Register for bivirkninger ved bruk av kosmetiske produkter 2008-2010

Meldingene som har kommet inn til bivirkningsregisteret viser at bivirkninger ved bruk av kosmetiske produkter utgjør et problem hos forbrukerne. I løpet av de to første årene mottok bivirkningsregisteret 96 meldinger. De fleste meldingene ble sendt inn av apotekfarmasøyter. Kun ni av meldingene kom fra leger og dette er et lavere antall enn forventet. De fleste meldingene omhandlet produkttyper som fuktighetskremer, renseprodukter, solkremer og produkter for hårfarging/bleking. De hyppigst rapporterte bivirkningene er eksem med ødem, blemmedannelse og/eller svie. Det er utført vurdering av årsakssammenhenger for 35 av meldingene som totalt omfatter 33 produkter. For 25 av de 35 meldingene ble det vurdert å være en meget sannsynlig eller sannsynlig sammenheng mellom bruken av produktet og de meldte bivirkningene. Vårt norske register for bivirkninger ved bruk av kosmetiske produkter har mottatt i underkant av 50 meldinger per år. I Nederland mottar de derimot rundt 100 meldinger per måned. Dette registeret har, i motsetning til det norske registeret hvor helsepersonell sender inn meldinger, en internettbasert rapporteringsløsning hvor forbrukerne selv rapporterer om sine bivirkninger. Det høye antallet meldinger til det nederlandske registeret tyder på at bivirkninger etter bruk av kosmetiske produkter forekommer relativt hyppig samtidig som det viser at det en stor grad av underrapportering til det norske registeret. Erfaringer fra de første to årene tyder på at dette skyldes at både forbrukerne og helsepersonell lar være å melde fra om bivirkninger til registeret. En mer komplett rapportering vil kunne gi et mer pålitelig bilde av situasjonen med hensyn til bivirkninger og potensielle problemprodukter. I tiden fremover vil derfor arbeidet med å øke meldefrekvensen være en prioritert oppgave

Laboratory parameters in AP.

<p>The only parameters shown are where statistical differences were found between the AP severity groups. Green: mild AP; yellow: moderate AP; red: severe AP; <b>ns:</b> no significant difference (p>0.05); <b>+:</b> significant difference (p<0.05). In the left-hand panel of graphs, laboratory parameters were analysed by distinct values, grouped in ranges. The first dotted column represents the AP severity groups of the entire cohort. Here, the Chi-square test was employed. In the right-hand panel of graphs, the average laboratory parameters were compared in the three AP severity groups. Here, we used the Kruskal–Wallis test and Mann–Whitney U test with a Bonferroni correction to compare the pairs of groups under examination. <b>A.</b> White blood cell count (WBC, n = 21–204). A WBC count above 23,000/μL was associated with elevated risk of severe AP (<b>a:</b> p = 0.020), and the average WBC counts also showed significant differences between the mild versus moderate and mild versus severe AP groups (p<0.001). <b>B.</b> C-reactive protein (CRP: n = 32–144). CRP above 200 mg/L was associated with severe AP (<b>b:</b> p = 0.007). In addition, average CRP levels differed significantly between the mild versus moderate and mild versus severe AP groups (p<0.001). <b>C.</b> Procalcitonin (PCT, n = 5–54). PCT levels above 10 U/L were associated with elevated risk of severe AP (<b>c:</b> p<0.001); however, average PCT levels did not differ significantly between the three AP severity groups (p = 0.143). <b>D.</b> Calcium (Ca, n = 12–40). Ca levels below 2 mmol/L were associated with a heightened risk of severe AP (<b>d:</b> p = 0.004); however, the average calcium levels did not differ significantly between the three AP severity groups (p = 0.077). <b>E.</b> Triglycerides (Tg: n = 10–48). Tg levels above 41 mmol/L were associated with greater risk of severe AP (<b>e:</b> p = 0.012); however, average Tg levels did not differ significantly between the three AP severity groups (p = 0.153). <b>F.</b> Glucose. (n = 3–175). Significant differences in severity associated with particular glucose levels were not found (<b>f:</b> p = 0.191); however, average glucose levels differed significantly between the mild versus moderate and mild versus severe AP groups (p<0.001).</p

Epidemiology and aetiology.

<p><b>A</b>. Sex distribution of AP cases. <b>B.</b> Age distribution of AP cases. <b>C.</b> AP severity groups. Mod: moderate; sev: severe. <b>D.</b> Age distribution of mild, moderate and severe AP cases and mortality. <b>E.</b> Overall mortality and distribution in the severity groups. p<0.001 was between the severe and other groups according to Fisher’s exact test. <b>F.</b> Days of hospitalization. Mann-Whitney U test with Bonferroni correction was used to compare the group pairs (p<0.001 between groups). <b>G.</b> Aetiology of AP. (<b>a:</b> p<0.001; <b>b:</b> p<0.001; <b>c:</b> p = 0.022, <b>d:</b> p = 0.030; <b>e:</b> p = 0.006; <b>f:</b> p<0.001; <b>g:</b> p = 0.011; <b>h:</b> p = 0.025).</p

Conservative therapy in AP.

<p><b>A.</b> Effect of fluid resuscitation on severity and mortality in the first 24 hours. The first dotted column represents the AP severity groups and mortality for each group in the entire cohort. Green: mild AP; yellow: moderate AP; red: severe AP; *: p = 0.030 (Fisher’s exact test on severity) versus the cohort (n = 8–185). A polynomial regression curve was fitted to demonstrate the mortality trend (n = 8–185). <b>B.</b> Enteral and parenteral feeding in AP. Mortality is shown for the severe AP group. NG: nasogastric feeding; NJ: nasojejunal feeding. <b>C.</b> Antibiotic therapy and its indications in AP. Table shows the indications for antibiotic therapy in the three severity groups. <b>D.</b> Probiotic therapy in AP.</p

Diagnosis, anamnestic data and symptoms at admission.

<p><b>A.</b> Anamnestic data. The percentages of severe AP and mortality in severe AP are also shown in relation to alcohol consumption, smoking, diabetes and history of earlier AP. <b>B.</b> Relationship between time of onset of abdominal pain and presentation at ER units. <b>C.</b> Time of onset of abdominal pain and presentation at ER in the three severity groups and association with mortality in the severe group. <b>D.</b> Diagnosis. Distribution of diagnostic criteria in the overall cohort (pie chart) and in the three severity groups (table) and association with mortality in severe AP (table). P: pain; E: enzyme elevation; I: imaging alteration. ^O p = 0.189 (Fisher’s exact test) * p = 0.005 (Chi-square test) *** p<0.001 (Chi-square test). <b>E.</b> Type and localisation of abdominal pain. EPI: epigastric pain; URA: upper right abdomen; ULA: upper left abdomen; MD: middle abdomen; L: lower abdomen; D: diffuse. <b>F.</b> Symptoms in the entire cohort and in the severe AP group and association with mortality in the severe AP group. ^O p = 0.189 (Fisher’s exact test) ^OO p = 0.051 (Chi-square test) * p = 0.029 (Chi-square test).</p

Type, indication and outcome of interventions in AP.

<p>Data show the mortality differences between early and late interventions in AP.</p

Frequency of organ failure and mortality in AP.

<p><b>A.</b> Frequency of individual organ failure (pancreas, lung, cardiac, kidney and brain) and mortality in severe AP. <b>B.</b> Frequency of combined organ failure and mortality in severe AP. <b>C.</b> Frequency of pancreatic complications and mortality in AP. Mortality was only calculated in severe AP. <b>a:</b> p = 0.020 (Fisher’s exact test); <b>b:</b> p = 0.002 (Chi-square test); <b>c:</b> p = 0.043 (Fisher’s exact test); <b>d:</b> p = 0.003 (Chi-square test); <b>e:</b> p = 0.030 (Fisher’s exact test).</p