Evaluation Of Clinical Efficacy Research Articles

Evaluation of Clinical Efficacy Between Forsus and Advansync Fixed Functional Appliance for the Treatment of Skeletal Class II Malocclusion Using 3D Cone Beam Computed Tomography (CBCT): A Prospective Randomized Clinical Trial.

The objective is to assess and compare whether AdvanSync gives better skeletal, dental, and soft tissue outcomes than Forsus fixed functional appliance in post-pubertal skeletal Class II malocclusion patients. A prospective study was conducted using 3D-CBCT of patients taken before and after fixed functional appliance therapy. The sample consisted of 16 patientsdivided into two groups: Group 1 was treated with Forsus and group 2 with AdvanSync appliance. All subjects were in their post-pubertal growth phase. Treatment changes were evaluated between the study groups using 12 angular and 14 linear parameters. The data were subjected to statistical analysis. Statistically significant changes in SNB(P:0.04) and ANB (P:0.01) in Forsus appliance andAdvanSync (SNB, P:008), (ANB, P: <0.001)were found between the pre and post-fixed functional appliance protocol. The effective mandibular length increased in both groups Forsus(P-value: 0.01) and AdvanSync (P-value: 0.01). Group 1 resulted in lower incisor proclination and intrusion, a reduction in an overbite, whereas group 2 resulted in lower incisor proclination, upper incisor extrusion, and retroclination. Both groups showed significant improvement in the molar relation and overjet. An increase in the total facial convexity was shown in group 1; group 2 showed an increase in the facial convexity and total facial convexity. There was no statistically significant differencebetween the effects of the Forsus and Advansync appliance groups in the post-fixed functional period. Both groups presented similar results. Forsus and Advansync appliances are effective with similar results in normalizing skeletal Class II malocclusion in post-pubertal patients. There was no statistically significant difference between the groups using Forsus or AdvanSync. Thechanges were minimal - mandibular skeletal effects, majorly dentoalveolar effects, and mild soft tissue effects.

The Regulation of Cell Therapy and Gene Therapy Products in Switzerland.

This chapter describes the regulation of cell and gene therapy products (CGTPs) in Switzerland and its legal basis. The Swiss Agency for Therapeutic Products, Swissmedic, is the lead Regulatory Authority and its ATMP Division is responsible for the regulation of these products at the level of clinical trials and marketing authorization. CGTPs are regulated similarly to medicinal products. The legal basis is set by the Therapeutic Product Act, the Transplantation Act, the Human Research Act, and associated ordinances. The ATMP Division is involved in processes such as scientific advice meetings, presubmission advice meetings, pharmacovigilance, market surveillance, import/export approvals, manufacturing license approval, and inspections. In Switzerland, guidance documents relevant for cell and gene therapy provided by PIC/S, OECD, ICH, Ph.Eur., EMA, or FDA are considered. In order to harmonize requirements for CGTPs, the ATMP Division is in constant exchange of information with foreign Regulatory Authorities and part of working groups of ICH, IPRP, and Ph.Eur. As CGTPs are biologically and technically complex, a risk-based approach is applied on a case-by-case basis for the evaluation of clinical trial and marketing applications. A substantial part of this chapter will provide requirements with respect to the manufacturing and quality, nonclinical and clinical evaluation of CGTPs. Furthermore, information will be provided regarding the use of real-world evidence in evaluation of clinical long-term efficacy and safety in case of rare diseases where the numbers of patients are too small for statistically meaningful analysis during clinical trials. Finally, the chapter will provide information on a health technology assessment (HTA) program that was launched in 2015 in Switzerland by the federal authorities.

Клиническая эффективность и переносимость применения миноциклина (Минолексин®) у женщин с хроническими цервицитами, ассоциированными с бактериальной инфекцией

Background: bacterial-associated chronic cervicitis (CC) occupies a leading place in the cervical pathology structure. At the same time, the disease recurrence rate reaches 59–68% in the setting of resistance to antibacterial therapy, which determines the need to find new effective drugs. Aim: to evaluate the clinical efficacy, safety and compliance of therapy with minocycline in patients with bacterial-associated CC. Patients and Methods: a multicenter prospective observational clinical study was conducted in women's health clinics and medical centers in Yekaterinburg. The study included 60 female patients with a confirmed diagnosis of bacterial-associated CC. Group 1 (n=31) received the antibacterial drug minocycline (Minolexin®) 100 mg twice a day in the morning and evening, 10 days + antimycotic prebiotic 1 suppository once a day intravaginally for 6 days, starting from the 3rd day of antibiotic therapy. Group 2 (n=29) received doxycycline 100 mg twice a day for 10 days + antimycotic prebiotic 1 suppository once a day intravaginally for 6 days, starting from the 3rd day of antibiotic therapy. Clinical and laboratory efficacy (cervicitis signs, results of laboratory microbiome research methods) and drug tolerability were evaluated 10 and 30 days after the treatment initiation. Results: as a result of CC antibacterial therapy with minocycline, pathogen eradication was observed in 83.9% of female patients (group 2 — in 69.9%, p=0.0001), the original squamous epithelium 30 days after the minocycline was detected in 27 (87.1%) female patients (group 2 — in 19 (65.5±5.8%) female patients, p=0.0001), which indicates a higher efficacy of minocycline versus doxycycline. Patients of the minocycline group had more therapy adherence — 96.8% vs. 82.9% in the doxycycline group (p=0.0001) due to the minimal number of side effects (3.2% vs. 17.2%, respectively; p=0.0001). Conclusion: minocycline is a systemic antibiotic of the tetracycline group, which can be considered as the front-line drug for antibacterial therapy of patients with CC due to its high clinical efficacy, minimal risk of side effects and high compliance. KEYWORDS: chronic cervicitis, antibacterial therapy, tetracyclines, minocycline, efficacy. FOR CITATION: Dobrokhotova Yu.E., Kononova I.N., Kareva E.N., Shmakova N.A., Graban I.V., Ogurtsova T.A. Minocycline (Minolexin®) clinical efficacy and tolerability evaluation in women with bacterial-associated chronic cervicitis. Russian Journal of Woman and Child Health. 2023;6(4):340–346 (in Russ.). DOI: 10.32364/2618-8430-2023-6-4-3.

Partial vertebrectomy with spine shortening for old spondyloptosis at the thoracolumbar spine: a case series study and literature review.

We aimed to report the surgical outcomes of serial cases and retrospectively analyze the value of partial vertebrectomy and spinal shortening in the reduction of old spondyloptosis at the thoracolumbar spine. From 2015 to 2021, eight cases of patients who received a spinal intervention of partial vertebrectomy and spinal shortening for thoracolumbar spondyloptosis over 3 weeks post-trauma were retrospectively summarized. Medical records and surgical outcomes were extracted for clinical safety and efficacy evaluation. Acceptable reduction and immediate stabilization were achieved for all eight cases without causing iatrogenic damage to the viscera. The mean operation time was 3.7 h (range, 3.2-4.2 h) with a mean blood loss average of 1,081 ml (range, 900-1,300 ml). Postoperative stay in the spine department was an average of 11.4 days (range, 8-17 days), followed by an early rehab program. The mean visual analog scale (VAS) for low back pain decreased from 8.0 preoperatively to 1.4 at the last follow-up. The average follow-up period was 19.9 months. As for neurological function recovery, six patients with preoperative ASIA-A status remained unchanged throughout the follow-up period and improvement of one ASIA grade was noted in two patients. At the latest follow-up, sound interbody fusion as well as good alignment of the spinal column were confirmed radiologically in seven patients, while one patient encountered slight re-dislocation 3 months after surgery, but eventually achieved spinal fusion. Partial vertebrectomy and spine shortening via a posterior approach showed good efficacy and safety in the management of old spondyloptosis of the thoracolumbar spine, allowing for a one-step good reduction and spinal fusion for early rehabilitation.

Comparative Evaluation of Clinical Efficacy of Diode LASER and Cryosurgery for Gingival Pigmentation: A Split-Mouth Randomized Clinical Study

Comparative Evaluation of Clinical Efficacy of Diode LASER and Cryosurgery for Gingival Pigmentation: A Split-Mouth Randomized Clinical Study

Comparative evaluation of clinical efficacy of systemically administered commercially available antioxidant formulations as an adjunct to scaling and root planing in the treatment of chronic periodontitis

Comparative evaluation of clinical efficacy of systemically administered commercially available antioxidant formulations as an adjunct to scaling and root planing in the treatment of chronic periodontitis

Research progress on prostate-specific membrane antigen ligand positron emission tomography imaging of prostate cancer

Prostate cancer is the most common malignant tumor in male urinary system, and the morbidity and mortality rate are increasing year by year. Traditional imaging examinations have some limitations in the diagnosis of prostate cancer, and the advent of molecular imaging probes and imaging technology have provided new ideas for the integration of diagnosis and treatment of prostate cancer. In recent years, prostate-specific membrane antigen (PSMA) has attracted much attention as a target for imaging and treatment of prostate cancer. PSMA ligand positron emission tomography (PET) has important reference value in the diagnosis, initial staging, detection of biochemical recurrence and metastasis, clinical decision-making guidance and efficacy evaluation of prostate cancer. This article briefly reviews the clinical research and application progress on PSMA ligand PET imaging in prostate cancer in recent years, so as to raise the efficiency of clinical applications.

Embolic Decision Making in Musculoskeletal Embolization

In his pioneering work, Okuno and colleagues demonstrated the benefit of musculoskeletal (MSK) embolization, using imipenem as an embolic agent, in various diseases such as knee osteoarthritis (KOA), adhesive capsulitis (AC), tennis elbow and other sports injuries. As imipenem is a last-resort, broad spectrum antibiotic, its use is often not feasible depending on countries and their drug regulation. Since then, several other studies have used other material products such as microparticles or liquid embolics. In addition, several products in development or that are used in other indications may prove useful after full clinical evaluation of safety and efficacy. In this article we will develop our recommendations, through an analysis of recent publications on MSK embolization.

Medial meniscus posterior root tear reconstructed with gracilis autograft improve healing rate and patient reported outcome measures

BackgroundMany surgeries have not reversed or prevented progressive symptomatic knee arthritis, and there is no consensus regarding the ideal repair or reconstruction technique for meniscal root treatment. Additionally, there is a lack of studies comparing the clinical efficacy evaluation of different repair techniques. The aim of the present study is to compare the clinical efficacy and healing rates of meniscus root in the treatment of medial meniscus posterior root tear (MMPRT) with the arthroscopically assisted meniscus root reconstruction with gracilis autograft and transtibial pull-out technique.MethodsPatients with MMPRT (type II) who received treatment of posterior meniscus root attachment point through the tibial tunnel between January 2018 and April 2019 were included in this study. Patients were divided into 2 groups (arthroscopically assisted gracilis autograft reconstruction technique: 29 cases; transtibial pull-out technique group: 35 cases) according to the different treatment methods. The mean follow-up period was 26.9 ± 2.3 months. The demographics, functional recovery of the knee, and meniscus root healing rates (assessed using knee magnetic resonance imaging (MRI) at the final follow-up) were compared between the two groups.ResultsThere was a statistically significant improvement in the Lysholm score, international knee documentation committee (IKDC) score, and visual analogue scale (VAS) score (P < 0.001 in both groups). Additionally, compared with the transtibial pull-out repair group, the arthroscopically assisted reconstruction with gracilis autograft showed significant improvement in the meniscus root healing rates, Lysholm score, and IKDC score at the end of follow-up (P < 0.05).ConclusionsCompared with the transtibial pull-out technique, the arthroscopically assisted meniscus root reconstruction with gracilis autograft was advantageous for treating these patients with superior clinical outcome and higher meniscus root healing rates.Level of evidenceLevel III.

The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial

In animal studies, β-nicotinamide mononucleotide (NMN) supplementation increases nicotinamide adenine dinucleotide (NAD) concentrations and improves healthspan and lifespan with great safety. However, it is unclear if these effects can be transferred to humans. This randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial included 80 middle-aged healthy adults being randomized for a 60-day clinical trial with once daily oral dosing of placebo, 300 mg, 600 mg, or 900 mg NMN. The primary objective was to evaluate blood NAD concentration with dose-dependent regimens. The secondary objectives were to assess the safety and tolerability of NMN supplementation, next to the evaluation of clinical efficacy by measuring physical performance (six-minute walking test), blood biological age (Aging.Ai 3.0 calculator), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and subjective general health assessment [36-Item Short Form Survey Instrument (SF-36)]. Statistical analysis was performed using the Per Protocol analysis with significant level set at p = 0.05. All 80 participants completed the trial without trial protocol violation. Blood NAD concentrations were statistically significantly increased among all NMN-treated groups at day 30 and day 60 when compared to both placebo and baseline (all p ≤ 0.001). Blood NAD concentrations were highest in the groups taking 600 mg and 900 mg NMN. No safety issues, based on monitoring adverse events (AEs), laboratory and clinical measures, were found, and NMN supplementation was well tolerated. Walking distance increase during the six-minute walking test was statistically significantly higher in the 300 mg, 600 mg, and 900 mg groups compared to placebo at both days 30 and 60 (all p < 0.01), with longest walking distances measured in the 600 mg and 900 mg groups. The blood biological age increased significantly in the placebo group and stayed unchanged in all NMN-treated groups at day 60, which resulted in a significant difference between the treated groups and placebo (all p < 0.05). The HOMA-IR showed no statistically significant differences for all NMN-treated groups as compared to placebo at day 60. The change of SF-36 scores at day 30 and day 60 indicated statistically significantly better health of all three treated groups when compared to the placebo group (p < 0.05), except for the SF-36 score change in the 300 mg group at day 30. NMN supplementation increases blood NAD concentrations and is safe and well tolerated with oral dosing up to 900 mg NMN daily. Clinical efficacy expressed by blood NAD concentration and physical performance reaches highest at a dose of 600 mg daily oral intake. This trial was registered with ClinicalTrials.gov, NCT04823260, and Clinical Trial Registry - India, CTRI/2021/03/032421.

Clinical Evaluation of Efficacy and Tolerability of Oral Tranexamic Acid in Comparison with Hydroquinone plus Sunscreen in Subjects with Melasma: A Single Blind, Randomized Clinical Trial Study

Background: Melasma is a common chronic acquired hyper pigmentary disorder of skin, particularly among Asian and Hispanics. Females are more affected than men. It has a significant impact on appearance, causing psychosocial and emotional distress and reducing the quality of life of the affected individual. Tranexamic acid (TA) can be used to treat melasma. Objectives: To compare the efficacy of oral Tranexamic acid and Hydroquinone (HQ) plus sunscreen in the treatment of melasma. Methods: It was prospective, interventional clinical trial conducted among 150 Bangladeshi melasma patients visiting the Dermatology and Venereology OPD of DMCH between January 2016 and June 2017. Patients were divided randomly into two groups, 75 in each, by lottery method. First group (Group A) was treated with 4% Hydroquinone plus sunscreen (regular) daily for 12 weeks and second group (Group B) was treated with Tranexamic acid 250mg twice a day for 12 weeks. Response was evaluated on the basis of Melasma Area and Severity Index (MASI) and Melasma Quality of Life (MELASQoL) Questionnaire. The mean scores of both variables were compared between both groups. Results: Epidermal melasma was comparatively quicker and better responded to the treatment than dermal or mixed variants. The mean MASI and mean MELASQoL scores between both groups were not significantly different at 4 weeks (p&gt;0.05) but was significantly effective in Group B at 8 and 12 weeks (p&lt;0.05). The mean MASI scores of Group A (HQ &amp; sunscreen) were 11.43±1.82, 9.98±1.99 and 8.94±2.16 at 4, 8 and 12 weeks respectively. The mean MASI scores of Group B (TA) were 11.34±1.92, 9.30+2.07 and 7.19±2.16 at 4, 8 and 12 weeks respectively. Similarly, the mean MELASQoL scores of Group A (HQ &amp; sunscreen) were 34.95±6.61, 29.40±6.60 and 25.87±7.19 at 4, 8 and 12 weeks respectively. The mean MELASQoL scores of Group B (TA) were 33.12±6.40, 26.19±6.43 and 20.63±6.70 at 4, 8 and 12 weeks respectively. Conclusion: Oral Tranexamic acid is more ..

Identification of a claudin-low subtype in clear cell renal cell carcinoma with implications for the evaluation of clinical outcomes and treatment efficacy.

In bladder and breast cancer, the claudin-low subtype is widely identified, revealing a distinct tumor microenvironment (TME) and immunological feature. Although we have previously identified individual claudin members as prognostic biomarkers in clear cell renal cell carcinoma (ccRCC), the existence of an intrinsic claudin-low subtype and its interplay with TME and clinical outcomes remains unclear. Transcriptomic and clinical data from The Cancer Genome Atlas (TCGA)- kidney clear cell carcinoma (KIRC) cohort and E-MTAB-1980 were derived as the training and validation cohorts, respectively. In addition, GSE40435, GSE53757, International Cancer Genome Consortium (ICGC) datasets, and RNA-sequencing data from local ccRCC patients were utilized as validation cohorts for claudin clustering based on silhouette scores. Using weighted correlation network analysis (WGCNA) and multiple machine learning algorithms, including least absolute shrinkage and selection operator (LASSO), CoxBoost, and random forest, we constructed a claudin-TME related (CTR) risk signature. Furthermore, the CTR associated genomic characteristics, immunity, and treatment sensitivity were evaluated. A claudin-low phenotype was identified and associated with an inferior survival and distinct TME and cancer immunity characteristics. Based on its interaction with TME, a risk signature was developed with robust prognostic prediction accuracy. Moreover, we found its association with a claudin-low, stem-like phenotype and advanced clinicopathological features. Intriguingly, it was also effective in kidney chromophobe and renal papillary cell carcinoma. The high CTR group exhibited genomic characteristics similar to those of claudin-low phenotype, including increased chromosomal instability (such as deletions at 9p) and risk genomic alterations (especially BAP1 and SETD2). In addition, a higher abundance of CD8 T cells and overexpression of immune checkpoints, such as LAG3, CTLA4 and PDCD1, were identified in the high CTR group. Notably, ccRCC patients with high CTR were potentially more sensitive to immune checkpoint inhibitors; their counterparts could have more clinical benefits when treated with antiangiogenic drugs, mTOR, or HIF inhibitors. We comprehensively evaluated the expression features of claudin genes and identified a claudin-low phenotype in ccRCC. In addition, its related signature could robustly predict the prognosis and provide guide for personalizing management strategies.

Abstract 13553: Remote Monitoring of the Haemodynamic Response to Clinically Indicated Therapeutic Escalation and Clinical Worsening Events in Patients With Pulmonary Arterial Hypertension

Background Hospital-based assessment of haemodynamics, exercise capacity and right heart function/strain are used for risk-stratification to aid clinical decision making and guide treatment in patients with pulmonary arterial hypertension. Advances in haemodynamic and cardiac monitoring now provide the capacity to remotely measure physiological parameters that relate to mortality from a patient’s home. We sought to examine remote monitored physiology in the time preceding and following increase in standard of care therapy and clinical worsening events in patients with pulmonary arterial hypertension. Methods Between January 2020 and October 2021 22 patients with WHO functional class III PAH and a hospitalisation in the preceding year were implanted with a pulmonary artery pressure monitor (CardioMEMS, Abbott) and an insertable cardiac monitor (LinQ, Medtronic) (FITPH 19/YH/0354). Remote data and clinical events were reviewed in a multidisciplinary team identifying 18 increases in therapy and 13 worsening events. For each parameter baseline was set at the 30-days preceding the event and daily data analysed as change from baseline. Statistical significance was determined using Wilcoxon matched pairs and One-way ANOVA with Dunnett’s correction as appropriate. Results Following clinically indicated increase in therapy improvements in field walk test, WHO functional class and NT-proBNP were observed (p&lt;0.05) with mean time to follow up of 5.1 months. Remote monitored mean pulmonary artery pressure and total pulmonary resistance were reduced and cardiac output and physical activity increased compared to baseline at day 7, 4, 22 and 42 respectively (p&lt;0.05). Clinical worsening events led to deterioration in field walk test, WHO functional class and NT-proBNP (p&lt;0.05). Remote monitored mean pulmonary artery pressure and total pulmonary resistance were increased and cardiac output and physical activity reduced 10 days prior to a clinical worsening event (p&lt;0.05). Conclusion Remote haemodynamic and cardiac monitoring may provide a means for early, remote evaluation of clinical efficacy and early identification of clinical worsening in patients with pulmonary arterial hypertension.

Abstract 13527: The Development of a Remote Pulmonary Arterial Hypertension Risk Score Utilising Remote Monitoring Technology to Monitor Parameters Associated With Mortality in Pulmonary Arterial Hypertension

Background: In patients with pulmonary arterial hypertension (PAH) risk stratification is used to aid clinical decision making and guide treatment categorising patients as low (&lt;5%), intermediate (5-10%), or high mortality risk (&gt;10%) at 1 year based on hospital investigations. Risk stratification based on remote parameters may facilitate early evaluation of clinical efficacy following treatment change or indicate clinical stability/deterioration, thereby permitting early intervention. Methods: Patients with PH were identified from the ASPIRE (6/YH/0352) database 2/2001-6/2019. Random allocation was used to form a derivation (n=3832). Univariate Cox Regression and stepwise forward multivariate analysis were undertaken in the derivation cohort to identify parameters that may be remote monitored that were associated with mortality. Mortality weighted z-scores of age, incremental shuttle walk test (ISWT), heart rate (HR) and total pulmonary resistance (TPR) were summed to give an individual remote risk score value. LOESS regression was used to determine 1 year risk thresholds applied to a PAH validation cohort (n=590). Results: Multivariate analysis of the derivation cohort demonstrated that ISWT, HR and TPR had statistically significant relationships to mortality. Survival analysis showed increased mortality with each decile of baseline risk score with the 10 th decile at increased risk of mortality compared the 1 st decile (OR 5.5, 95%CI 4.3-7.0, each decile p&lt;0.01, Figure). In patients with PAH, LOESS derived thresholds identified patients at low, intermediate and high risk with 1 year mortalities of 4.6, 9.8 and 15.1% respectively (low-int OR 1.9, low-high OR 2.7,p&lt;0.01,Figure). Conclusion: A score of remote monitored parameters, when applied at diagnosis, accurately categorised patients as low, intermediate, or high risk. This system may be applied to remote monitored physiological data to provide real time risk stratification.

Acupuncture Combined with Chinese Herbal Medicine for Insomnia: A Systematic Review and Meta-Analysis

Background: Insomnia affects more than a tenth of the world’s population. Acupuncture combined with Chinese herbal medicine (CHM), which is used for the treatment of insomnia, has been clinically demonstrated to be effective. However, Evidence-based medicine is still lacking. A systematic review of the treatment of insomnia was conducted to obtain a consistent evaluation of clinical efficacy between acupuncture &amp; CHM and West Medicine (WM). Methods: Articles about insomnia published before Oct 1, 2022, were searched in English databases Pubmed, EMbase, Web of Science, Cochrane Library, CNKI, CQVIP, and Wanfang. Two researchers assessed the quality of the studies that were included in the review. Review manager 5.3 was used to conduct a meta-analysis on the efficacy of the included studies. Results: Data on 734 (372/362) patients from 7 studies were included in the meta-analysis. It was shown that treatment of insomnia with acupuncture &amp; CHM had higher effective rate [RR=1.22, 95%CI (1.07, 1.38), P=0.0003], comparing with WM. Conclusion: This study extended complementary alternative therapies for insomnia by providing evidence of the efficacy of acupuncture &amp; CHM in the treatment of insomnia.

Evaluation of clinical efficacy of Ginkgo biloba extract in the treatment of knee osteoarthritis: a randomized clinical trial

Background: Osteoarthritis (OA) is a degenerative joint disease characterized by deteriorating articular cartilage. Most patients may not get enough control of symptoms in spite of the availability of various treatment options. Because of the synergistic impact of flavonoids and ginkgolides, Ginkgo biloba (GB) has been shown to possess antioxidant and anti-inflammatory properties besides its generally safe profile. This study aims to assess the efficacy of the Ginkgo biloba extract (GBE) in patient with Knee OA. Methods: This is a randomized double blinded clinical trial conducted in a private orthopaedic clinic in Al-Najaf Government-Iraq. Patients were randomized into two groups; Group A administered the standard treatment (diclofenac capsule 100 milligram sustained released with paracetamol 1 gram twice daily) with GBE 120 milligram twice daily, while Group B administered the standard treatment with placebo (starch) capsule only. The Knee injury and Osteoarthritis Outcome Score (KOOS) was performed to assess the efficacy of the GBE in patient with Knee OA for eight weeks. Results: 60 patients successfully completed the eight weeks follow up. Pain, symptoms, sport, activity of daily living (ADL) scores showed significant improvement in Group A from the first two weeks after treatment with GB in comparison with group B. however, scores of quality of life (QOL) were not significantly improved in two group comparison at each assessment week. Only 10 patients reported gastrointestinal adverse effects during the study which were all mild. Conclusions: GB may provide additional beneficial health effects to patients with knee OA based on KOOS scores when add to the standard treatment regime. Registration: ClincialTrials.gov (NCT05398874, https://clinicaltrials.gov/ct2/show/NCT05398874).

Clinical Efficacy and Safety Evaluation of Calcitriol Combined with Bisphosphonates in the Therapy of Postmenopausal Osteoporosis: Based on a Retrospective Cohort Study.

A retrospective cohort study to explore the clinical efficacy and safety evaluation of calcitriol combined with bisphosphonates in the therapy of postmenopausal osteoporosis is conducted. The postmenopausal osteoporosis sufferers admitted to our hospital from January 2020 to June 2021 are retrospectively collected and divided into a contrast set and a study set, with 60 cases in each set. For the contrast set, all sufferers are treated with bisphosphonates. For the study set, on the basis of the therapy drugs in the contrast set, they are treated with calcitriol capsules. Firstly, the curative effects, bone mineral density standards, and bone metabolism standards of the two sets are contrasted; then, the lumbar spine bone mineral density, VAS score, and quality of life between the two sets of sufferers before therapy and 1 year after therapy are contrasted, and the correlation between bone mineral density and VAS and quality of life of the sufferers is analyzed. Lastly, the readmission situation between the two sets at one year is contrasted. The experimental results show that for postmenopausal women with osteoporosis, calcitriol combined with bisphosphonate therapy can notoriously enhance the clinical therapy effect of sufferers, with low adverse reactions, and can effectively enhance the bone mineral density and bone density of sufferers.

Evaluation of clinical efficacy and laboratory indicators of non-cultured epidermal cell suspension and hair follicle cell suspension in surgical management of stable vitiligo: A randomized comparative trial.

Non-cultured epidermal cell suspension (ECS) and hair follicle cell suspension (HFCS) are well-established methods of surgical treatment of stable vitiligo. The aim of the present study was to compare the laboratory indicators and clinical efficacy of ECS and HFCS in the treatment of stable vitiligo. This was a single centre, open-labeled randomized trial. Vitiligo patches from 74 patients were randomized to receive either ECS or HFCS. Both cell suspensions were analyzed for total cell count, cell viability and melanocyte count. Percentage re-pigmentation was assessed at regular intervals for 36 weeks. The percentage re-pigmentation with ECS was significantly higher than HFCS at week 4 (p=.01) and week 16 (p=.03) however, no difference was observed at weeks 24 (p=.38) and 36 (p=.05). Forty-seven patients completed the study follow-up duration and excellent re-pigmentation (>90%) was achieved in 61.7% and 53.2% and complete re-pigmentation (100%) was observed in 6.4% and 12.8% of participants using ECS and HFCS, respectively. Significantly higher cell yield (p < .01) and percentage of HMB45+ melanocytes (p=.01) were obtained using ECS. No difference was noted in the percentage of viable cells or S100 + melanocytes. The median cell yield was eight times higher in ECS than in HFCS with a significantly higher percentage of HMB45+ melanocytes in the former group. The median percentage of re-pigmentation in both groups was 90% at the end of 36 weeks. ECS provides faster re-pigmentation; however, both ECS and HFCS have comparable safety and efficacy over a longer duration of follow-up.

Clinical Evaluation of Efficacy on Ultrasound Combined with Neuromuscular Electrical Stimulation in Treating Lumbar Disc Herniation.

Purpose To investigate the clinical efficacy of ultrasound (US) combined with neuromuscular electrical stimulation (NMES) in treating lumbar disc herniation (LDH) and its effect on the level of inflammatory factors. Methods The data of 240 patients with LDH treated at our hospital from January 2020 to February 2021 were reviewed and classified into an US combined with NMES treatment group (US+NMES, n = 80), NMES only treatment group (NMES, n = 80), and US only treatment group (US, n = 80). Their Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) scores, levels of inflammatory factors and pain mediators, recovery rate, and total recovery time before and after treatment were compared. Additionally, the incidence of complications/adverse reactions was also investigated. Results Compared with data before treatment, the three groups had lower VAS and ODI scores, inflammatory factor levels (interleukin- [IL-] 1, IL-6, and tumor necrosis factor- [TNF-] α), and pain mediators (transforming growth factor- [TGF-] β1, prostaglandin E2 [PEG2], and 5-hydroxytryptamine [5-HT]) after treatment, with the most significant decrease observed in the US+NMES group. Compared with patients who received US or NMES treatment alone, patients from the US+NMES had faster recovery time and lower incidence of complications/adverse reactions. Conclusion Collectively, US combined with NMES was associated with significant relief in pain and lumbar dysfunction and reduced local inflammatory response and pain mediator levels in LDH patients, suggesting that this combined approach could achieve better efficacy than US or NMES alone.

Evaluation of safety and clinical efficacy of bilateral percutaneous kyphoplasty in treatment of osteoporotic thoraco-lumbar burst fractures

Objective: To evaluate the safety and clinical efficacy of bilateral percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral burst fractures. Methods: It was a prospective study, 28 patients with osteoporotic thoraco-lumbar burst fractures who were treated in Beijing Chao-Yang Hospital from January 2021 to July 2021 were included, including 10 males and 18 females, with a median age of 73.6 years (range: 56.0-87.0 years). The X-ray radiographs, bone mineral density (BMD), CT three-dimensional reconstruction scan and MRI were taken and measured before operation to observe the fracture location and the posterior wall of the vertebral body, and further to determine the diagnosis. The X-ray radiographs and CT three-dimensional reconstruction scans were taken on the first day after operation and the last follow-up to observe whether there were bone cement leakage or not. The changes of kyphosis angle (KA), the height of anterior wall (HAW) and the height of posterior wall (HPW) before the operation, on the 1st day post operation and at the last follow-up were recorded. The visual analogue scale (VAS) of back pain and Oswestry dysfunction index (ODI) before the operation, 1 day post operation and at the last follow-up were used to evaluate the clinical effect of the operation. Results: All the patients were followed up for (12.2±6.0) months. The HAW on the 1st day post operation [(22.5±2.0) mm] was significantly increased as compared with that before the operation [(21.2±2.4) mm] (P<0.05). The HAW at the last follow-up [(18.9±1.6) mm] decreased signficantly as compared with that on the 1st day post opertion [(22.5±2.0) mm] (P<0.05). The HPW was also significantly corrected after surgery (P<0.05). At the end of the follow-up, the HPW [(27.2±1.3) mm] was comparable with that on the 1st day after surgery [(27.5±1.6) mm] (P>0.05). The KA on the 1st day after the operation (14.2°±1.5°) decreased significantly when compared with that before the operation (18.8°±1.3°) (P<0.05), but it was increased to 17.6°±1.4° at the last follow-up and was higher than that on the 1st day after the operation (P<0.05). There were bone cement leakage in 5 cases and adjacent vertebral fracture in 1 case. The VAS and ODI scores were all significantly lower on the 1st day and at last follow-up than that before the operation (all P<0.05). Conclusions: Bilateral PKP is effective, safe and reliable in the treatment of osteoporotic vertebral burst fracture. Careful evaluation of preoperative imaging data, accurate puncture and timing of bone cement injection are the key factors to ensure the success of the operation.