ObjectiveTo study the short-term efficacy and safety of tocilizumab in treating patients with active and resistant rheumatoid arthritis (RRA). MethodForty patients with RRA treated with tocilizumab between October 2013 and October 2014 were included in our study. The combined drug treatment was continued with the addition of tocilizumab 8 mg/kg per four weeks. The clinical responses and laboratory parameters were evaluated at the baseline, week 1, 4, 12, 16 and 24, and week 4 and 8 of tocilizumab withdrawal. ResultsTocilizumab was effective for several clinical lesions and laboratorial parameters at all time points. With the extension of treatment, the effect was better. At week 1, the visual analogue scale score of pain by patients, erythrocyte sedimentation rate, C-reactive protein (CRP), disease activity score 28 (DAS28) and health assessment questionnaire (HAQ) results decreased significantly (P<0.05). At week 12, the inflammatory biomarkers of all patients were normal, and 62.9% (22/35) of the patients achieved American College of Rheumatology (ACR)20, and 28.6% (10/35) of the patients achieved ACR50. At week 24, twelve patients achieved ACR50 and low activity (DAS28 score≤3.2), and the score of HAQ was minimum (3.1±1.6). The score of HAQ was significantly different between week 24 and the baseline (20.2±6.7) (P<0.01). All parameters were not significantly changed at week 4 of tocilizumab withdrawal compared with those before the withdrawal. Most parameters increased significantly at week 8 of tocilizumab withdrawal compared with week 4 of withdrawal (P<0.01) except for swollen joints, CRP, DAS28 and HAQ. The main adverse reactions were abnormal hepatic function and dyslipidemia followed by leukopenia. Only one patient stopped treatment because of adverse reaction. ConclusionsTocilizumab has rapid efficacy onset and good safety. After tocilizumab withdrawal, the efficacy can be maintained for 4 to 8 weeks.
ObjectivesTo systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.