RESUMO
OBJECTIVE To evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility.
RESUMO
OBJECTIVE:To study and evaluate the efficacy and safety of homemade sterilized powder for injection of rifampicin(weifunin) in the treatment of pulmonary tuberculosis(PT) and to compared with same import preparation . METHODS:Divide the 121 of bacteriological positive PT patients in the proportion of 1 to 1 with computer automatically into the trial group and the control group used with homemade rifampicin (weifuxin) and import rifampicin(nifu)respectively,the others regimens was same in 2 groups,to evaluate the sputum culture negative conversion rates,X-ray results and adverse drug event etc.after treatment 1 and 2 months . RESULTS: 116 cases were finished ,at the end of 2 month the sputum smear negative conversion rates were 86.21 % and 91.38% (X2=0.780,P=0.377), the sputum culture negative conversion rates were 91.38% and 93.10%(X2=0.120,P=0.729)in the trial group and the control group respectively .The X-ray remarkable effective rates of 2 groups were 82.76% amd 70.69%(X2=2.365,P=0.124)respectively, and the effective rates of the 2 groups were both be 96.55% .The adverse drug event rates were 8.20% and 11.67% respectively, there was on sighificant difference in each indexes .CONCLUSIONS:2 preparation were similar in efficacy ,safety and tolerance.