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目的观察固定剂量复合制剂(fixed-dose combination,FDC)治疗肺结核的效果与不良反应。方法选择初治肺结核患者(包括痰涂片阴性和痰涂片阳性的患者),按照不同体重范围(≤37kg、38~54kg、55~70kg、≥71kg)作为使用FDC治疗的对象,但排除已知耐药、对药物敏感、肝肾功能不全,严重胃肠疾病的患者。监测用药前、用药中、用药后的结核菌涂片镜检情况,肝、肾功能的变化、服药后是否出现不良反应以及患者对服用FDC的感受。结果在403例结核病患者中,用药前有96例为痰菌阳性,用药到2月末仅6例为痰菌阳性,用药到6月末仅2例痰菌阳性,其结核菌阴转率为98%(94/96)。服用FDC的403例患者中,泌尿系统和关节均未见不良反应;仅有16.4%(66/403)的患者有恶心的症状;有少量患者出现轻微的头晕(6.0%)和皮疹(9.4%),停药后均恢复正常。服用FDC到1~2个月,谷丙转氨酶(ALT)、谷草转氨酶(AST)、尿酸都有明显升高(P<0.01),但继续服用FDC到6月时,则恢复为正常。胆红素(D-BIL、T-BIL)、肌酐、血尿素氮在服药前、服药中、服药末均未见明显变化(P>0.05)。99.7%(402/403)的患者能接受6个月的服药;15.1%(61/403)的患者认为药片太多,但能忍受;99.3%(400/403)的患者在6个月的治疗中,都能按照医生的吩咐服药。结论 FDC治疗肺结核患者的效果明显,不良反应低,服药患者反应良好,可以作为治疗肺结核新剂型药物使用。
Objective To observe the effects and adverse reactions of fixed-dose combination (FDC) in the treatment of pulmonary tuberculosis. Methods Patients with newly diagnosed pulmonary tuberculosis (including sputum smear-negative and sputum smear-positive patients) were enrolled as FDC-treated subjects with different body weight (≤37kg, 38 ~ 54kg, 55 ~ 70kg, ≥71kg) Knowledge of drug resistance, drug sensitivity, liver and kidney dysfunction, severe gastrointestinal disease in patients. Before medication, medication, TB smear microscopy, changes in liver and kidney function, adverse reactions after taking the medication, and the patient’s feelings of taking FDC. Results In 403 cases of tuberculosis patients, 96 cases were positive for sputum before treatment. Only 6 cases were sputum positive at the end of February. Only 2 cases of sputum positive were detected by the end of June, and the negative conversion rate of TB was 98% (94/96). Of the 403 patients who took FDC, no adverse reactions were found in the urinary system and joints; only 16.4% (66/403) of patients had nausea; slight dizziness (6.0%) and rash (9.4% ), Returned to normal after stopping. FDC to 1 to 2 months, alanine aminotransferase (ALT), aspartate aminotransferase (AST), uric acid were significantly increased (P <0.01), but continued to take FDC until June, then returned to normal. Bilirubin (D-BIL, T-BIL), creatinine, blood urea nitrogen in the medication before taking medication, no significant changes at the end of medication (P> 0.05). 99.7% (402/403) of patients received 6 months of medication; 15.1% (61/403) of patients considered the pill too much but tolerated; 99.3% (400/403) of patients treated at 6 months In accordance with the doctor’s instructions can take medicine. Conclusion FDC is effective in treating pulmonary tuberculosis patients with low adverse reactions and good response in patients taking FDC. It can be used as a new drug for the treatment of pulmonary tuberculosis.