国产利福喷丁治疗肺结核的临床对照研究(附三年随访结果)

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以利福平为对照,全面考核利福喷丁治疗排菌肺结核的效果以及满疗程三年随访结果。560名排菌肺结核患者,其中486例为初治、74例为复治病例。全部病例随机分成Ⅰ、Ⅱ、Ⅲ甲和Ⅲ乙组。给药方案分别为1LHZE/8L_1H_2E_2、1LHZE/8L_1H_2E_2、1RHZE/8R_2H_2E_2和1RHZE/8RHE。511例满疗程。治疗结果表明:(1)所有各组在治疗的第二个月痰培养阴性的结果是相似的(P>0.05);(2)治疗完毕痰培养阴性率,初治组为98.7~100%(P>0.05),复治组93.7~100%(P>0.05);(3)利福喷丁组未见严重副作用。506例痰培养阴性病例中有456例作三年随访。402例初治病例中,细菌学和X线检查观察到有旧病复发在Ⅱ组有2例、Ⅲ乙组有1例;X线检查证实复发同时直接涂片阳性但培养测定仍为阴性的,Ⅰ组、Ⅱ组各1例。54例复治病例中,痰涂片阳性和培养阳性及X线检查证实复发和X线检查复发Ⅱ组有1例。根据上述结果作者认为国产利福喷丁是一个高效、长效、安全的抗结核药,推荐在国内推广应用。 Rifampicin as a control, a full assessment of the effect of rifapentine treatment of pulmonary tuberculosis, and full course of three-year follow-up results. 560 patients with pulmonary tuberculosis, of which 486 were untreated, 74 cases of retreatment cases. All cases were randomly divided into Ⅰ, Ⅱ, Ⅲ A and Ⅲ B group. Dosing regimens were 1LHZE / 8L_1H_2E_2, 1LHZE / 8L_1H_2E_2, 1RHZE / 8R_2H_2E_2, and 1RHZE / 8RHE, respectively. 511 cases of full course of treatment. The results of the treatment showed that: (1) sputum culture negative results were similar in all groups in the second month of treatment (P> 0.05); (2) The negative rate of sputum culture after the treatment was 98.7% to 100% (P> 0.05). The recovery group was 93.7% ~ 100% (P> 0.05). (3) There were no serious side effects in the rifabbine group. Among 506 cases of negative sputum culture, 456 cases were followed up for three years. 402 cases of newly diagnosed cases, bacteriological and X-ray examination of the old disease recurrence was observed in 2 cases of group Ⅱ, Ⅲ B group of 1 case; X-ray examination confirmed the recurrence of direct smear positive but the culture was still negative, Ⅰ group, Ⅱ group of 1 case. 54 cases of retreatment cases, positive sputum smear and culture positive and X-ray examination confirmed recurrence and X-ray examination in 1 case of recurrence group. According to the above results, the authors believe that domestic rifapentine is an effective, long-acting and safe anti-TB drug recommended for domestic application.
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