Abstract:

Objective To observe the effect of chemotherapy regimen and Qinbudan Tablet on clinical symptoms and life quality of patients with retreated smear-positive pulmonary tuberculosis. Methods A total of 181 cases were collected from a multicenter, randomized, double-blind, placebo-controlled clinical trial of chemotherapy regimen and Qinbudan tablet on retreated pulmonary tuberculosis (Clinical trial registration number: NCT02313610) led by Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from April 2011 to March 2013. According to random number table, all cases were randomly divided into observation group (2H-R-Z-E-S/6H-R-E+Qinbudan tablets, 93 cases) and the control group (2H-R-Z-E-S/6H-R-E+placebo, 88 cases). Observe the differences in Traditional Chinese medicine (TCM) symptom score (including 8 single symptom scores of cough, expectoration, chest pain, hot flashes, cheeky red, night sweats, thirst and dry throat) and SF-36 scale (including physical function, role-physical, bodily pain, vitality, social functioning, role-emotional, mental health, general health and health transition) before and after treatment. Results At the end of treatment, the effective rate of TCM symptom improving for the observation group (91.4%, 85/93) was obviously higher than that in the control (78.4%, 69/88) group with a significant statistical difference (χ ²=6.010, P=0.012). The effective rate of 6 clinical symptom scores including hot flashes, cheeky red, night sweats, phlegm, thirst and dry throat for the observation group (83.9%,78/93;71.0%,66/93;86.0%,80/93;84.9%,79/93;80.6%,75/93;87.1%,81/93) were higher than those in the control group (68.2%,60/88;53.4%,47/88;73.9%,65/88;70.5%,62/88;54.5%,48/88;65.9%,58/88),and the differences were statistically significant (χ ²=6.415,P=0.013;χ ²=5.943,P=0.015;χ ²=4.195,P=0.041;χ ²=5.516,P=0.019;χ ²=14.144,P<0.001;χ ²=11.391,P=0.001). At the end of treatment, the mean rank of the four SF-36 scores including health transition, physical function, vitality and general health in the observation group were 98.58,99.03,102.27,100.47 which were higher than those in the control group (82.99,82.51,78.69,82.99), the differences statistically significant (U=3387.000, P=0.027;U=3345.000, P=0.028;U=3009.000, P=0.002; U=3211.000, P=0.012). Conclusion Qinbudan tablet can help improve the clinical symptoms and life quality of the retreated pulmonary tuberculosis.

Key words: Tuberculosis,pulmonary, Retreatment, Antitubercular agents, Medicine,Chinese traditional, Drug therapy,combination, Comparative effectiveness research, Qinbudan tablet