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1.
Medicine (Baltimore) ; 98(15): e15174, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30985703

RESUMEN

INTRODUCTION: This is a prospective, open-label, parallel-group, randomized controlled trial that evaluates the effectiveness and safety of adjuvant application of Jaungo (JUG) for radiation-induced dermatitis (RD) in breast cancer patients undergoing radiation therapy, in comparison with general supportive care (GSC). METHODS/DESIGN: Eighty female patients, who have been diagnosed with unilateral breast cancer, will be allocated to either the JUG or GSC group with an allocation ratio of 1:1 after breast conservation surgery, in the Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea. Both the groups will be subjected to GSC, but only the JUG group participants will apply adjuvant JUG ointment on the irradiated skin for 6 weeks, twice a day. The primary outcome of this study is the assessment of incidence rate of RD using the Radiation Therapy Oncology Group (RTOG) for toxicity gradation of 2 or more. Maximum pain level, quality of life, adverse reactions, and pharmacoeconomic evaluations will also be included. DISCUSSION: The primary outcome will be statistically compared using the logrank test after estimating the survival curve using the Kaplan-Meier method. Continuous variables will be tested using independent t test or Mann-Whitney U test. The adverse events will be evaluated with Chi-square or Fisher exact test. All the data will be analyzed at a significance level of 0.05 (two-sided) with R software (The R Foundation). TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003506, 14 February 2019.


Asunto(s)
Fármacos Dermatológicos/uso terapéutico , Medicamentos Herbarios Chinos/uso terapéutico , Protectores contra Radiación/uso terapéutico , Radiodermatitis/tratamiento farmacológico , Dolor Abdominal , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Protocolos Clínicos , Fármacos Dermatológicos/efectos adversos , Fármacos Dermatológicos/economía , Medicamentos Herbarios Chinos/efectos adversos , Medicamentos Herbarios Chinos/economía , Femenino , Humanos , Persona de Mediana Edad , Pomadas/efectos adversos , Pomadas/economía , Pomadas/uso terapéutico , Selección de Paciente , Fitoterapia/efectos adversos , Fitoterapia/economía , Protectores contra Radiación/efectos adversos , Protectores contra Radiación/economía , Radioterapia/efectos adversos , Adulto Joven
3.
MedGenMed ; 3(2): 3, 2001 Mar 06.
Artículo en Inglés | MEDLINE | ID: mdl-11549952

RESUMEN

CONTEXT: Moist exposed burn ointment (MEBO), from China, has been said to revolutionize burn management. OBJECTIVE: Our study was conducted to compare MEBO with conventional management (C) with respect to the rate of wound healing, antibacterial and analgesic effect, and hospital costs. DESIGN: This is a prospective, randomized, controlled clinical trial conducted between 1 March 1997 and 24 October 1998. SETTING: The trial was conducted in a specialized burn facility located in a tertiary referral hospital in a developed and industrialized island-state in Southeast Asia. PATIENTS: We randomly assigned 115 consecutive patients between the ages of 12 and 80 who had partial-thickness thermal burns covering less than 40% of body surface area (BSA) to receive either MEBO or C. Fifty-seven patients were assigned to MEBO and 58 patients to C. The latter group received twice-daily dressing changes; MEBO patients received MEBO every 4 hours. MAIN OUTCOME MEASURES: Patients were hospitalized until 75% BSA had healed. BSA was determined by visual inspection and charted on Lund and Browder charts regularly. Wound healing rate, bacterial infection rate, pain score, and hospitalization costs were recorded. RESULTS: The median time to 75% healing was 17.0 and 20.0 days with MEBO and C, respectively (HR = 0.67, 95% CI = 0.41-1.11, P =.11), suggesting similar efficacy between the 2 modalities. Bacterial infection rates were similar between the 2 groups (HR = 1.10, 95% CI = 0.59-2.03, P =.76). MEBO imparted a greater analgesic effect in the first 5 days of therapy and reduced hospital costs by 8%. CONCLUSIONS: MEBO is as effective as conventional management but is not the panacea for all burn wounds. The use of MEBO eases the management of face and neck burns and facilitates early institution of occupational therapy in hand burns. It confers better pain relief such that fewer opiates are used during the first 5 days after burn injury.


Asunto(s)
Vendajes , Quemaduras/terapia , Terapias Complementarias , Medicamentos Herbarios Chinos , Pomadas , Adulto , Anciano , Antiinfecciosos/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Vendajes/economía , Berberina , Quemaduras/economía , Terapias Complementarias/economía , Costos de la Atención en Salud , Hospitalización/economía , Humanos , Persona de Mediana Edad , Pomadas/economía , Dimensión del Dolor , Extractos Vegetales , Estudios Prospectivos , Aceite de Sésamo , Singapur , Sitoesteroles , Resultado del Tratamiento , Cicatrización de Heridas
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