Int J Tuberc Lung Dis. 1997 Dec;1(6):509-17.
The Tuberculosis Research Centre, Chennai, and its unit at Madurai, South India.
To design oral short-course regimens for the treatment of sputum-positive pulmonary tuberculosis that could be more easily implemented under field conditions.
A total of 1203 patients was randomly allocated to one of three regimens. I (2EHRZ7/6EH7): 8-month daily regimen of ethambutol (E), isoniazid (H), rifampicin (R) and pyrazinamide (Z) for 2 months, followed by E and H for 6 months. II (2EHRZ2/4EHR2): 6-month twice-weekly regimen with the same four drugs for 2 months, followed by EHR for 4 months. III (2HRZ2/4HR2): similar to Reg. II, but without ethambutol. In Reg. I, drugs were given completely unsupervised. Regs. II and III were either completely or partially supervised.
Drug-susceptible group: At the end of treatment, 3.6% of 305 patients in Reg. I, 0.4% of 263 in Reg. II and 9.3% of 257 in Reg. III had an unfavourable bacteriological response. By 24 months after start of treatment, 5% of 290 in Reg. I, 11% of 258 in Reg. II and 10% of 229 in Reg. III had a bacteriological relapse requiring treatment. Giving the twice-weekly regimens partly unsupervised did not influence the response to treatment, emergence of drug resistance or relapse rates. Isoniazid resistant group: Unfavourable response and relapse with Reg. I (94 patients) was 17% and 8%, with Reg. II (59 patients) 20% and 25%, and with Reg. III (74 patients) 62% and 15%, respectively.
A fully unsupervised ethambutol-containing regimen given daily for 8 months (Reg. I) was found to be very effective even in the presence of isoniazid-resistant bacilli. With the ethambutol-containing twice-weekly regimen, the response at the end of treatment was near 100%, but the relapse rate was high (11%). The non-ethambutol twice-weekly regimen was not satisfactory. All three regimens failed in the presence of bacilli resistant to rifampicin and isoniazid.
印度南部金奈的结核病研究中心及其在马杜赖的分支机构。
设计用于治疗痰菌阳性肺结核的口服短程治疗方案，使其在现场条件下更易于实施。
总共1203例患者被随机分配至三种治疗方案之一。方案I（2EHRZ7/6EH7）：采用乙胺丁醇（E）、异烟肼（H）、利福平（R）和吡嗪酰胺（Z）进行为期8个月的每日治疗方案，前2个月联合使用这四种药物，随后6个月仅使用乙胺丁醇和异烟肼。方案II（2EHRZ2/4EHR2）：为期6个月的每周两次治疗方案，同样联合使用这四种药物2个月，随后4个月仅使用乙胺丁醇、异烟肼和利福平。方案III（2HRZ2/4HR2）：与方案II相似，但不含乙胺丁醇。在方案I中，药物完全不进行监督给药。方案II和III则完全或部分进行监督给药。
药物敏感组：治疗结束时，方案I的305例患者中有3.6%、方案II的263例患者中有0.4%以及方案III的257例患者中有9.3%出现不良细菌学反应。治疗开始后24个月时，方案I的290例患者中有5%、方案II的258例患者中有11%以及方案III的229例患者中有10%出现需要治疗的细菌学复发。每周两次给药方案部分不进行监督给药并不影响治疗反应、耐药性的出现或复发率。异烟肼耐药组：方案I（94例患者）的不良反应和复发率分别为17%和8%，方案II（59例患者）分别为20%和25%，方案III（74例患者）分别为62%和15%。
发现为期8个月每日给药的完全不进行监督的含乙胺丁醇方案（方案I）即使在存在异烟肼耐药菌的情况下也非常有效。对于含乙胺丁醇的每周两次治疗方案，治疗结束时的反应接近100%，但复发率较高（11%）。不含乙胺丁醇的每周两次治疗方案效果不佳。在存在对利福平及异烟肼耐药的结核菌时，所有这三种方案均无效。
