Clinical Safety Research Articles

Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis: Extended Results of a Placebo-Controlled Phase 2 Trial.

Vidofludimus calcium suppressed MRI disease activity compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS) in the first cohort of the phase 2 EMPhASIS study. Because 30 mg and 45 mg showed comparable activity on multiple end points, the study enrolled an additional low-dose cohort to further investigate a dose-response relationship. In a randomized, placebo-controlled, phase 2 trial, patients with RRMS, aged 18-55 years, and with ≥2 relapses in the last 2 years or ≥1 relapse in the last year, and ≥1 gadolinium-enhancing brain lesion in the last 6 months. Patients were randomly assigned (1:1:1) vidofludimus calcium (30 or 45 mg) or placebo in cohort 1 and vidofludimus calcium (10 mg) or placebo (4:1) in cohort 2 for 24 weeks. The primary end point was the cumulative number of combined unique active (CUA) lesions at week 24. Secondary end points were clinical outcomes and safety. Across cohorts 1 and 2, 268 patients were randomized to placebo (n = 81), 10 mg (n = 47) vidofludimus calcium, 30 mg (n = 71) vidofludimus calcium, or 45 mg (n = 69) vidofludimus calcium. The mean cumulative CUA lesions over 24 weeks was 5.8 (95% CI 4.1-8.2) for placebo, 5.9 (95% CI 3.9-9.0) for 10 mg treatment group, 1.4 (95% CI 0.9-2.1) for 30 mg treatment group, and 1.7 (95% CI 1.1-2.5) for 45 mg treatment group. Serum neurofilament light chain decreased in a dose-dependent manner. The number of patients with confirmed disability worsening after 24 weeks was 3 (3.7%) patients receiving placebo and 3 (1.6%) patients receiving any dose of vidofludimus calcium. Treatment-emergent adverse events occurred in 35 (43%) placebo patients compared with 11 (23%) and 71 (37%) patients in the 10 mg or any dose of vidofludimus calcium groups, respectively. The incidence of liver enzyme elevations and infections were similar between placebo and any dose of vidofludimus calcium. No new safety signals were observed. Compared with placebo, vidofludimus calcium suppressed the development of new brain lesions with daily doses of 30 mg and 45 mg, but not 10 mg, establishing the lowest efficacious dose is 30 mg. This study provides Class II evidence that among adults with active RRMS and≥1 Gd+ brain lesion in the past 6 months, the cumulative number of active lesions decreased with vidofludimus calcium. ClinicalTrials.gov (NCT03846219) and EudraCT (2018-001896-19).

Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort

Background and objectiveThe influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown.Design, setting, participants and outcome measuresA retrospective cohort study was performed,...

Double-blind, randomized, 8-week multicenter study of the efficacy and safety of STW 5-IIversus placebo in functional dyspepsia.

Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting >4 weeks are widely lacking. We evaluated the efficacy and safety of 8 weeks of treatment with the herbal combination product STW 5-II for patients with functional dyspepsia (FD) meeting Rome II criteria. We also conducted a post hoc analysis including patients meeting Rome IV criteria for FD and evaluated the effect of the G-protein beta 3 (GNB3) subunit polymorphism (C825T) on therapeutic response. This multicenter, placebo-controlled, double-blind study included 272 FD patients meeting Rome II criteria in the intention-to-treat cohort and 266 meeting Rome IV criteria. We used the validated Gastrointestinal Symptom Score (GIS) to assess GI symptoms, defining response rate as the proportion of patients with ≥50% GIS improvement in at least three of four assessments. After 8 weeks, the response rate was significantly higher in the STW 5-II group versus placebo (61.2% vs 45.1%, P = 0.008). Mean GIS non-significantly improved with STW 5-II treatment (7.9 ± 4.41 vs 6.7 ± 4.91 with placebo; P = 0.07). In the Rome IV subgroup analysis, STW 5-II yielded a better response rate (P = 0.01) versus placebo and greater postprandial distress symptom improvement (P = 0.04) versus placebo. Safety parameters did not differ between groups, and GNB3 status was not linked with therapeutic response. STW 5-II is efficacious, with no observed safety signals at up to 8 weeks of treatment in patients with FD meeting Rome II or IV criteria.

Anti-angiogenic agents combined with immunotherapy for advanced non-small cell lung cancer: a systematic review and meta-analysis.

Anti-angiogenic agents could enhance tumor immunity response, and anti-angiogenesis plus immunotherapy has become a novel treatment option for advanced non-small cell lung cancer (NSCLC). The efficacy of this combination therapy remains controversial and obscure. We conducted a meta-analysis to evaluate the clinical efficacy and safety of this therapeutic strategy in patients with advanced NSCLC and provide more guidance for treating NSCLC clinically. A systematic literature search was performed in PubMed, Embase, Web of Science, CNKI, and Wanfang databases to identify relevant studies published up to December 2021. The primary endpoint was the objective response rate (ORR). Second endpoints were progression-free survival (PFS), overall survival (OS), and grade ≥3 AEs adverse events (AEs). The sensitivity analysis was conducted to confirm the stability of the results. STATA 15.0 was utilized for all pooled analyses. Eleven studies were eventually included in the meta-analysis, involving 533 patients with advanced NSCLC. The pooled ORR rate was 27% (95% CI 18% to 35%; I2 =84.2%; p<0.001), while the pooled median PFS and OS was 5.84 months (95% CI 4.66 to 7.03 months; I2=78.4%; p<0.001) and 14.20 months (95% CI 11.08 to 17.32 months; I2=82.2%; p=0.001), respectively. Most common grade ≥3 AEs included hypertension, hand-foot syndrome, diarrhea, adrenal insufficiency, hyponatremia, proteinuria, rash, thrombocytopenia, and fatigue. Anti-angiogenesis combined with immunotherapy demonstrated satisfactory antitumor activity and an acceptable toxicity profile in patients with advanced NSCLC. The pooled results of our meta-analysis provided further evidence supporting the favorable efficacy and safety of this therapeutic strategy.

Comparative Bleeding Risk of Brand Vs Generic Rivaroxaban in Elderly Inpatients with Atrial Fibrillation.

Atrial fibrillation (AF) is the most common abnormal heart rhythm in elderly patients. Rivaroxaban has been widely used for stroke prevention. The anticoagulant response to rivaroxaban increases with age, which may make elderly patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products. We designed a cohort study of ≥65-year-old inpatients with AF. Sociodemographic and laboratory measures of qualified patients who received brand or generic rivaroxaban for at least 72 hours at the study hospital from January 2021 to June 2023 were collected retrospectively. The primary outcome was the incidence of bleeding. A total of 1008 qualifying patients were included for analysis, with 626 (62.1%) receiving brand rivaroxaban and 382 (37.9%) receiving generic rivaroxaban. After propensity score matching and weighting to account for confounders, the odds ratios comparing brand vs generic rivaroxaban (95% confidence intervals) for the bleeding was 1.15 (0.72-1.82). Results from subgroup analyses of patients with age ≥85, HAS-BLED score ≥3, containment of antiplatelet drugs, and female patients were consistent with the primary analysis. It provides evidence regarding the clinical safety outcome of generic rivaroxaban in the elderly AF population that may be particularly susceptible to adverse outcomes resulting from small allowable differences in pharmacokinetics.

Re-discover the value of protein binding assessments in hepatic and renal impairment studies and its contributions in drug labels and dose decisions.

One of the key pharmacokinetic properties of most small molecule drugs is their ability to bind to serum proteins. Unbound or free drug is responsible for pharmacological activity while the balance between free and bound drug can impact drug distribution, elimination, and other safety parameters. In the hepatic impairment (HI) and renal impairment (RI) clinical studies, unbound drug concentration is often assessed; however, the relevance and impact of the protein binding (PB) results is largely limited. We analyzed published clinical safety and pharmacokinetic studies in subjects with HI or RI with PB assessment up to October 2022 and summarized the contribution of PB results on their label dose recommendations. Among drugs with HI publication, 32% (17/53) associated product labels include PB results in HI section. Of these, the majority (9/17, 53%) recommend dose adjustments consistent with observed PB change. Among drugs with RI publication, 27% (12/44) of associated product labels include PB results in RI section with the majority (7/12, 58%) recommending no dose adjustment, consistent with the reported absence of PB change. PB results were found to be consistent with a tailored dose recommendation in 53% and 58% of the approved labels for HI and RI section, respectively. We further discussed the interpretation challenges of PB results, explored treatment decision factors including total drug concentration, exposure-response relationships, and safety considerations in these case examples. Collectively, comprehending the alterations in free drug levels in HI and RI informs treatment decision through a risk-based approach.

Risks of Vaginally and Sexually Transmitted Infections With Contraceptive Vaginal Rings Compared to Oral Contraceptives [ID 2683643

INTRODUCTION: Use of combined contraceptive vaginal ring (CCVR) has been found to upregulate immune-related genes in the endocervix and mediators within the cervicovaginal fluid. Attachment and infection rates of certain pathogens within this tract can vary based on hormones within the local environment. Rat studies have shown treatment with estrogen prior to chlamydial infections was protective. Continued clinical safety analyses are critical as CCVR use continues to increase. We calculated risk of vaginal infections associated with CCVR compared to oral contraceptive pills (OCPs) via retrospective chart review. METHODS: De-identified data was collected from TriNetX. Using ICD-10 and RxNorm codes, study cohorts included women receiving etonogestrel and ethinyl estradiol CCVRs without segesterone, versus women on OCPs without vaginal hormones. Cohorts (n=30,796 each) were matched for age, race, and ethnicity. Statistical analysis within 1 year of CCVR placement used risk ratios (RRs); P&lt;.05 was considered significant. RESULTS: Combined contraceptive vaginal rings showed increased risk of HSV-2 (RR 1.790; P&lt;.0005), acute vaginitis (RR 1.722; P&lt;.0005), subacute/chronic vaginitis (RR 1.904; P&lt;.0005), subacute/chronic vulvitis (RR 1.969; P&lt;.0005), acute vulvitis (RR 1.894; P&lt;.0005), candidiasis (RR 1.464; P&lt;.0005), trichomoniasis (RR 2.162; P&lt;.0005), and pelvic inflammatory disease (PID) (RR 2.984; P&lt;.0005). Combined contraceptive vaginal rings showed a decreased risk of chlamydia (RR 0.760; P=.047). There were no differences in risk of gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP cohorts CONCLUSION: In this chart review, women using CCVRs had increased risks for HSV-2, vaginitis, vulvitis, PID, trichomoniasis, and candidiasis and decreased risk of chlamydia compared to OCPs. Further study of local hormone delivery on the vaginal mucosa is warranted.

Comparison of clinical efficacy and safety of original and generic forms of etoricoxib in patients with knee osteoarthritis

Background. Nonsteroidal anti-inflammatory drugs (NSAIDs) are an important drug class for the treatment of osteoarthritis (OA). Despite existing studies on the bioequivalence of original and generic NSAIDs, comparative studies related to their clinical efficacy and safety are limited. The purpose of the study was to compare the clinical efficacy and safety of the original and generic forms of etoricoxib in patients with knee OA. ­Materials and ­methods. In an open, comparative, randomized, multicenter study, 150 patients with knee OA were examined: group I — 50 persons who received the original etoricoxib (60 mg/d for 10 days), groups II and III — 50 subjects each who received generic etoricoxib (60 mg/d for 10 days). The effectiveness of the treatment was evaluated using the four-component visual analog scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lequesne index before the start of therapy and on the 10th day. Assessment of tolerability and safety was studied by controlling adverse events based on clinical and laboratory indicators. Results. The use of the original and generic forms of etoricoxib in patients with knee OA led to positive dynamics of pain syndrome and functional activity, while the dynamics of indices were the greatest in the case of using the ori­ginal etoricoxib (VAS: group I — 50.0 [35.4–60.0] %, group II — 29.1 [16.7–55.0] % and III — 28.6 [14.3–33.3] %). The most pronounced positive dynamics of the pain syndrome against the background of taking the original etoricoxib compared to the generic forms was registered in the subgroup of patients with severe knee pain (VAS &gt; 60 mm). The use of all forms of etorico­xib was safe and did not lead to serious clinical side effects or clinically signi­ficant changes in laboratory blood parameters. The hi­ghest rates of satisfaction with the treatment by patients and physicians were observed in the case of the original etoricoxib use. Conclusions. The use of the original etoricoxib in patients with knee OA, especially in the presence of severe pain syndrome (VAS &gt; 60 mm) is the most justified and safe.

Clinical Efficacy and Safety of Clofazimine in Treatment Regimens for Drug Resistant Tuberculosis (Meta-Analysis)

The objective: based on a systematic review and meta-analysis of data from published results of clinical studies, to evaluate clinical efficacy and safety of chemotherapy regimens containing clofazimine in MDR-TB patients.Subjects and Methods. A systematic analysis of publications was performed using key words “clofazimine”, “tuberculosis treatment”, “mycobacteria drug resistance”, and “safety” in electronic libraries: PubMed, Google Scholar, eLIBRARY.RU, and medRvix. 7 clinical studies were selected for further analysis.Results. The risk of treatment failure in main groups receiving regimens containing clofazimine was 1.7 times lower versus control groups (without clofazimine) (p = 0.02; RR = 0.6 (95% CI: 0.39 – 0.92)). The risk of sputum conversion by week 12 of treatment is 7 times higher in main groups receiving regimens containing clofazimine versus control groups (p = 0.01; RR = 0.14 (95% CI: 0.03 – 0.25)). The risk of adverse events in main groups receiving regimens containing clofazimine was comparable to control groups (p = 0.54; RR = 1.27 (95% CI: 0.59 – 2.71)).

Improved wound healing by direct cold atmospheric plasma once or twice a week: a randomized controlled trial on chronic venous leg ulcers.

This study compared the effect of two frequencies of direct cold atmospheric plasma (direct-CAP) treatment with standard of care (SOC) alone on healing of venous leg ulcers (VLUs). Open-label, randomized controlled trial (ClinicalTrials.gov: NCT04922463) on chronic VLUs at two home care organizations in the Netherlands. All three groups received SOC for 12 weeks or until healing. Additionally, treatment groups received direct-CAP once (1x direct-CAP) or twice (2x direct-CAP) a week, at specialized wound care facilities and the patients' residences. Primary outcome was percentage of wounds healed. Secondary outcomes included wound area reduction and adverse events. 46 patients were randomly allocated to receive SOC only (n=15), SOC + direct-CAP once a week (n=17) or SOC + direct-CAP twice a week (n=14). A higher percentage of wounds healed within 12 weeks in the treatment groups: 53.3% (1x direct-CAP, p=0.16) and 61.5% (2x direct-CAP, p=0.08) vs 25.0% (control). The largest wound area reduction was obtained with 2x direct-CAP (95.2%, p=0.07), followed by 1x direct-CAP (63.9%, p=0.58), vs control (52.8%). Absolute wound area reduced significantly compared with baseline in both treatment groups (p≤0.001), not in control (p=0.11). No device-related serious adverse events occurred. Direct-CAP applied once or twice a week could substantially improve wound healing of VLUs in primary care. Together with other clinical safety and efficacy data, these results support the integration of direct-CAP as a valuable therapy for complex wounds.

The Investigation of Hyaluronic Acid (The Chaeum Premium No.2&lt;sup&gt;®&lt;/sup&gt;) to Evaluate the Efficacy and Safety for Injection Laryngoplasty in Unilateral Vocal Cord Paralysis: A Single Center, Phase II Trial

Background and Objectives This study aimed to evaluate the clinical efficacy and safety of hyaluronic acid (HA) (The Chaeum Premium No.2&lt;sup&gt;®&lt;/sup&gt;) for injection laryngoplasty (IL) in unilateral vocal cord paralysis (UVCP) patients.Materials and Method This clinical trial has been registered with the clinical research information service of the Republic of Korea (No. KCT0007597). Ten patients with UVCP were enrolled. Auditory-perceptual evaluation, acoustic analysis, aerodynamic analysis, electroglottography, laryngoscopy, and voice handicap index (VHI)-30 were assessed before injection, at 1, 3, and 6 months after injection.Results All auditory-perceptual parameters gradually showed statistically significant improvements at 1, 3, and 6 months after injection. Acoustic, aerodynamic parameters, electroglottography, and VHI-30 showed gradual improvements at 1 and 3 months after injection. Then, they showed slight deterioration 6 months after injection. There were no adverse effects in all patients.Conclusion IL using HA is an effective and safe treatment for UVCP patients.

Interplay of OATP1A/1B/2B1 uptake transporters and ABCB1 and ABCG2 efflux transporters in the handling of bilirubin and drugs

Transmembrane drug transporters can be important determinants of the pharmacokinetics, efficacy, and safety profiles of drugs. To investigate the potential cooperative and/or counteracting interplay of OATP1A/1B/2B1 uptake transporters and ABCB1 and ABCG2 efflux transporters in physiology and pharmacology, we generated a new mouse model (Bab12), deficient for Slco1a/1b, Slco2b1, Abcb1a/1b and Abcg2. Bab12 mice were viable and fertile. We compared wild-type, Slco1a/1b/2b1-/-, Abcb1a/1b;Abcg2-/- and Bab12 strains. Endogenous plasma conjugated bilirubin levels ranked as follows: wild-type = Abcb1a/1b;Abcg2-/- <<Slco1a/1b/2b1-/- <Bab12 mice. Plasma levels of rosuvastatin and fexofenadine were elevated in Slco1a/1b/2b1-/- and Abcb1a/1b;Abcg2-/- mice compared to wild-type, and dramatically increased in Bab12 mice. Although systemic exposure of larotrectinib and repotrectinib was substantially increased in the separate multidrug transporter knockout strains, no additive effects were observed in the combination Bab12 mice. Significantly higher plasma exposure of fluvastatin and pravastatin was only found in Slco1a/1b/2b1-deficient mice. However, noticeable transport by Slco1a/1b/2b1 and Abcb1a/1b and Abcg2 across the BBB was observed for fluvastatin and pravastatin, respectively, by comparing Bab12 mice with Abcb1a/1b;Abcg2-/- or Slco1a/1b/2b1-/- mice. Quite varying behavior in plasma exposure of erlotinib and its metabolites was observed among these strains. Bab12 mice revealed that Abcb1a/1b and/or Abcg2 can contribute to conjugated bilirubin elimination when Slco1a/1b/2b1 are absent. Our results suggest that the interplay of Slco1a/1b/2b1, Abcb1a/1b, and Abcg2 could markedly affect the pharmacokinetics of some, but not all drugs and metabolites. The Bab12 mouse model will represent a useful tool for optimizing drug development and clinical application, including efficacy and safety.

Targeting of KOR by famotidine promotes OPC maturation differentiation and CNS remyelination via STAT3 signaling pathway

This study aims to identify FDA-approved drugs that can target the kappa-opioid receptor (KOR) for the treatment of demyelinating diseases. Demyelinating diseases are characterized by myelin sheath destruction or formation that results in severe neurological dysfunction. Remission of this disease is largely dependent on the differentiation of oligodendrocyte precursor cells (OPCs) into mature oligodendrocytes (OLGs) in demyelinating lesions. KOR is an important regulatory protein and drug target for the treatment of demyelinating diseases. However, no drug targeting KOR has been developed due to the long clinical trials for drug discovery. Here, a structure-based virtual screening was applied to identify drugs targeting KOR among 1843 drugs of FDA-approved drug libraries, and famotidine was screen out by its high affinity cooperation with KOR as well as the clinical safety. We discovered that famotidine directly promoted OPC maturation and remyelination using the complementary in vitro and in vivo models. Administration of famotidine was not only effectively enhanced CNS myelinogenesis, but also promoted remyelination. Mechanically speaking, famotidine promoted myelinogenesis or remyelination through KOR/STAT3 signaling pathway. In general, our study provided evidence of new clinical applicability of famotidine for the treatment of demyelinating diseases for which there is currently no effective therapy.

Effects of Paraspinal Intramuscular Injection of Atelocollagen in Patients with Chronic Low Back Pain: A Retrospective Observational Study.

Background/Objectives: Atelocollagen is used for soft tissue repair and reconstruction by replacing defective or damaged muscles, membranes, ligaments, and tendons. This study aimed to evaluate the clinical efficacy and safety of additional paraspinal intramuscular injection of atelocollagen on lumbar epidural steroid injection for reducing pain and improving functional capacity of patients with chronic low back pain (CLBP). Methods: We retrospectively enrolled 608 consecutive patients with CLBP who received lumbar epidural steroid injection with or without additional paraspinal intramuscular injection of atelocollagen. The Numerical Rating Scale and the Oswestry Disability Index were used to assess pain and functional capacity, respectively, before the procedure, and three months after the injection. Also, we analyzed the relationship between the additional paraspinal intramuscular injection of atelocollagen and the success rate. Results: Both Numerical Rating Scale and the Oswestry Disability Index scores were significantly reduced in both groups at three months after injection. However, there was a significant difference between the two groups. Furthermore, the success rate was significantly higher in the additional paraspinal intramuscular injection of atelocollagen group. Conclusions: This study's results showed that additional paraspinal intramuscular injection of atelocollagen on lumbar epidural steroid injection reduced pain and improved functional capacity for patients with CLBP. Therefore, the paraspinal intramuscular injection of atelocollagen may be a promising option for the treatment of patients with CLBP.

Comparing the effects of argon plasma coagulation and interferon therapy in patients with vaginal intraepithelial neoplasia: a single-center retrospective study.

This study aimed to evaluate the clinical efficacy and safety of argon plasma coagulation (APC) therapy and interferon therapy in patients with grade I and II vaginal intraepithelial neoplasia (VaIN). A total of 112 patients with VaIN were diagnosed via colposcopy-induced biopsy and classified into the APC group (n = 77) and interferon group (n = 35). Clinical data including age, grade, symptoms, historical or concomitant neoplasia of the lower genital tract, indications for hysterectomy, pregnancy history, cytology, human papillomavirus (HPV) subtype, treatment modalities, and clinical outcomes were analyzed, retrospectively. Complications and clinical outcomes were assessed at 6- and 12-month follow-ups. There was no significant difference in the HPV clearance rate between the APC (53.42%) and interferon (33.33%) groups at 6 months after treatment. However, the 12-month follow-up of the APC group showed a significantly higher HPV clearance rate as compared to the interferon group (87.67% vs. 51.52%, P < 0.05). The APC group exhibited a significantly higher cure rate (79.22% vs. 40.0%) and lower persistence rate (12.99% vs. 37.14%) than the interferon group (P < 0.05). Adverse reaction analysis revealed that the primary reaction in the APC group was vaginal drainage, in contrast to the increased vaginal discharge in the interferon group; though the difference was significant (68.83% vs. 28.57%, P < 0.05), no serious complications were observed. Treatment with APC is a safe and more effective procedure against VaIN I and II, compared to interferon. APC may serve as a viable alternative to other physiotherapies.

Comparing short‐axis versus long‐axis ultrasound‐guided techniques for internal jugular vein cannulation: A meta‐analysis of clinical outcomes and safety

AbstractIntroductionCentral venous access plays a crucial role in various clinical settings, and ultrasound guidance has become increasingly popular for improving its safety and success rates. The aim of this meta‐analysis was to compare the short‐axis (SAX) and long‐axis (LAX) ultrasound‐guided techniques for internal jugular vein (IJV) cannulation in terms of first needle pass success rate, number of cannulation attempts, access time, guidewire insertion time, posterior IJV wall puncture, arterial puncture, haematoma and catheter‐related bloodstream infection.MethodsA comprehensive literature search was conducted, and randomised controlled trials (RCTs) comparing SAX and LAX techniques for IJV cannulation on adults were included.ResultsA total of 11 RCTs involving 1183 patients were included in the meta‐analysis. The SAX technique demonstrated a significantly greater first needle pass success rate and faster IJV access time compared to the LAX technique. However, more posterior IJV wall puncture was significantly associated with the SAX technique. There was no significant difference between the two techniques in terms of number of cannulation attempts, guidewire insertion time, arterial puncture, haematoma and catheter‐related bloodstream infection.ConclusionThis meta‐analysis suggests that the SAX technique may have advantages over the LAX technique in terms of first needle pass success rate and potentially reducing cannulation attempts and access time. However, the occurrence of posterior IJV wall puncture raises concerns. The decision on the choice of technique should be based on individual patient factors and operator proficiency.

Clinical effect of anlotinib in combination with docetaxel in treating advanced non-small cell lung cancer.

This study aimed to explore the clinical performance of anlotinib in combination with docetaxel in treating advanced non-small cell lung cancer (NSCLC). One hundred advanced NSCLC patients admitted to our hospital from January 2019 to December 2022 were retrospectively chosen to be the study objects, and separated into observation group (OG, n=50) and control group (CG, n=50) based on the different drugs used. The CG was given docetaxel injection. The OG was treated with anlotinib hydrochloride capsule combined with docetaxel injection. The clinical effective rate, levels of serum tumor markers, quality of life and occurrence of adverse reactions in both groups were compared. The total clinical effective rate in the OG presented elevated relative to the CG (P<0.01). After treatment, CEA, CA125, SCC and CYFRA21-1 levels in both groups were decreased in both groups, and those in the OG presented lower relative to the CG (P<0.05). After treatment, KPS score in both groups was increased in both groups and that in the OG presented higher relative to the CG (P<0.05). No difference was seen in the occurrence of adverse reactions between 2 groups (P=0.35). In treating advanced NSCLC patients, anlotinib combined with docetaxel can promote efficacy to a certain extent, effectively regulate the level of serum tumor markers, promote the quality of life of patients, and will not significantly affect clinical safety.

Clinical efficacy and safety of Xuanfei Touxie Fang as a complementary medicine in the treatment of SARS-CoV-2 Omicron variant: A retrospective study

IntroductionTo explore the clinical efficacy and safety of Xuanfei Touxie Fang (XFTXF) as a complementary medicine in the treatment of SARS-CoV-2 Omicron variant. MethodsA retrospective study of 317 patients with ordinary symptoms admitted to our hospital from December 2022 to February 2023 were divided into the observation group (n = 224) and the control group (n = 93). The observation group was treated with Xuanfei Touxie Fang combined with conventional treatment and the control group treated with conventional treatment alone. Recovery time of symptoms, length of hospital stay, clinical cure rate and recovery rate of chest CT manifestations were compared between the two groups. ResultsThe time to recover from fever (median: 1 vs 3 days) and the length of hospital stay (median: 7 vs 9 days) of the observation group after treatment were significantly shorter than the control group. The difference was statistically significant (P < 0.05). The clinical cure rate (68.3% vs 54.84 %) and the recovery rate of chest CT manifestations (87.95% vs 66.67 %) of the observation group after treatment were higher than the control group. The difference was statistically significant (P < 0.05). There was no adverse reactions during the treatment for two groups. The difference was no statistically significant (P > 0.05). DiscussionNumerous studies have demonstrated that Xuanfei Touxie Fang, which is frequently used in respiratory diseases, has anti-coronavirus effects by inhibiting viral replication, release, penetration, and RNA synthesis. Therefore, we treated COVID-19 with it and evaluated its safety and effectiveness. ConclusionsXuanfei Touxie Fang as a complementary medicine has a significant effect in the treatment of COVID-19, which can reduce the duration of fever and the length of hospital stay, improve the clinical cure rate and recovery rate of chest CT manifestations.

Effect of 5-aminolevulinic acid photodynamic therapy versus loop electrosurgical excision procedure for cervical intraepithelial neoplasia grade 2 treatment

BackgroundBoth the traditional loop electrosurgical excision procedure (LEEP) and the newly developed 5-aminolevulinic acid photodynamic therapy (ALA-PDT) are used to treat high-grade squamous intraepithelial lesions. However, the clinical efficacy and safety of these two therapies have rarely been compared. Thus, this study aimed to compare the clinical efficacy and safety of the two treatment regimens. MethodsOne hundred and twenty patients in two groups (60 + 60) with grade 2 cervical intraepithelial neoplasia (CIN2) were voluntary treated with photodynamic therapy or LEEP between June 2020 and December 2022. Follow-up was conducted at 3, 4–6, and 7–12 months after treatment. ResultsAlthough the total effective rate of LEEP was higher during the first 6 months after treatment, both the total effective rate of lesion degradation and the double-negative rate of high-risk HPV16/18 and liquid-based cervical cytology by ALA-PDT treatment increased with time and finally exceeded those of LEEP at 7–12 months. ConclusionsALA-PDT may be more promising than LEEP for treating patients with CIN2 because of the better CIN2 degradation and high-risk HPV negativity, less damage, and greater fertility conservation, especially after 6 months.

Developing innovative strategies of tumor‑infiltrating lymphocyte therapy for tumor treatment.

Cancer is the main cause of global mortality, and thus far, effective therapeutic strategies for cancer treatment are in high demand. Adoptive transfer of tumor‑infiltrating lymphocytes (TILs) represents a promising avenue in immunotherapy for the management of malignancies. The clinical safety and efficacy of TIL‑based therapy have been established through numerous rigorous clinical trials. However, the efficacy of TIL infusion in inducing an anti‑tumor response is limited to a subset of clinical patients with cancer. Therefore, there is an urgent need to develop innovative strategies aimed at enhancing the effectiveness of TIL‑based therapy. In the present review, the developmental history of TIL‑based therapy was systematically summarized and analyzed, while also presenting a unique perspective on enhancing the multi‑dimensional anti‑tumor capabilities of TILs. The insight and conclusions presented in this review may contribute to improving the efficacy of TIL‑based therapy and expediting its development.