关于对照药的考虑: 对耐多药结核病, 可供选择的药物有限, 尤其是利福霉素类, 由于利福平出现耐药机会较多, 目前在国内耐药结核的联合化疗方案中, 利福平一直作为一种可供选择的药物在广泛应用, 而且被临床和基础试验证明该药用于耐药结核的治疗是安全、有效的, 因此, 该研究选利福平作阳性对照药。两个组除试验药和对照药不同外, 其他的治疗药物种类、来源、给药方法、疗程、观察指标均完全相同上海翻译公司。
Consideration for control drugs: drugs for choice for multi-drug resistant tuberculosis are limited, particularly rifomycins, since the possiblilities of drug tolerance are frequently seen in rifampin, rifampin has always been widely used as a kind of drug for choice in the combination chemotherapy program for drug resistant tuberculosis in our country, and it has been confirmed by clinical investigations and basic tests that the application of this drug in the treatment on drug resistant tuberculosis is safe and effective, therefore, the present study selected rifampin as the positive control drug. Except the test drug and the control drug were different between the two groups, other drug categorization, source, administration route, course of treatment and indexes for observation were all the same.
关于开放试验的说明: 因为所选病例均为耐多药复治结核病人, 病情重, 治疗难度大, 联合用药种类多, 用药方案复杂, 疗程长至少18个月, 且试验药和对照药服药剂量及时间间隔不同, 采用双盲法执行难度大。而且, 肺结核治疗的主要疗效评价指标—痰菌阴转率、X-射线检查病灶吸收率和空洞关闭率都是客观的、明确的, 很少受主观因素影响。因此, 从患者服药方便性及心理接受度考虑, 研究采用开放式设计北京翻译公司
Descriptions for open test: since the selected cases were all patients of multi-drug resistant tuberculosis retreatment, their conditions were serious, the treatments were difficult, the categorizations of combined drug administration were complex, the courses of treatment were 18 months at the least, the dosages and the intervals for drug administration of the test drug and the control drug were different, and the implement of double blind method was difficult. Furthermore, the major indexes for therapeutic efficaicy evaluation on pulmonary tuberculosis treatment – sputum negative conversion rate, X-ray examination on the absorption rate of infection foci, cavity closure rate were all objective, definite and seldom affected by subjectve factors. Therefore, the present study carried out open design after taking the convenience of drug administration and psychological acceptance of patients.
