Diagnosis and outcomes of cachexia in Asia: Working Consensus Report from the Asian Working Group for Cachexia.

Chronic diseases often lead to metabolic disorders, causing anabolic resistance and increased energy consumption, which result in cachexia. Cachexia, in turn, can lead to major clinical consequences such as impaired quality of life, shortened life expectancy, and increased healthcare expenditure. Existing international diagnostic criteria for cachexia employ thresholds derived from Western populations, which may not apply to Asians due to differing body compositions. To address this issue, the Asian Working Group for Cachexia (AWGC) was initiated. The AWGC comprises experts in cachexia research and clinical practice from various Asian countries and aims to develop a consensus on diagnostic criteria and significant clinical outcomes for cachexia in Asia. The AWGC, composed of experts in cachexia research and clinical practice from several Asian countries, undertook three-round Delphi surveys and five meetings to reach a consensus. Discussions were held on etiological diseases, essential diagnostic items for cachexia, including subjective and objective symptoms and biomarkers, and significant clinical outcomes. The consensus highlighted the importance of multiple diagnostic factors for cachexia, including chronic diseases, either or both weight loss or low body mass index, and at least one of the following: anorexia, decreased grip strength (<28 kg in men and <18 kg in women), or elevated C-reactive protein levels (>5 mg/L [0.5 mg/dL]). The AWGC proposed a significant weight change of 2% or more over a 3-6 month period and suggested a tentative cut-off value of 21 kg/m2 for low body mass index in diagnosing cachexia. Critical clinical outcomes were determined to be mortality, quality of life as assessed by tools such as EQ-5D or the Functional Assessment of Anorexia/Cachexia Therapy, and functional status as measured by the Clinical Frailty Scale or Barthel Index, with significant emphasis on patient-reported outcomes. The AWGC consensus offers a comprehensive definition and user-friendly diagnostic criteria for cachexia, tailored specifically for Asian populations. This consensus is set to stimulate future research and enhance the multidisciplinary approach to managing cachexia. With plans to develop further guidelines for the optimal treatment, prevention, and care of cachexia in Asians, the AWGC criteria are expected to drive research across chronic co-morbidities and cancer in Asia, leading to future refinement of diagnostic criteria.

Dietary diversity predicts the mortality among older people: Data from the fifth Thai national health examination survey.

OBJECTIVE: To examine the association between dietary diversity (DD) and mortality among Thai older people and to investigate whether age, sex, and nutritional status modify this association. METHODS: The national survey conducted from 2013 to 2015 recruited 5631 people aged >60 years. Dietary diversity score (DDS) was assessed for the consumption of eight food groups using food frequency questionnaires. The Vital Statistics System provided the data on mortality in 2021. The association between DDS and mortality was analyzed by Cox proportional hazard model and adjusted for the complex survey design. Interaction terms between DDS and age, sex, and BMI were also tested. RESULTS: The DDS was inversely associated with mortality (HRadj 0.98, 95%CI: 0.96-1.00). This association was stronger in people aged >70 years (HRadj 0.93, 95%CI: 0.90-0.96 for aged 70-79 years, and HRadj 0.92, 95%CI: 0.88-0.95 for aged >80 years). Inverse association between DDS and mortality was also found in the underweight older population (HRadj 0.95, 95%CI: 0.90-0.99). A positive association was found between DDS and mortality in the overweight/obese group (HRadj 1.03, 95%CI: 1.00-1.05). However, the interaction between the DDS with sex to mortality was not statistically significant. CONCLUSION: Increasing DD reduces mortality among Thai older people, especially in those above 70, and underweight. In contrast, an increase in DD also meant an increase in mortality among the overweight/obese group. Focus should be placed on the nutritional interventions aimed to improve DD for those 70 and over and underweight to reduce mortality.

Dietary diversity associated with risk of cardiovascular diseases among community-dwelling older people: A national health examination survey from Thailand.

Background: Cardiovascular diseases (CVD) are the common comorbidities in older people. Healthy diet is an essential strategy to alleviate the risk of developing CVD. Dietary diversity (DD) is an indicator of diet quality. Currently, limited research exists regarding DD and CVD in older people in developing countries, such as Thailand, despite rapid growth of older population. Therefore, this study aims to determine associations of DD with the risk of CVD and the cardiometabolic risk factors among Thai older people. Methods: This cross-sectional study used the sub-sample of the fifth Thai National Health Examination Survey conducted from 2013 to 2015. A total of 6,956 older people aged 60 years and older and no pre-existing CVD were included.Dietary diversity score (DDS) was assessed the consumption of eight food groups using food frequency questionnaires. Each food group was scored from 0 to 4. The DDS was calculated as the sum of the scores (0-32). The risk of CVD was calculated by using a Thai cardiovascular (CV) risk score. The cardiometabolic risk factors included hypertension, diabetes mellitus (DM), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels. Data were adjusted for a complex survey design and analysed using linear and logistic regression models. Results: In the adjusted model, DDS had a significant negative association with log-Thai CV risk score, with adjusted ß (95% CI) values of -0.01 (-0.01, -0.01). Regarding the cardiometabolic risk factors, DDS had a significant negative association with hypertension, DM and log-TG levels, with adjusted OR (95% CI) values of 0.97 (95% CI 0.97, 0.98) for hypertension, 0.94 (0.93, 0.95) for DM, and adjusted ß (95% CI) values of -0.002 (-0.004, -0.001) for log-TG level. DDS was positively associated with TC and LDL-C, with adjusted ß (95% CI) values of 0.59 (0.38, 0.80) for TC and 0.59 (0.38, 0.79) for LDL-C levels, while DDS was not associated with HDL-C level. Conclusion: Higher DD was associated with a lower risk of CVD among Thai older people. The nutritional policies or interventions should encourage a diverse food intake for the prevention of CVD in this population.

Body Mass Index Combined With Possible Sarcopenia Status Is Better Than BMI or Possible Sarcopenia Status Alone for Predicting All-Cause Mortality Among Asian Community-Dwelling Older Adults.

Background: Body mass index (BMI) and sarcopenia are common indicators of nutritional status. Possible sarcopenia, defined as low muscle strength or performance, was recently introduced by the Asian Working Group for Sarcopenia (AWGS) in 2019. We investigated for association between all-cause mortality and BMI combined with possible sarcopenia severity in Asian older adults. Methods: This study included a subpopulation (8,195 participants aged ≥60 years; male gender: 49.4%; mean age: 69.2 ± 6.8 years) from the Fourth Thai National Health Examination Survey (NHES-IV). BMI was classified using Asia-Pacific cut-offs. Possible sarcopenia was defined using quadriceps strength based on AWGS 2019 criteria, and possible sarcopenia severity was determined using study population quartile cut-offs. All-cause mortality data was derived from the national vital registry in 2020. Results: The prevalence of underweight status and possible sarcopenia was 11.8 and 38.9%, respectively. Multivariate analysis showed underweight individuals with severe possible sarcopenia to be at highest risk for increased mortality [adjusted hazard ratio (aHR): 3.98, 95% confidence interval (CI): 2.89-5.48], and higher risk was found in men compared to women (aHR: 5.35, 95% CI: 1.19-8.97). Obese status without possible sarcopenia was an independent protective factor (aHR: 0.61, 95% CI: 0.38-0.97). Conclusion: BMI combined with possible sarcopenia severity is a better predictor of mortality risk than either parameter alone.

Effects of water-soluble mangosteen extract on cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's disease (WECAN-AD): A randomized controlled trial.

Introduction: The water-soluble mangosteen pericarp extract's (WME) effect was investigated in Alzheimer's disease (AD). Methods: The participants received 4 mg/kg/day of WME for 24 weeks (low dose, n = 33), 4 mg/kg/day for 12 weeks and then 8 mg/kg/day for 12 weeks (high dose, n = 33); or a placebo (n = 42). The outcomes were neuropsychiatric test scores, safety, tolerability, and the blood 4-hydroxynonenal level. Results: The proportion of participants who achieved the minimum clinically important difference for the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog; -2.6 points) at 24 weeks was significantly higher in the low-dose group (and a trend in the high-dose group) than in the placebo group. WME appeared safe and well tolerated. At 24 weeks, the 4-hydroxynonenal level declined in both intervention groups. The participants with a 5% reduction in this level showed greater ADAS-Cog improvements. Conclusion: WME is a safe and well-tolerated cognitive enhancer in AD with varying benefits across individuals based on antioxidative response.

Socio-demographic characteristics associated with the dietary diversity of Thai community-dwelling older people: results from the national health examination survey.

BACKGROUND: Dietary diversity (DD) is an indicator of nutrient intake and is related to health outcomes in older people. Currently, limited research exists regarding factors associated with DD in older people in developing countries, such as Thailand, despite rapid growth in this population. Therefore, this study aims to examine the association between socio-demographic characteristics and DD in Thai older people. METHODS: A cross-sectional study based on the fifth Thai National Health Examination Survey (NHES-V) conducted between 2013 and 2015 was performed. A total of 7,300 nationally representative older participants aged ≥ 60 years were included. The individual-level dietary diversity score (DDS) was assessed as the frequency of consumption of eight food groups using food frequency questionnaires. Each food group was scored from 0 to 4 according to the frequency of consumption. The DDS was calculated as the sum of the scores, ranging from 0 to 32. Socio-demographic characteristics, including age, sex, highest education level, wealth index, living conditions, and residential area, were assessed. Data were analyzed using multiple linear regression and adjusted for complex survey design. RESULTS: The participants had a mean age of 69.7 (SD 7.6) years. The mean DDS of participants was 18.4 (SD 3.9). In the adjusted model, a higher educational level, a higher wealth index, and living in an urban area were positively associated with DDS, with adjusted ß (95% CI) values of 1.37 (1.04, 1.70) for secondary education or higher, 0.81 (0.55, 1.06) for the richest group, and 0.24 (0.10, 0.44) for living in an urban area. Nevertheless, living alone had negative associations with DDS, with a ß (95% CI) of - 0.27 (- 0.53, - 0.00). CONCLUSIONS: This study showed that a higher educational level, a higher wealth index, and living in an urban area had a positive association, whereas living alone had a negative association with DD among Thai older participants. Interventions aiming to improve dietary diversity among older people might benefit from targeting more vulnerable groups, particularly those with less education and wealth, those living alone, or those in rural areas.

A simpler screening tool for sarcopenia in surgical patients.

BACKGROUND: Sarcopenia is defined as decreased skeletal muscle mass and muscle functions (strength and physical performance). Muscle mass is measured by specific methods, such as bioelectrical impedance analysis and dual-energy X-ray absorptiometry. However, the devices used for these methods are costly and are usually not portable. A simple tool to screen for sarcopenia without measuring muscle mass might be practical, especially in developing countries. The aim of this study was to design a simple screening tool and to validate its performance in screening for sarcopenia in older adult cancer patients scheduled for elective surgery. METHODS: Cancer surgical patients aged >60 years were enrolled. Their nutritional statuses were evaluated using the Mini Nutrition Assessment-Short Form. Sarcopenia was assessed using Asian Working Group for Sarcopenia (AWGS) criteria. Appendicular skeletal muscle mass was measured by bioelectrical impedance analysis. Four screening formulas with differing combinations of factors (muscle strength, physical performance, and nutritional status) were assessed. The validities of the formulas, compared with the AWGS definition, are presented as sensitivity, specificity, accuracy, and area under a receiver operating characteristic curve. RESULTS: Of 251 enrolled surgical patients, 84 (34%) were diagnosed with sarcopenia. Malnutrition (odds ratio [OR]: 2.89, 95% CI: 1.40-5.93); underweight status (OR: 2.80, 95% CI: 1.06-7.43); and age increments of 5 years (OR: 1.78, 95% CI: 1.41-2.24) were independent predictors of preoperative sarcopenia. The combination of low muscle strength and/or abnormal physical performance, plus malnutrition/risk of malnutrition had the highest sensitivity, specificity, and accuracy (81.0%, 78.4%, and 79.3%, respectively). This screening formula estimated the probability of sarcopenia with a positive predictive value of 65.4% and a negative predictive value of 89.1%. CONCLUSION: Sarcopenia screening can be performed using a simple tool. The combination of low muscle strength and/or abnormal physical performance, plus malnutrition/risk of malnutrition, has the highest screening performance.

The benefits of a novel chicken-based oral nutritional supplement for older adults: A double-blind randomized controlled trial.

BACKGROUND AND OBJECTIVES: A considerable proportion of older adults are lactose intolerant. The aim of this study was to investigate the clinical safety, efficacy, and tolerability of a chicken-based oral nutritional supplement (ONS). METHODS AND STUDY DESIGN: Double-blind randomized controlled trial. Subjects in the intervention group received chicken-based ONS, and those in the control group received a similarly flavored oral fluid placebo. All subjects were followed-up every two months for a total of 6 months. RESULTS: Thirty-eight older adults aged ≥70 years were recruited. The mean age and BMI were 81.5±5.6 years and 19.6±2.5 kg/m2. At the end of this trial, there was no statistically significant change in sarcopenia-related variables in the intervention group. However, the higher-level physical activity (PA) group within the intervention group had a significantly improved usual gait speed (UGS) compared to the lower-level PA group (p=0.04). The adjusted mean differences in UGS between the high and low level PA groups in the intervention and placebo groups were 0.149 m/sec and 0.083 m/sec, respectively. Significant difference was observed for changes in two bone markers between the intervention and placebo groups. CONCLUSIONS: The chicken-based ONS evaluated in this study was well-tolerated. No improvement of sarcopenia-related components was shown by the study ONS. Up to nearly an 80% increase in adjusted mean difference in UGS between the high and low level PA groups was observed in the nutritional intervention group compared to the zero-protein calorie placebo group. Significant improvement in age-related bone resorption was the earliest advantage of taking our ONS.

Exploring the Experience and Determinants of the Food Choices and Eating Practices of Elderly Thai People: A Qualitative Study.

Over the past decade, Thailand has experienced a rapid increase in its elderly population. Many unfavorable health outcomes among elderly people are associated with nutrition. Nutrition in elderly people is affected by physical, mental, and social factors. This study explored the food choices and dietary practices among community-dwelling elderly people in Thailand from the perspective of both caregivers and the elderly people themselves. Six focus group discussions and six semistructured interviews were conducted in the Samut Sakhon Province of Thailand. Deductive thematic analyses were conducted based on the "food choice process model framework." The results show that physical and mental factors and societal factors are important determinants of food choices. Moreover, a changing food environment and economic factors were found to affect food choices. Issues of trust in food safety and food markets were highlighted as growing issues. Therefore, fostering healthy food choice interventions that consider both environmental and societal aspects is necessary.

Characteristics and Real-Life Outcomes of Dementia and Cognitive Impairment at a Geriatric Clinic.

BACKGROUND: Various patterns of dementia care have been developed in different settings, depending on the availability of healthcare resources and facilities. The purpose of this study was to examine the epidemiology and characteristics of dementia care at a geriatric clinic, a field that has been subject to little prior evaluation. METHODS: A retrospective chart review was undertaken of cohort patients with cognitive impairment who had received a diagnosis and were still on active follow-up at a geriatric clinic. A total of 892 patients were included. In addition, 203 geriatric patients with no cognitive impairment who attended the clinic during the study period were sampled as a control. RESULTS: The main diagnoses of dementia were Alzheimer's disease (AD) (40.1%), vascular dementia (16.9%), unspecified dementia (16.3%), mixed dementia (9.0%), AD with cerebrovascular disease (8.7%), and Parkinson's disease dementia (6.1%). Atypical dementia was presented in 3.0% of cases. There were 178 patients with mild cognitive impairment, 20 with vascular cognitive impairment, and 18 with subjective cognitive decline. Other comorbidities were found in 97% of the subjects. Patients with cognitive impairment had a higher total number of other geriatric syndromes and higher percentages for delirium, falls, immobility, loss of appetite, and incontinence. Potentially reversible causes of dementia were found in 11.3% of the cases. Acetylcholinesterase inhibitors were administered to 61%, whereas 23.5% received an NMDA receptor antagonist. The need for a change in the antidementia medication was identified for 10.7% of the subjects; the major cause was adverse drug side effects. Nonpharmacological therapy only was administered to 52.4% of the people with dementia who had behavioral and psychological symptoms. CONCLUSIONS: Mixed brain pathologies, comorbidities, and the coexistence of other geriatric syndromes are common at geriatric clinics. Holistic, integrated, and continuous care are needed to improve the outcomes of patients with more complicated comorbidities.

Prevalence and Factors Associated with Frailty and Cognitive Frailty Among Community-Dwelling Elderly with Knee Osteoarthritis.

Physical frailty and cognitive impairment are risk factors for adverse outcomes in older people with osteoarthritis of the knee (knee OA). This cross-sectional study was conducted to determine the prevalence and associated factors of frailty and cognitive frailty among community-dwelling older patients with knee OA in four representative cities of Thailand. Data composed of three parts, Part 1: Demographic data, Part 2: The assessment of frailty by Fried phenotype and cognitive function by MiniCog and Part 3: The assessment of factors associated with frailty. Of 780 elders (mean age, 69.4 ± 6.9 years) screened, 101 (12.9%) were classified to be frail, 511 (65.6%) pre-frail and 168 (21.5%) non-frail. The prevalence of cognitive frailty was 2.44%. The correlation between physical activity rated by the Global Physical Activity Questionnaire (GPAQ) and self-rated methods was high (kappa 0.721; p < 0.001). Self-rated physical activity yielded similar prevalence of frail (9.4%), pre-frail (69.1%) and non-frail (21.5%). In multivariate analysis, aging (OR 3.42; 95% CI 1.16-10.11), severe knee OA symptoms (OR 18.96; 95% CI 3.53-101.65), malnutrition (OR 2.50; 95% CI 1.23-5.09), and functional dependence (OR 3.94; 95% CI 1.19-13.03) were associated with frailty. The prevalence of frailty and pre-frailty was high in knee OA and associated with aging, severe knee OA symptoms, malnutrition, and functional dependence, whereas the prevalence of cognitive frailty was not uncommon in community-dwelling elderly. Physical activity rated by the GPAQ and self-rated methods were highly correlated. Self-rated physical activity may be used in community surveys of frailty.

Vitamin D insufficiency predicts mortality among older men, but not women: A nationwide retrospective cohort from Thailand.

AIM: Previous studies on the association between low vitamin D level and increased mortality mainly came from high-income countries. The primary objective of the present study was to examine the effect of sex on the association between 25-hydroxyvitamin D2 and D3 and mortality among community-dwelling older people in Thailand. METHODS: A cohort of individuals aged ≥60 years from the Thai 4th National Health Examination Survey carried out in 2008 were followed and linked to a vital registry in 2015. Data regarding comorbid diseases, physical activity and serum vitamin D were obtained at the baseline assessment. Factors associated with all-cause mortality were determined using Cox proportional hazards models. RESULTS: A total of 1268 participants with a median age of 74.0 years (interquartile range 67.0-81.0) were included. The prevalence of vitamin D insufficiency was 24.5% and 43.9% in men and women, respectively. Vitamin D insufficiency was significantly associated with all-cause mortality only among men (adjusted HR 1.77, 95% CI 1.25-2.51), but not women. Analysis of 25-hydroxyvitamin D3 divided into tertiles also showed an association with an adjusted HR of 1.83 (95% CI 1.23-2.72) for the lowest tertile in men. Diabetes was an effect modifier for low serum vitamin D and male sex, with HR 3.34 (95% CI 1.76-6.33, P < 0.001) in diabetic men with vitamin D insufficiency. CONCLUSIONS: Low serum vitamin D is an independent risk factor for increased mortality in community-dwelling Thai older men. Further randomized controlled study to investigate the benefit of vitamin D3 supplementation in older persons, particularly men, is warranted. Geriatr Gerontol Int 2018; 18: 1585-1590.

The effectiveness of holistic diabetic management between Siriraj Continuity of Care clinic and medical out-patient department.

BACKGROUND: Diabetes mellitus is one of the most common diseases in the Thai population, and it is well known that diabetic complications could be prevented with appropriate management. Despite published guidelines, most Thai patients with diabetes do not achieve treatment goals. Siriraj Continuity of Care clinic (CC clinic) was recently established in order to provide training for medical students and internal medicine residents. It is possible that the training component in the CC clinic may contribute to better overall outcomes in type 2 diabetes mellitus (type 2 DM) patients when compared with usual care at the medical out-patient department (OPD). OBJECTIVE: To compare the effectiveness of diabetic management in type 2 diabetes mellitus patients who attended the CC clinic and the medical OPD. MATERIAL AND METHOD: Retrospective chart review was performed in type 2 diabetes mellitus patients who were treated at either clinic at Siriraj Hospital in 2007-2011. Baseline demographics, treatment strategies and outcomes, and participation in an appropriate health maintenance program were assessed in both groups. RESULTS: Seven hundred and fifty seven medical records were reviewed, including 383 patients in the CC clinic group and 374 in the OPD group. Mean HbA1c was significantly lower in the CC clinic group compared with the OPD group (7.3 +/- 0.9% and 7.8 +/- 1.3%, respectively, < 0.001). The number of patients who achieved goal HbA1c of less than 7% in CC clinic group was 123 (32.1%) compared with 91 (24.3%) in the OPD group (p = 0.039). More patients were screened for diabetic complications in the CC clinic group compared with the OPD group, including screening for diabetic neuropathy (57.4% vs. 2.1%, p < 0.001), diabetic retinopathy (56.7% vs. 36.6%, p < 0.001), and diabetic nephropathy (80.9% vs. 36.9%, p < 0.001). Patients in the CC clinic group had a higher rate of age-appropriate cancer screening than those in the OPD group (54.2% vs. 13.3%, p < 0.001 for breast cancer; 24.0% vs. 0.9%, p < 0.001 for cervical cancer; and 23.0% vs. 7.4%, p < 0.001 for colon cancer). Moreover, significantly more patients in the CC clinic group received recommended immunization (influenza, diphtheria tetanus and pneumococcal vaccine) compared with the control group (p < or = 0.001). CONCLUSION: Diabetic patients treated at the CC clinic had better clinical outcomes and healthcare maintenance compared with those who received usual care at the medical OPD. Continuity of care and integrated training component may have contributed to the improved outcomes.

Microbiological equivalence of bacteriostatic and bactericidal activities of the sera from healthy volunteers receiving generic piperacillin/tazobactam (Pipertaz) and original piperacillin/tazobactam (Tazocin).

BACKGROUND: Several generic piperacillin/ tazobactam formulations have been approved by Thai Food andDrugAdministration, Ministry of Public Health. Piperacillin/ tazobactam is a parenteral drug. Therefore, a study demonstrating a biological equivalence of generic piperacillin/ tazobactam is not required for drug registration in Thailand. OBJECTIVE: The study was to determine microbiological equivalence of serum bacteriostatic and bactericidal activities of the sera from healthy volunteers receiving generic piperacillin/ tazobactam (PipertazA) and original piperacillin/tazobactam (Tazocin). MATERIAL AND METHOD: This was a randomized crossover study in 16 adult healthy volunteers. Each subject received 4.5 grams of Pipertaz and Tazocin in 50 ml of normal saline via intravenous infusion for 30 minutes. The blood samples were drawn at baseline prior to receiving the study drug, at 30 minutes after initiating infusion, and at 8 hours after initiating infusion. The serum bacteriostatic activity against E. coli ATCC 25922, K. pneumoniae, P aeruginosa ATCC 27853 and A. baumannii was performed by disk diffusion The serum bactericidal activity against E. coli ATCC 25922 was performed by Serum Bactericidal Titre. RESULTS: The average inhibition zone diameter of the serum samples from the subjects while receiving Pipertaz against each tested organisms was <1 mm smaller than that while receiving Tazocin and such difference was not significantly different. All serum samples collected at 30 minutes after initiating Tazocin and Pipertaz had bactericidal titres 1:64 to 1:256 against E. coli ATCC 25922. All serum samples collected at 8 hours after initiating Tazocin and Pipertaz had bactericidal titres < 1:2 against E. coli ATCC 25922. The differences of serum bactericidal titres of the serum samples collected at 30 minutes (p = 0.7) and 8 hours (p = 1.0) after initiating Tazocin and Pipertaz were not statistically significant. CONCLUSION: The sera from healthy volunteers receiving Pipertaz contain bacteriostatic and bactericidal activities not significantly different from those receiving Tazocin.

Microbiological equivalence of serum bacteriostatic and bactericidal activities of the sera from healthy volunteers receiving original meropenem (Meronem) and generic meropenem (Mero).

BACKGROUND: Several generic meropenem formulations have been approved by Thai Food and Drug Administration, Ministry of Public Health since 2008. Meropenem is a parenteral drug. Therefore, a study demonstrating a biological equivalence of generic meropenem is not required for drug registration in Thailand. The objective of the study was to determine microbiological equivalence of serum bacteriostatic and bactericidal activities of the sera from healthy volunteers receiving original meropenem (Meronem) and generic meropenem (Mero). MATERIAL AND METHOD: This was a randomized crossover study in 16 adult healthy volunteers. Each subject received one gram of Meronem and Mero in 50 ml of normal saline via intravenous infusion for 30 minutes. The blood samples were drawn at baseline prior to receiving the study drug, at 30 minutes after initiating infusion, and at 8 hours after initiating infusion. The serum bacteriostatic activity against E. coli ATCC 25922, K. pneumoniae, P. aeruginosa ATCC 27853 and A. baumannii was performed by disk diffusion. The serum bactericidal activity against E. coli ATCC 25922 was performed by Serum Bactericidal Titre. RESULTS: The average inhibition zone diameter of the serum samples from the subjects while receiving Mero against each tested organisms was < 1 mm smaller than that while receiving Meronem and such difference was not significantly different. All serum samples taken at 30 minutes after initiating Meronem and Mero had bactericidal titres against E. coli ATCC 25922 > or = 1:256. Only 3 serum samples taken from the subjects while receiving Mero at 8 hours had less bactericidal titre for 1-fold dilution when compared with that of Meronem. CONCLUSION: The sera from healthy volunteers receiving Meronem and Mero had microbiological equivalence in terms of serum bacteriostatic and bactericidal activities.