ABSTRACT
@#Objective To evaluate the effects of various polysorbates(PS)on the stability of different types of monoclonal antibody(mAb)drugs.Methods Three types of monoclonal antibodies mAbA(IgG1 proantibody drug),mAbB(IgG1 mAb)and mAbC(IgG1 mAb with Fc N297A mutation)were used as model proteins,and different kinds or contents of PS were added into the mAb formulations respectively to investigate the influencing factors.The effects of PS on the stability of mAb drugs were evaluated comprehensively by detecting the changes of quality attributes,such as protein aggregates and insoluble particles.Results PS20 and PS80 showed no significant difference in inhibiting the formation of aggregates and charge variants in the three mAbs(P>0.05),while the addition of PS80 in mAbB and PS20 in mAbC significantly inhibited the increase of insoluble particles respectively(P<0.05);The content of PS20 showed a significant effect on the detection indexes of charge variants and insoluble particles in mAbC(P<0.05).Conclusion Different types of mAbs have different sensitivities to various kinds and contents of PS.Therefore,when designing the formulation of mAbs,it is necessary to select appropriate kinds and contents of PS to further improve the stability of mAb drugs.
ABSTRACT
<p><b>OBJECTIVE</b>Accidents are an important cause of childhood injury. It is hypothesized that safety education programs can reduce accidents in primary school-aged children. This study aimed to determine whether child and parent safety education programs can decrease the incidence of accidental injury in children when compared with controls.</p><p><b>METHODS</b>The study population (aged 7-13 years) were recruited from four local primary schools, and randomly assigned into an Intervention or a Control group. The Intervention group received child and parent safety education and was taught injury prevention strategies. The Control group received no injury prevention education or intervention. The incidence of accidental injury was compared between the two groups.</p><p><b>RESULTS</b>In the first year after intervention the incidence of accidental injury was 262 cases in the Intervention group (8.26%) and 234 cases (8.67%) in the Control group (P > 0.05). In the second year after intervention, however, the incidence of accidental injury was significantly less in the Intervention group (211 cases, 6.54%) compared with the Control group (229 cases, 8.63%) (P < 0.01).</p><p><b>CONCLUSIONS</b>Injury prevention strategies and child and parent safety education can reduce risks of accidental injury in children.</p>
Subject(s)
Adolescent , Child , Female , Humans , Male , Accident Prevention , Methods , Parents , Safety , Wounds and InjuriesABSTRACT
<p><b>OBJECTIVE</b>To investigate effects of anti-dsDNA autoantibodies on growth of tumor in vitro and in vivo.</p><p><b>METHODS</b>BALB/c mice were inoculated with inactivated tumor cells and challenged s.c. with SP 2/0 and Wehi 164 tumor cells four weeks after the last inoculation. The naïve mice were inoculated with SP 2/0 tumor cells immediately after incubating with sera derived from the immunized mice at week 6. Then the tumor size was examined. In vitro, the cytotoxicity of anti-dsDNA autoantibodies to tumor cells was analysed. Furthermore, apoptosis of SP 2/0 and Wehi 164 tumor cells induced by anti-dsDNA autoantibodies was examined by FACS.</p><p><b>RESULTS</b>In vivo study showed that the growth of SP 2/0 and Wehi 164 tumors were inhibited in mice with anti-dsDNA autoantibodies, but not in mice lack of anti-dsDNA autoantibodies. In vitro, apoptosis of SP 2/0 and Wehi 164 tumor cells was induced when the tumor cells were incubated with the sera containing anti-dsDNA autoantibodies. Statistical analysis showed that the ability of anti-dsDNA autoantibodies to induce apoptosis of SP 2/0 and Wehi 164 tumor cells was significantly correlated with affinity (r = 0.990, P < 0.01 and r = 0.901, P < 0.05).</p><p><b>CONCLUSION</b>Anti-dsDNA autoantibodies have inhibitory effect on tumor cells via inducing apoptosis.</p>