Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0085593 (chills)
 4,268 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Thirty-five patients with advanced malignancies were treated with doxorubicin-DNA complex in a phase I clinical trial. The patients ranged in age from 30 to 77 years (median, 51) and received doxorubicin-DNA in doses that ranged from 20 to 135 mg/m2. Of the doses administered, 73% were 60-90 mg/m2 (median, 60). Nonhematologic toxic effects included nausea and vomiting in 32% of the patients, fever and chills in 24% mucositis in 18%, and decreases in ECG QRS voltage of greater than 30% in 18%. Fever of unknown origin was seen in 26% of the patients, with documented infection in 9%; 6% had drug-related deaths. All patients experienced alopecia. Hematologic toxic effects (median day, Day 14) included median granulocyte count nadirs of 0.8 X 10(3)/microliter at a 60-mg/m2 dose and 0.3 X 10(3)/microliter at 75 mg/m2. Thrombocytopenia was less severe, with median nadir counts of 131,000 cells/microliter at a 60-mg/m2 dose on median day. Day 13. Treatment courses could be repeated every 3 weeks. Clinical responses (complete plus partial) were seen in 12% of the patients, with an additional 48% showing stable disease. No patients entered in the study were known to be doxorubicin-resistant. Based on these data, we recommend a starting dose of 60 mg/m2 in patients with adequate bone marrow reserve and 50 mg/m2 in those with compromised bone marrows. Doxorubicin-DNA exhibits major clinical toxic effects on the gastrointestinal and hematopoietic systems, with dose-limiting granulocytopenia.
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PMID:Doxorubicin-DNA complex: a phase I clinical trial. 713 45

Doxorubicin (DOX) efflux in drug-resistant cells is blocked by phenothiazines such as trifluoperazine (TFP) and prochlorperazine (PCZ) in vitro. The present phase I study was conducted in 13 patients with advanced, incurable, nonhematologic tumors to determine whether PCZ plasma levels high enough to block DOX efflux could be achieved in vivo. The treatment schedule consisted of prehydration and i.v. administration of 15, 30, 50, and 75 mg/m2 PCZ followed by a standard dose of 60 mg/m2 DOX. The hematologic toxicities attributable to DOX were as expected and independent of the PCZ dose used. Toxicities attributable to PCZ were sedation, dryness of the mouth, cramps, chills, and restlessness. The maximal tolerated dose (MTD) of PCZ in this schedule was 75 mg/m2. Pharmacokinetic analysis indicated a large interpatient variation in peak plasma PCZ levels that ranged from 95 to 1100 ng/ml. The three plasma half-lives of PCZ were: t1/2 alpha (+/- SE), 20.9 +/- 5.3 min; t1/2 beta, 1.8 +/- 0.3 h; and t1/2 gamma, 21.9 +/- 5.3 h. The volume of distribution (Vd), total clearance (ClT), and area under the curve (AUC) for PCZ were 2254 +/- 886 l/m2, 60.2 +/- 13.5 l m-2 h-1, and 1624 +/- 686 ng ml-1 h, respectively. DOX retention in tumor cells retrieved from patients during the course of therapy indicated the appearance of cells with enhanced DOX retention. The combination of DOX and high-dose i.v. PCZ appeared to be safe, well tolerated, and active in non-small-cell lung carcinoma.
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PMID:Prochlorperazine as a doxorubicin-efflux blocker: phase I clinical and pharmacokinetics studies. 845 81

Results of locoregional intraarterial treatment with recombinant Interleukine-2 (Ronkoleukine) in patients with hepatic metastases of colon cancer are presented, efficacy of locoregional arterial chemoembolisation and chemoimmunoembolisation in combined treatment of hepatic metastases are evaluated. The drugs were administered through catheter installed in the right or left branch of the own hepatic artery with Selinger method. Endovascular treatment was carried out 6-10 months after removing of primary tumor. In group 1 (8 patients) infusion of 5-fluororuracil during 3 days (2.0 g/day) with subsequent intraarterial immunoembolisation with recombinant Interleukine-2 (Ronkoleukine) 2 mln IU and 10.0 ml lipiodol were performed. In group 2 (13 patients) infusion of 5-fluororuracil during 3 days (2.0 g/day) with subsequent intraarterial chemoembolisation with Doxorubicin 60 mg/kg and 10.0 ml lipiodol were carried out. All the patients underwent cytoreductive surgery on the liver (in the scope from segmentectomy to hemihepatectomy). The patients of group 1 are alive, mean follow-up from removing primary tumor is 22.8 +/- 7.4 months, from start of endovascular treatment--9.2 +/- 2.3 months. Patients of group 2 died due to progression of disease, mean survival from removing primary tumor was 25.7 +/- 4.2 months, from start of endovascular treatment--7.6 +/- 6.3 months. In group 1 postembolic syndrome with transient fever and chill was seen, in group 2--fever, plains in epigastric area, increase of transaminases in blood, abscesses of metastatic tumors (n = 2) and alopecia (in all patients). It is concluded that regional arterial chemoimmunoembolisation is a perspective and safe method in combined treatment of colon cancer with hepatic metastases compared with locoregional chemoembolisation. It increases lifespan and improves quality of life.
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PMID:[Regional arterial chemoembolisation and chemoimmunoembolisation in combined treatment of colon cancer with hepatic metastases]. 1292 43

In this study, January 2009-December 2012 national adverse drug reaction monitoring center Shuxuetong the SRS data for the study, using the reporting rate ratio method and Bayesian belief propagation neural network Shuxuetong ADR warning signal, and balanced use of propensity score methods confounders. The results showed that chills as a possible warning signal. Tip clinical use Shuxuetong injection when, for the elderly, children, liver and kidney dysfunction are more prone to adverse reactions in patients with other special populations, the need to pay attention to the prevention of systemic allergic reactions, in particular the prevention shivering.
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PMID:[Spontaneous reportintg system data based on shuxuetong injection adverse reactions signal warning analysis]. 2447 18

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
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PMID:[Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background]. 2724 17

This paper is to report the implementation and results of safety monitoring of Shenfu injection. Prospective, multicenter, large sample, registry-type centralized hospital monitoring mode was used, and the three-level quality control and anti-omissive mechanisms were used strictly. In the monitoring was carried out in 28 hospitals and lasted for 4 years. 30 106 patients were registered; ADE occurred in 114 patients, and ADR was identified in 23 patients with an incidence rate of 0.076% for ADR [95% confidence interval (0.045%,0.108%), which was in a rare level. The main ADRs included rash, pruritus, discomfort at the site of the infusion, nausea, vomiting, abdominal pain, dizziness, chest tightness, heart palpitations, chills, fever and dyspnea. No severe ADRs were found in the monitoring. This paper also fund that history of allergy, methods of administration, dosage, solvent, concentration, and combined medication may affect the incidence of ADR in the use of Shenfu injection.
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PMID:[Clinical safety imtensive hospital monitoring on Shenfu injection with 30 106 cases]. 2913 50