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BACKGROUND AND OBJECTIVE: Cytisine serves as an affordable smoking cessation aid with acceptable safety profile. However, data comparing its efficacy and safety to standard therapies are limited. We aimed to examine efficacy and safety of cytisine compared to nortriptyline, which is the only approved smoking-cessation medication in Thailand. METHODS: A 12-month, multicentre, randomized, double-blinded, placebo-controlled trial was conducted. Participants aged ≥20 years who smoked ≥10 cigarettes/day were randomly assigned to receive a 25-day cytisine or a 12-week nortriptyline treatment course. Brief interventions (BI) for smoking cessation were provided to all participants. The primary outcome was biochemically verified continuous abstinence rate (CAR) at 12 months. Additionally, self-reported abstinence, verified by exhaled carbon monoxide (CO) ≤ 10 ppm, was collected at 2 weeks, 1, 3, 6 and 12 months to assess both CAR and 7-day point prevalence abstinence rate (PAR). RESULTS: A total of 1086 participants were recruited and randomized into cytisine (n = 540) and nortriptyline (n = 546) groups. The 12-month CAR was 12.22% for cytisine and 9.52% for nortriptyline. The relative difference was 0.03 (95% confidence interval [CI]; -0.01 to 0.06) and the relative risk was 1.28 (95% CI; 0.91-1.81). No differences were observed in secondary outcomes between both groups. The incidence of adverse effects from cytisine appeared to be lower than that of nortriptyline. CONCLUSION: At 12 months, cytisine plus BI was as effective as nortriptyline plus BI for smoking cessation. The adverse events for both cytisine and nortriptyline were minimal and well-tolerated.
RESUMO
Background We wanted to determine the impact of combined Clinical Pulmonary Infection Score (CPIS) and a spot serum procalcitonin (PCT)-guided protocol to shorten the duration of antibiotic treatment in patients with ventilator-associated pneumonia (VAP), mainly caused by nonfermentative gram-negative bacilli (NF-GNB). Methods Patients with VAP who received appropriate antibiotics for 7 days, temperature ⩽ 37.8°C, without shock, and CPIS ⩽ 6 were allocated to the PCT group or conventional group according to the treating physicians' decisions. In the PCT group, antibiotics were stopped if the PCT level on day 8 < 0.5 ng/ml. In the conventional group, antibiotics were stopped according to physicians' discretion. Results There were 24 patients in the PCT group and 26 patients in the conventional group. NF-GNB were responsible for VAP in 79.2% of the PCT group and 65.4% of the conventional group. PCT group had a greater number of antibiotic-free days alive during the 28 days after VAP onset than the conventional group (14.6 ± 5.4 days versus 5.9 ± 5.7 days, respectively; p <.001). In the multivariate, propensity score-adjusted analysis, the PCT group [coefficient = -9.1 (-12.2 to -6); p <.001] and extrapulmonary infections [coefficient = 6.4 (3.3-9.5); p <.001] were independent predictors of total antibiotic exposure days. There was no relapse in both groups. Meanwhile, 12.5% of the PCT group and 26.9% of the conventional group subsequently developed recurrent VAP compatible with superinfections. Conclusions CPIS and a spot serum PCT level appeared effective and safe to guide discontinuation of antibiotic treatment in patients with VAP caused by NF-GNB. TRIAL REGISTRATION: TCTR20160726002.