B1tta/Drug-ACE huggingface dataset:
[Title]: Safety and efficacy of pravastatin therapy for the prevention of hyperlipidemia in pediatric and adolescent cardiac transplant recipients.
[Abstract]: BACKGROUND: Hyperlipidemia is common after cardiac transplantation and it is a risk factor for post-transplantation coronary artery disease. Immunosuppression with corticosteroids and cyclosporine has been associated with hyperlipidemia. Pravastatin, a HMG-CoA reductase inhibitor, has been shown to be effective and safe for cholesterol reduction in adult heart transplant recipients. To our knowledge the safety and efficacy of pravastatin therapy in pediatric and adolescent heart transplant populations have not been previously analyzed. Therefore, we evaluated lipid profiles, liver transaminases, rejection data, and possible side effects in pediatric and adolescent cardiac transplant recipients treated with pravastatin. METHODS: The study group consisted of 40 cardiac transplant recipients 10 to 21 years old (mean age 16.9 years). Twenty-two patients received pravastatin in addition to an immunosuppressive regimen of either cyclosporine or tacrolimus, azathioprine or mycophenolate mofetil, and prednisone. Serial determinations of total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein, and triglycerides were available for all pravastatin-treated patients. Pre-treatment lipid values and hepatic transaminases were compared with those measured after therapy with pravastatin. Comparison of pravastatin-induced lipid reduction between groups treated with cyclosporine vs tacrolimus was also made. RESULTS: Patients receiving pravastatin experienced a mean 32 mg/dl decrease in TC (p < 0.005) and a mean 31 mg/dl decrease in LDL (p < 0.005), regardless of their immunosuppressive regimen. No statistical differences occurred in the magnitude of mean lipid reduction induced by pravastatin between the groups treated with cyclosporine vs tacrolimus. No significant changes in hepatic transaminase levels were noted, and no clinical evidence of pravastatin-induced myositis occurred in any subjects. CONCLUSION: Pravastatin therapy is effective and safe when used in pediatric and adolescent cardiac transplant recipients. Although the pravastatin-induced reduction in TC and LDL was more pronounced in patients receiving cyclosporine, the reduction was not statistically different from that in the tacrolimus group. No evidence of hepatic dysfunction or rhabdomyolysis in patients treated with pravastatin was noted. Long-term studies are required to evaluate the effect of pravastatin therapy on the incidence of accelerated coronary atherosclerosis in this population.
[Drug-Disease]: pravastatin - hyperlipidemia
[Title]: Relationship between dose-intensity of treatment and outcome for patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy.
[Abstract]: One hundred and forty-four patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy at the authors' institution between 1986 and 1989 were retrospectively analyzed to evaluate the relationship between the dose-intensity of chemotherapy actually received (RDI) and the prognosis. Preoperative chemotherapy consisted of high-dose methotrexate i.v., cisplatin i.a., and doxorubicin i.v. After surgery "good responder" patients (90% or more tumor necrosis) had a 31-weeks of chemotherapy with the same drugs, while "poor responder" patients (less than 90% tumor necrosis) received a 40 weeks treatment with ifosfamide and etoposide added to the three drugs used preoperatively. Due to delays and dose-reductions, only 17 patients (12%) received the treatment exactly as scheduled by the protocol, 66 (46%) received a dose-intensity between 90 and 99%, and 61 (42%) a dose-intensity between 63 and 89%. At a follow-up ranging between 10 and 13 years, 97 patients (67%) remained continuously free of disease, 45 relapsed, and two died of doxorubicin-induced cardiopathy. The continuous disease-free survival (CDFS) was not related to patients' gender and age, tumor histology, site and size, serum value of alkaline phosphatase, type of surgery and histologic response to chemotherapy. According to the RDI, CDFS resulted significantly higher for those 81 patients who received 90% or more of the scheduled dose-intensity than for those 61 who had less than 90% of the scheduled dose-intensity (76.5% v.s. 57.3%; p<0.02). These results seem to suggest that in neoadjuvant treatment of osteosarcoma the dose-intensity of chemotherapy is crucial for outcome, therefore every effort should be made to avoid reductions of doses and/or delays in performing the cycles of chemotherapy.
[Drug-Disease]: cisplatin - osteosarcoma
[Title]: Relationship between dose-intensity of treatment and outcome for patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy.
[Abstract]: One hundred and forty-four patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy at the authors' institution between 1986 and 1989 were retrospectively analyzed to evaluate the relationship between the dose-intensity of chemotherapy actually received (RDI) and the prognosis. Preoperative chemotherapy consisted of high-dose methotrexate i.v., cisplatin i.a., and doxorubicin i.v. After surgery "good responder" patients (90% or more tumor necrosis) had a 31-weeks of chemotherapy with the same drugs, while "poor responder" patients (less than 90% tumor necrosis) received a 40 weeks treatment with ifosfamide and etoposide added to the three drugs used preoperatively. Due to delays and dose-reductions, only 17 patients (12%) received the treatment exactly as scheduled by the protocol, 66 (46%) received a dose-intensity between 90 and 99%, and 61 (42%) a dose-intensity between 63 and 89%. At a follow-up ranging between 10 and 13 years, 97 patients (67%) remained continuously free of disease, 45 relapsed, and two died of doxorubicin-induced cardiopathy. The continuous disease-free survival (CDFS) was not related to patients' gender and age, tumor histology, site and size, serum value of alkaline phosphatase, type of surgery and histologic response to chemotherapy. According to the RDI, CDFS resulted significantly higher for those 81 patients who received 90% or more of the scheduled dose-intensity than for those 61 who had less than 90% of the scheduled dose-intensity (76.5% v.s. 57.3%; p<0.02). These results seem to suggest that in neoadjuvant treatment of osteosarcoma the dose-intensity of chemotherapy is crucial for outcome, therefore every effort should be made to avoid reductions of doses and/or delays in performing the cycles of chemotherapy.
[Drug-Disease]: doxorubicin - osteosarcoma
[Title]: Relationship between dose-intensity of treatment and outcome for patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy.
[Abstract]: One hundred and forty-four patients with osteosarcoma of the extremity treated with neoadjuvant chemotherapy at the authors' institution between 1986 and 1989 were retrospectively analyzed to evaluate the relationship between the dose-intensity of chemotherapy actually received (RDI) and the prognosis. Preoperative chemotherapy consisted of high-dose methotrexate i.v., cisplatin i.a., and doxorubicin i.v. After surgery "good responder" patients (90% or more tumor necrosis) had a 31-weeks of chemotherapy with the same drugs, while "poor responder" patients (less than 90% tumor necrosis) received a 40 weeks treatment with ifosfamide and etoposide added to the three drugs used preoperatively. Due to delays and dose-reductions, only 17 patients (12%) received the treatment exactly as scheduled by the protocol, 66 (46%) received a dose-intensity between 90 and 99%, and 61 (42%) a dose-intensity between 63 and 89%. At a follow-up ranging between 10 and 13 years, 97 patients (67%) remained continuously free of disease, 45 relapsed, and two died of doxorubicin-induced cardiopathy. The continuous disease-free survival (CDFS) was not related to patients' gender and age, tumor histology, site and size, serum value of alkaline phosphatase, type of surgery and histologic response to chemotherapy. According to the RDI, CDFS resulted significantly higher for those 81 patients who received 90% or more of the scheduled dose-intensity than for those 61 who had less than 90% of the scheduled dose-intensity (76.5% v.s. 57.3%; p<0.02). These results seem to suggest that in neoadjuvant treatment of osteosarcoma the dose-intensity of chemotherapy is crucial for outcome, therefore every effort should be made to avoid reductions of doses and/or delays in performing the cycles of chemotherapy.
[Drug-Disease]: methotrexate - osteosarcoma
[Title]: [Clinical efficacy of treatment with low-dose flutamide in maximum androgen blockade therapy].
[Abstract]: To prevent treatment withdrawal due to flutamide-induced liver dysfunction, we performed maximum androgen blockade (MAB) therapy by combining a luteinizing hormone-releasing hormone agonist or orchiectomy with low-dose flutamide (125 mg x 2/day) in patients with prostate cancer. In this study, the efficacy, adverse effects such as hepatotoxicity, and compliance were compared retrospectively between 35 patients who received low-dose flutamide therapy (1995-1999) and 27 patients who received flutamide at its ordinary dose (125 mg x 3/day). No significant difference was observed in the response rate (> or = PR) as determined from the prostate-specific antigen parameter (p = 0.6211) or the incidence of hepatotoxicity based on the aspartate aminotransferase and alanine aminotransferase levels. However, flutamide withdrawal due to liver dysfunction was less frequent in the low-dose group (2.9%) than in the ordinary dose group (18.5%) (p = 0.0386). MAB therapy using low-dose flutamide is expected to prevent the reduction in the compliance due to side effects and to improve the long-term prognosis in patients with prostate cancer, who are mostly elderly individuals.
[Drug-Disease]: flutamide - prostate cancer
[Title]: [Comparison of ropivacaine and bupivacaine for epidural analgesia during labor].
[Abstract]: OBJECTIVES: To compare the analgesic efficacy and level of motor block using two local anesthetics, ropivacaine and bupivacaine, during labor. MATERIAL AND METHODS: Sixty nulliparous women were enrolled during labor after full-term pregnancies. They were randomly assigned to receive epidural analgesia with ropivacaine (group R) or bupivacaine (group B). Group R patients received 10 ml of 0.18% ropivacaine with 5 microgram/ml of fentanyl followed by continuous epidural infusion of 0.1% ropivacaine with 2 microgram/ml of fentanyl at a rate of 10 ml/h. Group B patients received 10 ml of 0.15% bupivacaine with 5 microgram/ml of fentanyl followed by continuous epidural perfusion of 0.0625% bupivacaine with 2 microgram/ml of fentanyl at the same rate. Pain intensity was assessed on a visual analog scale, motor blockade on a Bromage scale, and level of sensory block at different moments. We also recorded total doses of local anesthetic employed during continuous epidural infusion, manner of final delivery, Apgar score, degree of maternal satisfaction and side effects. RESULTS: The demographic and delivery characteristics were similar in both groups. We found no statistically significant differences between the two groups for level of motor blockade, which was nil for 29 patients (96.66%) in group R and 28 patients (93.33%) in group B. No differences in degree of pain or level of sensory block (T8-T10 in both groups) were observed. The total doses of local anesthetic used were similar at 23.7 +/- 11.6 mg in group R and 16.5 +/- 7.3 mg in group B (non-significant difference). Nor did we find differences in manner of delivery, neonatal Apgar scores, degree of maternal satisfaction or side effects. CONCLUSION: Ropivacaine and bupivacaine are equally effective for epidural analgesia during labor at the doses used and they do not cause a relevant level of motor blockade.
[Drug-Disease]: Ropivacaine - labor
[Title]: [Comparison of ropivacaine and bupivacaine for epidural analgesia during labor].
[Abstract]: OBJECTIVES: To compare the analgesic efficacy and level of motor block using two local anesthetics, ropivacaine and bupivacaine, during labor. MATERIAL AND METHODS: Sixty nulliparous women were enrolled during labor after full-term pregnancies. They were randomly assigned to receive epidural analgesia with ropivacaine (group R) or bupivacaine (group B). Group R patients received 10 ml of 0.18% ropivacaine with 5 microgram/ml of fentanyl followed by continuous epidural infusion of 0.1% ropivacaine with 2 microgram/ml of fentanyl at a rate of 10 ml/h. Group B patients received 10 ml of 0.15% bupivacaine with 5 microgram/ml of fentanyl followed by continuous epidural perfusion of 0.0625% bupivacaine with 2 microgram/ml of fentanyl at the same rate. Pain intensity was assessed on a visual analog scale, motor blockade on a Bromage scale, and level of sensory block at different moments. We also recorded total doses of local anesthetic employed during continuous epidural infusion, manner of final delivery, Apgar score, degree of maternal satisfaction and side effects. RESULTS: The demographic and delivery characteristics were similar in both groups. We found no statistically significant differences between the two groups for level of motor blockade, which was nil for 29 patients (96.66%) in group R and 28 patients (93.33%) in group B. No differences in degree of pain or level of sensory block (T8-T10 in both groups) were observed. The total doses of local anesthetic used were similar at 23.7 +/- 11.6 mg in group R and 16.5 +/- 7.3 mg in group B (non-significant difference). Nor did we find differences in manner of delivery, neonatal Apgar scores, degree of maternal satisfaction or side effects. CONCLUSION: Ropivacaine and bupivacaine are equally effective for epidural analgesia during labor at the doses used and they do not cause a relevant level of motor blockade.
[Drug-Disease]: bupivacaine - labor
[Title]: [Comparison of ropivacaine and bupivacaine for epidural analgesia during labor].
[Abstract]: OBJECTIVES: To compare the analgesic efficacy and level of motor block using two local anesthetics, ropivacaine and bupivacaine, during labor. MATERIAL AND METHODS: Sixty nulliparous women were enrolled during labor after full-term pregnancies. They were randomly assigned to receive epidural analgesia with ropivacaine (group R) or bupivacaine (group B). Group R patients received 10 ml of 0.18% ropivacaine with 5 microgram/ml of fentanyl followed by continuous epidural infusion of 0.1% ropivacaine with 2 microgram/ml of fentanyl at a rate of 10 ml/h. Group B patients received 10 ml of 0.15% bupivacaine with 5 microgram/ml of fentanyl followed by continuous epidural perfusion of 0.0625% bupivacaine with 2 microgram/ml of fentanyl at the same rate. Pain intensity was assessed on a visual analog scale, motor blockade on a Bromage scale, and level of sensory block at different moments. We also recorded total doses of local anesthetic employed during continuous epidural infusion, manner of final delivery, Apgar score, degree of maternal satisfaction and side effects. RESULTS: The demographic and delivery characteristics were similar in both groups. We found no statistically significant differences between the two groups for level of motor blockade, which was nil for 29 patients (96.66%) in group R and 28 patients (93.33%) in group B. No differences in degree of pain or level of sensory block (T8-T10 in both groups) were observed. The total doses of local anesthetic used were similar at 23.7 +/- 11.6 mg in group R and 16.5 +/- 7.3 mg in group B (non-significant difference). Nor did we find differences in manner of delivery, neonatal Apgar scores, degree of maternal satisfaction or side effects. CONCLUSION: Ropivacaine and bupivacaine are equally effective for epidural analgesia during labor at the doses used and they do not cause a relevant level of motor blockade.
[Drug-Disease]: fentanyl - labor
[Title]: [The efficacy and safety of continuous epidural analgesia versus intradural-epidural analgesia during labor].
[Abstract]: OBJECTIVE: To determine the efficacy and safety of intradural-epidural analgesia in comparison with continuous epidural analgesia during labor and childbirth. PATIENTS AND METHOD: Forty-two women whose labor began spontaneously were enrolled and distributed randomly in two groups. The intradural-epidural analgesia group (IEA, n = 21) received 25 microgram of intradural fentanyl with 2.5 mg of isobaric bupivacaine with adrenalin, after which analgesia was maintained with epidural administration of one 8 mL bolus of 0.125% bupivacaine, followed by perfusion of a balanced concentration at a rate of 8 ml/h. Patients in the continuous epidural analgesia group (CEA, n = 21) were given 8 ml of 0.25% bupivacaine with adrenalin; the epidural perfusion of 0.125% bupivacaine and 1 microgram/ml of fentanyl was started at the same rate as in the IEA group. We recorded pain as assessed on a visual analog scale, extension of sensory and motor block, maternal hemodynamic constants, number of boluses of bupivacaine used, total doses of bupivacaine and oxytocin, instruments needed for childbirth, and side effects (pruritus, nausea and vomiting). RESULTS: Analgesic efficacy during the first 30 minutes was greater in the IEA group. The total dose of bupivacaine, required top-up boluses, and the extension of sensory block at 30 minutes, one hour and two hours were also significantly less in the IEA group. The incidence of pruritus was higher in the IEA group. No significant differences were observed for other variables. CONCLUSIONS: Intradural-epidural analgesia provides effective analgesia for labor, with rapid onset, reduced extension of sensory block, lower total doses of local anesthetics and few side effects.
[Drug-Disease]: bupivacaine - labor
[Title]: [The efficacy and safety of continuous epidural analgesia versus intradural-epidural analgesia during labor].
[Abstract]: OBJECTIVE: To determine the efficacy and safety of intradural-epidural analgesia in comparison with continuous epidural analgesia during labor and childbirth. PATIENTS AND METHOD: Forty-two women whose labor began spontaneously were enrolled and distributed randomly in two groups. The intradural-epidural analgesia group (IEA, n = 21) received 25 microgram of intradural fentanyl with 2.5 mg of isobaric bupivacaine with adrenalin, after which analgesia was maintained with epidural administration of one 8 mL bolus of 0.125% bupivacaine, followed by perfusion of a balanced concentration at a rate of 8 ml/h. Patients in the continuous epidural analgesia group (CEA, n = 21) were given 8 ml of 0.25% bupivacaine with adrenalin; the epidural perfusion of 0.125% bupivacaine and 1 microgram/ml of fentanyl was started at the same rate as in the IEA group. We recorded pain as assessed on a visual analog scale, extension of sensory and motor block, maternal hemodynamic constants, number of boluses of bupivacaine used, total doses of bupivacaine and oxytocin, instruments needed for childbirth, and side effects (pruritus, nausea and vomiting). RESULTS: Analgesic efficacy during the first 30 minutes was greater in the IEA group. The total dose of bupivacaine, required top-up boluses, and the extension of sensory block at 30 minutes, one hour and two hours were also significantly less in the IEA group. The incidence of pruritus was higher in the IEA group. No significant differences were observed for other variables. CONCLUSIONS: Intradural-epidural analgesia provides effective analgesia for labor, with rapid onset, reduced extension of sensory block, lower total doses of local anesthetics and few side effects.
[Drug-Disease]: adrenalin - labor
[Title]: [The efficacy and safety of continuous epidural analgesia versus intradural-epidural analgesia during labor].
[Abstract]: OBJECTIVE: To determine the efficacy and safety of intradural-epidural analgesia in comparison with continuous epidural analgesia during labor and childbirth. PATIENTS AND METHOD: Forty-two women whose labor began spontaneously were enrolled and distributed randomly in two groups. The intradural-epidural analgesia group (IEA, n = 21) received 25 microgram of intradural fentanyl with 2.5 mg of isobaric bupivacaine with adrenalin, after which analgesia was maintained with epidural administration of one 8 mL bolus of 0.125% bupivacaine, followed by perfusion of a balanced concentration at a rate of 8 ml/h. Patients in the continuous epidural analgesia group (CEA, n = 21) were given 8 ml of 0.25% bupivacaine with adrenalin; the epidural perfusion of 0.125% bupivacaine and 1 microgram/ml of fentanyl was started at the same rate as in the IEA group. We recorded pain as assessed on a visual analog scale, extension of sensory and motor block, maternal hemodynamic constants, number of boluses of bupivacaine used, total doses of bupivacaine and oxytocin, instruments needed for childbirth, and side effects (pruritus, nausea and vomiting). RESULTS: Analgesic efficacy during the first 30 minutes was greater in the IEA group. The total dose of bupivacaine, required top-up boluses, and the extension of sensory block at 30 minutes, one hour and two hours were also significantly less in the IEA group. The incidence of pruritus was higher in the IEA group. No significant differences were observed for other variables. CONCLUSIONS: Intradural-epidural analgesia provides effective analgesia for labor, with rapid onset, reduced extension of sensory block, lower total doses of local anesthetics and few side effects.
[Drug-Disease]: fentanyl - labor