ObjectiveTo evaluate the efficacy and safety of Fugui ostealgia particles for cervical spondylosis (Yang-asthenia and cold-damp type). MethodsFrom December 2010 to July 2011, we carried out a multi-centered, randomized, double-blind and double-simulation clinical observation study based on the Guiding Principles for the Clinical Research on New Chinese Traditional Medicine (TCM). A total of 240 patients were divided into experimental group and control group with the number of patients at a ratio of 3:1. The treatment group (n=180) was treated by Fugui ostealgia particles, while patients in the control group (n=60) received Kangguzengsheng capsules. The treatment course lasted for 90 days. ResultsThe total effective rate in the experimental group was 92.44%, and was 75.47% in the control group, with a significant difference between the two groups (P<0.05). The total effective rate for TCM syndromes was significantly different between the two groups (P<0.05). The effect on main symptoms such as nuchal pain, aversion to cold, and cold hands and feet, was significantly different between the two groups (P<0.05). Laboratory test results showed no abnormality before and after treatment, and no drug-related adverse reactions occurred. ConclusionFugui ostealgia particles are safe and effective for the treatment of Yang-asthenia and cold-damp type cervical spondylosis, especially for the treatment of nuchal pain, aversion to cold, and cold hands and feet.
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.