality of life were assessed at baseline and at 12- and 24-month follow-ups.

Results:

Four hundred and sixty one participants completed this study. Serum levels of 25-hydroxyvitamin D were significantly increased in group C, but not changed in groups A and B at 24-month follow-up. Serum levels of parathyroid hormone, bone turnover marker β-CTX and bone formation marker P1NP were significantly decreased in group C, while serum levels of β-CTX were increased in group A at 24-month follow-up. The participants in group C maintained the grip strength, while those in groups A and B exhibited decreased grip strength at 24-month follow-up. The quality of life for the participants in groups B and C remained consistent, but that in group A was deteriorated at 24-month follow-up.

Conclusion:

Supplementation with calcitriol and calcium modifies the bone turnover marker levels, and maintains muscle strength and quality of life in postmenopausal Chinese women, whereas supplementation with cholecalciferol and calcium prevents aging-mediated deterioration in quality of life.     

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

ABSTRACT

Objective: The European Forsteo^* Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry.

Methods: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL.

Results: The mean (standard deviation [SD]) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T?score was –3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ?5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients.

Conclusions: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.     

Economic burden and quality of life of vulvodynia in the United States

Abstract

Objective:

To explore the economic burden and quality of life of vulvodynia in the United States.     

唑来磷酸盐对绝经后骨质疏松女性硫酸脱氢表雄酮的影响分析

目的：观察分析唑来磷酸盐对绝经后骨质疏松女性硫酸脱氢表雄酮的影响。方法选取收治的绝经后骨质疏松女性80例,患者随机分为观察组（ n =40）和对照组（ n =40）。对照组患者给予骨化三醇胶丸治疗,观察组患者在此基础上给予唑来磷酸盐治疗。比较2组疗效、硫酸脱氢表雄酮含量、骨痛症状、不良反应情况。结果治疗后,观察组总有效率为92烫．50%高于对照组的72．50%,差异有统计学意义（ P <0．05）。入组时,2组患者硫酸脱氢表雄酮含量比较无统计学意义（ P >0．05）;治疗60 d时,观察组硫酸脱氢表雄酮含量上升幅度较对照组大;治疗90 d时,观察组患者硫酸脱氢表雄酮含量上升幅度明显高于对照组患者,差异有统计学意义（ P <0．05）。治疗后,观察组骨痛症状缓解率为92．50%,明显高于对照组的75．00%,差异有统计学意义（ P <0．05）。观察组不良反应发生率为7．50%明显低于对照组57．50%,差异有统计学意义（ P <0．05）。治疗后,观察组患者骨密度增加比对照组患者明显,差异有统计学意义（ P <0．05）。结论应用唑来磷酸盐治疗绝经后骨质疏松女性疗效显著,能有效增加硫酸脱氢表雄酮含量,减少不良反应发生,安全性高。     

Health-related quality of life in type 1 diabetes mellitus pediatric patients and their caregivers in Spain: an observational cross-sectional study

Objectives: This study assessed the health-related quality of life (HRQOL) of pediatric patients with type 1 diabetes mellitus (T1DM) and their caregivers.

Methods: CHRYSTAL was an observational cross-sectional study conducted in Spain in 2014 on 275 patients under 18?years old diagnosed with T1DM. Patient/caregiver pairs were stratified by patients’ HbA1c level (≥7.5% versus <7.5%) and by presence or absence of T1DM complications and/or comorbidities. EQ-5D and PedsQL questionnaires were administered to patients and caregivers.

Results: On the EQ-5D, according to caregivers’ perception, 17.7% of children experienced moderate pain or discomfort, 9.7% suffered problems performing usual activities, and 13.2% demonstrated moderate anxiety or depression. Mean EQ-5D index score was 0.95 and mean visual analog scale (VAS) score was 86.1. By HbA1c level (≥7.5% versus <7.5%), mean index scores were 0.94 and 0.95, and mean VAS scores were 82.8 and 89.2, respectively. Mean index scores were 0.91 for children with complications and/or comorbidities and 0.96 for children without. Mean VAS scores were 83.7 and 87.2, respectively. HRQOL per the PedsQL tool ranged from 68.1 (ages 2–4) to 73.1 (ages 13–18). EQ-5D index and VAS scores were significantly correlated (rho = 0.29–0.43) with several age groups of the PedsQL. EQ-5D scales showed significant moderate correlation between EQ-5D-Y and EQ-5D-3L proxy VAS score (rho = 0.45; p?<?.001).

Conclusions: Patients with few complications and controlled HbA1c reported a relatively high HRQOL. The results suggest that parent-proxy EQ-5D ratings are valid for use as part of an overall health outcomes assessment in clinical studies of T1DM in pediatric patients.     

健康教育对绝经后骨质疏松患者生活质量的影响

目的：探讨健康教育对绝经后骨质疏松症患者生活质量的影响。方法将160例绝经后骨质疏松患者随机分为实验组和对照组各80例,实验组进行系统健康教育并于出院后随访,对照组只进行常规的健康教育指导,应用SF-36生活质量量表分别对两组干预前及干预6个月后的生活质量进行评分。结果实验组干预后的各维度（总体健康、生理职能、社会功能、情感职能等）评分均明显升高,与干预前及对照组比较,差异有统计学意义（P＜0.05）。对照组干预前后的各维度评分比较,差异无统计学意义（P＞0.05）。结论对绝经后骨质疏松症患者实施系统的健康教育,可以提高患者的生活质量。     

女性尖锐湿疣118例生活质量分析

目的 探索女性尖锐湿疣患者的生活质量.方法 对118例女性尖锐湿疣患者使用含中文版SF-36量表问卷进行面对面询问式调查,采用t检验和x2检验等统计方法比较女性尖锐湿疣患者及健康对照人群SF-36量表各维度评分.结果 有效问卷101份,尖锐湿疣患者以躯体功能(PF)和躯体疼痛(BP)两个维度最高,分别为(92.9±10.5)分和(75.0±11.2)分;情感所致功能限制(RE)维度最低,为(50.8±13.7)分.两组比较,除PF无统计学意义外,各维度评分均为尖锐湿疣患者显著低于对照组(均P＜0.01).结论 女性尖锐湿疣患者生活质量显著低于对照人群,尤其是在心理功能上.     

唑来膦酸对绝经后骨质疏松患者骨密度、骨代谢指标、生活质量及疗效的影响

目的 探讨唑来膦酸对绝经后骨质疏松患者骨密度、骨代谢指标、生活质量及疗效的影响.方法 114例绝经后骨质疏松症患者依据随机数字表法随机分为观察组与对照组,每组57例.对照组采用常规治疗,观察组在对照组基础上结合唑来膦酸治疗.2组疗程均为12个月.比较2组患者骨密度、骨代谢指标、生活质量、疗效及不良反应情况.结果 2组腰椎和Ward三角区骨密度治疗后增加(P＜0.05);观察组腰椎和Ward三角区骨密度治疗后高于对照组(P＜0.05);2组S-Ca、S-P治疗前后比较差异均无统计学意义(P＞0.05);2组ALP治疗后下降(P＜0.05);观察组ALP低于对照组(P＜0.05);观察组SF-36量表中躯体疼痛、精神健康、生理功能、生理职能、情感职能、社会功能、生命活力、总体健康治疗后高于对照组(P＜0.05);观察组总有效率高于对照组(P＜0.05);2组均未见严重用药不良反应.结论 唑来膦酸可明显改善患者骨密度,降低ALP水平,提高患者生活质量,疗效显著,安全可靠,具有重要研究价值.     

利塞膦酸治疗绝经后骨质疏松症的随机双盲对照临床研究

目的:探讨利塞膦酸治疗绝经后骨质疏松症的有效性和安全性。方法:采用随机双盲安慰剂对照平行临床比较研究,共入选病例48例。利塞膦酸组给予利塞膦酸钠片5 mg,qd;安慰剂组给予安慰剂1片,qd;每组均同时给予钙维D,咀嚼片1片,qd;疗程均为12 mo。结果:完成病例共46例,每组各23例。用药后腰椎和髋骨总骨密度,利塞膦酸组增加了(0．04±s 0．04)g·cm-2和(0．03±0．05)g·cm-2,与治疗前比较差异非常显著(P<0．01);安慰剂组无明显变化,2组间比较,差异有非常显著意义(P< 0．01)。利塞膦酸组用药后血骨钙素和I型胶原交联C端多肽分别下降(4±7)μg·L-1和(0．6±0．4)nmol·L-1,与治疗前比较差异非常显著(P<0．01)。不良事件2组各发生1例,组间无显著差异(P>0．05)。结论:利塞膦酸是一种疗效和安全性均良好的治疗绝经后骨质疏松症的药物。     

Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients

SUMMARY

Objective: The aim of this study was to evaluate the construct validity of a generic health related quality of life (HRQOL) instrument – the EQ-5D – in a sample of schizophrenic patients receiving antipsychotic treatment.

Research design and methods: A total of 2128 schizophrenic patients treated with olanzapine, 417 treated with risperidone, and 112 with haloperidol responded to the EQ-5D. The study also assessed the effect of patient age, gender, and co-morbidity variables on patient's HRQOL

Main outcomes measures: EQ-5D scores at the start of treatment and after 3 and 6?months of therapy were compared with results from the Clinical Global Impression (CGI) severity of illness scale and the (GAF) scale. The effect of antipsychotics and sociodemographic variables on patient's HRQOL over time was tested through a three-factor doubly multivariate repeated measures MANCOVA.

Results: High scores in the GAF scale and low scores in the CGI were linked with high scores on the EQ-5D scale. The correlational effects observed between the EQ-5D and the clinical indices ranged from 0.33 to 0.54. A significant effect of ‘visit time’ as well as an interaction of ‘visit time’ x drug, ‘visit time’ x gender, and ‘visit time’ x co-morbidity was observed.

Conclusions: Results suggest the EQ-5D is a valid instrument capable of detecting HRQOL differences between schizophrenic patients with different degrees of severity of illness.     

Patient compliance with alendronate,risedronate and raloxifene for the treatment of osteoporosis in postmenopausal women

ABSTRACT

Objectives: The aim was to investigate patient compliance with different osteoporosis medications commonly prescribed in clinical practice, to determine risk factors associated with discontinuation and to evaluate quality of life changes.

Research design and methods: We conducted a 1-year observational study of patients of age ≥ 60 years in a clinical setting at 917 sites in 10 European countries (Germany, Greece, UK, Sweden, Netherlands, Romania, Norway, Finland, Denmark, Estonia), Lebanon and South Africa. Demographic data, concomitant diseases, the reasons for intervention, educational, socio-economical status and disease knowledge were captured at baseline. Self-reported compliance, discontinuation data and health status were collected.

Main outcome measures: Out of 5198 patients, 3490 (67.1%) patients received 60?mg daily raloxifene (RAL), 452 (8.7%) 10?mg daily alendronate (AQD), 769 (14.8%) 70?mg once weekly alendronate (AQW) and 487 (9.4%) 5?mg daily risedronate (RIS). Among patients completing the study (4231, 81%), the percentage of patients with high compliance was 80% (RAL), 79% (AQD), 65% (AQW) and 76% (RIS). The discontinuation due to side effects was highest on AQW (7.0%), followed by AQD (6.4%), RAL (3.8%) and RIS (3.4%). The discontinuation-rate was higher for patients with a history of surgical menopause, increased age, lack of knowledge about medical prevention of osteoporosis and thin frame as a reason for intervention. The EQ-5D weighted index showed the highest improvement for RIS (0.13), followed by RAL (0.11), AQD (0.08) and AQW (0.07).

Conclusions: Data from this non-interventional observational study indicate moderate overall compliance and discontinuation rate with the prescribed osteoporosis medications.     

SF-36量表在测定慢性病患者生命质量中的应用考评

目的 通过测定6种慢性病患者的生命质量，对SF-36英国发展版量表的信度、效度和反应度进行考评。方法 用 SF-36英国发展版对住院的6种慢性病患者进行生命质量的测定，分析包括内部一致性信度和重测信度；结构效度、效标效度和区分效度；反应度。结果 SF-36具有较好的信度，除SF外，各领域的内部一致性系数和重测信度系数均在0．7以上，SF的信度系数也在0．6以上。反应度分析显示。SF-36的反应度较好，但测量时间对反应度有一定的影响。SF-36的效度一般，特别是在VT、MH方面效度不佳。结论 SF-36用于慢性病患者的生命质量评估还有待进一步研究，应用于治疗效果评价时注意评价时间对结果的影响。     

Study description and baseline characteristics of the population enrolled in a multinational,observational study of teriparatide in postmenopausal women with osteoporosis: the Asia and Latin America Fracture Observational Study (ALAFOS)

Objective: To describe the study design and baseline patient characteristics of the Asia and Latin America Fracture Observational Study (ALAFOS) to better understand the profile of patients receiving teriparatide during the course of routine clinical practice in Asia, Latin America, the Middle East and Russia.

Methods: Prospective, observational, non-interventional study in postmenopausal women with osteoporosis who are prescribed teriparatide for up to 24?months, according to local medical standards, with a 12?month post-treatment follow-up.

Measures: Demographics, risk factors for osteoporosis and fractures, history of fracture, prior osteoporosis medications, comorbidities, physical function, back pain and quality of life (QoL).

Results: In total 3031 postmenopausal women (mean age 72.5?years) recruited at 152 sites in 20 countries were analyzed; 62.9% had a history of fragility fracture after age 40 (33.0% of patients with spinal, 14.2% with hip fractures). The mean (SD) bone mineral density T-scores at baseline were ?3.06 (1.40) and ?2.60 (1.05) at the lumbar spine and femoral neck, respectively. At entry, 43.7% of patients were naïve to prior osteoporosis treatments; 40.5% of patients reported ≥1 fall in the past year. The median (Q1; Q3) EuroQoL Visual Analog Scale (EQ-VAS) for perceived overall health status was 60 (50; 80). The mean (SD) worst back pain Numeric Rating Scale in the last 24?hours was 4.6 (3.3).

Conclusions: Our data indicates that patients who were prescribed teriparatide in the ALAFOS participant countries had severe osteoporosis, high prevalence of fractures, disabling back pain and poor QoL. The frequency of patients receiving prior osteoporosis medications was lower than in previous observational studies conducted in other locations.     

重组人甲状旁腺素(1-34)对绝经后骨质疏松患者血基质金属蛋白酶1及其组织抑制因子的影响

目的观察重组人甲状旁腺素(1-34)[rhPTH(1-34)]对绝经后骨质疏松患者血清基质金属蛋白酶1(MMP-1)及其组织抑制因子(TIMP-1)水平的影响,探讨其调节骨代谢的机制。方法绝经后女性90名分为骨质疏松组和正常组,骨质疏松组每日皮下注射rhPTH(1-34)20μg+钙剂600 mg+维生素D_3 200 IU,正常组不给予任何药物干预。检测腰椎骨密度(BMD),血钙、磷、MMP-1、TIMP-1、内源性全段甲状旁腺素(iPTH)、骨特异性碱性磷酸酶(BSAP)以及尿Ⅰ型胶原交联氨基末端肽(NTX)水平,并分析参数之间的相关关系。结果正常组BMD、血钙高于骨质疏松组(p<0.01),而iPTH、BSAP、MMP-1和尿NTX低于骨质疏松组(P<0.05)。rhPTH(1-34)治疗后,骨质疏松组患者腰椎BMD,血钙、磷、MMP-1、BSAP和尿NTX增高,而iPTH下降,与治疗前相比差异显著(P<0.05)。血TIMP-1与腰椎BMD成负相关(r=-0.376,P=0.014),校正年龄、体重指数后关系仍然存在;MMP-1与其他指标没有相关性。结论小剂量rhPTH(1-34)可促进绝经后骨质疏松患者血MMP-1水平增高,从而使成骨活性增强,这可能是其促进骨形成的机制之一。