Finally, an FDA Approval for an Immunization Against COVID-19: Hope on the Horizon

Objective Coronavirus disease 2019 (COVID-19) is a respiratory infection known as severe respiratory acute syndrome coronavirus 2 (SARS-CoV-2). The purpose of this manuscript is to review information leading to the Food and Drug Administration (FDA) approval of the Pfizer-BioNTech COVID-19 Vaccine. Data Sources A literature search was conducted of PubMed and clinicaltrials.gov (August 2018—October 2021) to identify trials related to the FDA approval of Pfizer-BioNTech COVID-19 Vaccine. Study selection and data extraction Trials included are those the FDA deemed significant and accurate enough to be included in the FDA approval process. Information not recognized by the Centers of Disease Control and Prevention (CDC) nor FDA is omitted to not add to further confusion and misinformation. Data synthesis In persons 16 years or older without evidence of prior SARS-CoV-2 infection, a total of 77 COVID-19 cases (0.39%) in the vaccine group from 7 days onward after the second dose vs 833 (4.1%) in the placebo group (Vaccine efficacy 91.1%; 95% confidence interval [CI]: 88.8-93.1). According the CDC definition of severe infection, there were no severe infections in the vaccine group 7 days and onward after the second dose, compared to 31 (0.15%) in the placebo group (Vaccine efficacy 100%; 95% CI: 87.6-100.0). Relevance to Patient Care and Clinical Practice: Reduction of infection by SARS-COV-2 is a top priority in protecting the health of all people and the official approval of the Pfizer-BioNTech vaccination may improve this goal. Conclusions Data available show a high efficacy rate of preventing SARS -CoV-2 with relatively low rates of ADE after full vaccination with Pfizer-BioNTech COVID-19 vaccine.

Ultrasound-Guided Percutaneous Thermal Ablation of Hepatic Focal Nodular Hyperplasia——A Multicenter Retrospective Study

Background and Aim: To evaluate the clinical effect of ultrasound (US)-guided percutaneous thermal ablation of hepatic focal nodular hyperplasia (FNH).Methods: A retrospective analysis of the clinical data of patients undergoing US-guided percutaneous thermal ablation of FNH from November 2008 to August 2021 at five medical centers in China was conducted.Results: A total of 53 patients were included (26 males and 27 females). The mean age was 35.1 ± 10.8 years. Sixty-five lesions (46 solitary cases and 7 cases with multiple lesions) were included, 70.8% (46/65) of which were located in the right liver lobe. The mean tumor length was 2.9 ± 1.5 cm. All patients successfully completed the ablation treatment. Immediate postoperative imaging showed that the primary technical success rate was 94.3% (50/53). Two patients underwent ablation 3 and 6 months after the primary ablation, and the secondary technical success rate was 100% (2/2). The incidence of complications was 3.8% (2/53). Imaging follow-up was conducted regularly after ablation, and no residual lesion enlargement or tumor recurrence was observed during the follow-up period. The technique efficacy rate was 98.1% (52/53).Conclusion: US-guided percutaneous thermal ablation is a safe and effective treatment for FNH of the liver.

Safety and efficacy of the Novavax vaccine—a narrative review

Mass vaccination programs are a public health priority for managing the global coronavirus disease (COVID-19) pandemic. The NVX-CoV2373 vaccine is being developed by Novavax. It consists of a SARS-CoV-2 spike glycoprotein subunit (NVX-CoV2373), which has been shown to have structural stability with pH and temperature perturbations, and the saponin-based Matrix-M adjuvant, which is added to enhance the B- and T-cell-mediated immune response. Animal studies in mice, olive baboons, and cynomolgus macaques demonstrated the potential of this vaccine in protecting the respiratory tract against COVID-19. Subsequent phase 1 and 2 trials then confirmed its safety and the dose-sparing potential of Matrix-M. The results led to the use of a low dose (5 μg) of NVX-CoV2373 in phase 3 trials. In a phase 3 trial involving 14,039 participants, the vaccine efficacy rate was 89.7% (prevention of symptomatic infection). Local and systemic adverse events were mild and self-limiting; commonly reported symptoms included injection-site pain and tenderness, headache, myalgia, and fatigue. A subgroup study confirmed the safety and efficacy of co-administering the NVX-CoV2373 vaccine and the seasonal influenza vaccine. Overall, the vaccine has been found to be safe and effective, meeting the minimum vaccine efficacy rate of 50% to be considered for COVID-19 vaccine emergency use listing approval. Keywords: Clinical trials, COVID-19, COVID-19 vaccine, immunology

Efficacy and Safety of Mucopolysaccharide Polysulfate Cream for Non-Exudative Eczema: A Systematic Review and Meta-Analysis

Background: Mucopolysaccharide polysulfate (MPS) cream as a moisturizer is widely applied to treat eczema, and a lot of clinical trials have demonstrated its efficacy and safety. However, there is no further research to collect and analyze these studies.Objective: This meta-analysis aimed to assess the efficacy and safety of MPS cream as monotherapy or add-on therapy for non-exudative eczema.Methods: Ten databases were searched to identify the eligible randomized controlled trials (RCTs) from their inception to July 31, 2021. Revman 5.3 software was used for the meta-analysis.Results: A total of eligible 20 studies were included. Among the 20 studies, 2 studies compared MPS cream with other moisturizers, 14 compared MPS cream plus topical corticosteroids (TCS) with TCS alone, and 4 compared with MPS cream plus tacrolimus ointment with tacrolimus ointment alone. The pooled results demonstrated that MPS cream had a higher total efficacy rate [Risk ratio (RR) 1.21, 95% CI: 1.12 to 1.30, P < 0.00001], a lower recurrence rate (RR 0.44, 95% CI: 0.26 to 0.74, P = 0.002) and a lower pruritus score [mean difference (MD) −1.78, 95% CI: −2.16 to −1.40, P < 0.00001] than urea cream or vaseline ointment. Moreover, in comparison with TCS or tacrolimus ointment alone, the combination treatment performed better in terms of total efficacy rate, total symptom score, recurrence rate, and pruritus score. For safety, the skin adverse events were mild, and MPS cream as monotherapy or add-on therapy did not increase the risk of skin adverse events.Conclusions: MPS cream as monotherapy or add-on therapy could provide a good effect for treating non-exudative eczema with mild and tolerable skin adverse events. However, due to the suboptimal quality of the included studies, high-quality and large-sample RCTs are needed in the future for update or validation.Systematic Review Registration: PROSPERO (https://www.crd.york.ac.uk/PROSPERO/), identifier: CRD42021265735.

A Systematic Review and Meta-Analysis of the Effects of Herbal Medicine Buyang Huanwu Tang in Patients with Poststroke Fatigue

Poststroke fatigue (PSF) is reported to occur in 30%–72% of all patients with stroke. PSF not only is a symptom of stroke but has also been reported to adversely affect the prognosis of patients with stroke. However, no treatment has had a significant effect on PSF. In East Asian countries, several herbal medicines have been used to treat stroke, with Buyang Huanwu Tang (BHT) being the most common. This review aimed to evaluate the efficacy and safety of BHT for PSF. A literature search was conducted on MEDLINE, CENTRAL, Scopus, CiNii, CNKI, OASIS, NDSL, and KTKP databases for randomized controlled trials that evaluated the effects and safety of BHT on PSF. Six studies (n = 427) were included. The overall methodological quality of these studies was relatively low. In the adjunctive BHT group, the meta-analysis indicated statistically significant improvements in the Fatigue Severity Scale score (mean difference −1.49, 95% CI [−2.25, −0.73]) and total clinical efficacy rate (risk ratio 0.11, 95% CI [0.03, 0.41]) compared to those in the nonherbal group. Adverse events were only reported in one study, and no serious adverse events occurred. BHT administration might be effective in the treatment of PSF. We were unable to draw definitive conclusions owing to the limitations of the included studies. The trial is registered with CRD42019130178 in PROSPERO.

Efficacy and safety of single-step transepithelial photorefractive keratectomy with the all-surface laser ablation SCHWIND platform without mitomycin-C for high myopia: A retrospective study of 69 eyes

Background Studies suggest that transepithelial photorefractive keratectomy (TransPRK) with the all-surface laser ablation (ASLA)-SCHWIND platform is effective and safe for both low-moderate myopia and high myopia. In most studies, mitomycin-C is administered immediately after surgery to prevent corneal opacification (haze), which is a significant complication of photorefractive keratectomy in general. However, there is evidence that adjuvant mitomycin-C induces endothelial cytotoxicity. Moreover, a recent study showed that omitting adjuvant mitomycin-C did not increase haze in low-moderate myopia. The present case-series study examined the efficacy, safety, and haze rates of eyes with high myopia that underwent ASLA-SCHWIND TransPRK without adjuvant mitomycin-C. Methods All consecutive eyes with high myopia (≤-6 D) that were treated in 2018–2020 with the SCHWIND Amaris 500E® TransPRK excimer laser without adjuvant mitomycin-C in a tertiary-care hospital (France) and were followed up for 6 months were identified. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), and spherical equivalent (SE) were recorded before and after surgery. Postoperative haze was graded using the 4-grade Fantes scale. Efficacy rate (frequency of eyes with 6-month UCVA ≤0.1 logMAR), safety rate (frequency of eyes that lost <2 BSCVA lines), predictability (frequency of eyes with 6-month SE equal to target SE±0.5 D), efficacy index (mean UCVA at 6 months/preoperative BSCVA), and safety index (BSCVA at 6 months/preoperative BSCVA) were computed. Results Sixty-nine eyes (38 patients) were included. Mean preoperative and 6-month SE were -7.44 and -0.05 D, respectively. Mean 6-month UCVA and BSCVA were 0.00 and -0.02 logMAR, respectively. Efficacy rate and index were 95.7% and 1.08, respectively. Safety rate and index were 95.7% and 1.13, respectively. Predictability was 85.5%. Grade 3–4 haze never arose. At 6 months, the haze rate was zero. Conclusions ASLA-SCHWIND TransPRK without mitomycin-C appears to be safe as well as effective and accurate for high myopia.

Chinese Medicine for Coronavirus Disease 2019 (COVID-19): A GRADE-Assessed Systematic Review and Meta-Analysis

Coronavirus disease 2019 (COVID-19) has caused enormous public health and socioeconomic burden globally. This study aims to evaluate the efficacy and safety of Chinese medicine (CM) against COVID-19. Eleven databases were searched on April 30, 2021, and 52 studies were included. The RoB 2.0, ROBINS-I, and GRADE tools were employed to assess the risks and evidence grades. The findings with moderate certainty in GRADE showed that compared with routine treatment (RT), Lianhua Qingwen granules (LHQW) adjunctive to RT showed significantly improved efficacy rate (relative risk (RR) = 1.19, 95% confidence interval (CI): [1.09, 1.31]), febrile score (standard mean difference (SMD) = −1.21, 95% CI: [−1.43, −0.99]), and computerized tomography (CT) lung images (RR = 1.23, 95% CI: [1.10, 1.38]); Qingfei Paidu decoction (QFPD) plus RT significantly shortened the length of hospital stay (SMD = −1.83, 95% CI: [−2.18, −1.48]); Feiyan Yihao formula (FYYH) plus RT significantly improved the clinical efficacy rate (RR = 1.07, 95% CI: [1, 1.15]), febrile time (SMD = −0.02, 95% CI: [−0.23, 0.19]), and time to negative PCR test for COVID-19 (SMD = −0.72, 95% CI: [−0.94, −0.51]). Adjunctive effects of CM with lower certainty of evidence were found, including the improvements of symptoms, laboratory findings, and mortality. No or mild adverse events were observed in most of the studies. In conclusion, the current evidence indicates that CM formulae, particularly LHQW, QFPD, and FYYH, have adjunctive effects on the standard treatment of COVID-19.

Resection of extrahepatic bile ducts with partial hepatectomy for treating intra- and extrahepatic hepatolithiasis

Background To evaluate the efficacy and safety of our new surgical procedures for primary intra- and extrahepatic hepatolithiasis. Hepatolithiasis is an intractable disease with frequent recurrences. Methods From 1996 to 2005, 142 patients with intrahepatic and/or extrahepatic hepatolithiasis treated with the conventional surgical methods were included as the control group, while 128 consecutive patients treated with new surgical methods from 2006 to 2015 were included as the observation group. The new surgical procedures included a comprehensive intraoperative exploration of the bile ducts, focusing on the structure and function of the hilar bile duct and duodenal papilla, exploration of the affected liver, and bile culture. Results The observation group had a significantly higher complete stone clearance rate than the control group (100% vs. 65.96%). The observation group had significantly lower incidences of cholangitis and bile duct stones, as well as a higher excellent and good long-term surgical efficacy rate (86.24% vs. 52.73%). Multivariate Cox analysis showed that the control group had a higher risk for fair + poor efficacy than the observation group (HR: 8.47). Conclusions Our new surgical procedures are safe and can provide a good long-term efficacy for treating primary hepatolithiasis intra- and extrahepatic hepatolithiasis.

Deep-Data-Driven Neural Networks for COVID-19 Vaccine Efficacy

Vaccination strategies to lessen the impact of the spread of a disease are fundamental to public health authorities and policy makers. The socio-economic benefit of full return to normalcy is the core of such strategies. In this paper, a COVID-19 vaccination model with efficacy rate is developed and analyzed. The epidemiological parameters of the model are learned via a feed-forward neural network. A hybrid approach that combines residual neural network with variants of recurrent neural network is implemented and analyzed for reliable and accurate prediction of daily cases. The error metrics and a k-fold cross validation with random splitting reveal that a particular type of hybrid approach called residual neural network with gated recurrent unit is the best hybrid neural network architecture. The data-driven simulations confirm the fact that the vaccination rate with higher efficacy lowers the infectiousness and basic reproduction number. As a study case, COVID-19 data for the state of Tennessee in USA is used.