Cold atmospheric plasma (CAP) is a group of various chemical active species, such as ozone and nitric oxide, generated by working gas. CAP was demonstrated to have an effect on tissue regeneration and wound healing. We conducted this study to evaluate the efficacy and safety of CAP as a novel therapy for diabetic wounds in vitro and in vivo. The plasma consists of ionised helium gas that is produced by a high‐voltage and high‐frequency power supply. Eight‐week‐old male db/db mice and C57BL mice were treated with helium gas (control group), 90s' CAP (low‐dose group), and 180s' CAP (high‐dose group). Mice were treated and observed for 2 weeks. Skin samples from around the wound and blood samples were collected. Our in vitro analysis included scratch wound‐healing assays by using human HaCaT immortalised human epidermal cells. After 14 days of treatment, CAP could obviously promote diabetic wound healing. Wound closure rates were significantly higher in the low‐dose group and high‐dose groups compared with the control group. Meanwhile, compared with the control group, the protein expression of IL‐6, tumour necrosis factor‐α, inducible nitric oxide synthase, and superoxide dismutase in two CAP groups significantly decreased, while the protein expression of vascular endothelial growth factor and transforming growth factor‐β in two CAP groups significantly increased (all P < .05); these data show good agreement with the change in mRNA level (all P < .05). In vitro, scratch wound‐healing assays showed that plasma treatment could effectively ensure healing within 3 minutes of exposure (all P < .05). In addition, no difference was found in histological observations of normal skin and the level of serum alanine transaminase, aspartate aminotransferase, blood urea nitrogen, creatinine, and white blood cells among the CAP groups and control group. CAP treatment for 3 minutes every day improves wound healing in diabetic mice by suppressing inflammation, reducing oxidative stress, and enhancing angiogenesis, involving several proteins signalling, and it is safe for the liver and kidney.
Benefits of a transtheoretical model‐based exercise program on exercise adherence (primary outcome) and secondary outcomes (self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical function) were assessed among older adults with knee osteoarthritis.
A two‐arm, superiority, assessor‐blinded, cluster randomized trial with randomization at the community level.
Participants were recruited from 14 communities in Beijing between April and October 2018 (N = 189). The intervention was a 24‐week transtheoretical model‐based exercise program and the control group underwent a non‐theory‐based exercise program. Exercise adherence was collected every four weeks and secondary outcomes were measured at baseline, 12 and 24 weeks. An independent t‐test and repeated measures ANOVA were the main statistical tests.
Most participants were women (92.5%), married (81.4%), with high‐school education (36.0%), with both knees affected (50.3%) and did not make use of a walker (93.8%). There were no significant differences between groups in any of the outcome measures at baseline. Repeated measures ANOVA indicated that there was a significant difference in the trend of adherence scores between the two groups from 0 to 24 weeks. The independent t‐test showed that scores in the intervention group were significantly better than in the control group at 16 weeks, 20 weeks and 24 weeks. Improvements in the intervention group were also significantly greater in all secondary outcomes than in the control group.
A theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, knee osteoarthritis symptoms and physical functioning in older adults with knee osteoarthritis.
The 24‐week theory‐based exercise program could improve exercise adherence, self‐efficacy, decisional balance, symptoms of knee osteoarthritis and physical functioning in older adults with knee osteoarthritis. The theory‐based exercise program could help older adults with knee osteoarthritis to improve their symptoms and knee function.
by Shuangshuang Li, Xudong Feng, Guodong Cao, Qianhui Wang, Ling WangObjectives
To investigate the association between inflammatory indices and clinical outcomes of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE) by performing meta-analysis.Methods
A systematic literature search for relevant studies published up to August 2019 was performed by using PubMed, Web of Science, EMBASE, China National Knowledge Internet (CNKI) and Wanfang databases. Pooled hazard ratios (HR) or odds ratio (OR) and 95% confidence intervals (95% CI) were calculated.Results
A total of 5280 patients from 22 studies were finally enrolled in the meta-analysis. The results demonstrated that elevated preoperative NLR, PLR, and CRP was associated with poor OS in HCC patients treated by TACE (HR = 1.81, P3 cm (OR = 2.42, P = 0.005).Conclusions
Elevated preoperative NLR, PLR, and CRP are associated with poor prognosis in HCC patients treated with TACE. These inflammatory indices may be convenient, accessible, affordable and dependable biomarkers with prognostic potential for HCC patients treated by TACE.
by Yi-Hsuan Lin, Ya-Chi Hsu, Ming-Chih Lin, Chao-Huei Chen, Teh-Ming WangBackground
Breast milk is the optimal choice for feeding premature babies. However, the prevalence rate of extrauterine growth restriction in preterm infants remains high.Objectives
The purpose of this study was to analyze the macronutrients present in human milk and the correlation with the growth of in-hospital preterm infants.Methods
This prospective study is based on data from 99 in-hospital preterm infants younger than 37 weeks of gestational age on an exclusively human milk diet. Infants who had previously received parenteral nutrition were eligible, but they had to have reached full enteral feeding at the time that the samples were taken. A total of 3282 samples of raw human milk or donor pasteurized milk were collected. The levels of lactose, protein, fat, and energy in the samples were measured using a Miris human milk analyzer. The primary outcome was weight growth velocity (g/kg/day) which was obtained using two-point approach.Results
The mean (±standard deviation) macronutrient composition per 100 mL of milk was 7.2 (±0.3) g of lactose, 1.1 (±0.2) g of true protein, 3.5 (±0.9) g of fat, and 66.9 (±6.5) kcal of energy. The protein concentration in human milk had a positive, significant correlation with body weight gain, with a coefficient of 0.41 (p Conclusion
Both the protein concentration in human milk and the daily total protein intake had a positive correlation with the body weight gain of premature infants. Routine analysis of breast milk and individualized fortification might be indicated to optimize the growth of preterm infants.
In 2015, most governments of the world committed to achieving 17 sustainable development goals (SDGs) by the year 2030. Efforts to improve eye health contribute to the advancement of several SDGs, including those not exclusively health-related. This scoping review will summarise the nature and extent of the published literature that demonstrates a link between improved eye health and advancement of the SDGs.
Searches will be conducted in MEDLINE, Embase and Global Health for published, peer-reviewed manuscripts, with no time period, language or geographic limits. All intervention and observational studies will be included if they report a link between a change in eye health and (1) an outcome related to one of the SDGs or (2) an element on a pathway between eye health and an SDG (eg, productivity). Two investigators will independently screen titles and abstracts, followed by full-text screening of potentially relevant articles. Reference lists of all included articles will be examined to identify further potentially relevant studies. Conflicts between the two independent investigators will be discussed and resolved with a third investigator. For included articles, data regarding publication characteristics, study details and SDG-related outcomes will be extracted. Results will be synthesised by mapping the extracted data to a logic model, which will be refined through an iterative process during data synthesis.
As this scoping review will only include published data, ethics approval will not be sought. The findings of the review will be published in an open-access, peer-reviewed journal. A summary of the results will be developed for website posting, stakeholder meetings and inclusion in the ongoing Lancet Global Health Commission on Global Eye Health.
To integrate intrinsic surgical risk into the paediatric preoperative risk prediction score (PRPS) model to construct a more comprehensive risk scoring system (modified PRPS) and improve the prediction accuracy of postoperative intensive care unit (ICU) admission in paediatric patients.
This was a retrospective study conducted between 1 January and 30 December 2016. Data on age, American Society of Anaesthesiology physical status (ASA-PS), oxygen saturation, prematurity, non-fasted status, severity of surgery and immediate transfer to the ICU after surgery were collected. The modified PRPS was developed by logistic regression in the derivation cohort; it was tested and compared with the paediatric PRPS and ASA-PS by the Hosmer-Lemeshow test, the receiver operating characteristic (ROC) curve and Kappa analysis in the validation cohort.
Hospital-based study in China.
Paediatric patients (≤14 years) who underwent surgery under general anaesthesia were included, and those who needed reoperation due to surgical complications or stayed in the ICU preoperatively were excluded.
ICU admission rate, defined as any patients’ direct disposition from the operating room to the ICU immediately after the surgery.
A total of 9261 paediatric patients were included in this study, with 418 patients admitted to the ICU. In the validation cohort, the modified PRPS model fit the test data well (deciles of risk goodness-of-fit 2=6.84, p=0.077). The area under the ROC curve of the modified PRPS, paediatric PRPS and ASA-PS were 0.963, 0.941 and 0.870, respectively (p
The modified PRPS integrating intrinsic surgical risk shows better prediction accuracy than the previous PRPS.
Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.
The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.
The study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.
The aim of our study is to give insight into congenital ectopia lentis (CEL) patients’ care-seeking behaviour and explore the factors affecting their follow-up visits.
Cross-sectional study; in-depth and face-to-face semistructured interview.
A large-scale ophthalmology hospital in China.
35 patients with CEL and their parents from May 2017 to August 2017.
Themes and categories. The interviews were audio-recorded, transcribed verbatim, coded and analysed using grounded theory. Data collection was closed when new themes did not emerge in subsequent dialogues.
The factors affecting the timely visits included insufficient awareness of CEL, shame on hereditary disease, lack of effective doctor–patient communication, lack of reliable information online and daily stressors.
Continuing medical education of severe and rare disease, reforming the pattern of medical education, constructing an interactive platform of the disease on the internet and improving healthcare policy are effective ways to improve the diagnosis and treatment status of CEL in China.
Previous studies have shown that an elevated heart rate is associated with a higher risk of cardiovascular events. This study aimed to prospectively examine the relationship between resting heart rate (RHR) and all-cause mortality in Chinese patients with hypertension.
An observational, prospective and population-based cohort study.
The Kailuan cohort study was conducted in Tangshan City in northern China.
We enrolled 46 561 patients who did not receive beta-blocker treatment and were diagnosed with hypertension for the first time during an employee health examination in Kailuan Group in 2006 and 2008.
The primary outcome of this study was all-cause mortality.
The patients in this study were followed for 9.25±1.63 years. All patients were followed up face to face every 2 years. According to the distribution of RHR in the study population, RHR was categorised into five groups on the basis of quintiles: Q1: RHR ≤68 beats per minute (bpm); Q2: RHR >68 and ≤72 bpm; Q3: RHR >72 and ≤76 bpm; Q4: RHR >76 and ≤82 bpm; Q5: RHR >82 bpm. Cox proportional hazards model, which was adjusted for traditional risk factors, was used.
During follow-up, 4751 deaths occurred. After adjustment for potential confounders, restricted cubic spline regression showed that the risk of all-cause mortality increased with heart rate. In multivariate Cox regression analyses adjusted for age, sex and major covariates, the HR for all-cause mortality was 1.31 (95% CI 1.27 to 1.33) in the highest quintile group (Q5) compared with the lowest quintile group (Q1).
An increase in RHR is a long-term risk factor of all-cause mortality in Chinese patients with hypertension.
To perform the cross-cultural adaption of the Breast Cancer Awareness Measurement (BCAM) and to test its psychometric properties among Chinese women.
This is a cross-sectional study.
This study was conducted in communities, schools and institutions in Changchun, Jilin Province, China.
A total of 328 women voluntarily participated in and completed the Chinese version of the BCAM (C-BCAM), resulting in an effective response rate of 91.1%.
Psychometric properties, including item analysis (the extreme group comparison and item-total correlations), content validity (item-level content validity index (I-CVI) and scale-level content validity index (S-CVI)), construct validity (exploratory factor analysis (EFA) and confirmatory factor analysis (CFA)) and internal consistency (Cronbach’s α and test–retest reliability), were measured.
The C-BCAM has excellent internal consistency (Cronbach’s α=0.90), with alpha coefficients of 0.88, 0.84 and 0.94 for its three domains. The test–retest reliability coefficient was 0.72. The I-CVI ranged from 0.86 to 1.00, and the S-CVI was 0.92. CFA showed that the three-factor model explained 51.56% of the total variance, with a good model fit (likelihood ratio 2/df=1.86, incremental fit index=0.94, comparative fit index=0.94, goodness-of-fit index=0.84, adjusted goodness-of-fit index=0.80, standardised root mean square error of approximation=0.06 and root mean square residual=0.05).
The C-BCAM has satisfactory validity and reliability and is a culturally appropriate and reliable tool for evaluating breast cancer awareness among Chinese women. This reliable instrument can help researchers and health professionals evaluate women’s knowledge about the symptoms and risk factors of breast cancer and identify their barriers to seeking medical help. It also helps healthcare providers identify women with poor breast cancer awareness and encourage them to perform screening practice.
Peer education is an intervention within the voluntary medical male circumcision (VMMC)–adolescent sexual reproductive health (ASRH) linkages project in Bulawayo and Mount Darwin, Zimbabwe since 2016. Little is known if results extend beyond increasing knowledge. We therefore assessed the extent of and factors affecting referral by peer educators and receipt of HIV testing services (HTS), contraception, management of sexually transmitted infections (STIs) and VMMC services by young people (10–24 years) counselled.
A cohort study involving all young people counselled by 95 peer educators during October–December 2018, through secondary analysis of routinely collected data.
All ASRH and VMMC sites in Mt Darwin and Bulawayo.
All young people counselled by 95 peer educators.
Censor date for assessing receipt of services was 31 January 2019. Factors (clients’ age, gender, marital and schooling status, counselling type, location, and peer educators’ age and gender) affecting non-referral and non-receipt of services (dependent variables) were assessed by log-binomial regression. Adjusted relative risks (aRRs) were calculated.
Of the 3370 counselled (66% men), 65% were referred for at least one service. 58% of men were referred for VMMC. Other services had 5%–13% referrals. Non-referral for HTS decreased with clients’ age (aRR: ~0.9) but was higher among group-counselled (aRR: 1.16). Counselling by men (aRR: 0.77) and rural location (aRR: 0.61) reduced risks of non-referral for VMMC, while age increased it (aRR ≥1.59). Receipt of services was high (64%–80%) except for STI referrals (39%). Group counselling and rural location (aRR: ~0.52) and male peer educators (aRR: 0.76) reduced the risk of non-receipt of VMMC. Rural location increased the risk of non-receipt of contraception (aRR: 3.18) while marriage reduced it (aRR: 0.20).
We found varying levels of referral ranging from 5.1% (STIs) to 58.3% (VMMC) but high levels of receipt of services. Type of counselling, peer educators’ gender and location affected receipt of services. We recommend qualitative approaches to further understand reasons for non-referrals and non-receipt of services.
Obesity is a major health concern in postmenopausal women, and chronic low-grade inflammation contributes to the development of obesity. Cellular studies and high-fat-diet-induced obese mouse model mimicking obesity show the antiobesity effect of annatto-extracted tocotrienols (TT) with antioxidant capability. We aim to assess the safety and efficacy of TT consumption for lipid-related parameters in obese postmenopausal women.
Eligible obese postmenopausal women will be randomly assigned to placebo group (430 mg olive oil) and TT group (DeltaGold Tocotrienol 70%) for 24 weeks. In the present study, the primary outcome is total/regional fat mass and visceral adipose tissue. The secondary outcomes include lipid profile in serum, mRNA expression of fatty acid synthase and carnitine palmitoyltransferase 1A in fat tissue, oxylipins and endocannabinoids in plasma and adipose tissue, abundance and composition of intestinal microbiome in faeces, high-sensitivity C-reactive protein (hs-CRP) in serum and leptin in serum. Every participant will be evaluated at 0 (prior to starting intervention) and 24 weeks of intervention, except for serum lipid profile and hs-CRP at 0, 12 and 24 weeks. ‘Intent-to-treat’ principle is employed for data analysis. Hierarchical linear modelling is used to estimate the effects of dietary TT supplementation while properly accounting for dependency of data and identified covariates. To our knowledge, this is the first randomised, placebo-controlled, double-blinded study to determine dietary TT supplementation on an obese population. If successful, this study will guide the future efficacy TT interventions and TT can be implemented as an alternative for obese population in antiobesity management.
This study has been approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock. An informed consent form will be signed by a participant before enrolling in the study. The results from this trial will be actively disseminated through academic conference presentation and peer-reviewed journals.
Patient decision-aids (PDAs) support patients in selecting evidence-based treatment options. PDA is useful only if the user understands the content to make personalised decisions. Cultural adaptation is a process of adjusting health messages so that the information is accurate, relevant and understandable to users from a different population. A PDA has been developed to assist Malaysian patients with secondary drug failure to initiate insulin therapy to control their type 2 diabetes mellitus (T2DM). Likewise, patients with T2DM in neighbouring Singapore face similar barriers in commencing insulin treatment, which a PDA may facilitate decision-making in selecting personalised therapy.
The study aimed to explore the views and perceptions of Singaporean primary care providers on the Malaysia PDA to initiate insulin therapy and described the cultural adaptation process used in the design and development of a new PDA, which would be trialled in a Singapore primary healthcare institution.
Qualitative research method was deployed to conduct one-to-one in-depth interviews of the healthcare providers at the trial site (SingHealth Polyclinics—SHP), including six primary care physicians and four nurses to gather their views and feedbacks on the Malaysian PDA. The interviews were transcribed, audited and analysed (standard content analysis) to identify themes relating to the content, layout, concerns of the original PDA and suggestions to the design of the new SHP PDA.
Cultural adaptation of the new PDA includes change to the overall design, graphics (including pictograms), presentation styles, additional contextualised content (personalisation, subheadings, cost and treatment option), modified phrasing of the subtitles and concerns (choice of words) relevant to the new users.
A PDA on insulin therapy underwent cultural adaptation before its implementation in another population in a neighbouring country. Its relevance and effectiveness will be evaluated in future research.
To assess the efficacy of topical silicone gel in the management of scars, we conducted this meta‐analysis. The systematic search was performed on PubMed, Web of Science and Embase, and six randomised controlled trials with a total of 375 patients were involved. The outcome data of Vancouver Scar Scale were extracted from the studies and their effect sizes were calculated using Review Manager 5.3. As a result, topical silicone gel significantly reduced pigmentation, height, and pliability scores postoperatively compared with placebos or no treatment (Pigmentation: standard mean difference [SMD] = −0.55 [−0.83 to –0.26], P = .0002; Height: SMD = −0.73 [−1.02 to –0.44], P < .00001; Pliability: SMD = −0.49 [−0.95 to –0.03], P = .04). Topical silicone gel and silicone gel sheet were comparably effective (P > .05). The performance of topical silicone gel and other non‐silicone topical treatment was also similar (P > .05). In summary, topical silicone gel was effective in post‐operative scar prevention.
Insomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.
This study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.
This protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.
Postoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.
This is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.
The study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.
To test prospective pathways of a Comprehensive Reminder System based on the Health Belief Model (CRS‐HBM), stroke knowledge, health belief in health behaviour, blood pressure (BP) control, and disability in hypertensive ischaemic stroke patients at 6‐month postdischarge.
A nested cohort study design.
Data were derived from a randomized controlled trial evaluating the effects of the intervention (N = 174, performed during February 2015 ‐ March 2016). Data were collected by questionnaires and analysed in structural equation modelling in Mplus software.
The proposed model provided a good fit to the data. This model accounted for 51.5% of the variance in health behaviour, 34.1% in BP control, and 5.7% in modified Rankin Scale score at 6‐month postdischarge. The CRS‐HBM had: (a) direct positive effect (β = .391, p < .001) and indirect positive effects (β = .186, p = .002) on health behaviour; (b) direct positive effect (β = .356, p < .001) and indirect positive effects (β = .183, p = .009) on BP control; and (c) indirect negative effect (β = −.146, p = .008) on disability. Being female was linked to better health behaviour. Higher education predicted higher level of stroke knowledge and health belief.
The CRS‐HBM can not only directly but also indirectly improve patients' health behaviours by improving their health knowledge or health belief. Better health behaviour can improve patients' BP control and reduce disability. Therefore, nurses need to pay more attention to not only patients' health knowledge but also their health belief when providing education.
The CRS‐HBM intervention accounted for 51.5% of variance in health behaviour, 34.1% in BP control, and 5.7% in modified Rankin Scale score at 6‐month postdischarge. This research can help nurses improve health education strategies in postdischarge and community contexts to achieve better health results.
by Sheng Feng Lin, Shui-Yi Tung, Kuo-Liang Wei, Chien-Hung Chen, Tsung-Hui Hu, Chien Heng Shen, Te-Sheng Chang, Wei-Ming Chen, Chih-Wei Yen, Jing-Houng Wang, Chao-Hung Hung, Sheng-Nan LuBackground
Hepatitis C virus core antigen (HCV Ag) assay has been proposed as a more economical alternative to HCV RNA detection. This study aimed to investigate the clinical utility of HCV Ag assay in the monitoring of direct-acting antivirals (DAAs) for chronic hepatitis C patients.Methods
We analyzed serum samples from 110 patients treated with paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) with or without ribavirin. The levels for both HCV Ag and HCV RNA assessed by COBAS TaqMan HCV (CTM) Test or Abbott RealTime HCV (ART) assay were evaluated at baseline, week 2, 4, and 12 during treatment and 12 weeks after completion.Results
Baseline HCV Ag levels showed good correlations with HCV viral load (r = 0.879; pp = 0.074). The concordance of HCV Ag and HCV RNA undetectability was significantly better in CTM test than in ART assay at week 2 (p = 0.003) and week 4 (p = 0.003). A sustained viral response 12 weeks off therapy (SVR12) was achieved in 108 patients (98%); the HCV Ag assay identified 99% of these patients. Both undetectability of serum HCV Ag and HCV RNA had high positive predictive value at week 2 (98% vs. 100%) and at week 4 (97% vs. 99%) in predicting SVR12.Conclusions
HCV Ag assay may be a feasible alternative to HCV RNA for the determination of SVR12 in patients treated with DAAs.