Abstract

Objective To assess the clinical efficacy and safety of a novel chemotherapy regimen for retreatment of smear-positive pulmonary tuberculosis. Methods A total of 88 cases of recurrent smear-positive pulmonary tuberculosis for the first time were enrolled from Wenzhou Central Hospital during July 2013 and March 2014. All subjects were randomly divided into ultra-short course group (58 cases) and standard course group (30 cases). Patients in ultra-short course group were given 5MfxRfb (Rft) PaZE regimen (Mfx: moxifloxacin, Rfb: rifabutin, Rft: rifapentine, Pa: isoniazid aminosalicylate, Z: pyrazinamide, E: ethambutol), and those in standard course group were given 2SHREZ/6HRE or 3HREZ/6HRE regimen (S: streptomycin, H: isoniazid, R: rifampicin). Clinical symptoms and signs, negative conversion rates of sputum smear or culture at the end of the second month and the end of the course, absorption of pulmonary lesions and cavity closure were observed. t test or chi-square test was used for data analysis. Results There were 10 patients withdrew from the study, and the rest 78 patients completed whole treatments (50 cases in ultra-short course group and 28 cases in standard course group). No significant difference was observed in the improvements of clinical symptoms and signs between two groups at the end of the treatment (χ2=0.836, P>0.05). Negative conversion rates of sputum smear and culture at the end of the second month were 76.00% (38/50) and 72.00% (36/50) in ultra-short course group, while in standard course group were 71.43% (20/28) and 67.86% (19/28), and there was no significant difference between two groups (χ2=0.197 and 0.148, P>0.05). At the end of the treatment, negative conversion rates of both sputum smear and culture in ultra-short course group were 92.00% (46/50), while those in the standard course group were 92.00% (46/50) (χ2=0.239, P>0.05). In ultra-short course group, marked lesion absorption was observed in 33 cases at the end of the treatment, absorption in 12 cases, deterioration in 1 case, and no significant change was observed in 4 cases. While in the standard course group, marked lesion absorption was observed in 8 cases at the end of the treatment, absorption in 13 cases, deterioration in 2 cases, and no significant change was observed in 5 cases. There was significant difference in the absorption of pulmonary lesions between two groups (χ2=10.582, P 0.05). In ultra-short course group, clinical cure was obtained in 44 patients, 5 patients completed full course of treatments but did not meet the criterial for cure, and 1 patient failed in the treatment. While in standard course group, clinical cure was obtained in 24 patients, 2 patients completed full course of treatments but did not meet the criterial for cure, and 2 patients failed in the treatment. The clinical outcomes in two groups were of significant difference (χ2=1.468, P>0.05). Adverse effects during treatment were observed in 16 (32.00%) patients in ultra-short course group and 9 (32.14%) patients in standard course group, and the difference was not significant (χ2=0.001, P>0.05). Conclusion Ultra short course regimen is effective and safe for retreatment of smear-positive pulmonary tuberculosis. Key words: Tuberculosis, pulmonary; Recurrence; Therapy

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