Τρίτη 8 Νοεμβρίου 2022

Efficacy and tolerability of concomitant use of bedaquiline and delamanid for multidrug- and extensively drug-resistant tuberculosis: a systematic review and meta-analysis

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Abstract
The introduction of two novel drugs, bedaquiline and delamanid, has given hope for better and shorter treatments of drug-resistant tuberculosis. A systematic review was conducted to evaluate the efficacy and safety of concomitant bedaquiline and delamanid administration. Pooled estimates of WHO-defined favorable treatment outcome and significant QTc-interval prolongation (QTc ≥500 ms or ≥60 ms increase from baseline) were calculated using a random effects model. Thirteen studies including a total of 1031 individuals with multidrug-resistant/rifampicin-resistant tuberculosis who received bedaquiline and delamanid were included. The pooled estimate of favorable treatment outcome was 73.1% (95%CI: 64.3-81.8). Sputum culture conversion at six months ranged from 61-95%. Overall, the pooled proportion of QTc-prolongation was 7.8% (95%CI: 4.1-11.6) and few cardiac events were reported (0.8%, n = 6/798). Rates of sputum culture conversion and favorable treatment outcome were high in patients treated concomitantly with bedaquiline and delamanid, and the treatment seemed tolerable with low rates of clinically significant cardiac toxicity.
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A novel stapler‐assisted technique for closure of persistent tracheoesophageal puncture fistula

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Abstract

Tracheoesophageal puncture (TEP) is a reliable method to restore voice and is an important part of voice rehabilitation following laryngectomy. However, complications following this procedure, including peri-prosthetic leakage and resulting aspiration pneumonia, may necessitate surgical closure. In this study, we present an effective and reliable method for TEP closure using a stapler-assisted technique. Case series study for patients who underwent stapler-assisted TEP closure reviewed from 2017 to 2021. All five patients had successful closure of their TEP tract without further leakage. No postoperative bleeding, wound infection, or esophageal stenosis occurred. One patient had postoperative stomal stenosis. The stapler-assisted technique for TEP closure is easy, quick, and effective. The reliability and quick return to oral intake post-operatively make it a preferable option over previous techniques.

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Efficacy and safety of rituximab biosimilars or reference product as first‐line treatment in patients with low‐tumour‐burden follicular lymphoma: A systematic review and meta‐analysis

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Efficacy and safety of rituximab biosimilars or reference product as first-line treatment in patients with low-tumour-burden follicular lymphoma: A systematic review and meta-analysis

Follicular lymphoma is a subtype of B-cell Non-Hodgkin lymphoma and is the second most common lymphoma diagnosed in the United States and Western Europe. The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial. Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. Studies were screened according to inclusion and exclusion criteria. Then the risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis. Finally, four clinical randomized controlled trials involving 1223 patients were included. There were no statistically significant differences in efficacy and safety between biosimilars and MabThera groups. Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of low-tumour-burden follicular lymphoma are highly similar to those of the original drug.


Abstract

What is Known and Objective

The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma (LTB-FL) has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial.

Methods

Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. The risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis.

Results and Discussion

A total of 1223 patients were included in four clinical randomized controlled trials. There was no statistical difference in efficacy between biosimilars and MabThera groups (the objective response rate: RR = 1.00, 95% CI: 0.93–1.08, p = 0.92; the progression-free survival: RR = 1.04, 95% CI: 0.96–1.12, p = 0.30; the overall survival: RR = 1.00, 95% CI: 0.98–1.03, p = 0.76; the serious adverse events: RR = 1.15, 95% CI: 0.69–1.89, p = 0.59; the infusion-related reaction: RR = 0.91, 95% CI: 0.77–1.09, p = 0.32). In terms of safety, there was also no significant difference between two groups.

What is New and Conclusion

Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of LTB-FL are highly similar to those of the original drug.

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