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两种间歇短程治疗方案(78剂)用于肺结核初始治疗的试验。

Trial of two intermittent short-course regimens (78 doses) in the initial treatment of pulmonary tuberculosis.

出版信息

Tubercle. 1977 Mar;58(1):1-8. doi: 10.1016/s0041-3879(77)80002-0.

Abstract

A controlled trial was done in Roumania to compare 2 regimens in patients with culture-positive pulmonary tuberculosis. Both regimens were of twice-weekly doses under supervision for 9 months, a total of 78 doses. Patients were followed up for 15 months after the end of treatment. The regimens were as follows: IR, isoniazid and rifampicin for 3 months followed by isoniazid and either streptomycin or ethambutol for 6 months; ISE, isoniazid, streptomycin and ethambutol for 3 months followed by isoniazid and either streptomycin or ethambutol for 6 months. Of 128 IR cases and 104 ISE cases with sensitive cultures initially all were culture-negative at 6 months. At the end of 9 months there were 1.8% of 112 in the IR group which had had 2 positive cultures in the 6-9 month period and 3.4% of 88 in the ISE group. After 15 months from the end of treatment 5.6% of 89 in the IR group had had a bacteriological relapse and 8.9% of 79 in the ISE group. Cultures from all relapsed cases were still sensitive to the drugs used. All relapses occurred during the first 12 months. In only 5.6% of 232 patients did adverse reactions necessitate change of treatment. The efficacy, cost, tolerance and suitability of the regimens for a national programme are discussed.

摘要

在罗马尼亚进行了一项对照试验,以比较两种治疗方案对培养阳性肺结核患者的疗效。两种方案均为每周两次给药,在监督下持续9个月,共78剂。治疗结束后对患者进行了15个月的随访。方案如下:IR方案,异烟肼和利福平治疗3个月,随后异烟肼与链霉素或乙胺丁醇联合治疗6个月;ISE方案,异烟肼、链霉素和乙胺丁醇治疗3个月,随后异烟肼与链霉素或乙胺丁醇联合治疗6个月。最初128例采用IR方案和104例采用ISE方案且培养结果敏感的患者,在6个月时所有患者培养结果均为阴性。在9个月末,IR组112例中有1.8%在6至9个月期间有2次培养阳性,ISE组88例中有3.4%培养阳性。治疗结束15个月后,IR组89例中有5.6%发生细菌学复发,ISE组79例中有8.9%发生细菌学复发。所有复发病例的培养物对所用药物仍敏感。所有复发均发生在治疗后的前12个月内。232例患者中只有5.6%因不良反应需要更换治疗方案。文中讨论了这两种方案对于国家结核病防治规划的疗效、成本、耐受性和适用性。

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