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American College of Rheumatology Updates Rheumatoid Arthritis Guidelines
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American College of Rheumatology Updates Rheumatoid Arthritis Guidelines The American College of Rheumatology (ACR) has updated its 2002 guidelines on the use of nonbiologic disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA), which now include data on the use of biologic agents as well. The updated recommendations are reported in the June 15 issue of Arthritis Care and Research. "The majority of patients with a confirmed diagnosis of . . . RA use nonbiologic. . . DMARDs and the rate of biologic DMARD use is rising rapidly," write Kenneth G. Saag, MD, MSc, from the University of Alabama, Birmingham, and colleagues. "The . . . ACR has not updated its recommendations for nonbiologic DMARDs since 2002 and has not previously developed recommendations for biologic agents. Although past guidelines have been derived from an informal consensus approach, we used a formal group process to develop recommendations that were as evidence-based as possible." These guidelines were developed following the principles set forth by the Appraisal of Guidelines for Research and Evaluation Collaboration. A systematic review of scientific evidence was conducted to create an evidence report and draft guidelines addressing 5 domains prespecified by the ACR: (1) indications for use, (2) screening for tuberculosis (TB; for biologic DMARDs only), (3) monitoring for adverse effects, (4) evaluating clinical response, and (5) the roles of cost and patient preferences in decision making (for biologic DMARDs only). A Task Force Panel that critiqued and rated proposed recommendations included internationally recognized clinicians, methodologists, and patient representatives with broad expertise in the use of nonbiologic and biologic DMARDs, evidence-based medicine, patient preference, and healthcare economics. Indications for starting or resuming a nonbiologic or biologic DMARD highlight the use of these agents on the background of optimal and appropriate use of nonmedical therapy such as physical and occupational therapy as well as the use of nonsteroidal anti-inflammatory drugs and intraarticular and oral glucocorticoids. Biologic DMARDs should be used only after failure of nonbiologic DMARDs. Patients with RA should be seen regularly to evaluate disease activity and severity and to determine whether alternative therapies should be used. The only nonbiologic agents included in these recommendations are hydroxychloroquine, leflunomide, methotrexate, minocycline, and sulfasalazine, and the only biologics included are abatacept, adalimumab, etanercept, infliximab, and rituximab. The remaining DMARDs were not included because of very infrequent use, the high incidence of adverse events, or both. Nonbiologic DMARD combinations best supported by evidence and used most commonly are methotrexate plus hydroxychloroquine, methotrexate plus sulfasalazine, methotrexate plus leflunomide, sulfasalazine plus hydroxychloroquine, and sulfasalazine plus hydroxychloroquine followed by methotrexate. Methotrexate or leflunomide monotherapy should be started for patients with all disease durations and for all degrees of disease activity irrespective of poor prognostic features. Hydroxychloroquine monotherapy is recommended for patients without poor prognostic features, with low disease activity, and with disease duration not greater than 24 months. Minocycline monotherapy is recommended for patients without poor prognostic features, with low disease activity, and with short disease duration. Sulfasalazine monotherapy is recommended for patients with all disease durations and without poor prognostic features and includes those with all degrees of disease activity. Methotrexate plus hydroxychloroquine is recommended for patients with moderate to high disease activity regardless of disease duration or poor prognostic features. Methotrexate plus leflunomide is recommended for patients with intermediate or longer disease duration (≥ 6 months), with high disease activity irrespective of prognostic features. Methotrexate plus sulfasalazine is recommended in patients with all disease durations provided they have high disease activity and poor prognostic features. Hydroxychloroquine plus sulfasalazine is recommended only for patients with intermediate disease duration (6 - 24 months) and high disease activity but without poor prognostic features. The triple DMARD combination of sulfasalazine, hydroxychloroquine, and methotrexate is recommended for all patients with poor prognostic features and moderate or high levels of disease activity, regardless of disease duration. Recommendations for the use of biologic DMARDs are separated according to disease duration (< 6 months and ≥ 6 months). The use of antitumor necrosis factor–alpha (TNFα) agents (etanercept, infliximab, and adalimumab) is stratified for durations of 3 months or longer or 3 to 6 months. Anti-TNFα agents can be used interchangeably with methotrexate in patients with early RA who have never received DMARDs and have high disease activity. Patients with early RA and only low or moderate disease activity are not considered candidates for biologic therapy. An anti-TNFα agent plus methotrexate is recommended for patients with high disease activity for 3 months or longer with poor prognosis and no barriers related to treatment cost and no insurance restrictions to accessing medical care. In intermediate-duration and longer-duration RA, the anti-TNFα agents can be used interchangeably in patients with inadequate response to prior methotrexate monotherapy, moderate disease activity, and features of a poor prognosis as well as for patients with high disease activity, regardless of prognostic features. Anti-TNFα agents can also be used interchangeably in patients with inadequate response and at least moderate residual disease activity after previous therapy with methotrexate in combination or with sequential administration of other nonbiologic DMARDs, regardless of prognostic features. Contraindications to the use of nonbiologic and biologic DMARDs may include infectious disease or pneumonitis, or both; and hematologic, oncologic, cardiac, liver, renal, neurologic, and pregnancy and breast-feeding contraindications. "Using a formal group process and the scientific evidence as much as possible, we provide recommendations for the use of nonbiologic and biologic therapies in patients with RA when starting or resuming these therapies," the guidelines authors conclude. "These recommendations are not meant to take the place of personalized patient care and are intended to help guide therapy rather than proscribe appropriate therapies. The recommendations are extensive but not comprehensive, and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology." Dr. Saag's work was supported by the Agency for Healthcare Research and Quality, the University of Alabama, Birmingham Center for Education and Research on Therapeutics of Musculoskeletal Diseases, and the American College of Rheumatology. Four other guidelines authors have received support from the ACR, and one of these authors also was supported by the National Institutes of Health. Some of the guidelines authors have disclosed various financial relationships with Roche, UCB, Nitec, Amgen, Abbott, Centocor, Wyeth, Merck, Procter and Gamble, Eli Lilly, Novartis, Mathematica, Bristol-Myers Squibb, WellPoint, Genentech, Pfizer, Incyte, Hoffman-LaRoche, Actelion, Array, Biogenidec, Gilead, GlaxoSmith-Kline, Encysive, TAP, Xoma, Actelion, and Celgene. Arthritis Care Res. 2008;59:762-784. |
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