POPULARITY
FDA 连续批准2个CGRP受体拮抗剂治疗急性偏头痛NEJM 中国41家三甲医院参加的DIRECT-MT研究NEJM 连续发表2种脊髓侧索硬化症在研新疗法瑞美吉泮(rimegepant)降钙素基因相关肽(CGRP)受体位于疼痛信号通路、颅内动脉和肥大细胞中,其活化被认为在偏头痛的病理生理学中起着因果作用。例如,偏头痛发作时血清中CGRP水平升高。瑞美吉泮(rimegepant)是一种新型的口服、小分子血管舒张剂-CGRP受体拮抗剂。2020年2月,FDA批准瑞美吉泮用于治疗偏头痛急性发作。《随机对照研究:瑞美吉泮治疗急性偏头痛的3期临床研究》Lancet,2020年8月 (1)在这项双盲、随机、安慰剂对照、多中心的第三期试验中,纳入偏头痛病史≥1年的、偏头痛患者1466人,被随机分配接受瑞美吉泮口腔崩解片75mg 和安慰剂治疗。给药后2小时,瑞美吉泮口腔崩解片在止痛方面优于安慰剂(21%对11%,p
Background: The aim of the study was to analyze the effect of preoperative patient characteristics on health outcomes 6 months after total hip replacement (THR), to support patient's decision making in daily practice with predicted health states and satisfaction thresholds. By giving incremental effects for different patient subgroups, we support comparative effectiveness research (CER) on osteoarthritis interventions. Methods: In 2012, 321 patients participated in health state evaluation before and 6 months after THR. Health-related quality of life (HRQoL) was measured with the EQ-5D questionnaire. Hip-specific pain, function, and mobility were measured with the WOMAC in a prospective observation of a cohort. The predictive capability of preoperative patient characteristics - classified according to socio-demographic factors, medical factors, and health state variables - for changes in health outcomes is tested by correlation analysis and multivariate linear regressions. Related satisfaction thresholds were calculated with the patient acceptable symptom state (PASS) concept. Results: The mean WOMAC and EQ-5D scores before operation were 52 and 60 respectively (0 worst, 100 best). At the 6-month follow-up, scores improved by 35 and 19 units. On average, patients reported satisfaction with the operation if postoperative (change) WOMAC scores were higher than 85 (32) and postoperative (change) EQ-5D scores were higher than 79 (14). Conclusions: Changes in WOMAC and EQ-5D scores can mainly be explained by preoperative scores. The lower the preoperative WOMAC or EQ-5D scores, the higher the change in the scores. Very good or very poor preoperative scores lower the probability of patient satisfaction with THR. Shared decision making using a personalized risk assessment approach provides predicted health states and satisfaction thresholds.
Background: To facilitate the discussion on the increasing number of total hip replacements (THR) and their effectiveness, we apply a joint evaluation of hospital case costs and health outcomes at the patient level to enable comparative effectiveness research (CER) based on the preoperative health state. Methods: In 2012, 292 patients from a German orthopedic hospital participated in health state evaluation before and 6 months after THR, where health-related quality of life (HRQoL) and disease specific pain and dysfunction were analyzed using EQ-5D and WOMAC scores. Costs were measured with a patient-based DRG costing scheme in a prospective observation of a cohort. Costs per quality-adjusted life year (QALY) were calculated based on the preoperative WOMAC score, as preoperative health states were found to be the best predictors of QALY gains in multivariate linear regressions. Results: Mean inpatient costs of THR were 6,310 Euros for primary replacement and 7,730 Euros for inpatient lifetime costs including revisions. QALYs gained using the U.K. population preference-weighted index were 5.95. Lifetime costs per QALY were 1,300 Euros. Conclusions: The WOMAC score and the EQ-5D score before operation were the most important predictors of QALY gains. The poorer the WOMAC score or the EQ-5D score before operation, the higher the patient benefit. Costs per QALY were far below common thresholds in all preoperative utility score groups and with all underlying calculation methodologies.
Background: Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design: 60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. Discussion: This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains.
Background: Little is known as to how health-related quality of life (HRQoL) when measured by generic instruments such as EQ-5D differ across smokers, ex-smokers and never-smokers in the general population; whether the overall pattern of this difference remain consistent in each domain of HRQoL; and what implications this variation, if any, would have for economic evaluations of tobacco control interventions. Methods: Using the 2006 round of Health Survey for England data (n = 13,241), this paper aims to examine the impact of smoking status on health-related quality of life in English population. Depending upon the nature of the EQ-5D data (i.e. tariff or domains), linear or logistic regression models were fitted to control for biology, clinical conditions, socio-economic background and lifestyle factors that an individual may have regardless of their smoking status. Age-and gender-specific predicted values according to smoking status are offered as the potential `utility' values to be used in future economic evaluation models. Results: The observed difference of 0.1100 in EQ-5D scores between never-smokers (0.8839) and heavy-smokers (0.7739) reduced to 0.0516 after adjusting for biological, clinical, lifestyle and socioeconomic conditions. Heavy-smokers, when compared with never-smokers, were significantly more likely to report some/severe problems in all five domains - mobility (67%), self-care (70%), usual activity (42%), pain/discomfort (46%) and anxiety/depression (86%) -. `Utility' values by age and gender for each category of smoking are provided to be used in the future economic evaluations. Conclusion: Smoking is significantly and negatively associated with health-related quality of life in English general population and the magnitude of this association is determined by the number of cigarettes smoked. The varying degree of this association, captured through instruments such as EQ-5D, may need to be fed into the design of future economic evaluations where the intervention being evaluated affects (e. g. tobacco control) or is affected (e. g. treatment for lung cancer) by individual's (or patients') smoking status.
Objective: To analyse the psychometric properties of the EuroQol questionnaire (EQ-5D) applied to patients with acute coronary syndromes (ACS).Setting: Rehabilitation hospital.Patients and design: 106 consecutive patients with ACS (51% myocardial infarction, 42% coronary artery bypass grafting, 7% angina) completed the EQ-5D, the 36 item short form health survey (SF-36), and the MacNew questionnaire at admission, at discharge, and three months after inpatient cardiac rehabilitation. Acceptance, validity, reliability, and responsiveness of the EQ-5D were tested.Results: The EQ-5D was highly accepted. The EQ-5D index showed substantial ceiling effects after rehabilitation. As expected the EQ-5D visual analogue scale (VAS) score (70.3 v 57.1) and EQ-5D index (77.8 v 64.5) were significantly better for patients with myocardial infarction than for patients who underwent surgery (both p ⩽ 0.001). Significant correlations were found between the EQ-5D VAS score, EQ-5D index, and domains of the SF-36 (r = 0.21 to r = 0.74). The correlation with the MacNew subscores and with the global score ranged between 0.55 and 0.78. With repeated measurement the EQ-5D showed reasonable reliability in stable patients with intraclass correlation ranging between 0.91 and 0.54. EQ-5D was responsive in patients who indicated improvement in health states between admission and discharge (effect size 0.74--0.82).Conclusion: The psychometric properties of the EQ-5D were satisfying. It is a reasonably valid, reliable, and responsive instrument for patients with ACS. It may be useful in clinical research and epidemiological studies to generate preference based valuations of health related quality life.