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1.
Clin Gastroenterol Hepatol ; 17(7): 1303-1310.e18, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-29654915

RESUMO

BACKGROUND & AIMS: The Chinese herbal medicine, MaZiRenWan (MZRW), has been used for more than 2000 years to treat constipation, but it has not been tested in a randomized controlled trial. We performed a trial to evaluate the efficacy and safety of MZRW, compared with the stimulant laxative senna or placebo, for patients with functional constipation (FC). METHODS: We performed a double-blind, double-dummy, trial of 291 patients with FC based on Rome III criteria, seen at 8 clinics in Hong Kong from June 2013 through August 2015. Patients were observed for 2 weeks and then assigned randomly (1:1:1) to groups given MZRW (7.5 g, twice daily), senna (15 mg daily), or placebo for 8 weeks. Patients were then followed for 8 weeks and evaluated at baseline and weeks 4, 8 (end of treatment), and 16 (end of follow up). Participants recorded information on stool form and frequency, feeling of complete evacuation, and research medication taken. Data on individual bowel symptoms, global symptom improvement, and adverse events were collected. A complete response was defined as an increase ≥1 complete spontaneous bowel movement (CSBM)/week from baseline (the primary outcome). Secondary outcomes included response during the follow-up period, colonic transit, individual and global symptom assessments, quality of life measured with 36-item short form Chinese version, and adverse events. RESULTS: Although there was no statistically significant difference in proportions of patients with a complete response to MZRW (68%) vs. senna (57.7%) (P = .14) at week 8, there was a statistically significant difference vs. placebo (33.0%) (P < .005). At the 16-week timepoint (after the 8-week follow-up period), 47.4% of patients had a complete response to MZRW, 20.6% had a complete response to senna, and 17.5% had a complete response to placebo (P < .005 for MZRW vs. placebo). The group that received MZRW group also had significant increases in colonic transit and reduced severity of constipation, straining, incomplete evacuation, and global constipation symptoms compared with the groups that received placebo or senna in (P < .05 for all comparisons). CONCLUSIONS: In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week. MZRW did not appear to be more effective than senna and might be considered as an alternative to this drug. ClincialTrials.gov no: NCT01695850.


Assuntos
Constipação Intestinal/tratamento farmacológico , Defecação/efeitos dos fármacos , Medicamentos de Ervas Chinesas/uso terapêutico , Qualidade de Vida , Constipação Intestinal/fisiopatologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
2.
J Gastroenterol Hepatol ; 29(11): 1897-904, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24734957

RESUMO

BACKGROUND AND AIM: Transarterial radioembolization with yttrium-90 microspheres is one treatment option for inoperable hepatocellular carcinoma. We compared the survival in a cohort of patients receiving radioembolization or no radioembolization. METHODS: The data of 46 patients referred for radioembolization was retrospectively reviewed. The patient, tumor characteristics, and the survival were compared in the two groups. The independent predictors for survival were studied with multivariate analysis. The side-effects and the complication of radioembolization-induced liver disease was recorded. RESULTS: Thirty patients received radioembolization; 16 patients did not. The two groups did not differ in the mean age, Child-Pugh classes, Barcelona Clinic of Liver Cancer (BCLC) stages, tumor types, sum of diameter of the two biggest tumors, and extent of portal vein invasion. Those with BCLC stage C tumor, with portal vein thrombus, or with less than three nodules had significantly longer survival after radioembolization. There was a trend of longer survival in patients with Child-Pugh A liver function, or with BCLC stage B tumor after radioembolization. The median survival was more than 31.9 months, 14.5 months, and 5.2 months in patients with BCLC stage A, B, and C tumors. The independent predictors for longer survival were Child-Pugh class, tumor diameter sum, BCLC stage, and receiving radioembolization. Grade 2 irradiation-induced gastritis occurred in three patients (10%). Radioembolization-induced liver disease occurred in four patients (13%). CONCLUSIONS: Radioembolization may prolong survival for patients with inoperable hepatocellular carcinoma. Radioembolization-induced liver disease occurred and should be further studied.


Assuntos
Carcinoma Hepatocelular/radioterapia , Embolização Terapêutica/métodos , Neoplasias Hepáticas/radioterapia , Microesferas , Compostos Radiofarmacêuticos/uso terapêutico , Radioisótopos de Ítrio/uso terapêutico , Idoso , Carcinoma Hepatocelular/mortalidade , Carcinoma Hepatocelular/patologia , Estudos de Coortes , Feminino , Humanos , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
3.
Trials ; 14: 366, 2013 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-24180235

RESUMO

BACKGROUND: Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. METHODS/DESIGN: This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. DISCUSSION: This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. TRIAL REGISTRATION: NCT01695850.


Assuntos
Constipação Intestinal/terapia , Defecação/efeitos dos fármacos , Medicamentos de Ervas Chinesas/uso terapêutico , Laxantes/uso terapêutico , Projetos de Pesquisa , Extrato de Senna/uso terapêutico , Protocolos Clínicos , Constipação Intestinal/diagnóstico , Constipação Intestinal/fisiopatologia , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Motilidade Gastrointestinal/efeitos dos fármacos , Hong Kong , Humanos , Laxantes/efeitos adversos , Estudos Prospectivos , Recuperação de Função Fisiológica , Extrato de Senna/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
6.
J Hepatol ; 46(2): 198-205, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17125879

RESUMO

BACKGROUND/AIMS: Exposure to HBV leads to a distinct clinical course which is partially pertained to host genetic variability. We aimed to study polymorphisms of type I interferon receptor 1 (IFNAR1) promoter and their potential effects on chronic HBV infection. METHODS: Polymorphisms of IFNAR1 promoter were identified in 320 chronic hepatitis B patients, 148 spontaneously recovered individuals, 148 healthy Chinese donors and 114 Caucasians. Their functional capability in driving reporter gene expression was analyzed. RESULTS: Four polymorphic alleles were identified at loci -568, -408, -77 and -3. Association analysis revealed that carriers of alleles -568G, -408C and their related haplotype I were less susceptible to chronic HBV infection whereas those of alleles -568C, -408T and related haplotype III were significantly associated with higher risk to chronic hepatitis B (P<0.01). In a reporter-driven system, the promoter variants with alleles -408C and -3C could drive higher expression of the reporter gene than those with alleles -408T and -3T (P<0.01). Interestingly, an allele with 9 GT repeats at -77 that was rarely found in Chinese but prevalent in Caucasian exhibited the highest transcriptional ability. CONCLUSIONS: Our results showed that polymorphisms of IFNAR1 promoter may affect, at least in part, the outcomes of HBV infection.


Assuntos
Convalescença , Predisposição Genética para Doença , Hepatite B Crônica/genética , Polimorfismo de Nucleotídeo Único , Receptor de Interferon alfa e beta/genética , Povo Asiático/genética , Feminino , Haplótipos , Humanos , Desequilíbrio de Ligação , Masculino , Regiões Promotoras Genéticas/genética , Transcrição Gênica
7.
J Gastroenterol Hepatol ; 18(4): 450-5, 2003 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-12653895

RESUMO

BACKGROUND AND AIM: Adjuvant locoregional chemotherapy has been shown to be useful to prevent recurrence after curative resection of hepatocellular carcinoma (HCC) in some retrospective studies. Our aim was to compare the dose effect in the prevention of tumor recurrence. METHODS: A prospective randomized controlled trial was conducted in patients with curative resection of HCC; they were given either one intra-arterial dose of cisplatin/lipiodol, or received four doses, once every 3 months. The rates of recurrence, disease-free and overall survival were compared. RESULTS: During a median follow up of 818 days, 21 patients received one dose and 19 received four doses, with 10 (47.6%) and eight (42.1%) recurrences, respectively. The 1-year, 2-year and 3-year disease-free survival rates were 71%, 54% and 44% for the one-dose group and 74%, 60% and 40% for the four-dose group (P = 0.78). The respective overall survival rates were 85%, 74%, 55% and 84%, 71%, 40% (P = 0.64). The only prognostic factor was presence of vascular permeation. The side-effects were mild and tolerable. CONCLUSIONS: There is no significant difference in the survival rates between the two groups. Adjuvant chemotherapy may not be useful.


Assuntos
Antineoplásicos/administração & dosagem , Antineoplásicos/uso terapêutico , Carcinoma Hepatocelular/tratamento farmacológico , Carcinoma Hepatocelular/cirurgia , Cisplatino/administração & dosagem , Cisplatino/uso terapêutico , Hepatectomia , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/cirurgia , Recidiva Local de Neoplasia/prevenção & controle , Adulto , Idoso , Carcinoma Hepatocelular/mortalidade , Quimioterapia Adjuvante , Meios de Contraste/administração & dosagem , Intervalo Livre de Doença , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Injeções Intra-Articulares , Óleo Iodado/administração & dosagem , Neoplasias Hepáticas/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Taxa de Sobrevida
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