Immune globulin subcutaneous, human – klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study

Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human – klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with immune globulin injection (human), 10% caprylate/chromatography purified (IGIV-C 10%). Patients & methods: About 53 participants enrolled. Total 44 received IGIV-C 10% in the run-in phase and then entered the IV phase (with an additional nine who were already receiving IGIV-C 10% and entered the IV phase directly) for steady-state IV PK assessments. Total 49 entered the SC phase (weekly doses of IGSC-C 20% for ∼24 weeks). The PK profiles of IGIV-C 10% and IGSC-C 20% and their safety and tolerability parameters were compared. Results: At a dose adjustment factor of 1.37, IGSC-C 20% provided comparable (noninferior and bioequivalent) overall total immunoglobulin G exposure to IGIV-C 10% over an equal time interval. About 33 participants reported 79 adverse events during run-in + IV phases; 41 participants reported 141 adverse events during the SC phase, with most being local infusion site reactions. The majority of infusion site reactions were mild to moderate in severity. Conclusion: IGSC-C 20% was bioequivalent to IGIV-C 10% and was well tolerated, with a safety profile comparable with IGIV-C 10%, in this study. Trial registration: ClinicalTrials.gov identifier: NCT02604810

Study on Deformation Prediction of the Tunnel Surrounding Rocks Based on Non-Equal Time-Interval Grey Model

The thesis develops an non-equal time-interval GM (1, 1) model to forecast the deformation of the tunnel surrounding rock. A program is compiled via MATLAB 7.1 platform to implement the model. With the assistance of the program and the monitoring record of the convergence, the deformation is predicted and the error is analyzed. The numerical results indicate that the non-equal time-interval GM (1, 1) model does well in predicting the deformation of tunnel surrounding rock and is worthy to put into use in tunnel engineering.

ОЦІНКА БАКТЕРИЦИДНИХ ВЛАСТИВОСТЕЙ КОМПЛЕКСНОГО МЕТАЛОМІСТКОГО ДЕЗІНФЕКТАНТУ

Наведені дані за результатами досліджень бак-терицидної дії комплексного металомісткого дез-інфектанту. Для цього визначали фенольний кое-фіцієнт, який виражає відношення концентраціїрозчинів досліджуваної речовини до концентраціїфенолу, що спричиняють у рівний проміжок часуза однакової температури рівнозначний темпера-турний дезінфікуючий ефект. Також визначалибілковий індекс, показник зниження активностідезінфікуючого засобу в присутності білків. У ре-зультаті досліджень встановлено, що бактери-цидна дія комплексного металомісткого дезінфе-ктанту (КМД) сильніша за бактерицидну дію кар-болової кислоти в 157,98 разу. КМД може прояв-ляти бактерицидну дію на оброблюваних поверх-нях навіть за контакту з білковими субстанціями,хоча в такому випадку його ефективність зни-зиться в 2,92 разу, що враховано при встановленніефективних концентрацій робочих розчинів КМД. The data on research of bactericidal action of complex metallicdisinfectant are given in article. Phenolic factor which expresses therelation of concentration of solutions of investigated substance toconcentration of phenol that defines in an equal time interval atidentical temperature equivalent temperature disinfectant effect wasdefined for this purpose. Albuminous index, an indicator ofdecrease in activity of a disinfectant in the presence of fiber wasalso defined. As a result of researches it is established that,bactericidal action complex metallic disinfectant is stronger thanbactericidal action phenylic acid in 157,98 times. KMD can showbactericidal action on processed surfaces during contact withalbuminous substances, but in that case its efficiency decreases in2,92 times. That is considered at installation of effectiveconcentration of working solutions KMD.

Analysis of Accumulated Damage Effects on the Roof of Mined-Out Areas under Blasting Vibration

Under the repeated blasting vibrations, the roof of the mined-out areas will suddenly collapse and fall because of its accumulated damage, which is a hidden danger for the miners and equipment on the surface. Based on the mined-out areas in Antaibao Surface Mine, the three-dimension engineering geological model and computational model were built using FLAC3D technique. According to the effect of the load of the mechanical construction equipment, and the blasting vibration velocity recorded by field monitoring, the equal-time-interval blasting vibration as normal incidence was exerted on the surface of the mined-out areas three times. Consequently the accumulated damage effect of the roof and surrounding rocks of mined-out areas were analyzed, the stress concentration extent and the range of principal stress were discussed as well. The dynamic response characteristics of deformation and the accumulated progressive displacement were revealed via the monitoring displacement curves. The above mentioned results can provide theoretical and technical basis for similar projects on reducing the hidden danger and ensuring safe mining.