ABSTRACT
Objective To compare the efficacy and safety of a new low-dose oral contraceptive pill (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 μg with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD). Methods This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles (84 days) with daily symptom charting; 187 women with symptoms of PMDD were randomized to either placebo group (n=94) or YAZ group (n=93), and assessed with daily record of severity of problems scale (DRSP) and clinical global impressions scale (CGI) before, during and after the treatments. Hormones were administered for 24 days, followed by 4 days of inactive pills. Results Compared with baseline level of DRSP, both groups got improvement after treatment; the YAZ group (median-28.7, range:-82.5 to 2.3) had greater improvement than that in the placebo group (median-23.7, range:-86.0 to 11.8), while there was not significant difference (P>0.05). The main adverse effects of YAZ included intermenstrual bleeding [13% (12/93) versus 3% (3/94)], menorrhagia [9% (8/93) versus 1%(1/94)], nausea [5%(5/93) versus 4%(4/94)] and skin rash [4%(4/93) versus 2%(2/94)]. Conclusions YAZ could improve symptoms of PMDD better than placebo, while without statistic significance in this study. The most common adverse effects are intermenstrual bleeding, menorrhagia, nausea and rash.
ABSTRACT
BACKGROUND: As the first long-acting atypical antipsychotics, the therapeutic effect and safety of risperidone microsphere have been proved. However, it may lead to serious pain due to the deep intramuscular injection.OBJECTIVE: To evaluate the pain levels by 12-week injection of rispeddone microsphere and to explore the relationship among dose and times of injection of risperidone microsphere and pain levels.METHODS: A total of 57 patients diagnosed as schizoprenia by DSM-Ⅳ, aged 18-65 years, were selected and injected risperidone microsphere once every 2 weeks with doses of 25, 37.5 and 50 mg. The pain levels were evaluated using 100 mm visual analogue scale during injection and at the injected sites. The effects of injected dose, injected frequency and injected sites on the pain were analyzed by the nurse questionnaire.RESULTS AND CONCLUSION: The pain levels among the different doses groups had no notable differences (F=1.35,P> 0.05), which demonstrated that the pain had no relationship with injected dose. However, the pain level of injected sites had correlation to injected doses. The pain level of the 50 mg group was greater than that of the 37.5 and 25 mg groups. Accordingly,patients who treated by high dose of risperidone microsphere should be intervened by nurses.