A meta-analysis for Lianhua Qingwen on the treatment of Coronavirus disease 2019 (COVID-19)

BackgroundTraditional Chinese medicine (TCM) has been proven to played a great important role on the treatment of COVID-19. As one of the drugs recommended in Chinese guidelines, Lianhua Qingwen Granules or Capsules (LQ) are widely used.This systematic review and meta-analysis amis to evaluate the clinical efficacy of LQ on the treatment of COVID-19.MethodsSeven databases (PubMed, EMBASE, CENTRAL, CNKI, VIP, CBM and Wanfang) were searched to include all appropriate clinical trials that explore the efficacy of LQ on the treatment of COVID-19.ResultA total of 3 trials including 245 COVID-19 patients were eventually enrolled.Compared with the control group,the LQ group showed great significant difference on reducing the rate of clinical change to severe or critical condition[RR = 0.38, 95 %CI (0.17,0.85), P < 0.05]and the fever time (SMD =-0.57,95 %CI (-0.96,-0.17), P<0.05),as well as the significant improvement on the disappearance rate of the clinical symptoms: fever [RR = 1.36,95 %CI (1.14,1.61), P < 0.05],cough[RR = 1.99,95 %CI (1.39,2.86), P < 0.05],fatigue[RR = 1.52,95 %CI (1.15,2.01), P < 0.05] and anhelation [RR = 4.18,95 %CI (1.99,8.81), P < 0.05], but no significance on expectoration[RR = 2.46,95 %CI (0.81,7.51), P < 0.05].ConclusionThe clinical application of LQ on the treatment of COVID-19 has significant efficacy in improving clinical symptoms and reducing the rate of clinical change to severe or critical condition. Nevertheless, due to the limited quantity and quality of the included studies, more and higher quality trials with more observational indicators are expected to be published.     

A Phase I Dose Escalation Study of the Safety,Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors

Lessons Learned

• The overall safety profiles of ipilimumab 3 mg/kg and 10 mg/kg administered every 3 weeks, were consistent between Chinese patients with solid tumors in the current study and patients from previous U.S. ipilimumab monotherapy studies. No new safety signals were identified.
• The mean systemic exposures to ipilimumab (assessed by first dose area under the curve during the dosing interval and maximum serum concentration) were numerically lower in the Chinese patient population than in U.S. patients for both 3 mg/kg and 10 mg/kg doses; however, the range of serum concentrations in the Chinese and U.S. populations overlapped (3 mg/kg and 10 mg/kg), suggesting that ipilimumab pharmacokinetics was ethnically insensitive in this study.

BackgroundThis phase I, open‐label study assessed ipilimumab safety, tolerability, pharmacokinetics (PK), immunogenicity, and antitumor activity in Chinese patients with unresectable, metastatic, recurrent malignant melanoma (MM) or nasopharyngeal carcinoma (NPC).MethodsOf 39 patients enrolled, 25 received ipilimumab (11 patients received 3 mg/kg, and 14 patients received 10 mg/kg). Reasons for not receiving treatment were withdrawal of consent (3 patients), no longer meeting the criteria (10 patients), and one recorded as “other.” During the induction phase, patients received ipilimumab (3 mg/kg, i.v.), on day 1 of a 3‐week cycle, to a maximum of four doses or progressive disease (PD). During the maintenance phase at week 24, patients received ipilimumab (3 mg/kg, i.v.) on day 1 of a 12‐week cycle, to a maximum of 3 years or PD. Considering the co‐primary safety and PK endpoints, the successive dosing required nine patients with two or fewer dose‐limiting toxicities during the 42‐day observation period to proceed with a new cohort of nine patients at 10 mg/kg.ResultsIpilimumab safety and PK profiles were similar in Chinese and predominantly White populations. Ipilimumab was well tolerated. Most adverse events (AEs) were grades 1–2 and experienced by 11 patients treated with 3 mg/kg and 14 patients treated with 10 mg/kg. There were no new safety concerns. Incidence of anti‐ipilimumab antibodies was low (1 of 10 in the 3 mg/kg patients and 2 of 13 in the 10 mg/kg patients) and without safety implications. In the 3 mg/kg group, 8 of 11 patients had PD. In the 10 mg/kg group (all NPC, 0 MM patients), 11 of 14 patients had PD. Three patients had stable disease (one at 3 mg/kg and two at 10 mg/kg).ConclusionIpilimumab was well tolerated in Chinese patients, showing similar safety and PK to previous studies in predominantly White populations.     

Lipids,Lipid-Lowering Therapy,and Neuropathy: A Narrative Review

Statins, or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, are the mainstay of treatment for hypercholesterolemia as they effectively reduce LDL-C levels and risk of atherosclerotic cardiovascular disease. Apart from hyperglycemia, dyslipidemia and HDL dysfunction are known risk factors for neuropathy in people with obesity and diabetes. Although there are case reports of statin-induced neuropathy, ad hoc analyses of clinical trials and observational studies have shown that statins may improve peripheral neuropathy. However, large randomized controlled trials and meta-analyses of cardiovascular outcome trials with statins and other lipid-lowering drugs have not reported on neuropathy outcomes. Because neuropathy was not a prespecified outcome in major cardiovascular trials, one cannot conclude whether statins or other lipid-lowering therapies increase or decrease the risk of neuropathy. The aim of this review was to assess if statins have beneficial or detrimental effects on neuropathy and whether there is a need for large well-powered interventional studies using objective neuropathy end points.     

Pulmonary Functions in Patients With Chronic Neck Pain: A Case-Control Study

ObjectiveThe purpose of the study was to investigate pulmonary functions of patients with chronic neck pain and compare them with those of asymptomatic controls.MethodsThis case-control study was conducted with 25 patients with chronic neck pain (age, 26.84 ± 7.89 years) and 27 age-matched asymptomatic controls (age, 25.96 ± 7.13 years). Pulmonary function tests were performed using spirometry (Quark PFT, COSMED, Rome, Italy). Forced vital capacity (FVC), forced expiratory volume in the first second (FEV₁), forced expiratory flow at 25% to 75% vital capacity, peak expiratory flow, maximum voluntary ventilation, and the FEV₁/FVC ratio were measured and are expressed as (%) predicted value for patients with chronic neck pain and asymptomatic controls.ResultsThe chronic neck pain group had lower FEV₁ (P = .015), FVC (P = .029), forced expiratory flow at 25% to 75% vital capacity (P = .040), and maximum voluntary ventilation (P = .042) compared with asymptomatic controls; however, FEV₁/FVC (P = .470) and peak expiratory flow (P = .183) were similar in both groups.ConclusionThese results demonstrated that dynamic lung volumes were lower in patients with chronic neck pain compared with asymptomatic controls.     

青少年非自杀性自伤患者父母人格特征及认知调节情绪策略

  目的  分析青少年非自杀性自伤(non-suicidal self-injury，NSSI)患者父母人格特征、认知调节情绪策略对青少年NSSI行为的影响。  方法  选取2020年1月至2021年1月到山东第一医科大学第二附属医院、泰安市中心医院、泰安市精神病医院就诊的青少年NSSI患者为病例组(60人)，在学校、社区及医院选取健康青少年为对照组(60人)，采用中国大五人格问卷简式版、认知情绪调节问卷中文版(CERQ-C)对其父母进行问卷调查，利用Logistic回归评价青少年NSSI的影响因素。  结果  对照组父母开放性、严谨性人格得分[(40.90±6.19)(48.18±6.12)]高于病例组父母[(36.88±5.02)(44.12±6.58)](t值分别为3.90，3.50，P值均＜0.05)。对照组父母面对负性事件时在接受、积极再评价、再关注计划、积极再关注、合理分析的策略得分高于病例组父母(t值分别为3.43，3.58，2.36，5.44，3.53，P值均＜0.05)。病例组父母的神经质与合理分析(r=0.31)、灾难性(r=0.37)呈正相关；开放性与积极再关注(r=0.30)、积极再评价(r=0.27)呈正相关；接受与外向性、开放性、严谨性呈负相关(r值分别为-0.29，-0.40，-0.26)；责备他人与外向性(r=-0.35)、宜人性呈负相关(r=-0.36)；外向性与积极再关注呈负相关(r=-0.32)(P值均 < 0.05)。二元Logistic回归分析结果显示，病例组父母的经济水平、受教育年限、接受、积极再评价、合理分析、神经质、开放性、严谨性与NSSI行为呈负相关(OR值分别为0.49，0.60，0.59，0.45，0.53，0.81，0.76，0.74)，自我责难、再关注计划与青少年NSSI行为呈正相关(OR值分别为1.55，2.09)(P值均＜0.05)。  结论  青少年NSSI患者父母的人格特征、面对负性事件时的情绪调节策略影响青少年NSSI行为的发生。