Overall Incidence Of Adverse Reactions Research Articles

Minocycline in the eradication of Helicobacter pylori infection: A systematic review and meta-analysis

BACKGROUND Difficulty in obtaining tetracycline, increased adverse reactions, and relatively complicated medication methods have limited the clinical application of the classic bismuth quadruple therapy. Therefore, the search for new alternative drugs has become one of the research hotspots. In recent years, minocycline, as a semisynthetic tetracycline, has demonstrated good potential for eradicating Helicobacter pylori (H. pylori ) infection, but the systematic evaluation of its role remains lacking. AIM To explore the efficacy, safety, and compliance of minocycline in eradicating H. pylori infection. METHODS We comprehensively retrieved the electronic databases of PubMed, Embase, Web of Science, China National Knowledge Infrastructure, SinoMed, and Wanfang database as of October 30, 2023, and finally included 22 research reports on H. pylori eradication with minocycline-containing regimens as per the inclusion and exclusion criteria. The eradication rates of H. pylori were calculated using a fixed or a random effect model, and the heterogeneity and publication bias of the studies were measured. RESULTS The single-arm meta-analysis revealed that the minocycline-containing regimens achieved good overall H. pylori eradication rates, reaching 82.3% [95% confidence interval (CI): 79.7%-85.1%] in the intention-to-treat analysis and 90.0% (95%CI: 87.7%-92.4%) in the per-protocol analysis. The overall safety and compliance of the minocycline-containing regimens were good, demonstrating an overall incidence of adverse reactions of 36.5% (95%CI: 31.5%-42.2%). Further by traditional meta-analysis, the results showed that the minocycline-containing regimens were not statistically different from other commonly used eradication regimens in eradication rate and incidence of adverse effects. Most of the adverse reactions were mild to moderate and well-tolerated, and dizziness was relatively prominent in the minocycline-containing regimens (16%). CONCLUSION The minocycline-containing regimens demonstrated good efficacy, safety, and compliance in H. pylori eradication. Minocycline has good potential to replace tetracycline for eradicating H. pylori infection.

Efficacy and safety of agomelatine versus SSRIs/SNRIs for post-stroke depression: a systematic review and meta-analysis of randomized controlled trials.

Agomelatine is effective in the treatment of depression, but its effect for post-stroke depression (PSD) remains unclear. This study was conducted to compare the efficacy and safety of agomelatine versus SSRIs/SNRIs in treating PSD. We systematically searched Embase, PubMed, Cochrane Library, WanFang Data, China National Knowledge Infrastructure, and Cqvip databases for double-blind randomized controlled studies comparing the efficacy and safety of agomelatine versus SSRIs/SNRIs for PSD until December 2022. The primary efficacy endpoint was the Hamilton Depression Rating Scale (HAMD) score, and the primary safety endpoint was the incidence of overall adverse reactions. Nine studies comprising 857 patients with PSD were included. After 6-12 weeks of treatment, the HAMD score ( P  = 0.16) and the overall response rates ( P  = 0.20) in the agomelatine group were comparable to that in the SSRIs/SNRIs group. Participants treated with agomelatine achieved higher Barthel Index scores compared with the SSRIs/SNRIs group ( P  = 0.02). There was a significantly lower incidence of overall adverse reactions ( P  = 0.008) and neurological adverse reactions ( P  < 0.0001) in the agomelatine group. The efficacy of agomelatine for treating PSD is probably comparable to that of SSRIs/SNRIs, and it may improve stroke outcomes with better safety.

A comparison of the time course of action and laryngeal mask airway insertion conditions with different doses of mivacurium for day-case urologic surgery in children: a prospective cohort study.

To investigate the time course of action of different doses of mivacurium and determine the appropriate dose for laryngeal mask airway (LMA) insertion for day-case urologic surgery in children. A total of 105 patients who enrolled in this study between March 2021 and December 2021 were randomised into 3 groups: Group A (mivacurium 0.15 mg/kg, n = 35), Group B (mivacurium 0.20 mg/kg, n = 35) and Group C (mivacurium 0.25 mg/kg, n = 35). The different doses of mivacurium were injected before LMA insertion. The primary outcomes included the grading of conditions for the LMA insertion-18 score, onset time, recovery index and the duration that mivacurium was effective. Secondary outcomes included pulse oxygen saturation, mean blood pressure, heart rate and the incidence of adverse events. The score of the conditions for LMA insertion in Group A was significantly lower than in Groups C and B (p < 0.005). There was a significant difference in the onset time between Groups B and A (p < 0.005). There was no significant difference in the overall incidence of adverse reactions between these groups (p > 0.05). Anaesthesia with 0.2 mg/kg of mivacurium can effectively shorten the onset time and facilitate insertion of the LMA in children undergoing day-case urologic surgery.

Dexmedetomidine nasal administration improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing general anesthesia

ObjectiveTo investigate the improvement of perioperative sleep quality and neurocognitive impairment in elderly patients under general anesthesia by nasal administration of dexmedetomidine.MethodsOne hundred and twenty patients admitted to our hospital for various laparoscopic elective gynecological surgeries lasting more than 1 h under general anesthesia from July 2021 to March 2023 were selected. All subjects were divided into 3 groups according to the random number table method. From 21:00 to 21:30 every night from one day before to 5 days after surgery, group A was given alprazolam 0.4 mg orally; group B was given dexmedetomidine 1.5ug/kg nasal drip; group C was given saline nasal drip. All subjects were observed for general information, sleep quality, postoperative cognitive function, anxiety status, sleep quality, adverse effects and complication occurrence.ResultsThe difference in general information between the three groups was not statistically significant, P > 0.05; the sleep quality scores of the three groups on admission were not statistically significant, P > 0.05. At the Preoperative 1d, postoperative 1d, 3d and 5d, the RCSQ scores of the subjects in group A and group B were higher than those in groups C, and with the postoperative RCSQ scores of subjects in group B were higher as the time increased; the assessment of anxiety status in the three groups 1d before surgery was not statistically significant, P > 0.05. The cognitive function scores of subjects in the three groups were not statistically significant in the preoperative 1d, P > 0.05. The postoperative 1d (24.63 ± 2.23), 3d (25.83 ± 2.53), and 5d (26.15 ± 2.01) scores of the subjects in group B were higher than those in groups A and C (P < 0.05), and the subjects in group B had better recovery of postoperative cognitive function with increasing time; the occurrence of postoperative delirium (POD) in group B (12.5%) were lower on postoperative 5d than those in groups A (37.5%) and C (32.5%) (P < 0.05). There was no statistical significance in the evaluation of anxiety state of the three groups on the first day before operation (P > 0.05). The scores in group B were lower than those in group C on the postoperative 1d, 3d, 5 d (P < 0.05). The overall incidence of adverse reactions and complications in subjects in group B was 17.5% significantly lower than that in groups A and C (P < 0.05).ConclusionDexmedetomidine can effectively improve the sleep disorder of elderly general anesthesia patients, reduce the damage to their neurocognitive function and the occurrence of POD, effectively reduce the anxiety of patients and the occurrence of adverse reactions and complications, and has better sedative, improve postoperative cognitive function and anti-anxiety effects, with a high drug safety, worthy of clinical application and promotion.

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months.

The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and middle-income countries. As part of a phase III clinical trial in which infants were given three doses of primary immunization at 2, 3, and 4 months of age, this study aimed to evaluate immune persistence following primary immunization, as well as the safety and immunogenicity of a booster of the 5-dose sIPV in infants aged 18 months. Infants aged 18 months were given one booster dose of 5-dose sIPV in stage one, which was open-label. Unblinding was performed for stage two after completing primary immunization, which was randomized, blinded, and controlled; infants aged 18 months in the test group I-III, IPV group, and single-dose sIPV group were given one booster dose of 5-dose sIPV, conventional IPV, and single-dose sIPV, respectively, in stage two. This study included 1438 infants in the immune persistence and safety set and 1387 infants in the booster per-protocol set. Fourteen months after primary immunization, the seropositivity rates (≥1:8) for types 1-3 were 100%, 99.88%, and 99.53% in the 5-dose sIPV groups; 100%, 98.97%, and 97.23% in the IPV group; and 99.66%, 100%, and 99.66% in the single-dose sIPV group. A total of 30 days after booster immunization, the seropositivity rates (≥1:8) of 3 serotypes in all the groups reached 100%. The geometric mean titers of neutralizing antibodies for types 1-3 in the 5-dose sIPV group were 9962.89, 10273, and 7870.21, with geometric mean increases of 15.76, 33.15, and 24.5, compared to the pre-booster level. The overall incidence of adverse reactions was 8.97%, with fever being the most common, observed at rates of 7.1%, 5.52%, and 7.96% in the 5-dose sIPV, IPV, and single-dose groups, respectively (p = 0.4845). The 5-dose sIPV has shown promising immune persistence and robust immune response following a booster immunization, coupled with an acceptable safety profile.

The impact of neoadjuvant chemotherapy on the clinical efficacy and serum tumor marker levels in patients undergoing radical surgery for gastric cancer.

The objective of this article is to study the impact of neoadjuvant chemotherapy (NAC) on the clinical efficacy and serum tumor marker levels in patients undergoing radical surgery for gastric cancer (GC). Thirty patients who underwent routine radical surgery for GC in our hospital from January 2020 to June 2021 were included in the control group. Thirty patients who underwent radical surgery for GC after receiving NAC from July 2021 to December 2022 were included in the observation group. The treatment outcomes of the observation group were assessed and analyzed. The surgical indicators, tumor markers, Karnofsky Performance Status (KPS), and occurrence of adverse reactions were compared between the 2 groups. Comparisons were made between the 2 groups in terms of surgical duration, number of lymph node dissections, intraoperative blood loss, time to postoperative ambulation, length of hospital stay, and time to postoperative passage of flatus (P > .05). The observation group had a higher proportion of R0 resection at the surgical margin compared to the control group (P < .05). The serum tumor markers of the 2 groups were compared before treatment (P > .05). After treatment, the levels of serum carcinoembryonic antigen, alpha-fetoprotein, cancer antigen 125, and carbohydrate antigen 72-4 decreased in both groups, and the observation group showed a greater reduction in these tumor marker levels compared to the control group (P < .05). The KPS scores of the 2 groups were compared before treatment (P > .05). After treatment, the KPS scores increased in both groups, with the observation group showing a higher improvement compared to the control group (P < .05). The overall incidence of adverse reactions, including incision infection, pleural effusion, pulmonary infection, intestinal obstruction, and gastric emptying disorders, was lower in the observation group (6.67%) compared to the control group (26.67%) (P < .05). The combination of NAC with radical surgery for GC is safe and feasible. It can significantly increase the R0 resection rate, effectively improve the levels of serum tumor markers, enhance patient's quality of life, and result in fewer surgical adverse reactions.

Effective doses of ciprofol combined with alfentanil in inhibiting responses to gastroscope insertion, a prospective, single-arm, single-center study

BackgroundCiprofol is a novel intravenous sedative and anesthetic. Studies have shown that it features a rapid onset of action, a fast recovery time, slight inhibition of respiratory and cardiovascular functions, and a low incidence of adverse reactions. This study aims to explore the median effective dose (ED50) and the 95% effective dose (ED95) of ciprofol in inhibiting responses to gastroscope insertion when combined with a low dose of alfentanil, and to evaluate its safety, to provide a reference for the rational use of ciprofol in clinical practices.MethodsWe included 25 patients aged 18–64 years of either sex who underwent gastroscopy under intravenous general anesthesia, with a Body Mass Index (BMI) 18–28 kg/m2, and an American Society of Anesthesiologists (ASA) grade I or II. In this study, the dose-finding strategy of ciprofol followed a modified Dixon’s up-and-down method with an initial dose of 0.30 mg/kg and an increment of 0.02 mg/kg. Ciprofol was administered after intravenous injection of 7 µg/kg of alfentanil, and 2 min later a gastroscope was inserted. When the insertion response of one participant was positive (including body movement, coughing, and eye opening), an escalation of 0.02 mg/kg would be given to the next participant; otherwise, a de-escalation of 0.02 mg/kg would be administered. The study was terminated when negative response and positive response alternated 8 times. A Probit model was used to calculate the ED50 and ED95 of ciprofol in inhibiting responses to gastroscope insertion when combined with alfentanil. Patients’ recovery time, discharge time, vital signs and occurrence of adverse reactions were recorded.ResultsThe ED50 of single-dose intravenous ciprofol injection with 7 µg/kg of alfentanil in inhibiting gastroscope insertion responses was 0.217 mg/kg, and the ED95 was 0.247 mg/kg. Patients’ recovery time and discharge time were 11.04 ± 1.49 min and 9.64 ± 2.38 min, respectively. The overall incidence of adverse reactions was 12%.ConclusionThe ED50 of ciprofol combined with 7 µg/kg of alfentanil in inhibiting gastroscope insertion responses was 0.217 mg/kg, and the ED95 was 0.247 mg/kg. Ciprofol showed a low incidence of anesthesia-related adverse events.Trial registrationhttp://www.chictr.org.cn (ChiCTR2200061727).

Safety, immunogenicity and immune-persistence of heterologous prime-boost immunization with BBIBP-CorV and ZF2001 against SARS-CoV-2 in healthy adults aged 18 years or older

ABSTRACTBackgroundBecause SARS-CoV-2 mutations and immunity wane over time, a third dose of heterologous COVID-19 vaccine is proposed for individuals primed with inactivated COVID-19 vaccine.Research design and methodsWe conducted a single-center, open-label trial to assess the safety, immunogenicity, and immune-persistence of a heterologous BBIBP-CorV/ZF2001 prime-boost vaccination in Chinese adults. 480 participants who had been primed with two doses of BBIBP-CorV, received a third dose of ZF2001 after an interval of 3–4, 5–6, or 7–9 months.ResultsThe overall incidence of adverse reactions within 30 days after vaccination was 5.83%. No serious adverse reactions were reported. The respective geometric mean titers (GMTs) of neutralizing antibodies for 3–4, 5–6, and 7–9 months groups at baseline were 2.06, 2.02, and 2.10; which increased to 55.42, 63.45, and 62.06 on day 14; then decreased to 17.53, 23.79, and 26.73 on day 30; before finally waning to 8.29, 9.24, and 9.51 on day 180. After the booster, the three groups showed no significant differences in GMTs. GMTs were lower in older participants than younger participants.ConclusionsA heterologous BBIBP-CorV/ZF2001 prime-boost vaccination was safe and immunogenic. Prime-boost intervals did not affect the immune response. The immune response was weaker in older adults than younger adults.Clinical trial identifierNCT05205083

Adrenocorticotropic hormone combined with magnesium sulfate therapy for infantile epileptic spasms syndrome: a real-world study

Abstract Background Infantile epileptic spasms syndrome (IESS) is a serious disease in infants, and it usually evolves to other epilepsy types or syndromes, especially refractory or super-refractory focal epilepsies. Although adrenocorticotropic hormone (ACTH) is one of the first-line and effective treatment plans for IESS, it has serious side effects and is not sufficiently effective. Methods A retrospective study of the clinical outcomes of ACTH combined with magnesium sulfate (MgSO4) therapy for IESS in two hospital centers was conducted. The major outcome of the single and combined treatment was evaluated by changes in seizure frequency and improvements in hypsarrhythmia electroencephalography (EEG). To reduce the confounding bias between the two groups, we used SPSS for the propensity score matching (PSM) analysis. Results We initially recruited 1205 IESS patients from two Chinese hospitals and treated them with ACTH combined with MgSO4 and ACTH alone. Only 1005 patients were enrolled in the treatment (ACTH combined with MgSO4: 744, ACTH: 261), and both treatment plans had a more than 55% response rate. However, compared to patients treated with ACTH alone, those patients treated with ACTH combined with MgSO4 had better performance in terms of the seizure frequency and hypsarrhythmia EEG. After PSM, the two groups also showed significant differences in responder rate [70.8% (95% confidence interval, CI) = 66.7%–74.8%) vs. 53.8% (95% CI = 47.4%–60.2%), P &lt; 0.001], seizure frequency (P &lt; 0.001) and hypsarrhythmia EEG resolution (P &lt; 0.001). Notably, multivariate analysis revealed that the lead time to treatment and the number of antiseizure medications taken before treatment were two factors that may affect the clinical outcome. Patients with less than 3 months of lead time responded to the treatment much better than those with &gt; 3 months (P &lt; 0.05). In addition, the overall incidence of adverse reactions in the ACTH combined with MgSO4 group was much lower than that in the ACTH group (31.4% vs. 63.1%, P &lt; 0.001). During the treatment, only infection (P = 0.045) and hypertension (P = 0.025) were significantly different between the two groups, and no baby died. Conclusion Our findings support that ACTH combined with MgSO4 is a more effective short-term treatment protocol for patients with IESS than ACTH alone, especially for those patients with short lead times to treatment.

Overcoming the Obstacles That Prevent Identification and Treatment of Women Who Have Iron Deficiency

Background: Iron deficiency (ID) is the most common nutritional deficiency in pregnancy, in women who have menstrual periods, and among people who have had bariatric surgery. In pregnant women, iron deficiency anemia (IDA) has been associated with maternal morbidity, peripartum complications, and impaired infant development. Among all populations with IDA, common symptoms include severe fatigue, shortness of breath, and impaired concentration, with consequences including diminished work productivity and reduced quality of life. Because women have ID more frequently than men do, ID may be viewed as a driver of gender inequality. It has been a challenge to identify and treat women who have ID. The barriers to identifying these women have included (1) lack of awareness about low iron among women and their physicians, (2) lack of understanding about the difference between hemoglobin testing and iron testing, (3) inability of women to get tested without a lab test order from their physician, (4) variation in interpretation of iron saturation and ferritin test results among providers, and (5) variation in interpretability of iron saturation and ferritin tests in different patient populations. The obstacles that prevent treatment of ID with iron infusions have included (1) lack of understanding about limited efficacy and tolerability of oral iron supplements, (2) lack of awareness about the safety, efficacy, and tolerability of iron infusions, (3) lack of patient access to infusion clinics that are capable of doing iron infusions promptly and safely, (4) lack of physician comfort writing iron infusion orders, and (5) variation in health plan coverage of iron infusion costs. Methods: We developed a system to overcome the barriers to identifying women who have ID and the obstacles that prevent women from receiving iron infusions. Our system included education of women's health physician practices, delivered by a clinician-led education team, as well as print and social media advertisements. Patients who were referred to our practice were promptly evaluated online in telemedicine hematology consults provided by one hematologist physician and a well-trained team of advanced practice providers (APP's). This enabled consistent interpretation of patients' symptoms and lab test results, as well as thorough explanations about ID and iron infusions. To overcome the obstacle of health plan coverage, we created a team of well-trained iron infusion coordinators to promptly obtain health plan authorization and troubleshoot lack of coverage. To do the infusions, we created a network of dedicated iron infusion centers with well-trained nurses and supervising APP's. We established protocols to address infusion reactions, and workflows to enable several women to safely receive iron infusions at the same time. Results: 6,101 patients were evaluated online in hematology telemedicine consults between June 2020 and June 2023, with a 5-10% month-to-month increase in referrals. Of these patients, 3,076 patients who had iron deficiency received a total of 7,246 iron infusions over two years. 1,383 (45%) of these were pregnant women. The iron formulations infused were partly determined by the patient's health plan coverage. These included Ferric Derisomaltose (1,055 infusions), Ferumoxytol (1,481 infusions), Iron Sucrose 200 mg doses (n=3,962 infusions), Iron Sucrose 400 mg doses (n=723 infusions), and Ferric Carboxymaltose (20 infusions). Our system enabled prompt patient evaluations because of the flexibility of doing telemedicine patient visits. Some patients were seen online the day after they were referred. The average time from a televisit to an iron infusion was nine days, with some patients receiving iron infusions the day after their televisit. Our retrospective chart review demonstrated that 94% of patients who received iron infusions reported improvement of one or more ID-related symptoms (shortness of breath, fatigue, or ice craving/ice chewing). The overall incidence of adverse reactions occurring during infusions was 4.5%, with some variation among the iron formulations. Conclusions: Our hematology practice has overcome barriers to identifying women who have iron deficiency, and obstacles that prevent treatment with iron infusions. The solution to this problem involves educating women and women's health providers, and creating a system to plan and perform iron infusions promptly and safely.

Safety and immunogenicity of the COVID-19 mRNA vaccine CS-2034: A randomized, double-blind, dose-exploration, placebo-controlled multicenter Phase I clinical trial in healthy Chinese adults

The novel coronavirus pneumonia (COVID-19) is an infectious disease caused by the infection of a novel coronavirus known as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which has resulted in millions of deaths. We aimed to evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine (CS-2034, CanSino, Shanghai, China) in adults without COVID-19 infection from China. This is a multicenter Phase I clinical trial with a randomized, double-blinded, dose-exploration, placebo-controlled design. The trial recruited 40 seronegative participants aged 18-59 years who had neither received any COVID-19 vaccine nor been infected before. They were divided into a low-dose group (administered with either the CS-2034 vaccine containing 30μg of mRNA or a placebo of 0.3ml type 5 adenovirus vector) and a high-dose group (administered with either the CS-2034 vaccine containing 50μg of mRNA or a placebo of 0.5ml type 5 adenovirus vector). Participants were randomly assigned in a 3:1 ratio to receive either the mRNA vaccine or a placebo on days 0 and 21 according to a two-dose immunization schedule. The first six participants in each dosage group were assigned as sentinel subjects. Participants were sequentially enrolled in a dose-escalation manner from low to high dose and from sentinel to non-sentinel subjects. Blood samples were collected from all participants on the day before the first dose (Day 0), the day before the second dose (day 21), 14 days after the second dose (day 35), and 28 days after the second dose (day 49) to evaluate the immunogenicity of the CS-2034 vaccine. Participants were monitored for safety throughout the 28-day follow-up period, including solicited adverse events, unsolicited adverse events, adverse events of special interest (AESI), and medically attended adverse events (MAE). This report focuses solely on the safety and immunogenicity analysis of adult participants aged 18-59 years, while the long-term phase of the study is still ongoing. This study is registered at ClinicalTrials.gov, NCT05373485. During the period from May 17, 2022, to August 8, 2022, a total of 155 participants aged 18-59 years were screened for this study. Among them, 115 participants failed the screening process, and 40 participants were randomly enrolled (15 in the low-dose group, 15 in the high-dose group, and 10 in the placebo group). Throughout the 28-day follow-up period, the overall incidence of adverse reactions (related to vaccine administration) in the low-dose group, high-dose group, and placebo group was 93.33% (14/15), 100.00% (15/15), and 80.00% (8/10), respectively. There was a statistically significant difference in the incidence of local adverse reactions (soreness, pruritus, swelling at the injection site) among the low-dose group, high-dose group, and placebo group (P=0.002). All adverse reactions were mainly of severity grade 1 (mild) or 2 (moderate), and no adverse events of severity grade 4 or higher occurred. Based on the analysis of Spike protein Receptor Binding Domain (S-RBD) IgG antibodies against the BA.1 strain, the seroconversion rates of antibodies at day 21 after the first dose were 86.67%, 93.33%, and 0.00% in the low-dose group, high-dose group, and placebo group, respectively. The geometric mean titer (GMT) of antibodies was 61.2(95%CI 35.3-106.2), 55.4(95%CI 36.3-84.4), and 15.0(95%CI 15.0-15.0), and the geometric mean fold increase (GMI) was 4.08(95%CI 2.35-7.08), 3.69(95%CI 2.42-5.63), and 1.00(95%CI 1.00-1.00) for each group. At day 28 after the full vaccination, the seroconversion rates of antibodies were 100.00%, 93.33%, and 0.00%, and the GMT of antibodies was 810.0(95%CI 511.4-1283.0), 832.2(95%CI 368.1-1881.6), and 15.0(95%CI 15.0-15.0), and the GMI was 54.00(95%CI 34.09-85.53), 55.48(95%CI 24.54-125.44), and 1.00(95%CI 1.00-1.00) for each group, respectively. Based on the analysis of CD3+/CD4+ cell cytokine response, the percentages of IL-2+, IL-4+, IFN-γ+, and TNF-α+ cells increased after 14 days and 28 days of full vaccination in both the low-dose group and high-dose group. The increase was most pronounced in the high-dose group. At day 28 after the full vaccination, both the low-dose and the high-dose CS-2034 vaccine were able to induce the production of high titers of S-RBD IgG antibodies against the BA.1 strain. Adverse reactions in the low-dose and high-dose groups were mainly of severity grade 1 or 2, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine.

Analgesic and safety analysis of dexmedetomidine combined with ropivacaine in ultrasound-guided brachial plexus nerve block

Purpose: To investigate analgesic effect and safety of dexmedetomidine combined with ropivacaine in ultrasound-guided brachial plexus block in intercostal space.Methods: A total of 90 patients were scheduled to undergo upper limb surgery and divided into control and study groups, respectively. Patients in control group were given ropivacaine nerve block, while those in study group were given ropivacaine combined with dexmedetomidine mixture nerve block. The efficiency of sensory and motor block, secondary evaluation of block effect, visual analogue scale (VAS) scores at different postoperative moments, remedial analgesia and adverse reactions were compared between the two groups after 30 min of drug injection.Results: The success rate of sensory block was not significantly different between control group (91.11 %) and study group (93.33 %; χ2 = 0.155, p &gt; 0.05) but success rate of the motor block was significantly higher in study group (93.33 %) than in control group (71.11 %; χ2 = 7.601, p &lt; 0.05). Compared with control group, onset of sensory block and motor block were significantly shorter in study group, while the duration of sensory block and motor block was significantly longer (p &lt; 0.05). The VAS scores at 12, 24, and 48 h postoperatively were significantly lower in study group than control group (p &lt; 0.05). The number of self-administered analgesia, number of patients, dose used, and overall incidence of adverse reactions in study group were significantly lower than in control group (p &lt; 0.05).Conclusion: Dexmedetomidine and ropivacaine, when administered together, have a significant anesthetic effect during nerve block, which is safe and enhances their analgesic effect. However, the mechanism of improving analgesic effect of the combined plan, using a larger number of samples should be further investigated.

Lyophilized recombinant human brain natriuretic peptide for chronic heart failure: Effects on cardiac function and inflammation.

Chronic heart failure (CHF) is a serious and prevalent condition characterized by impaired cardiac function and inflammation. Standard therapy for CHF has limitations, prompting the exploration of alternative treatments. Recombinant human brain natriuretic peptide (BNP) has emerged as a potential therapy, with evidence suggesting that it can improve cardiac function and reduce inflammation in patients with CHF. However, further research is required to determine the efficacy and safety of lyophilized recombinant human BNP in CHF patients and its impact on microinflammatory status. This study aimed to investigate the effects of lyophilized recombinant human BNP therapy on CHF patients' cardiac function and microinflammatory status. To investigate the effects of freeze-dried recombinant human BNP therapy on cardiac function and microinflammatory status in patients with CHF. In total, 102 CHF patients admitted to our hospital from January 2021 to January 2022 were randomly assigned to control and observation groups (n = 51 patients/group). The control patients were treated with standard HF therapy for 3 d, whereas the observational patients were injected with the recombinant human BNP for 3 d. Clinical efficacy, inflammatory factor levels, myocardial damage, cardiac function before and after the treatment, and adverse reactions during treatment were compared between the two groups. The overall clinical efficacy was higher in the observation group than in the control group. Compared with baseline, serum hypersensitive C-reactive protein, N-terminal proBNP, and troponin I level, and physical, emotional, social, and economic scores were lower in both groups after treatment, with greater reductions in levels and scores noted in the observation group than in the control group. The overall incidence of adverse reactions in the observation group was not significantly different compared with that in the control group (P > 0.05). Freeze-dried recombinant human BNP therapy can improve heart function and enhance microinflammatory status, thereby improving overall quality of life without any obvious side effects. This therapy is safe and reliable.

[Safety evaluation of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older].

Objective: To evaluate the safety of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older. Methods: From November 2021 to May 2022, eligible participants aged 60 years and older were recruited in Taizhou City, Jiangsu Province, China, and a total of 2 461 participants were ultimately enrolled in this study. Each participant simultaneously received one dose of quadrivalent influenza split virion vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine. The safety was observed within 28 days after vaccination. Safety information was collected through voluntary reporting and regular follow-ups. Results: All 2 461 participants completed the simultaneous administration of both vaccines and the safety follow-ups for 28 days after vaccination. The mean age of the participants was (70.66±6.18) years, with 54.61% (1 344) being male, and all participants were Han Chinese residents. About 22.51% (554) of the participants had underlying medical conditions. The overall incidence of adverse reactions within 0-28 days after simultaneous vaccination was 2.07% (51/2 461), mainly consisting of Grade 1 adverse reactions [1.83% (45/2 461)], with no reports of Grade 4 or higher adverse reactions or vaccine-related serious adverse events. The incidence of local adverse reactions was 0.98% (24/2 461), primarily presenting as pain at the injection site [0.93% (23/2 461)]. The incidence of systemic adverse reactions was 1.42% (35/2 461), with fever [0.85% (21/2 461)] being the main symptom. In the group with underlying medical conditions and the healthy group, their overall incidence of adverse reactions was 2.53% (14/554) and 1.94% (37/1 907), respectively. The incidence of local adverse reactions in the two groups was 1.62% (9/554) and 0.79% (15/1 907), respectively, and the incidence of systemic adverse reactions was 1.44% (8/554) and 1.42% (27/1 907), respectively, with no statistically significant differences between them (all P>0.05). Conclusion: It is safe for adults aged 60 years and older to receive quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine at the same time.

Effects of Multidisciplinary Specialized Nursing Care on the Short and Long-term Postoperative Quality of Life in Patients with Pancreatic Cancer: A Randomized Controlled Trial

Objective: To analyze the effects of multidisciplinary specialized nursing care on the short and long-term postoperative quality of life in patients with pancreatic cancer. Methods: This is a randomized controlled trial. In this study, 88 patients with pancreatic cancer who were treated at our hospital between January 2021 and January 2022 were recruited and allocated 1:1 either to receive into routine nursing care (n=44, routine group) or interdisciplinary specialist nursing care (n=44, study group). The outcome measures in both groups included surgery-related indices, short and long-term quality of life, and adverse responses. Results: There were no participants who dropped out of this study due to treatment intolerance, nor were there any additional participants. Patients in the study group had significantly shorter recovery time from gastrointestinal function, bed rest and hospital stay than those in the conventional group (P&lt;0.05). Before the intervention, there was no significant difference in the quality of life between the two groups (P&gt;0.05); 3 months and 1 year after the intervention, the quality of life of patients in the study group was higher than that of patients in the conventional group (P&lt;0.05). The overall incidence of adverse reactions was significantly lower in the study group than in the conventional group (P&lt;0.05). Conclusion: Multidisciplinary specialized nursing care produces an ideal clinical outcome for postoperative patients with pancreatic cancer. It substantially reduces recovery time, boosts short and long-term postoperative quality of life, and diminishes the incidence of adverse reactions in patients. This protocol merits clinical application.

Clinical effect of modified electroconvulsive therapy on schizophrenia.

To investigate the clinical efficacy of modified electroconvulsive therapy (MECT) in patients with schizophrenia and provide a reference for the selection of safe and effective treatment options in clinical practice. A total of 200 patients with schizophrenia, who were admitted to Wuhan Wudong Hospital Psychiatric Hospital from January 2019 to December 2020, were selected as the study subjects. They were divided into an observation group and a control group (100 cases in each group) according to a random number table. The control group was treated with conventional antipsychotics (risperidone and aripiprazole), and the observation group was given conventional antipsychotics (risperidone and aripiprazole) with MECT. After 8 weeks, the clinical efficacy, cognitive and memory functions and the occurrence of adverse reactions between the two groups were compared. The total clinical effective rate of the observation group was 90%, which was higher than that of the control group (74%), and the difference was statistically significant (p<0.05). The Wisconsin Card Sorting Test results of the observation group were better than those of the control group, and the cognitive function of the observation group was better than that of the control group (p<0.05). The Wechsler Adult Intelligence Scale-Fourth Edition index of the observation group was higher than that of the control group, and the memory function of the observation group was better than that of the control group (p<0.05). The overall incidence of adverse reactions in the observation group was lower than that in the control group, and the difference was statistically significant (p=0.001). The application of MECT in patients with schizophrenia can produce a good clinical curative effect, which is beneficial to the improvement and promotion of memory and cognitive functions in patients. Since the occurrence of adverse reactions is controllable, and safety is ideal, MECT has value in clinical application.

Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months

To evaluate the safety, immunogenicity, and lot-to-lot consistency of Sabin strain-based inactivated polio vaccine (sIPV) in a five-dose vial presentation. Stage I was an open-label safety observation, in which 72 healthy subjects (including 24 adults, children, and infants each) were given one or three doses of the five-dose vial sIPV; stage II was a randomized, blinded, and positive-control study, in which 1500 infants were randomized at the ratio of 1: 1: 1: 1: 1 into five groups to receive either three doses of the five-dose sIPV three lots, a conventional inactivated poliovirus vaccine, or a single-dose sIPV as controls, for primary immunization. Safety, immunogenicity, and lot-to-lot consistency were assessed. Among 1456 subjects who completed the primary immunization, the geometric mean titer ratios of types 1, 2, and 3 of each pair of lots were all within the equivalence criteria margin (0.67-1.50). The seroconversion rates of types 1, 2, and 3 in the combined test group were 98.02%, 94.07%, and 98.77%, respectively, which were noninferior to both control groups. The overall incidence of adverse reactions was 29.68% and erythema was the most common adverse reaction with incidences of 10.47%,9.33%, and 9.73% in the combined test group and control groups (P >0.05). The five-dose sIPV demonstrated good safety, immunogenicity, and lot-to-lot consistency.

Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac®) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China

ObjectiveTo evaluate the safety of primary immunization using CoronaVac® among population aged 3 years and above in a large-scale use. MethodA multi-center open-label study was carried out in 11 provinces of China. Individuals aged 3 years and older who had no history of COVID-19 vaccination or had received only one dose of CoronaVac® were enrolled in this study. Adults and elderly with or without underlying medical conditions(UMCs) were also recruited. Eligible participants received one or two doses of CoronaVac® with an interval of 28 days. Demographic information, vaccination and the occurrence of adverse events were recorded by participants or guardians using data collection system designed for this study. All adverse events occurred within 6 months after the second dose of vaccination were collected. The incidence of adverse events that cannot be ruled out as being caused by the vaccine were calculated to assess the safety of CoronaVac®. This study is registered with ClinicalTrials. Gov (NCT04911790 and NCT04992208). ResultsA total of 162,691 participants have been included in this study and 89.50 % had finished primary immunization. Among adults and elderly, people with UMCs accounted for 25.85 %, with the top five disease being hypertension, diabetes, chronic gastritis, coronary heart disease(CHD) and kidney stone. The overall incidence of adverse reactions (ARs) within 6 months after the second vaccination was 2.70 %, with incidence for children and adolescents, adults, and elderly being 2.03 %, 3.46 %, and 1.90 %, respectively. Most ARs were mild (grade 1). Pain at the injection sites, fatigue, induration/swelling, and headache were the most common symptoms, occurring in 1.64 %, 0.46 %, 0.31 % and 0.24 %, respectively. No serious adverse events related to vaccines were reported. No adverse events of special interest (AESIs) were identified.For children and adolescents, children aged 3–5 years had the highest incidence of ARs of 3.29 %.The incidence of ARs among those aged 18 years and older with and without UMCs were 2.81 % and 2.99 %, respectively, with no statistical significance between two groups(P = 0.089). And people with coronary heart disease had higher AR incidence compared to those with other UMCs, but the most common symptoms was pain at the injection site. ConclusionCoronaVac® is safe in a large-scale use and shows well-tolerance for children and adolescents and people with underlying medical conditions. Further studies need to be conducted to explore the relation of ARs incidence to age or different kinds of UMCs.

[Efficacy and safety of inactivated novel coronavirus vaccine inoculation in patients with chronic hepatitis B].

Objective: To explore the safety of inactivated novel coronavirus vaccine inoculation and the fluctuating neutralizing antibody in patients with chronic hepatitis B (CHB). Methods: Retrospective and prospective epidemiological research methods were employed. 153 CHB patients who visited the Department of Infectious Diseases at the First Hospital of Shanxi Medical University from September 2021 to February 2022 were selected as the research subjects. Information on vaccination-related adverse reactions was collected. Colloidal gold immunochromatography was used to identify neutralizing antibodies in the body after 3-6 months of vaccination. Statistical analysis was performed using the χ2-test or Fisher's exact test. Results: The positive rates of neutralizing antibodies after inactivated novel coronavirus vaccine inoculation in 153 patients with CHB were 45.50%, 44.70%, 40.00% and 16.20%, respectively, at 3, 4, 5, and 6 months. The neutralizing antibody concentrations were 10.00 (2.95, 30.01) U/ml, 6.08 (3.41, 24.50) U/ml, 5.90 (3.93, 14.68) U/ml, and 1.25 (0.92, 3.75) U/ml, respectively. The difference was not statistically significant (P>0.05) when the neutralizing antibody positivity rates in hepatitis B virus (HBV) DNA-negative and positive patients and HBeAg-negative and positive patients at different time points were compared. The overall incidence of adverse reactions following vaccination was 18.30%. Pain at the site of inoculation and fatigue were the main presentations, and no serious adverse reactions occurred. Conclusion: CHB patients, when inoculated with an inactivated novel coronavirus vaccine, can produce neutralizing antibodies, which can stay at certain levels for 3, 4, and 5 months. However, the neutralizing antibody level gradually decreases over time, and the decrease is remarkable at 6 months. So, it is recommended to boost vaccinations at an appropriate time. Additionally, the results of the study suggest that HBV replication status has little effect on the production of neutralizing antibodies in CHB patients with relatively stable liver function, which means the inactivated novel coronavirus vaccine has a good safety profile.

Adverse reactions to inactivated COVID-19 vaccination in patients with chronic liver disease: The effect of anxiety

ABSTRACT Studies have shown that patients with chronic liver disease are at a higher risk of contracting novel coronavirus pneumonia than healthy individuals, and many guidelines state that patients with chronic liver disease should be prioritized for COVID-19 vaccination, but there are a few studies on its safety in CLD patients. We aimed to evaluate the safety of the inactivated COVID-19 vaccine in patients with chronic liver disease, and the effect of anxiety on adverse reactions. A questionnaire survey for self-administered post-vaccination adverse reaction monitoring was conducted from June 17, 2021, to August 11, 2021, in patients with chronic liver disease attending a tertiary care hospital in Taizhou, China. We analyzed the data from of a total of 160 participants who scanned the QR code on social media to respond to the questionnaire. The overall incidence of adverse reactions after COVID-19 vaccination in patients with chronic liver disease was 44.4% (71/160), and the most common adverse reaction was local injection site reaction, accounting for 80.3% of adverse reactions (57/71). No serious adverse reactions were reported. Approximately 53.1% of the patients had anxiety about vaccination, and 51.8% of those who felt anxious reported adverse reactions. The safety of COVID-19 vaccination in patients with chronic liver disease is good, and there is a strong association between adverse reactions and vaccine anxiety. Pre-vaccination education for patients with vaccine anxiety and psychological counseling may reduce reports of adverse reactions and improve patients’ confidence in the vaccine.