RESUMO
Objective: To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym(®)) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs. Methods: A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym(®) group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated. Results: A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym(®) group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly (P<0.001), while they were similar between groups (P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment (P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym(®) group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym(®) group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym(®) group (P=0.041) and combined group (P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym(®) group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups. Conclusions: The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.
Assuntos
Benzamidas/uso terapêutico , Dispepsia/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Motilidade Gastrointestinal/efeitos dos fármacos , Glicosídeo Hidrolases/uso terapêutico , Morfolinas/uso terapêutico , Pancreatina/uso terapêutico , Peptídeo Hidrolases/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Povo Asiático , Benzamidas/efeitos adversos , China , Combinação de Medicamentos , Dispepsia/diagnóstico , Dispepsia/patologia , Feminino , Fármacos Gastrointestinais/efeitos adversos , Glicosídeo Hidrolases/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Morfolinas/efeitos adversos , Pancreatina/efeitos adversos , Peptídeo Hidrolases/efeitos adversos , Período Pós-Prandial , Estudos Prospectivos , Resultado do TratamentoRESUMO
Objective: To evaluate the effectiveness of hepatitis B vaccination in Fujian province. Methods: Based on the hepatitis B immunization strategy of China, a cohort study was designed, involving the population in Fujian province. The population under study was divided into natural exposure birth cohort before 1992 and the immunization birth cohort after 1992 (including voluntary vaccination cohort and standardized vaccination cohort). By cleaning the database of hepatitis B cases which directly reported through network and looked into the incidence and related death outcomes of acute hepatitis B from 2004 to 2017, the incidence levels of hepatitis B and immunization effects were analyzed and evaluated among different birth cohorts. Results: During the observation period, the overall prevalence of hepatitis B in Fujian province was 44.594 per 100 000, with mortality rate as 0.010 per 100 000. The incidence of natural exposure cohort of birth was 56.885 per 100 000. The incidence of voluntary vaccination cohort of birth was 14.502 per 100 000. Compared with the voluntary vaccination cohort, the risk of hepatitis B increased significantly in the natural exposed cohort (RR=3.923), and the difference was statistically significant (P=0.000 7), with attributable risk as 42.383 per 100 000. The attributable risk ratio was 74.507. The population attributable risk ratio was 70.967%. The population attributable risk was 35.448 per 100 000. The attributable rate in standardized vaccination cohorts born after 2002 was 2.336 per 100 000. Compared with the cohorts born before 1992, the RR was 24.347 (P=0.000 0), the attributable risk was 54.549 per 100 000, and the attributable risk ratio was 95.893%, the population attributable risk ratio was 95.300%, the population attributable risk was 47.371 per 100 000, comparing to the natural exposed population. Conclusions: The effectiveness of hepatitis B immunization program had been remarkable in Fujian province since 1992. However, further studies on the persistency of hepatitis B vaccine immunization and its public health significance still needed to be carried out.
Assuntos
Vacinas contra Hepatite B/administração & dosagem , Hepatite B/prevenção & controle , Imunização , Vacinação/estatística & dados numéricos , China/epidemiologia , Estudos de Coortes , Hepatite B/epidemiologia , Humanos , Incidência , Razão de Chances , Prevalência , Fatores de RiscoRESUMO
Objective: To analyze the epidemiological characteristics and spatial distribution of human brucellosis in Fujian province during 2011-2016, and provide evidence for the prevention and control of the disease. Methods: The surveillance data of human brucellosis in Fujian during 2011-2016 was analyzed with software R 3.3.1, ArcGIS 10.3.1, GeoDa 1.8.8 and SaTScan 9.4.3. Results: During 2011-2016, a total of 319 human brucellosis cases were reported, the incidence increased year by year (F=11.838, P=0.026) with the annual incidence of 0.14/100 000. The male to female rate ratio of the incidence was 2.50 ⶠ1. Farmers and herdsmen accounted for 57.37%. The incidence was 0.40/100 000 in Zhangzhou and 0.32/100 000 in Nanping, which were higher than other areas. The number of affected counties (district) increased from 12 in 2011 to 28 in 2016, showing a significant increase (F=13.447, P=0.021). The Moran's I of brucellosis in Fujian between January 2011 and December 2016 was 0.045, indicating the presence of a high value or low value clustering areas. Local spatial autocorrelation analysis showed that, high-high clustering area (hot spots) were distributed in Zhangpu, Longhai, Longwen, etc, while high-low clustering areas were distributed in Nan'an and Jiaocheng, etc. Temporal scanning showed that there were three clustering areas in areas with high incidence, the most possible clustering, occurring during January 1, 2013- December 31,2015, covered 6 counties, including Yunxiao, Pinghe, Longhai, etc, and Zhangpu was the center, (RR=7.96, LLR=92.62, P<0.001). Conclusions: The epidemic of human brucellosis in Fujian is becoming serious, and has spread to general population and non-epidemic areas. It is necessary to strengthen the prevention and control of human brucellosis in areas at high risk.