| Objective:1.Using meta-analysis to search evidence for the efficacy and safety of bedaquiline(Bdq)containing regimens in the treatment of multidrug-resistant pulmonary tuberculosis(MDR-PTB).2.Further explore the clinical efficacy and adverse effects of Bdq containing regimens in the treatment of MDR-PTB,and to provide more experience of Bdq.Methods:1.Meta-analysis: Randomized controlled trials(RCTs)of Bdq regimens in the treatment of MDR-PTB were collected through CNKI,Wanfang,VIP,Chinese Biomedical Database,Pub Med,Embase,Cochrane Library,and other Chinese and English databases.The retrieval time was from the establishment of the database to December 2021.After literature screening,data extraction,and literature quality evaluation by two researchers,the heterogeneity test was conducted using Revman 5.4.2.Clinical study: A total of 226 patients with MDR-PTB admitted to the Tuberculosis Department of the Third People’s Hospital of Kunming(hereinafter referred to as "our hospital")from March 2019 to March 2022 were selected as the study objects.Among them,93 patients were treated with background regimens containing Bdq as the experimental group,and 133 patients were treated with background regimens without Bdq as the control group.At the end of 24 weeks of treatment,the efficacy indexes of the two groups were compared,and the adverse effects,drug withdrawal events and follow-up were also observed.Results:1.Meta-analysis: A total of 10 articles were included in this meta-analysis,involving 802 patients.The treatment of MDR-PTB with Bdq containing regimens can improve the conversion rate of sputum-positive to negative state at the end of 12 weeks(OR=3.17,95%CI: 1.85?5.43,P<0.01),and can improve the negative conversion rate of sputum(OR=4.09,95% CI: 2.74?6.12,P<0.01),cavity closure rate(OR=3.11,95% CI: 1.68?5.74,P<0.01),lesion absorption rate(OR=4.44,95% CI: 2.44?8.22,P<0.01),and the treatment efficiency(OR=4.15,95% CI: 2.27?7.58,P<0.01)at the end of 24 weeks.The mortality was reduced(OR=0.18,95% CI: 0.05?0.63,P<0.01)at the end of 24 weeks.However,there was no significant difference in negative conversion rate of sputum(OR=1.79,95% CI: 0.98?3.26,P=0.06)and incidence of adverse effects(OR=2.72,95% CI: 0.61?12.19,P=0.19)after 8weeks of treatment.2.Clinical study: At the end of 24 weeks of treatment,the negative conversion rates of sputum smear from the experimental group and the control group were 87.1%(81/93)and70.7%(94/113),the negative conversion rates of sputum culture were 79.6%(74/93)and64.7%(86/113),the lesion absorption rates were 81.7%(76/93)and 66.2%(88/133),and the effective rates were 81.7%(76/93)and 60.9%(81/133),respectively.The above differences between the two groups were statistically significant(P<0.05).The cavity reduction rates of experimental and control groups were 76.7%(33/43)and 62.9%(39/62),the incidences of serious adverse events were 13.5%(33/245)and 18.5%(55/298),and the withdrawal rates were 12.7%(31/245)and 16.1%(48/298),respectively,and there was no significant difference between the two groups(P>0.05).However,the total incidences of adverse effects in the two groups were 69.9%(65/93)and 83.5%(111/133),the incidences of liver dysfunction were 20.4%(19/93)and 33.8%(45/133),the incidences of QT interval prolongation were 17.2%(16/93)and 0.8%(1/133),and the incidences of electrolyte imbalance were 9.7%(9/93)and 29.3%(39/133),respectively.The above differences between the two groups were statistically significant(P<0.05).Conclusion:1.The results of meta-analysis showed that the combination of Bdq on the basis of anti-tuberculosis treatment regimens can help accelerate the negative conversion of sputum bacteria,improve the efficacy of patients,and will not increase the incidence of adverse drug reactions.However,the included literature was a single-center,small-sample study,which still needs to be verified and supplemented by expanding the domestic sample size.2.The results of clinical studies showed that Bdq containing regimens is effective in the treatment of MDR-PTB,which is consistent with the conclusion of meta-analysis.The Bdq containing regimen can reduce the incidence of adverse drug reactions in MDR-PTB patients.The main types of adverse drug reactions are anemia,liver dysfunction,central nervous system disorders,and leukopenia.The incidence of QT interval extension caused by Bdq is low.Therefore,the safety of Bdq containing regimens is controllable and worthy of clinical application. |
