Safety and immunogenicity of a quadrivalent inactivated subunit non-adjuvanted influenza vaccine: A randomized,double-blind,active-controlled phase 1 clinical trial

Quadrivalent influenza inactivated vaccine (IIV4) is more likely to provide wider protection against yearly circulating influenza viruses than trivalent inactivated influenza vaccine (IIV3). In this study, a total of 320 participants were allocated to four age cohorts (6–35 months, 3–8 years, 9–17 years, and ≥ 18 years; 80 participants/cohort) according to their actual date of birth. Participants in each cohort were randomly assigned to two groups to receive intramuscular injection of the trial vaccine or the comparative vaccine in a one-dose (3–8 years, 9–17 years,and ≥ 18 years) schedule on day 0 or two-dose (6–35 months cohort) schedule on day 0 and 28. The first objective is to evaluate the safety and immunogenicity of the full-dose subunit non-adjuvanted IIV4 (FD-subunit NAIIV4) we developed versus an active-control, China-licensed split-virion NAIIV4, in people ≥ 3 years. The second objective is to evaluate the safety and immunogenicity of FD-subunit NAIIV4 versus the half-dose (HD-subunit NAIIV4) in toddlers aged 6–35 months. Results showed that all adverse reactions noted were rare, mild, and self-limited. In ≥ 3 years cohorts, systemic adverse reactions in FD-subunit NAIIV4 groups were less than the active control split-virion NAIIV4 groups ([Systemic adverse reaction rates (95%CI)], 15.0 (8.6–21.4) versus 19.2(12.1–26.2), p = 0.391). The overall seroprotection efficacy after vaccination were comparable between FD-subunit NAIIV4 and the active control split-virion NAIIV4([Seroprotection rates (95%CI)], H1N1, 99.2(81.3–100.0) versus 94.9(90.9–98.9), p = 0.117; H3N2, 81.7(74.7–88.6) versus 82.1(75.1–89.0), p = 0.939; BV, 75.8(68.2–83.5) versus 74.4(66.4–82.3), p = 0.793; BY, 94.2(90.0–98.4) versus 92.3(87.5–97.1), p = 0.568). Additionally, FD-subunit NAIIV4 has comparable safety and better seroprotection versus that of the half-dose in 6–35 months toddlers groups ([Total adverse reaction rates (95%CI)], 37.5(18.5–56.5) versus 47.5(26.1–68.9), p = 0.366) ([Seroprotection rates (95%CI)], H1N1, 85(56.4–100.0) versus 75.7(47.6–100.0), p = 0.117; H3N2, 50(28.1–71.9) versus 29.7(12.2–47.3), p = 0.070; BV, 75(48.2–100.0) versus 29.7(12.2–47.3), p < 0.001; BY, 75(48.2–100.0) versus 56.8(32.5–81.0), p = 0.091). As a result, the FD-subunit NAIIV4 we developed is safe and effective to provide broader and adequate protection against the circulating influenza viruses during 2018–2019, which could be an essential component of the global preventive strategy for influenza pandemic.     

嗜铬细胞瘤患者在CT增强检查中的安全性评价

目的 评价嗜铬细胞瘤患者注射低渗非离子型碘对比剂进行CT增强检查的安全性.方法 连续记录205例临床疑诊为肾上腺肿瘤患者检查前10 min(T0)及CT增强检查后5 min(T1)、10 min(T2)、20min(T3)、30 min(T4)、24h(T5)的收缩压(SBp)、舒张压(DBp)及心率(HR).其中50例经手术后病理证实为嗜铬细胞瘤患者作为A组；其余经临床及手术后病理排除嗜铬细胞瘤,从中随机抽取50例作为对照组(B组),统计分析2组各时间点血压和心率的变化情况.结果 2组检查前后及2组间各时间点的血压和心率均值比较无显著差异.2组均未发现注射对比剂后发生高血压危象者.结论 静脉注射低渗非离子型碘对比剂不会引起嗜铬细胞瘤患者血压和心率的明显变化,嗜铬细胞瘤患者接受CT增强检查与其他肾上腺肿瘤患者具有同样的安全性.     

骨化三醇治疗慢性肾功能不全患者肾性骨病的效果观察

目的研究慢性肾功能不全患者肾性骨病应用骨化三醇治疗的临床疗效,并分析其安全性。方法选择2014年7月~2016年11月期间所收治的68例肾性骨病患者作为本次研究病例,对患者进行分组治疗,采用随机数字表法进行分组,对照组和研究组各34例,对照组患者应用常规治疗方法,研究组在此基础上加用骨化三醇治疗,对比分析两组患者的临床各项指标,并分析其不良反应发生情况。结果治疗前,两组临床指标无明显统计学意义(P0.05),经治疗后,研究组患者的血清钙水平为(2.31±0.15)mmol/L,血清无机磷水平为(1.89±0.14)mmol/L,甲状旁腺激素为(202.01±35.87)pg/m L,碱性磷酸酶为(80.46±2.85)U/L,其中血清钙、血清无机磷与甲状旁腺激素水平与对照组比较具有统计学意义(t=4.1607、3.1260、5.7254,P0.05),碱性磷酸酶与治疗前比较无统计学意义(t=1.3055,P0.05);研究组患者不良反应发生率为8.82%(3例),对照组患者不良反应发生率为14.71%(5例),两组患者不良反应比较无统计学意义(χ~2=0.5667,P0.05)。结论慢性肾功能不全患者肾性骨病中应用骨化三醇治疗的效果明显,能够有效改善患者的临床症状,改善钙磷紊乱情况,并且不良反应少,可以在临床中推广使用。     

The Effectiveness of Seeking Safety on Reducing PTSD Symptoms in Clients Receiving Substance Dependence Treatment

An evaluation of the Seeking Safety (SS) program was conducted in a 28-day substance abuse treatment facility. The evaluation included 12 male and 28 female participants with a mean age of 33 years. The Trauma Symptom Checklist-40 was utilized as an outcome measure to statistically compare posttest to pretest group means. Results showed significant decreases, from pretest to posttest, on the total score and on several subscales of the measure. Effect sizes were large (d < 0.80) across all scales with the exception of Male Sexual Problems (d = .46). Overall, results suggest that incorporating SS as an adjunct to treatment as usual can help lower trauma symptoms in those receiving substance dependence treatment.     

Preserving the efficacy of front-line fluoroquinolones through selective use to optimise clinical outcomes

As antibiotic resistance is increasing worldwide, it is important to prescribe fluoroquinolone (FQ) antibiotics appropriately for a given infection to preserve class efficacy. Clinical studies reveal good efficacy and tolerability of the currently approved FQs (ciprofloxacin, levofloxacin and moxifloxacin) in a wide range of community- and hospital-acquired infections. However, certain features supporting their clinical efficacy suggest a rationale for inclusion of moxifloxacin and ciprofloxacin with complementary clinical benefit on a formulary rather than levofloxacin alone; it may also be more cost-effective. Ciprofloxacin has advantages over levofloxacin in the treatment of Gram-negative infections, whilst moxifloxacin has certain efficacy and ease of use advantages over levofloxacin in respiratory tract infections. To preserve the potential of FQs and to minimise the risk of resistance selection, agents with the highest in vitro activity and supportive pharmacokinetic/pharmacodynamic profiles should be used first-line, as appropriate for local guidelines and prescribing information.     

Efficacy and safety of garenoxacin tablets on clinically diagnosed atypical pneumonia: Postmarketing surveillance in Japan

We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent garenoxacin (Geninax^® Tablets 200 mg) against atypical pneumonia.Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients.1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain).2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively.In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice.