RESUMO
Gallstone lithotripsy (GSL) with the Technomed Sonolith 3000 extracorporeal lithotripter was studied in a multisite, international cooperative trial involving the United States, France, and Italy. All participating sites worked under a common protocol to investigate the safety and efficacy of GSL for symptomatic gallstone patients. These collective results are from a mix of 25 academic and community hospital sites using fixed and transportable/mobile versions of the lithotripter. As of November 1, 1990, 661 patients have been treated in this two-arm randomized study (GSL Only vs GSL + Ursodiol [Actigall]). Patients were treated with up to 2,500 shocks per session and only two treatments were allowed. All machines had standardized pressure settings (850 bar nominal) and operator adjustment of output voltage was not allowed. We saw no statistically significantly different results in initial fragmentation between patients pre-loaded with ursodiol for 2 weeks and those treated by GSL alone. Gallbladder clearance rates did vary with the stone number, size, and burden as well as the adequacy of initial fragmentation. In the GSL + Ursodiol Arm of the trial, 46.2% of patients with solitary, 5-to 20-mm calculi are stone-free at 6 months.
Assuntos
Colelitíase/terapia , Litotripsia/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Colecistectomia , Terapia Combinada , Segurança de Equipamentos , Feminino , Seguimentos , França , Humanos , Itália , Litotripsia/efeitos adversos , Litotripsia/métodos , Masculino , Pessoa de Meia-Idade , Estados Unidos , Ácido Ursodesoxicólico/uso terapêuticoRESUMO
Early comparative data is now available from several different American Gallstone Lithotripsy, ("GSL") trials (Technomed, Dornier, and Medstone). While the 6-month gallbladder clearance results appear to be remarkably similar (36%-43% in less than 20-mm solitary stones), they do not appear to match the results obtained by the Munich group in their first 175 patients (63% clearance at 4-8 months). We review the currently available American data and describe our on-going national clinical trial with the Technomed Sonolith 3000 investigation. In this trial, patients are randomized to lithotripsy plus ursodiol (Actigall,¿ Ciba Geigy), or lithotripsy alone to determine the effect of oral bile salts on the gallbladder fragment clearance rate. To date, the early success rate is clearly better in the GSL plus ursodiol arm. Following one or two lithotripsy sessions, 62.1% of patients with solitary stones, 5-20 mm in size, have had fragmentation to 7 mm or less. In the same group, 39.1% of gallbladders are clear at 6 months. While the 6-month gallbladder clearance rate appears to be a reliable indicator of eventual gallbladder status it should not be regarded as the end point of therapy and it clearly does not represent the final efficacy rate for gallstone lithotripsy. A review of the results obtained from on-going American IDE trials is compared with the published German results using GSL and combination oral dissolution therapy.
Assuntos
Colelitíase/terapia , Litotripsia/métodos , Competência Clínica , Alemanha , Humanos , Litotripsia/efeitos adversos , Litotripsia/instrumentação , Estados Unidos , Ácido Ursodesoxicólico/uso terapêuticoAssuntos
Colelitíase/terapia , Litotripsia/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos como Assunto , Estudos de Avaliação como Assunto , Cálculos Biliares/terapia , Humanos , Recém-Nascido , Litotripsia/efeitos adversos , Litotripsia/instrumentação , Pessoa de Meia-Idade , Fatores de TempoRESUMO
All of the information to date suggests that extracorporeal shock-wave lithotripsy will in many patients be a safe and effective method of dealing with uncomplicated gallstone disease. Litholytic drugs appear to be an important adjunct to the procedure and may play a significant role in minimizing stone recurrence. Ongoing studies will further delineate suitable candidates.
Assuntos
Colelitíase/terapia , Litotripsia/métodos , Colelitíase/tratamento farmacológico , Terapia Combinada , Estudos de Avaliação como Assunto , Alemanha Ocidental , Humanos , Litotripsia/efeitos adversos , Litotripsia/instrumentação , Litotripsia/normas , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ultrassonografia , Estados Unidos , Ácido Ursodesoxicólico/uso terapêuticoRESUMO
A consecutive series of 435 patients with breast cancer followed from six to thirty years is presented. Radical mastectomy was the surgical procedure of choice and our experience indicated that the degree of axillary nodal involvement is a most important guide in establishing prognosis in this disease. The majority of recurrences became evident within the first five postoperative years, the next most hazardous period for the patient being the half decade between the fifth and tenth years after initial therapy. A second independent malignancy developed in 37 of the 275 pateints who died, and it was the cause of death in 7.6 per cent of this group. Among the 160 patients still living to date a second independent malignancy has already developed in 10. Bilateral breast cancer was observed thirty-eight times in this entire series of 435 patients, an incidence of 8.7 per cent.
