简介：AbstractObjective:To compare the effects between carbetocin and oxytocin on reducing postpartum hemorrhage (PPH) after vaginal delivery in high risk pregnant women.Methods:A prospective double-blinded randomized study was conducted in the Nanjing Drum Tower Hospital from March to May 2018. Women at or beyond 28 gestational weeks, cephalic presentation, 18-45 years old, and with at least one risk factor for PPH, were enrolled. Using a computer-generated randomization sequence, women were randomized to carbetocin group or oxytocin group which receive 100 μg intravenous infusion carbetocin or 10 IU intravenous infusion of oxytocin after anterior shoulder and before placental delivery. The primary outcome was the incidence of blood loss ≥500 mL within 24 hours postpartum. The secondary outcomes were amount of total blood loss, blood loss within 2 hours after delivery, the rate of blood loss ≥ 1 000 mL postpartum, need for a second-line uterotonics and interventions, blood transfusion, difference between hemoglobin before and 48 hours after delivery, adverse maternal events attributed to the trial medication. Hemodynamic status (blood pressure and pulse) was measured at 0 minutes, 30 minutes, 60 minutes, and 120 minutes after delivery.Results:A total of 314 and 310 participants constituted the carbetocin and oxytocin groups, respectively. The baseline characteristics were comparable between the groups. The carbetocin group had similar rates of PPH (blood loss ≥500 mL) and rates of ≥1 000 mL PPH, (29.6% vs. 26.8%, P= 0.48) and (3.2% vs. 3.5%, P= 0.83), to the oxytocin group. The average amount of bleeding was (422.9 ± 241.4) mL in carbetocin group and (406.0 ± 257.5) mL in oxytocin group, which was no statistically significant difference (P= 0.40). Either the amount of blood loss within 2 hours ((55.5 ± 33.9) mL vs. (59.9 ± 48.7) mL) was no statistically significant difference (P= 0.19). The need for therapeutic uterotonics was 23.9% in carbetocin group and 23.5% in oxytocin group, which was also no statistically difference (P= 0.93). The rate of blood transfusion (P= 0.62) and hemoglobin change (P= 0.07) were not differ between the carbetocin and oxytocin groups. However, the rate of manually removing placenta was significantly different between two groups regarding the need for manually remove of placenta because of uterine bleeding in the third stage of labor (4 cases in carbetocin group vs. 13 cases in oxygen group), especially in those after oxytocin-induced or augmented labor (relative risk:3.39, 95% confidence interval: 1.09-10.52). After delivery, the blood pressure in the carbetocin group tend to be lower than that in the oxytocin group (P > 0.05), especially at 30 minutes postpartum (P < 0.05), while pulse tend to be simultaneously higher (P > 0.05).Conclusion:Among women with high risk of PPH, intravenous carbetocin infusion did not better than oxytocin in the prevention of blood loss ≥500 mL after vaginal delivery.

简介：AbstractBackground:Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.Methods:We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician’s global assessment (sPGA) at week 12.Results:The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.Conclusion:During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.Trial Registration:Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen. aspx?proj=6300.

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