[A study of efficiacy of infliximab treatment for Crohn's disease.].

OBJECTIVE: To investigated the potential and safety of the monoclonal antibody to TNFalpha infliximab (IFX) in the treatment of active Crohn's disease (CD). METHODS: Patients who were confirmed diagnosis of CD and were unresponsive to the conventional treatments, or recurred after surgeries, or discontinued treatment due to drug intolerance, were treated with IFX intravenously in a dose of 5 mg/kg at week 0, 2, 6 (IFX infusion continued at an interval of every 8 weeks if respond to initial dosing). Clinical assessments, including disease activity, blood biological markers and colonoscopic findings, were performed at baseline (week 0) and each week (4 weeks or later for colonoscopy) after IFX infusion were conducted until the week before 4(th) infusion from initiated. RESULTS: Ten patients (8 male, 2 female) with mean age of 31.4 years (ranged from 15 to 65 years old) were included in the analysis. The mean subjective score from baseline to week 14 was decreased from 2.2 +/- 0.6 to 1.2 +/- 0.4 (P < 0.05). The mean Harvey-Bradshaw index was 6.6 +/- 1.6 at baseline and 2.1 +/- 1.0 at week 14. The levels of ESR, CRP, serum total protein (TP) and albumin (Alb) were significantly improved during the 14-week period. Colonoscopy showed a remarkable improvement of Crohn's Disease Endoscopic Index of Severity (CDEIS). No infusion-related reaction was observed in all patients during the treatment. Mild or transient skin itching and headache were respectively reported in two patients. Transient elevation of serum ALT and AST after 3(rd) infusion in one patient, and severe anemia including leucopenia and thrombocytopenia at week 35 after 1(st) infusion in one male patient were observed. CONCLUSIONS: Treatment with three infusions of IFX in a dose of 5 mg/kg was effective for induction of remission for active and complex CD patients who failed to respond to conventional treatment. Long-term safety of the therapy effect was warranted in further investigations.

Short-term study of infliximab treatment for Crohn's disease in China.

OBJECTIVE: To determine the effectiveness and safety of short-term treatment of infliximab (IFX) in a group of Chinese patients with active Crohn's disease (CD). METHODS: Patients with established diagnosis of active CD were treated with IFX intravenously with a dose of 5 mg/kg at week 0, 2, 6. Clinical assessments were performed at baseline (week 0) and every week after IFX infusion until 8 weeks after the induction dose. RESULTS: Fourteen patients (nine male, five female) with a mean age of 29.7 years (range from 15 to 65 years) were included in the analysis. The mean subjective scores were decreased from 2.85 ± 0.57 at baseline to 1.3 ± 0.4 at week 14 (P < 0.05). The mean Harvey-Bradshaw index was 7.9 ± 1.5 at baseline and 2.3 ± 1.0 at week 14. The levels of erythrocyte sedimentation rate, serum C-reactive protein, total protein (TP) and albumin (ALB) were significantly improved during the 14-week period. Colonoscopy showed a remarkable improvement. Mild and transient adverse events including skin itching, headache and elevation of serum alanine aminotransferase and aspartate transaminase were each observed in one patient. Severe anemia, leucopenia and thrombocytopenia at week 27 after three infusions of IFX were observed in one patient. CONCLUSIONS: Treatment with three infusions of IFX at a dose of 5 mg/kg was effective for induction of remission for active CD patients who failed to respond to conventional therapies. Study of long-term efficacy and safety of IFX therapy is warranted for further investigations.