固定剂量复合制剂治疗403例肺结核的效果分析

Medication Effect of Fixed-dose Combination in 403 Tuberculosis Cases

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 medication effect of fixed - dose combination （FDC） and the adverse reac- tion in treating tuberculosis （TB） patients. Methods According to the weight range （ ≤37 kg, 38 -54 kg, 55 -70 kg, ≥71 kg）, untreated TB patients （including both smear- negative and smear- positive patients） were conducted FDC therapy. Patients with drug resistance, drug sensitivity, liver and kidney dysfunction and severe gastrointestinal diseases had been excluded. The results of TB smear before and after medication, the ehanges in liver and renal function, adverse reactions after therapy and the patients＇ feeling about taking the FDC were all monitored. Results In 403 patients, there were respectively 6 and 2 TB sputum positive cases after 2 months and 6 months medication, while there were 96 sputum positive cases before the medication. The rate of sputum negative conversion was 98% （94/96）. There were no adverse reactions in urinary system and joints in these patients. A proportion of 16. 4% （66/403） had symptom of nausea, a few patients showed symptoms of slight dizziness （6.0%） and rash （9.4% ）, all of those patients were back to normal after drug withdrawal. Alanine aminotransferase （ALT）, aspartate aminotransferase （AST） and uric acid significantly increased af- ter taking FDC one or two months （P 〈 0. 01 ）, and were all returned to normal after six months. Bilirubin （ D - BIL, T - BIL） , creatinine and blood urea nitrogen showed no significant change in the whole medication process （P 〉0. 05）; 99.7% （402/403） patients received the whole 6 months medication; 15.1% （61/ 403） of patients thought there were too many pills to take each day, yet could tolerate; 99. 3% （400/403） patients were able to take FDC following the doctor＇s instruction. Conclusion The FDC therapy is proved to be effective, acceptable, with low adverse reactions rate and well response from patients. Thus, it could be con- sidered as useful new complex drug in treating TB.