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Objectives. To assess the efficacy of acupuncture in treating opioid use disorder (OUD). Design. Systematic review and meta-analysis. Methods. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, ProQuest Dissertation and Theses, Allied and Complementary Medicine Database (AMED), Clinicaltrials.gov, and who.int/trialsearch were searched from inception to 23 December 2017. The methodological quality of selected studies and the quality of evidence for outcomes were assessed, respectively, by the Cochrane risk of bias assessment tool and the GRADE approach. Statistical analyses were conducted by RevMan 5.3. Results. A total of nine studies involving 1063 participants fulfilled the inclusion criteria. The results showed that acupuncture could be more beneficial than no treatment/sham acupuncture in terms of changes in craving for opioid (MD -2.18, 95% CI -3.10 to -1.26), insomnia (MD 2.31, 95% CI 1.97 to 2.65), and depression (SMD -1.50, 95% CI -1.85 to -1.15). In addition, these findings showed that, compared to sham electroacupuncture (EA), EA had differences in alleviating symptoms of craving (SMD -0.50, 95% CI -0.94 to -0.05) and depression (SMD -1.07, 95% CI -1.88 to -0.25) and compared to sham transcutaneous acupoint electrical stimulation (TEAS), TEAS had differences in alleviating symptoms of insomnia (MD 2.31, 95% CI 1.97 to 2.65) and anxiety (MD -1.26, 95% CI -1.60 to -0.92) compared to no treatment/sham TEAS. Conclusions. Acupuncture could be effective in treating OUD. Moreover, EA could effectively alleviate symptoms of craving for opioid and depression, and TEAS could be beneficial in improving symptoms of insomnia and anxiety. Nevertheless, the conclusions were limited due to the low-quality and small number of included studies. PROSPERO registration number is CRD42018085063. [ABSTRACT FROM AUTHOR]

Purpose: T0001 was the first mutant of recombinant fusion protein of human tumor necrosis factor receptor and Fc fragment (rhTNFR:Fc) based on etanercept on a global scale. This study was carried out to investigate the pharmacokinetics (PK) and immunogenicity of T0001 in healthy Chinese volunteers. Methods: This study was randomized, with a single ascending dose, and the first-in-human clinical trial of T0001. Healthy Chinese volunteers ( n = 56; male: female = 1:1) were randomly assigned to receive a single subcutaneous (sc) injection of 10, 20, 35, 50, 65 or 75 mg of T0001. Blood samples were collected at designated time points after sc injection to assess immunogenicity and pharmacokinetics of T0001. Results: During the study, no serious adverse events were observed. T0001 was slowly absorbed with a median T of 84 h and slowly eliminated with a T of 42.1-58.2 h. In the dose-exposure proportionality analysis, the estimated points for AUC and C were 0.87 with a 90% CI of 0.76-0.98 and 0.86 with a 90% CI of 0.74-0.97 respectively. The plasma concentration of free (unbound T0001) plasma TNFα and total (bound and unbound T0001) TNFα both increased significantly after the injection of T0001. Ten out of 56 volunteers (17.9%) tested positive for anti-drug antibodies (ADAs) at a low level. Conclusions: T0001 was safe and well-tolerated at doses up to 75 mg. C and AUC had an increasing tendency with dose levels, but we could not conclude that T0001 has linear PK properties in this study. [ABSTRACT FROM AUTHOR]

Accessible Summary: What is known on the subject?: Recurrence is common in patients diagnosed with major depressive disorder (MDD). Psychological resilience has been shown to be a protective factor against recurrence of depression. It has important clinical nursing significance to analyse the influencing factors of psychological resilience in major depressive disorder in remission (MDDR) patients. What the paper adds to existing knowledge?: There are few previous studies on the influencing factors of psychological resilience in patients diagnosed with MDDR. We found the education levels, personal monthly income, social support, well‐being and self‐efficacy were influencing factors of psychological resilience in patients diagnosed with MDDR. What are the implications for practice?: According to the factors affecting the psychological resilience of patients diagnosed with MDDR, targeted clinical nursing is helpful to prevent the recurrence of depression. Nurses should strengthen the nursing of patients with <12 years of education, and patients with personal monthly income less than 5000 RMB. In addition, nurses should cultivate patients' awareness of social support and identity, cultivate their ability to strive for social support, cultivate interpersonal skills and positive emotional experience to improve subjective well‐being and carry out self‐efficacy training to improve psychological resilience by enhancing patients' internal protective factors. Aim: Psychological resilience is closely related to recurrence of depression. There are few previous studies on the influencing factors of psychological resilience in patients diagnosed with major depressive disorder in remission (MDDR). Here, we investigated the current status of resilience in patients diagnosed with MDDR and its influencing factors. Methods: A descriptive cross‐sectional study was conducted from June 2019 to April 2021. One hundred and forty‐two patients diagnosed with MDDR were recruited from the Department of Psychiatry and Psychology of the General Hospital of Northern Theater Command. Demographic information, social support, well‐being, self‐efficacy and psychological resilience were collected using self‐reported questionnaires. Results: The psychological resilience of MDDR patients was lower than that of the healthy Chinese adults in China. Multiple logistic regression analysis showed that education, personal monthly income, social support, well‐being and self‐efficacy were associated with psychological resilience. Receiver operating characteristic (ROC) curve analysis further confirmed that social support, well‐being and self‐efficacy were associated with psychological resilience. Conclusion: The psychological resilience of MDDR patients was lower than that of the general population in China. The education levels, personal monthly income, social support, well‐being and self‐efficacy were influencing factors of psychological resilience. Implications for Practice: According to the factors affecting the psychological resilience of patients diagnosed with MDDR, targeted clinical nursing is helpful to prevent the recurrence of depression. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects.Methods: We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg. Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios of the GB242 to reference infliximab for maximum concentration (Cmax), area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUCt), and AUC from time zero to infinity (AUC∞) were within the predefined bioequivalence range of 80-125%.Results: The mean serum concentration-time curves were similar between GB242 and reference infliximab. The 90% CIs for the geometric mean ratios of the GB242 to reference infliximab for Cmax, AUCt, and AUC∞ were completely within 80-125% for the PK similarity comparison. The proportion of subjects with treatment-emergent adverse events was similar between the GB242 group and the reference infliximab group. Antidrug antibody profiles were comparable between the two treatments groups.Conclusions: This study demonstrated high PK similarity between GB242 and its marketed reference infliximab in healthy subjects. Both treatments showed comparable safety and immunogenicity.Registration number: ChiCTR-IPR-15007098 [ABSTRACT FROM AUTHOR]