Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases

Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.

Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.

Inclusion Criteria:

• Age 18-65 years with informed consent
• SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
• concomitant high dose glucocorticoid, defined as >1mg/kg/d prednisone or equivalent
• concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil

Exclusion Criteria:

• Pregnant or lactating
• WBC< 4×10^9/L，PLT<100×10^9/L
• Serum ALT or AST > 2 times upper limit of normal
• Serum creatinine > 1.5 mg/dL
• Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
• Active infection, including HIV, HCV, HBV, tuberculosis or PCP
• concomitant antibiotics other than trimethoprim/sulfamethoxazole
• Patient with malignancy
• Drug allergy, especially trimethoprim/sulfamethoxazole