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BACKGROUND: Currently, direct comparative safety between endothelin receptor antagonists (ERAs) in pulmonary arterial hypertension (PAH) is limited. Thus, a systematic review with network analysis was conducted. METHODS: An electronic search was performed for randomized controlled trials (RCTs) that reported the interested safety data (abnormal liver function, peripheral edema, and anemia) of ERAs in PAH. Risk ratios (RRs) with their confidence intervals (CIs) and the surface under the cumulative ranking curve (SUCRA) were calculated using a network analysis. RESULTS: Ten RCTs involving 2,288 patients were included. Compared with placebo, bosentan (RR, 2.93; 95% CI, 1.78-4.84) significantly increased the risk of abnormal liver function, ambrisentan (RR, 1.62; 95% CI, 1.23-2.13) significantly increased the risk of peripheral edema, and macitentan (RR, 3.42; 95% CI, 1.65-7.07) significantly increased the risk of anemia. SUCRA analysis suggested that bosentan 125 mg twice daily had the highest risk of abnormal liver function; ambrisentan 10 mg once daily had the highest risk of peripheral edema; macitentan 10 mg once daily had the highest risk of anemia. CONCLUSIONS: Abnormal liver function (bosentan), peripheral edema (ambrisentan), and anemia (macitentan) were the safety indicators of ERAs in patients with PAH. Different monitoring parameters should be considered for individual ERA.
RESUMO
<p><b>OBJECTIVE</b>To explore the effects of Tongmai decoction on the perioperative changes of serum concentrations of tumor necrosis factor alpha (TNF-alpha) and interleukin (IL)-6 in patients with femoral fractures, and conform the effectiveness of Tongmai decoction on inflammatory factors in patients with femoral fractures, providing the theoretical evidence for the clinical use of Tongmai decoction.</p><p><b>METHODS</b>From October 2007 to May 2009, 60 patients with closed traumatic femoral fractures were selected according to the inclusion criterias and exclusion criterias. All the patients were randomly divided into three groups (group A, group B and group C). Twenty patients in group A (Tpanax Notoginseng pill group), 13 patients were male and 7 patients were female; ranging in age from 20 to 45 years, averaged 32.0 years; the disease course ranged from 2.0 to 26.0 h, with an average of 9.5 h. Twenty patients in group B (Tpanax Notoginseng pills and Lornoxicam injection group),12 patients were male and 8 patients were female; ranging in age from 23 to 42 years, averaged 31.0 years; the disease course ranged from 3.5 to 25.0 h, with an average of 13.6 h. Twenty patients in group C (Tpanax Notoginseng pill, Lornoxicam injection and Tongmai decoction group), 14 patients were male and 6 patients were female; ranging in age from 21 to 44 years, averaged 31.5 years; the disease course ranged from 4.6 to 29.0 h, with an average of 13.3 h. Among all the patients, 42 patients with fractures were fixed with femoral intramedullary nailing, and other 18 patients with femoral locking plate fixation. The patients in group A took Tpanax Notoginseng pills orally, 4 g each time and twice daily; the patients in group B took Tpanax Notoginseng pills orally as group A, and at the same time received intramuscular injection of Lornoxicam, 8 mg each time and once daily; the patients in group C took Tpanax Notoginseng pills orally and received intramuscular injection of Lornoxicam as group B, and at the same time took Tongmai decoction (R ) orally, 200 ml each time and twice daily. The above medications were administered to the three groups on the second day after admission to hospital. Peripheral blood samples were taken for determination of pro-inflammatory cytokines of TNF-alpha and IL-6 in blood serum on the 2nd and 6th days before operation and on the 8th and 13th days after operation. And all the patients were evaluated liver and kidney function at the 2nd and 7th days after admission. Analysis of variance and least significant difference-test were done with the help of SPSS 17.0 statistic software.</p><p><b>RESULTS</b>The differences among three groups of TNF-alpha and IL-6 in blood serum at the 2nd day after admission and 2 days after operation had no statistical significance (P > 0.05). The TNF-alpha and IL-6 levels among 3 groups had statistical differences at the 7th day after admission and at the 7th day after operation (P < 0.05, P < 0.01). There were significant differences of TNF-alpha and IL-6 levels between the 7th day after admission and the 2nd day after admission, the 7th day after operation and the 2nd day after admission (P < 0.01). There were also significant differences of TNF-alpha and IL-6 levels between group C compared with group A and B at the 7th day after admission and the 7th day after operation(P < 0.05, P < 0.01).</p><p><b>CONCLUSION</b>The serum concentrations of TNF-alpha and IL-6 level significantly increased in perioperative period. The results indicate that the Tongmai decoction may play an important role in inhibiting the release of TNF-alpha and IL-6 into the blood stream and decreasing the incunabula complication at early traumatic stage.</p>
