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Re: con respecto a los tocoliticos...que opinan?
From: Andrea David (andreadavid@vtr.net)
Wed Nov 24 11:45:12 2004
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- Maybe in reply to: jaider gomez diaz: "con respecto a los tocoliticos...que opinan?"
Ojalá tengan tiempo de leerlo, es largo pero resume "la mejor" evidencia disponible en tocolisis.Han sabido de mi pero aun no me presento........hago mi residencia de ginecologia y obstetricia en el hospital gustavo fricke de viña por ende discipula de Ronnie y he seguido su foro anonimamente durante casi un año...Espero que este miniresumen sea un aporte.
Dra. Andrea David
We found no systematic review or RCTs comparing calcium channel blockers with placebo. One systematic review has found that calcium channel blockers significantly reduce deliveries within 48 hours, neonatal morbidity, and withdrawals caused by maternal adverse effects compared with other tocolytics (mainly b agonists).
Benefits: Versus placebo: We found no systematic review or RCTs comparing calcium channel blockers versus placebo. Versus other tocolytics: We found one systematic review (search date 2002, 12 RCTs, 1029 women) comparing calcium channel blockers (nifedipine and nicardipine in 2 RCTs) versus other tocolytics (see glossary) (10 RCTs v ritodrine; 1 RCT each v salbutamol and magnesium sulphate) for preterm labour (between 20 and 36 weeks).35 The review found that calcium channel blockers significantly reduced delivery within 48 hours and 7 days and reduced delivery before 34 weeks compared with other tocolytics (delivery within 48 hours, 9 RCTs, 761 women: 74/383 [19%] with calcium channel blocker v 87/378 [23%] with other tocolytics; RR 0.8, 95% CI 0.61 to 1.0; dielvery within 7 days, 4 RCTs, 453 women: 71/229 [31%] v 86/224 [38%]; RR 0.76, 95% CI 0.60 to 0.97; delivery before 34 weeks, 6 RCTs, 619 women: 107/311 [34%] v 122/308 [40%]; RR 0.83, 95% CI 0.69 to 0.99). It found that calcium channel blockers significantly reduced neonatal morbidity including respiratory distress syndrome, necrotising enterocolitis, and intraventricular haemorrhage (respiratory distress syndrome, 9 RCTs, 763 newborns: 48/386 [12%] with calcium channel blocker v 72/377 [19%] with other tocolytics; RR 0.63, 0.46 to 0.88; necrotising enterocolitis, 3 RCTs, 323 newborns: 1/166 [1%] v 8/157 [5%]; RR 0.21, 95% CI 0.05 to 0.96; intraventricular haemorrhage, 3 RCTs, 340 newborns: 19/173 [11%] v 31/167 [19%]; RR 0.59, 95% CI 0.36 to 0.98). No significant differences were found in perinatal mortality (10 RCTs, 810 newborns: 13/400 [3%] with calcium channel blocker v 7/410 [2%] with other tocolytics; RR 1.65, 95% CI 0.74 to 3.64).
Harms: Versus other tocolytics: The systematic review (search date 1998) found that calcium channel blockers significantly reduced discontinuation because of adverse effects compared with other tocolytics (10 RCTs, 833 women: 1/419 [0.2%] with calcium channel blocker v 29/414 [7.0%] with other tocolytics; RR 0.14, 95% CI 0.05 to 0.36).35 The systematic review did not report specific adverse effects of calcium channel blockers.
One systematic review has found no significant difference between b2 agonists and placebo or no treatment in perinatal mortality, respiratory distress syndrome or birth weight less than 2500 g. It found that b2 agonists increased maternal adverse effects such as chest pain, palpitations, dyspnoea, tremor, nausea, vomiting, headache, hyperglycaemia, and hypokalaemia compared with placebo or no treatment.
Benefits: We found one systematic review (search date 1998, 8 RCTs).34 The systematic review found no significant difference between b2 agonists and placebo or no treatment in perinatal (see glossary) mortality, respiratory distress syndrome or birth weight less than 2500 g (perinatal mortality; 62/682 [9%] with b2 agonists v 48/604 [8%] with placebo or no treatment; OR 1.08, 95% CI 0.72 to 1.62; respiratory distress syndrome, 6 RCTs: 117/639 [18%] with b2 agonists v 140/565 [25%] with placebo or no treatment; OR 0.76, 95% CI 0.57 to 1.01; birth weight less than 2500 g, 5 RCTs: 332/601 [55%] with b2 agonists v 332/525 [63%] with placebo or no treatment; OR 0.79, 95% CI 0.61 to 1.01).34 It found no significant difference between treatments in patent ductus arteriosus, necrotising enterocolitis, intraventricular haemorrhage, seizures, hypoglycaemia, or neonatal sepsis.34
Harms: The systematic review found that b2 agonists significantly increased maternal adverse effects, such as chest pain, palpitations, dyspnoea, tremor, nausea, vomiting, headache, hyperglycaemia, or hypokalaemia compared with placebo or no treatment (chest pain, 2 RCTs: 39/406 [10%] with b2 agonists v 3/408 [1%] with placebo or no treatment; OR 6.2, 95% CI 3.3 to 11.5), palpitations, 3 RCTs: 200/420 [48%] with b2 agonists v 19/423 [4%] with placebo or no treatment; OR 10.2, 95% CI 7.4 to 13.9; dyspnoea, 2 RCTs: 55/406 [14%] with b2 agonists v 4/408 [1%] with placebo or no treatment; OR 6.6, 95% CI 3.9 to 11.2; tremor, 1 RCT: 138/352 [39%] with b2 agonists v 13/356 [4%] with placebo or no treatment; OR 8.3, 95% CI 5.8 to 11.9; nausea, 1 RCT: 72/352 [20%] with b2 agonists v 42/356 [12%] with placebo or no treatment; OR 1.9, 95% CI 1.3 to 2.8; vomiting, 2 RCTs: 48/366 [13%] with b2 agonists v 29/371 [8%] with placebo or no treatment; OR 1.8, 95% CI 1.1 to 2.9; headache, 2 RCTs: 84/366 [23%] with b2 agonists v 22/371 [6%] with placebo or no treatment; OR 4.0, 95% CI 2.6 to 6.0; hyperglycaemia, 1 RCT: 106/352 [30%] with b2 agonists v 37/356 [10%] with placebo or no treatment; OR 3.4, 95% CI 2.4 to 4.9; hypokalaemia, 1 RCT: 138/352 [39%] with b2 agonists v 23/356 [6%] with placebo or no treatment; OR 6.4, 95% CI 4.5 to 9.1).34 Frequently, these adverse effects necessitated discontinuation of treatment (3 RCTs: 25/88 [28%] with b2 agonists v 0/86 with placebo or no treatment; OR 11.5, 95% CI 4.8 to 27.5).
----- Original Mess One systematic review found no significant difference between magnesium sulphate and placebo in delivery before 36 weeks; perinatal mortality, or respiratory distress syndrome. A second systematic review found no significant difference between magnesium sulphate and other tocolytics (betamimetics, calcium channel blockers, prostaglandin synthetase inhibitors, nitroglycerine, alcohol and dextrose infusion) in delivery within 48 hours, although results were heterogeneous.
Benefits: Versus placebo: One systematic review (search date 1998, 4 RCTs) found no significant difference between magnesium sulphate and placebo or no treatment in delivery before 36 weeks (2 RCTs, 191 women: 61/92 [66%] with magnesium sulphate v 74/99[75%] with control; OR 0.67, 95% CI 0.36 to 1.26).34 It found no significant difference between magnesium sulphate and placebo or no treatment for perinatal mortality or respiratory distress syndrome (perinatal mortality: 11/169 [6.5%] with magnesium sulphate v 7/182 [3.8%] with placebo or no treatment; OR 1.83, 95% CI 0.70 to 4.77; respiratory distress syndrome, 3 RCTs: 22/139 [16%] with magnesium sulphate v 22/153 [14%] with placebo or no treatment; OR 1.19, 95% CI 0.61 to 2.31).34 It also found no significant difference between magnesium sulphate and placebo or no treatment in birth weight less than 2500 g, patent ductus arteriosus, necrotising enterocolitis, intraventricular haemorrhage, seizures, hypoglycaemia, or neonatal sepsis. The number of newborns assessed for these outcomes was small. Versus other tocolytics (see glossary): A second systematic review (search date 2002) compared magnesium sulphate versus placebo, no treatment, and other tocolytics (betamimetics, calcium channel blockers, prostaglandin synthetase inhibitors, nitroglycerine, alcohol and dextrose infusion).36 The studies included in the review comparing magnesium sulphate versus placebo, no treatment, or sedation were the same as those included in the initial review except for the addition of a study that compared magnesium sulphate versus barbiturate and bed rest.37 The review found no significant difference between magnesium sulphate and other treatment in delivery within 48 hours, although significant statistical heterogeneity was found (11 RCTs, 881 women: RR 0.85, 95% CI 0.58 to 1.25).
Harms: Versus placebo: The systematic review found that magnesium sulphate significantly increased discontinuation of treatment compared with placebo or no treatment (3 RCTs: 10/137 [7%] with magnesium sulphate v 0/144 [0%] with placebo or no treatment; OR 8.36, 95% CI 2.36 to 29.61).34 Versus other tocolytics: The second systematic review found that the magnesium sulphate significantly increased fetal, neonatal, and infant mortality (7 RCTs, 727 babies: 18/340 [5%] with magnesium sulphate v 6/387 [2%] with other tocolytics; RR 2.82, 95% CI 1.20 to 6.62).36
One systematic review identified two RCTs that compared atosiban with placebo and found different results. The larger RCT found that atosiban prolonged pregnancy compared with placebo but found that atosiban appeared to increase fetal deaths below 28 weeks' gestation. The other RCT found that atosiban increased delivery within 48 hours.
Benefits: Versus placebo: We found one systematic review (search date 1998, 2 RCTs).34 The first RCT identified by the systematic review (120 women at 20 to 36 weeks' gestation, with more than 4 contractions/hour and with no cervical changes, 114 deliveries) found that atosiban (300µg/minute for 2 hours) increased delivery within 48 hours, but the statistical significance was not reported (5/56 [8.9%] with atosiban v 2/56 [3.6%] with placebo, P not reported).38 The second RCT identified by the review was identified as an abstract. The later full publication of this RCT (501 women with preterm labour diagnosed by uterine contractions and cervical changes, at 20 to 33 weeks) found that atosiban significantly increased the proportion women undelivered without use of an alternative tocolytic at 24 and 48 hours and 7 days (24 hours: 73% with atosiban v 58% with placebo, OR 1.93, 95% CI 1.30 to 2.86; 48 hours: 67% with atosiban v 36% with placebo, OR 1.62, 95% CI 1.10 to 2.37; 7 days: 62% with atosiban v 49% with placebo, OR 1.70, 95% CI 1.17 to 2.46).39 It found no significant difference between atosiban and placebo in the median time to delivery (25.6 days with atosiban v 21.0 days with placebo, P not reported). For pregnancies over 28 weeks' gestation (424 pregnancies), it found that atosiban significantly prolonged pregnancy for up to 24 hours, 48 hours, and up to 7 days compared with placebo (delay up to 24 hours: 150/203 [74%] with atosiban v 128/221 [58%] with placebo; RR 1.28, 95% CI 1.11 to 1.47; NNT 7, 95% CI 4 to 15; delay 48 hours: 140/203 [69%] with atosiban v 122/221 [55%] with placebo; RR 1.25, 95% CI 1.08 to 1.45; NNT 8, 95% CI 5 to 23; delay up to 7 days: 131/203 [65%] with atosiban v 105/220 [48%] with placebo; RR 1.35, 95% CI 1.14 to 1.60; NNT 6, 95% CI 4 to 14).39
Harms: The systematic review found increased nausea with atosiban compared with placebo or no treatment but found no significant difference in vomiting (nausea, 2 RCTs: 33/306 [11%] with atosiban v 15/307 [5%] with placebo or no treatment; OR 2.3, 95% CI 1.3 to 4.1; vomiting, 2 RCTs: 10/306 [3%] with atosiban v 13/307 [4%] with placebo or no treatment; OR 0.8, 95% CI 0.3 to 1.8).34 Atosiban significantly reduced chest pain and dyspnoea (chest pain, 2 RCTs: 3/306 [1%] with atosiban v 13/307 [4%] with placebo or no treatment; OR 0.3, 95% CI 0.1 to 0.8; dyspnoea, 1 RCT: 1/250 [0.4%] with atosiban v 7/251 [3%] with placebo or no treatment; OR 0.22, 95% CI 0.05 to 0.89) compared with placebo or no treatment). The subsequent full report of one of the included RCTs found that atosiban significantly increased injection site reactions after prolonged use and significantly increased withdrawal owing to adverse effects (injection site reaction: 110/250 [44%] with atosiban v 58/251 [23%] with placebo; RR 1.90, 95% CI 1.46 to 2.48; NNH 4, 95% CI 3 to 7; withdrawal: 16% with atosiban v 4% with placebo).39 It found that atosiban increased infant death compared with placebo (13/288 [4.5%] with atosiban v 5/295 [1.7%] with placebo, P not reported).39 Analysis by gestational age at admission found that most of the mortality with atosiban occurred in pregnancies less than 26 weeks' gestation (mortality in pregnancies < 26 weeks: 10/27 [37%] with atosiban v 0/16 [0%] with placebo; see comment below; 26 to 28 weeks: 0/26[0%] v 1/26 [4%]; 28 to 32 weeks: 2/126 [2%] v 2/125 [2%]; ³ 32 weeks: 1/109 [1%] v 2/128 [2%]).39
Comment: In the first RCT identified by the systematic review, infusions were halted in two people (one in each treatment group) and these people were not included in the analysis.38 Tocolytic rescue with ritodrine was used in the second RCT comparing atosiban versus placebo.39 In this RCT, 24/246 (10%) women randomised to receive atosiban and 13/255 (5%) women randomised to receive placebo were recruited at less than 26 weeks' gestation. This may have contributed to a higher incidence of fetal mortality at less than 26 weeks' gestation in the atosiban group.
One systematic review found limited evidence that indometacin reduced delivery within 48 hours and 7 days and delivery before 37 weeks' gestation compared with placebo. However, it found no significant difference between indometacin and placebo or no treatment in perinatal mortality, respiratory distress syndrome, bronchopulmonary dysplasia, necrotising enterocolitis, neonatal sepsis, or low birth weight. The review may have lacked power to detect a clinically important effect.
Benefits: We found one systematic review comparing indometacin versus placebo (search date 1998, 3 RCTs, 100 women).34 It found that indometacin significantly reduced delivery within 48 hours, 7 days and delivery before 37 weeks compared with placebo but the number of women studied was small (within 48 hours, 2 RCTs: 4/34 [12%] with indometacin v 22/36 [61%] with placebo, OR 0.12, 95% CI 0.05 to 0.32; within 7 days, 1 RCT: 3/18 [17%] with indometacin v 15/18 [83%] with placebo, OR 0.07, 0.02 to 0.27 before 37 weeks, 1 RCT: 3/18 [17%] with indometacin v 14/18 [78%] with placebo, OR 0.09, 95% CI 0.03 to 0.24). It found no significant difference between indometacin and placebo or no treatment in perinatal mortality, respiratory distress syndrome, bronchopulmonary dysplasia, necrotising enterocolitis, neonatal sepsis, or low birth weight.34 The number of newborns assessed for these outcomes may be too small to exclude a clinically important difference.
Harms: The systematic review found that indometacin significantly increased the incidence of postpartum haemorrhage compared with placebo or no treatment but found no significant difference in nausea or chorioamnionitis (haemorrhage, 1 RCT: 7/16 [44%] with indometacin v 2/18 [11%] with placebo or no treatment; OR 5.1, 95% CI 1.1 to 22.9; nausea, 1 RCT: 2/18 [11%] with indometacin v 0/18 with placebo or no treatment; OR 7.8, 95% CI 0.5 to 130.5; chorioamnionitis, 1 RCT: 2/15 [13%] with indometacin v 0/15 with placebo or no treatment; OR 7.9, 95% CI 0.5 to 133.3).34 The number of women assessed for these outcomes may be too small to exclude a clinically important difference.
From: ronnie martinez To: Multiple recipients of list OBGIN-L Sent: Wednesday, November 24, 2004 10:05 AM Subject: Re: con respecto a los tocoliticos...que opinan?
me parece que Andrea tiene algo que aportar
ronnie
> ----- Original Message -----
From: jm To: Multiple recipients of list OBGIN-L Sent: Wednesday, November 24, 2004 8:19 AM Subject: Re: con respecto a los tocoliticos...que opinan?Me gustaría preguntarte si estos AINEs tipo COX2 tienen las mismas contraindicaciones que los antiguos, como p.e. la edad gestacional mayor de 34 semanas, por el peligro de oligoamnios y cierre precoz de ductus.
Saludos
José M. Torreblanca Doblas ObGyn Melilla Sain -------Mensaje original-------
De: obgin-l@obgyn.net Fecha: 11/24/04 04:08:44 Para: Multiple recipients of list OBGIN-L Asunto: con respecto a los tocoliticos...que opinan?
Es cierto que el atosiban, constituirá el tocolitico de primera elección en el futuro, PERO en venezuela, no contamos con este fármaco. Mientras tanto, en mi practica personal, mas no como norma del servicio en el hospital donde laboro, el uso de los analgesicos antiinflamatorios COX-2, de uso endovenoso, sublingual u oral, por corto tiempo no mas de 3 a 5 dias, estan siendo mucho mas efectivos que los beta-miméticos, el sulfato de mg, progesterona y derivados e incluso que los antagonistas del calcio. Cada vez hay mas estudios médicos de evidencia, que la mayoria de las causas de amenaza de parto pretermino u amenza de aborto(en este caso mayor de 10semanas), va implicito un proceso inflamatorio como efecto final. Durante éste tiempo de tratamiento es suficiente para la busqueda de las causas y poder tratarla o mejorarla. Me gustaría saber su opinion: LOS AAINES TIPO COX-2, PODRIAN CONSIDERSE TOCOLITICOS DE PRIMERA ELECCION.
>From: 4carlosbrito@cantv.net
>Reply-To: obgin-l@obgyn.net
>To: Multiple recipients of list OBGIN-L <obgin-l@dns.obgyn.net>
>Subject: Re: no more please
>Date: Mon, 22 Nov 2004 19:32:18 -0600
>
>tambien venimos usando la nifedipina...
>
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