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BACKGROUND: CD83 are closely related to the pathogenesis of immune thrombocytopenia (ITP), but the exact mechanism remains unclear. AIM: To explore the relationship between CD83 and CD4+ T cell subsets and clarify the role of CD83 in the pathogenesis of ITP. METHODS: RT-qPCR and Flow cytometry were used to illustrate CD83 expression. The downregulation and overexpression of DC-CD83 were co-cultured with CD4+ T cells to detect cell proliferation, co-cultured supernatant cytokines and Tregs expression. RESULTS: The results indicate that the ITP patients showed higher expression of CD83 than the healthy controls. The proliferation of CD4+ T cells was inhibited by downregulation of DCs-CD83 but promoted by overexpression of DCs-CD83. siRNA-CD83 inhibited proinflammatory IFN-γ and IL-17 secretion while raising TGF-ß, IL-10 concentrations. Overexpression of DCs-CD83 promoted Tregs expression. CONCLUSION: The Th1/Th2 and Th17/Tregs polarization were reversed via interfering DCs with siRNA-CD83. CD83 plays an important role in ITP pathogenesis, suggesting novel treatment for ITP patients.
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Antígenos CD , Antígeno CD83 , Inmunoglobulinas , Glicoproteínas de Membrana , Púrpura Trombocitopénica Idiopática , Humanos , Púrpura Trombocitopénica Idiopática/inmunología , Púrpura Trombocitopénica Idiopática/patología , Glicoproteínas de Membrana/genética , Glicoproteínas de Membrana/metabolismo , Antígenos CD/metabolismo , Inmunoglobulinas/genética , Inmunoglobulinas/metabolismo , Femenino , Masculino , Adulto , Persona de Mediana Edad , Citocinas/metabolismo , Linfocitos T Reguladores/inmunología , Linfocitos T CD4-Positivos/inmunología , Linfocitos T CD4-Positivos/metabolismo , Células Dendríticas/inmunología , Células Dendríticas/metabolismoRESUMEN
Photocatalysis, which is an alternative technology to conventional methods, utilizes solar energy as the driving force to address environmental concerns and has attracted widespread attention from chemists worldwide. In this study, a series of photocatalytic materials composed of agricultural waste and titanium dioxide (TiO2) nanomaterial was prepared for the synergistic adsorption-photocatalytic reduction of hexavalent chromium in wastewater under mild conditions. The results showed that the TiO2 nanomaterial exhibited a higher photogenerated carrier separation efficiency and performance for the adsorption-photocatalytic reduction of Cr(VI) after loading straw biochar (BC). When the loading amount of BC was 0.025 g (i.e., TBC-3), the removal efficiency of Cr(VI) was as high as 99.9% under sunlight irradiation for 25 min, which was 2.9 and 3.5 times higher than that of pure TiO2 and BC samples, respectively. Additionally, after four cycles of experiments, the removal efficiency of Cr(VI) by TBC-3 remained at about 93.0%, proving its good chemical ability in our reaction system. Its excellent adsorption-photocatalytic performance is mainly attributed to the synergistic effect of the strong adsorption of BC and the outstanding photocatalytic performance of TiO2. Finally, the possible mechanism for the synergistic adsorption-photocatalytic reduction on BC/TiO2 to remove the highly toxic Cr(VI) in wastewater was proposed.
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Using traditional Chinese medicine residues as raw materials, different biochars (BC) were prepared through oxygen-limited pyrolysis at 300 °C, 500 °C, and 700 °C, and BC was ball-milled to produce ball-milled biochar (BMC). Using these adsorbents to adsorb the allelopathic autotoxic substance quercetin. The physical and chemical properties of various biochars derived from traditional Chinese medicine residues were characterized using the Brunauer-Emmett-Teller-N2 surface areas (BET), scanning electron microscopy (SEM), Fourier transform IR spectroscopy (FTIR), X-ray diffraction (XRD), and Raman spectroscopy (Raman). The study investigated the effects of the initial pH value, different humic acid concentrations, and multiple adsorption-desorption experiments on the removal of quercetin from the solution. The article discusses the adsorption mechanism of quercetin in solution by biochar from a traditional Chinese medicine residue, based on the results of adsorption kinetics and adsorption isotherm fitting. The findings indicate that increasing the pyrolysis temperature reduces the oxygen-containing functional groups of BC, enhances the aromaticity, and stabilizes the carbon structure. The pore structure of BMC becomes more complex after ball milling, which increases the number of oxygen-containing functional groups on the surface. Among the samples tested, BMC700 exhibits the best adsorption performance, with an adsorption capacity of 293.3 mg·g-1 at 318 K. The adsorption process of quercetin by BMC700 follows the pseudo-second-order kinetic model and the Freundlich adsorption isotherm model. The process is primarily a form of multimolecular layer adsorption. Its mechanism involves the pore-filling effect, hydrogen-bonding interaction, electrostatic interaction, and π-π coexistence, as well as the yoke effect. Additionally, they are highly recyclable and show promise in addressing continuous cropping issues.
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To examine the feasibility of single left bundle branch pacing for cardiac resynchronization therapy (CRT) by carrying out a frequency adaptive atrioventricular delay (RAAVD) algorithm and automatic optimization of the single left bundle branch pacing atrioventricular interval (AVI) based on the right atrioventricular interval (RAS-RVS). Thirty-six patients with CRT class Ia indications according to the European Society of Cardiology 2016 guidelines and implanted with RAAVD functional three-chamber pacemakers were prospectively enrolled in this study. Patients were divided into a single left bundle branch pacing group (n = 21) and a standard biventricular pacing group (n = 15). The optimization of the two groups was performed under standard cardiac colour Doppler ultrasound, followed by the comparison of the QRS width, cardiac function improvement, and echocardiography indicators. The ratio of AVI to the right atrial-right ventricular interval (RAS-RVS) after single LV pacing optimization was defined as the single left bundle branch pacing coefficient (LUBBPε). In comparison to the BVP, the QRS was significantly narrowed (P = 0.017), accompanied by a significantly increased proportion of patients with NYHA class I and II, as well as the 6MWT. Compared with standard biventricular pacing, LVEDD was significantly shortened (P = 0.045), accompanied by significantly improved LAD, AVVTI, EA distance/RR, IVMD, and TS-SD after the operation. RAS-RVS was 156 ± 33 ms, the optimized AVI was 102 ± 10 ms, and LUBBPε was calculated to be 0.66 ± 0.06. Depending on the LUBBPε, a three-chamber pacemaker with a single left bundle branch pacing system was developed based on RAS-RVS-optimized AVI automatically. A three-chamber pacemaker with single left bundle branch pacing can achieve CRT based on RAS-RVS, reaching the optimal AVI of 66% of RAS-RVS.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca , Humanos , Estudios de Factibilidad , Bloqueo de Rama/terapia , Resultado del Tratamiento , Insuficiencia Cardíaca/terapia , Electrocardiografía , Función Ventricular IzquierdaRESUMEN
Sodium-sulfur (Na-S) batteries are attracting intensive attention due to the merits like high energy and low cost, while the poor stability of sulfur cathode limits the further development. Here, we report a chemical and spatial dual-confinement approach to improve the stability of Na-S batteries. It refers to covalently bond sulfur to carbon at forms of C-S/N-C=S bonds with high strength for locking sulfur. Meanwhile, sulfur is examined to be S1-S2 small species produced by thermally cutting S8 large molecules followed by sealing in the confined pores of carbon materials. Hence, the sulfur cathode achieves a good stability of maintaining a high-capacity retention of 97.64% after 1000 cycles. Experimental and theoretical results show that Na+ is hosted via a coordination structure (N···Na···S) without breaking the C-S bond, thus impeding the formation and dissolution of sodium polysulfide to ensure a good cycling stability. This work provides a promising method for addressing the S-triggered stability problem of Na-S batteries and other S-based batteries.
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The conventional dose of recombinant human thrombopoietin (rhTPO) in the treatment of immune thrombocytopenia (ITP) is 300 U/kg per day, but the clinical reaction rate is not satisfactory. Accordingly, we explored the efficacy and safety of increasing rhTPO dose in the treatment of ITP. A retrospective study was conducted to collect the clinical data of 105 ITP patients who were divided into two groups, a low-dose group (15 000 U/day) and a high-dose group (30 000 U/day) according to the dose of rhTPO. The total effective rate of the low-dose group and the high-dose group was 31/44 (70.45%) vs. 56/61 (91.80%) (P = .049), and the average time of using rhTPO in the high-dose group was shorter than that in the low-dose group (7 days vs. 10 days, P = .001). On the 7th and 14th day of treatment, the efficacy of the high-dose group was better than that of the low-dose group [45/61 (73.77%) vs. 17/44 (38.64%), P < .001; 55/60 (91.67%) vs. 30/44 (68.18%), P < .05)]. The incidence of treatment related adverse events in the low-dose group and the high-dose group was 6/44 (13.64%) vs. 6/61 (9.84%) (P > .05), which were mild and transient in nature. In our study, high-dose rhTPO had good efficacy and high safety in the treatment of ITP with the efficacy better than low-dose rhTPO especially at day 7.
What is the context? Immune thrombocytopenia (ITP) is an acquired autoimmune disease characterized by low platelet counts due to increased platelet destruction and impaired platelet production.The therapy direction of ITP involves promoting platelet generation, reducing excessive platelet destruction, immune regulation and so on.Recombinant human thrombopoietin (rhTPO), a promote platelet production drug, has pharmacological action similar to that of endogenous TPO. It can increase platelet count rapidly and effectively and has immunological regulation effect as well.It is found that rhTPO can rapidly and effectively increase platelet count, which has potential clinical application value in emergency situations.What is new? Traditionally, rhTPO has been recommended at 300 U/kg per day. Although it can greatly improve the treatment effect of ITP, the effect is not very satisfactory. In clinical practice, it has been observed that rhTPO dosage is often relatively insufficient and the therapeutic effect is poor. Therefore, we explored the efficacy and safety of increasing rhTPO dose in the treatment of ITP.Within the efficacy and safety of rhTPO 15 000 U/day and 30 000 U/day in the treatment of ITP, our analyses suggest that:The early response rate of the high-dose group was better than that of the low-dose group.In the high-dose group, the effective rate of rhTPO alone or combined with glucocorticoids was more than 90%.Treatment related adverse events occurred at a low rate and remained mild and transient.What is the impact? Comparing with conventional dose rhTPO, high-dose rhTPO may have better efficacy and safety in the treatment of immune thrombocytopenia and shorter administration time.
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Púrpura Trombocitopénica Idiopática , Trombocitopenia , Humanos , Púrpura Trombocitopénica Idiopática/tratamiento farmacológico , Trombopoyetina/efectos adversos , Recuento de Plaquetas , Estudios Retrospectivos , Trombocitopenia/tratamiento farmacológico , Proteínas Recombinantes/uso terapéuticoRESUMEN
Sodium-ion batteries (SIBs) are attracting worldwide attention due to their multiple merits including abundant reserve and safety. However, industrialization is challenged by the scarcity of high-performance carbon anodes with high specific capacities. Here, we report the metal-assisted microcrystalline structure regulation of carbon materials to achieve high-capacity sodium storage. Systematic investigations of in situ thermal-treatment X-ray diffraction and multiple spectroscopies uncover the regulation mechanism of constructing steric hindrance (C-O-C bonds) to restrain the aromatic polycondensation reaction. The carbon precursor of polycyclic aromatic hydrocarbon-type pitch contributes to a high carbon yield rate (40%) compared with those of resin and biomass precursors. The as-synthesized carbon materials deliver high capacities of up to 390 mAh g-1, surpassing many reported carbon anodes for SIBs. Through correlating specific capacity with ID/IG values in Raman spectra and theoretical calculation of carbon materials regulated by different metal elements (Mn, Nb, Ce, Cr, and V), we identify and propose the binding energy as the descriptor for characterizing the capability of regulating the carbon microcrystalline structure to promote sodium storage. This work provides a universal method for regulating the carbon structure, which may lead to the controlled design and fabrication of carbon materials for energy storage and conversion and beyond.
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Hydrogen peroxide (H2O2) electrosynthesis through oxygen reduction reaction (ORR) is drawing worldwide attention, whereas suffering seriously from the sluggish oxygen evolution reaction (OER) and the difficult extraction of thermodynamically unstable H2O2. Herein, we present an electrosynthesis protocol involving coupling ORR-to-H2O2 with waste polyethylene terephthalate (PET) upcycling and the first H2O2 conversion strategy. Ni-Mn bimetal- and onion carbon-based catalysts are designed to catalyze ORR-to-H2O2 and ethylene glycol electrooxidation with the Faradaic efficiency of 97.5% (H2O2) and 93.0% (formate). This electrolysis system runs successfully at only 0.927 V to achieve an industrial-scale current density of 400 mA cm-2, surpassing all reported H2O2 electrosynthesis systems. H2O2 product is upgraded through two downstream routes of converting H2O2 into sodium perborate and dibenzoyl peroxide. Techno-economic evolution highlights the high gross profit of the ORR || PET upcycling protocol over HER || PET upcycling and ORR || OER. This work provides an energy-saving methodology for the electrosynthesis of H2O2 and other chemicals.
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In order to establish a method for simultaneous determination and extraction of quercetin and berberine in soil, HPLC-PDA multi-wavelength method was used to detect the content of berberine and quercetin in soil solution. The detection wavelength was 210 nm and 347 nm. The column temperature was 30 °C, the mobile phase A was acetonitrile, the mobile phase B was 0.1% phosphoric acid aqueous solution, and the flow rate was 1.0 mL min-1. Under the condition of isocratic elution, quercetin and berberine were completely separated within 20 min. The detection limit concentration of quercetin was 0.078 mg L-1, and the detection limit of berberine was 0.019 mg L-1. Both of them reached the trace level, and the recovery rate was between 97.2% and 107.4%. The response surface method was used to optimize the ultrasonic extraction method. The three main factors of extraction concentration, extraction temperature and solid-liquid ratio were optimized to obtain the highest extraction efficiency. The optimum extraction efficiency was as follows: 1 g soil sample was extracted with 80% ethanol aqueous solution, ultrasonic time was 10 min, ultrasonic temperature was 44 °C, and solid-liquid ratio was 1 : 17 g mL-1. The extracted quercetin and berberine concentrations were close to the predicted values of response surface optimization. The method of extracting and determining berberine and quercetin from soil established in this experiment is simple, fast, low cost and high safety. The feedback of the results also further verifies the feasibility in practical production and application, and provides reference value for further research and analysis of different allelochemicals in soil.
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Background and purpose: The diagnosis of tuberculous meningitis (TBM) is difficult due to the lack of sensitive methods. Identification of TBM-specific biomarkers in the cerebrospinal fluid (CSF) may help diagnose and improve our understanding of TBM pathogenesis. Patients and methods: Of the 112 suspected patients with TBM prospectively enrolled in the study, 32 patients with inconclusive diagnosis, non-infectious meningitis, and long-term treatment with hormones and immunosuppressants were excluded. The expression of 8 proteins in the CSF was analyzed using ELISA in 22 patients with definite TBM, 18 patients with probable TBM, and 40 patients with non-TBM. Results: Significant differences in the expression of 7 proteins were detected between the TBM and non-TBM groups (P < 0.01). Unsupervised hierarchical clustering (UHC) analysis revealed a disease-specific profile consisting of 7 differentially expressed proteins for TBM diagnosis, with an accuracy of 82.5% (66/80). Logistic regression with forward stepwise analysis indicated that a combination of 3 biomarkers (APOE_APOAI_S100A8) showed a better ability to discriminate TBM from patients with non-TBM [area under the curve (AUC) = 0.916 (95%CI: 0.857-0.976)], with a sensitivity of 95.0% (95%CI: 83.1-99.4%) and a specificity of 77.5% (95%CI: 61.5-89.2%). Conclusion: Our results confirmed the potential ability of CSF proteins to distinguish TBM from patients with non-TBM and provided a useful panel for the diagnosis of TBM.
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There are phenolic acids with allelopathy in the rhizosphere soil of plants. At present, the identification and quantification of phenolic acids in different matrix mixtures is usually analysed by high performance liquid chromatography, but the detection of phenolic acids in soil has rarely been studied. As well as, previous studies have evaluated a limited number of target compounds. In this work, we proposed and verified a method for quantitative determination of 14 phenolic acids, including gallic acid, vanillic acid, p-hydroxybenzoic acid, protocatechuic acid, caffeic acid, syringic acid, p-coumaric acid, ferulic acid, chlorogenic acid, benzoic acid, salicylic acid, 2-methoxycinnamic acid, 3-methoxycinnamic acid, and cinnamic acid, which are widely present in rhizosphere soil of plants and have allelopathy. This method used multiwavelength HPLC-PDA analysis for simultaneous determination of these compounds. The detection wavelengths selected 254 nm, 280 nm, 300 nm, and 320 nm. Chromatographic separation of all compounds was achieved using a column of Shim-pack VP-ODS (250 mm × 4.6 mm, 5 µm), kept at 30 °C. Mobile phase A was acetonitrile, B was a 0.5% acetic acid aqueous solution, and the flow rate was 1.0 mL min-1. Under the condition of gradient elution, the mobile phase A was acetonitrile, B was a 0.5% acetic acid aqueous solution, and the flow rate was kept constant at 1.0 mL min-1. The 14 target phenolic acids were completely separated within 45 min. All the calibration curves showed good linearity, and the correlation coefficient was 0.9994-0.9999. With the detection limit varying from 0.003 mg L-1 to 0.239 mg L-1. The recovery rates and the RSD of 14 phenolic acids were 80.54â¼107.0% and 1.43-4.35%, respectively. This method has the characteristics of high sensitivity, high accuracy, and high recovery rate. This method is a novel technical means for the simultaneous analysis of compound phenolic acids in soil.
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PURPOSE: Evaluation of the efficacy and safety of IL-2 in the treatment of drug-susceptible tuberculosis. METHODS: First, the cases of diagnosed drug-susceptible tuberculosis were randomized into two groups-the control group that received the background regimen of isoniazid, rifampin, pyrazinamide, and ethambutol, and the experimental group that received the background regimen plus IL-2. The efficacy and safety evaluations were performed throughout the therapy process as well as 12 months after the treatment completion. RESULTS: A total of 1151 patients underwent the randomization, among which 539 (96.2%) of the 560 in the experimental group achieved the sputum culture conversion to negative, compared to the 551 (93.2%) of the 591 in the control group, after 2 months of treatment, with significant difference observed between the groups (P = 0.025). Cavity closure after 2 months in the IL-2 (experimental) group was 60/211 (28.4%) compared to 46/248 (18.5%) in the control group, with a significant difference between the groups (P = 0.001). After treatment completion, the proportion of favorable outcomes was 559/560 (99.8%) in the experimental group and 587/591 (99.3%) in the control group, with no significant difference between the groups. Twelve months after treatment completion, relapse occurred in 15/560 (2.6%) in the IL-2 group and 19/591 (3.2%) in the control group, with no significant difference. CONCLUSION: IL-2 may enhance culture conversion and the cavity closure rate in the early treatment phase, although the enhancement may not be significant after treatment completion.
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Tuberculosis Pulmonar , Tuberculosis , Antituberculosos/uso terapéutico , Quimioterapia Combinada , Humanos , Interleucina-2/uso terapéutico , Resultado del Tratamiento , Tuberculosis/tratamiento farmacológico , Tuberculosis Pulmonar/tratamiento farmacológicoRESUMEN
The purpose of this study was to synthesize a magnetic material that could be easily separated by a magnetic field and combined the catalytic function of an acid/base ionic liquid with silicon for biodiesel preparation. A kind of magnetic catalyst-immobilized ionic liquid was synthesized by a three-step method. The synthesis conditions in each step were optimized by single-factor analysis. Under the optimum conditions, 206.83 mg of ionic liquid (>43.63%) was immobilized on SiO2 (per gram). Heating under reflux was applied to extract Schisandra chinensis seed oil with an average yield of 10.9%. According to the biodiesel yields, Fe3O4@SiO2@[C4mim]HSO4 was the most efficient catalyst in the methyl esterification reaction. Under the optimum reaction conditions, seed oil (10.0 g) was mixed with methanol (70 mL) under continuous mechanical stirring for 3 h, and the yield of biodiesel was 0.557 g/g (the catalyst efficiency was about 89.2%). Also, the thermal value was increased from 32.14 kJ/g (seed oil) to 38.28 kJ/g (biodiesel). The catalytic efficiency of Fe3O4@SiO2@[C4mim]HSO4 was 87.6% of the first being used after four reuse cycles, and 71.4% of the first being used after six reuse cycles in the methylation reaction. The yields and physical and chemical properties of biodiesel were determined.
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We aimed to investigate the effect of interval between food intake and drug administration at fasting condition on the plasma concentrations of first-line anti- tuberculosis (TB) drugs in Chinese population. Newly diagnosed TB patients administered the anti-TB drugs under fasting conditions orally, and then had prepared breakfast at 30âminutes and 120âmin after dosing, respectively. Blood sampling was also performed 120â minutes after dosing for the detection of Cmax purpose. Overall, twenty-five participants were included in our analysis. The Cmaxs of 30â minutes interval and 120â minutes interval were 21.8â±â2.0 and 19.2â±â2.0âµg/mL for rifampin, 1.6â±â0.2 and 2.1â±â0.2âµg/mL for isoniazid (INH), 1.5â±â0.1and 1.5â±â0.2âµg/mL for ethambutol (EMB), and 49.2â±â3.7 and 41.5â±â3.9âµg/mL for pyrazinamide, respectively. Statistical analysis revealed that there was no statistical difference between 2 groups. Additionally, 88.0% and 72.0% of the 25 participants at 2-hour interval group had peak concentrations less than the lower limit of the reference range for INH and EMB, respectively. The Cmaxs of INH were 0.9â±â0.4âµg/ml for rapid acetylator, which was significantly lower than those of intermediate (1.4â±â1.0âµg/mL), and slow acetylator (2.5â±â1.0âµg/mL), respectively (Pâ<â.01). In conclusion, our data demonstrate that early food intake at 30âminutes after drug administration had no significant influence on the plasma concentrations. In addition, a high proportion of patients receiving first-line anti-TB regimen fail to achieve the expected plasma drug ranges of INH and EMB (Pâ>â.05).
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Antituberculosos/sangre , Ingestión de Alimentos , Ayuno/sangre , Factores de Tiempo , Tuberculosis Pulmonar/sangre , Tuberculosis Pulmonar/tratamiento farmacológico , Administración Oral , Adulto , Antituberculosos/administración & dosificación , China , Esquema de Medicación , Etambutol/administración & dosificación , Etambutol/sangre , Femenino , Humanos , Isoniazida/administración & dosificación , Isoniazida/sangre , Masculino , Pirazinamida/administración & dosificación , Pirazinamida/sangre , Rifampin/administración & dosificación , Rifampin/sangre , Resultado del TratamientoRESUMEN
Tuberculosis (TB) patient serum cytokine levels may be predictive of anti-tuberculosis treatment progress. Here, serum levels of cytokines TNF-α, IL-4, sIL-2R and IFN-γ were measured then correlated to clinical TB manifestations, bacterial burden, chest imaging findings and clinical course. Study subjects included 67 newly diagnosed pulmonary TB (PTB) patients with active disease admitted to Beijing Chest Hospital for anti-TB chemotherapeutic treatment. Blood was drawn at 0 months (pre-treatment), 1-2 months (at any time between 1 and 2 month) and after 6 months completion of treatment and serum TNF-α, IL-4, sIL-2R and IFN-γ levels were measured in duplicate using enzyme-linked immunosorbent assays (ELISAs). Correlation analysis was conducted to evaluate sensitivity and specificity of cytokine levels as predictors of disease activity and treatment progress. The results indicated that the pre-treatment serum TNF-α level of the smear-negative group was lower than that of the smear 1+ group, while serum TNF-α after 6 months completion of treatment and IFN-γ levels at 1-2 months and after 6 months completion of treatment were significantly lower, respectively, than at 0 months (before treatment) (P < 0.05). Using a cut-off value of 845 pg/ml, serum TNF-α level was predictive of treatment progress, with a sensitivity of 51%, specificity of 60% and AUC of 0.594 (P = 0.013). Meanwhile, using a cut-off value of 393 pg/ml, serum IFN-γ provided superior monitoring efficacy, with a sensitivity of 60%, specificity of 64% and AUC of 0.651 (P = 0.017). In conclusion, both serum TNF-α and IFN-γ levels might be useful biomarkers for monitoring treatment progress.
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BACKGROUND: The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programs. METHODS: We carried out a prospective, randomized, multicenter study in China that was focused on the potential of a shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. There were 135 MDR-TB cases that met eligibility requirements and were randomly stratified into either the control group or experimental group. Patients in the control group received an 18-month treatment regimen, whereas patients in the experimental group received a 12-month treatment regimen containing CFZ. RESULTS: At the completion of the treatment period, the difference in sputum-culture conversion rates between the experimental group and the control group was not significant. Notably, by the end of 3 months of treatment, 68.7% patients receiving the experimental regimen had sputum-culture conversion, as compared with 55.9% of those receiving the control regimen; this was a significant difference, suggesting an early sputum conversion (P = .04). There were 67 adverse events reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group. No significant difference in the overall incidences of adverse events was observed between the 2 groups. CONCLUSIONS: The MDR-TB patients treated with the shorter regimen containing CFZ had a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned to the experimental group achieved more rapid sputum-culture conversion, reflecting superior antimicrobial activity against MDR-TB. CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry ChiCTR 1800020391.
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Clofazimina , Tuberculosis Resistente a Múltiples Medicamentos , Antituberculosos/uso terapéutico , China , Clofazimina/uso terapéutico , Humanos , Estudios Prospectivos , Resultado del Tratamiento , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológicoRESUMEN
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn] under identifier ChiCTR1800014800.).