Evaluation Of Clinical Efficacy Research Articles

Development of Granzyme B-targeted Smart Positron Emission Tomography Probes for Monitoring Tumor Early Response to Immunotherapy.

Granzyme B is an immune-related biomarker that closely correlates with cytotoxic T lymphocytes (CTLs), and hence detecting the expression level of granzyme B can provide a dependable scheme for clinical immune response assessment. In this study, two positron emission tomography (PET) probes [18F]SF-M-14 and [18F]SF-H-14 targeting granzyme B are designed based on the intramolecular cyclization scaffold SF. [18F]SF-M-14 and [18F]SF-H-14 can respond to granzyme B and glutathione (GSH) to conduct intramolecular cyclization and self-assemble into nanoaggregates to enhance the retention of probe at the target site. Both probes are prepared with high radiochemical purity (>98%) and high stability in PBS and mouse serum. In 4T1 cells cocultured with T lymphocytes, [18F]SF-M-14 and [18F]SF-H-14 reach the maximum uptake of 6.71 ± 0.29 and 3.47 ± 0.09% ID/mg at 0.5 h, respectively, but they remain below 1.95 ± 0.22 and 1.47 ± 0.21% ID/mg in 4T1 cells without coculture of T lymphocytes. In vivo PET imaging shows that the tumor uptake in 4T1-tumor-bearing mice after immunotherapy is significantly higher (3.5 times) than that in the untreated group. The maximum tumor uptake of [18F]SF-M-14 and [18F]SF-H-14 in the mice treated with BEC was 4.08 ± 0.16 and 3.43 ± 0.12% ID/g, respectively, while that in the untreated mice was 1.04 ± 0.79 and 1.41 ± 0.11% ID/g, respectively. These results indicate that both probes have great potential in the early evaluation of clinical immunotherapy efficacy.

A mechanical nano sensor based on magnetic-mediated sensitization for 5-HT detection

The real-time detection of neurotransmitters had attracted more attention due to the potential to provide vital information for pathology research, disease diagnosis, and clinical efficacy evaluation. Here, a magnetic-mediated nano sensor was developed to improve sensitivity for detection of serotonin (5-HT). The PDMS membrane doped with magnetic particles serves as a conversion element, enhancing the deformation of the thin film caused by surface stress under the action of a magnetic field and amplifying the resistance response signal of the nano sensor. The 5-HT detection associated with neurotransmitter diseases serve as a proof of concept revealing the magnetic sensitization. The detection limit of the 5-HT was decreased to 3.21 nM in the linear range of 5–500 nM, which was lower than that of the nano sensor without magnetic field. The clinical 5-HT samples were also been accurately detected, indicating a positive application potential of the as-prepared magnetic-mediated nano sensor. All these results reveal the high sensitivity and practicality of the as-prepared magnetic-mediated nano sensor and provide a new method for neurotransmitter diseases diagnosis.

Evaluation of Pathological Response and Surgical Safety of Total Neoadjuvant Therapy for Patients with Clinical Stage III Gastric Cancer in a Real-world Setting

BackgroundPerioperative chemotherapy is the standard treatment for locally advanced gastric cancer. However, the potential benefit of extending therapy before surgery remains largely unknown. In this study, we aimed to evaluate the efficacy and safety of total neoadjuvant chemotherapy, with or without immune checkpoint blockade. MethodA cohort of 174 patients with clinical stage III gastric cancer who underwent D2 gastrectomy from October 2021 to March 2024 in the real-world setting were included in this study. Among these patients, 101 were treated with total neoadjuvant therapy (TNT) and 73 were treated with perioperative neoadjuvant therapy (PNT). We compared the pathological complete response (pCR) rate, ypN0 rate, recurrence-free survival (RFS), overall survival (OS), and postoperative complications between the two groups. Multivariate logistic regression analysis was conducted to identify factors associated with pCR or ypN0. ResultsCompared to the PNT group, the patients in the TNT group were more frequently treated with intensive chemotherapy with triplets + immunotherapy. Apart from this, there were no significant differences in baseline characteristics. There were no statistically significant differences in pCR (16.8% vs. 12.3%), ypN0 (49.5% vs. 38.4%), RFS, OS, and postoperative complications (27.7% vs. 26.0%) between the TNT and PNT group. Older age, diffuse type, and stable disease/ progressive disease based on clinical efficacy evaluation were independently associated with non-pCR. Stable disease / progressive disease, linitis plastica, and poor differentiation were independently associated with ypN+. Neither the number of neoadjuvant therapy cycles nor the specific regimens were associated with pCR or ypN0. In the subgroup analysis of patients receiving total gastrectomy, there were still no statistically significant differences in pCR (16.7% vs. 2.6%), ypN0 (43.8% vs. 39.5%), and postoperative complications (43.8% vs. 39.5%) between the two groups. ConclusionAlthough TNT did not increase the postoperative complication rate, it also did not provide anyadditional short-term benefits compared to PNT for clinical stage III gastric cancer.

Application and research progress of patient-derived organoids in the multimodality treatment of pancreatic cancer

Pancreatic cancer is one of the most malignant tumors with a 5-year survival rate of 13%. Difficulty in early diagnosis,high tumor heterogeneity,high rate of drug resistance,and lack of effective new drugs are the main reasons for the poor therapeutic effect. Traditional cell line models cannot simulate the tumor environment in vitro and cannot reflect the heterogeneity of pancreatic cancer,while animal models have a long culture process and cannot be used for high-throughput screening. Pancreatic cancer organoids can be continuously expanded and cultured in vitro,which can realistically reflect the heterogeneity of pancreatic cancer and allow high-throughput drug screening,making it an ideal tool for individualized precision diagnosis and treatment of pancreatic cancer. According to recent studies on the evaluation of clinical drug efficacy using pancreatic cancer organoids,the drug sensitivity of pancreatic cancer organoids is highly consistent with the clinical efficacy,demonstrating the feasibility of drug sensitivity of pancreatic cancer organoids in guiding clinical therapy,comfirming the ability to discover potential therapeutic drugs through high-throughput drug screening of pancreatic cancer organoids. At the same time,this review reveals the importance of pancreatic cancer organoids as a model of the pancreatic cancer microenvironment for the development of new drugs and tumor microenvironment research. and the role of pancreatic cancer organoids as a model that can reflect the specific microenvironment of pancreatic cancer for new drug discovery and microenvironmental evaluation. Pancreatic cancer organoids and organ-on-chips are powerful tools for precision companion therapy and new drug discovery.

Clinical efficacy and safety evaluation of Dermatophagoides farinae drops in the treatment of allergic rhinitis with epistaxis.

Background. Epistaxis is frequently observed in allergic rhinitis (AR) patients. However, few studies focus on the outcome of epistaxis with treatment of AR patients. This study aimed to retrospectively analyze the efficacy and safety of AR patients with epistaxis treated with sublingual immunotherapy (SLIT). Methods. A total of 74 patients aged 4-60 years with house dust mite (HDM)-induced AR accompanied by epistaxis and who completed 1 year of SLIT treatment with standard Dermatophagoides farinae (D. farinae) drops were enrolled in this study. The symptom scores, total medication scores (TMS), combined symptom and medication score (CSMS), visual analog scales (VAS), and bleeding score (BS) were assessed, as well as the nasal endoscopic examinations were performed to observe nasal signs. Results. The levels of symptom scores, TMS, CSMS, VAS, and BS at 0.5 year and 1 year of SLIT treatment were significantly lower than those at the baseline (all p less than 0.01). Also, statistical differences were seen in CSMS (p less than 0.05) and VAS (p less than 0.01) between 0.5 year and 1 year. As expected, BS was positively correlated with CSMS (r = 0.617, 95% CI 0.517-0.699) and VAS (r = 0.777, 95% CI 0.719-0.822) at all three time points. Conclusions. SLIT with D. farinae drops was effective and safe for AR patients with epistaxis, resulting in improving the symptoms of rhinitis while relieving the symptoms of epistaxis.

Clinical evaluation of therapeutic efficacy of a Siddha herbo mineral formulation “Kumaara Veeriya Kaantha Chenduram’’ with “Nellikkai Legiyam” (internal) in the treatment of Iron Deficiency Anemia

Abstract: Background: Kumaara veeriya kaantha chenduram (KVKC) is a siddha herbomineral formulation indicated for paandunoi in Siddha literature (1).Paandu noi is a disease characterized by changes in the body's natural color andpallor found in the skin, nails and conjunctiva. Objectives: To determine the efficacy of the KVKC, the open labed clinical study was conducted in National Institute of Siddha OPD. Materials and Methods: The 30 patients with Iron deficiency anaemiawere selected and treated with KVKC orally with the dose of 260 milli gram twice in a day with Nellikailegiyam6 gram continuously for 45 days. Laboratory investigations for hemoglobin was done on 1st day and every 15 days once of the study. Results: Clinical assessment was done, based on the before and after treatment scores which was compared statistically and recorded.Regarding Hemoglobin level, 24(80%) patients showed increase of 1 to 3 grams from base level, 6(20%) patients showed increase of 0.1 to 0.9 grams from base level.Regarding Serum Ferritin, out of 30 patients, 9 (30%) patients showed 0.1-3.5 ng/ml increase from its base level, 21 (70%) patients showed 3.6-7.0 ng/ml increase from its base level.From the Statistical studies, the Mean ± Standard deviation for Haemoglobin before treatment was 9.7 ± 0.93 and after treatment was 11.18 ± 1.08 which was statistically highly significant (p<0.0001).And Serum ferritin before treatment was 9.27 ± 3.31, after treatment was 13.5 ± 3.49 which was statistically significant (p<0.0001).

Evaluation of clinical efficacy of scaling and root planing with copper nanoparticles gel and/or chlorhexidine gel in patients with periodontitis: A randomized control trial

Antibiotic resistance of bacteria to medications can be resolved using nanotechnology. Resistance to antibiotic mechanisms, such as regulation of permeability, multi-drug efflux pumps, antibiotic disintegration, and target area attraction, are dealt with by nanoparticles. These NPs are composed of Ag and Cu as heavy metals. Being both an essential nutrient as well as an especially hazardous matter, copper represents the two poles of the survival range for microorganisms. Because copper fittings and work surfaces are capable of eliminating methicillin-resistant S. aureus (MRSA) to prevent cross-contamination,they act as an additional obstacle. Additional research is needed, as the mode of action of nanoparticles is not fully understood. Existing information concerning NPs encourages further research to explore their use in the control of dental infections.

Importance of the accurate diagnosis and treatment of patients with lumbar degenerative scoliosis

Under the background of aging population, the incidence of degenerative lumbar scoliosis is increasing year by year. How to conduct reasonable clinical diagnosis and treatment has gradually become a hot topic in the field of spinal surgery. This article discusses the key issues in the diagnosis and treatment of degenerative spinal deformities, including symptom differentiation, spinal alignment reconstruction, fusion level selection, and clinical efficacy evaluation. The aim is to further promote the accurate diagnosis and treatment of degenerative spinal deformities.

Feasibility study of rehabilitation for cardiac patients aided by an artificial intelligence web-based programme: a randomised controlled trial (RECAP trial)—a study protocol

IntroductionCardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a...

Navigating the future of guided dental implantology: A scoping review.

The aim of this scoping review was to understand the development of robotics and its accuracy in placing dental implants when compared to other forms of guided surgery. An electronic search was conducted on the electronic databases of PubMed, Cochrane, and Science direct with the following queries: ((robotics) AND (dental implant)) AND (accuracy). The search timeline was between 2017 and 2022. A total of 54 articles were screened for title and abstract, of which 16 were deemed eligible for inclusion. Thirty-one articles were excluded mainly because they were out of topic (not relevant) or not in English. In total, 16 articles were included for analysis. This review thoroughly analyses 5years of literature concerning the evolution of robotics in dental implant surgery, underscoring the necessity for additional research on nascent technologies reported and a comparative study with static and dynamic systems for clinical efficacy evaluation.

Assessment of central nervous system vasculitis in children based on high-resolution vascular wall imaging.

Central nervous system vasculitis (CNSV) is a rare disease. High-resolution vessel wall imaging (HR-VWI) enables the identification of inflammatory changes within the vessel wall. Few studies have applied HR-VWI to assess CNSV in children. This study delves into the utility of HR-VWI for diagnosing and treating CNSV in children, with the aim of enhancing clinical diagnosis and efficacy evaluation. Imaging data were acquired from children who underwent HR-VWI examinations. The study meticulously analysed clinical data and laboratory tests to discern the characteristics and distribution patterns of diverse vasculitis forms. In children, CNSV mainly involves medium vessels with grade 1 and 2 stenosis (grade 4 stenosis is rare), and the imaging features generally show centripetal and moderate enhancement, suggesting that this feature is specific for the diagnosis of CNSV. High-grade stenosis, concentric enhancement and strong enhancement of the vasculature indicate more severe disease activity. Remarkably, HR-VWI proved to be significantly more sensitive than magnetic resonance angiography in detecting CNSV. Among the 13 cases subjected to imaging review, 8 demonstrated a reduction or resolution of vessel wall inflammation. In contrast, five patients exhibited worsening inflammation in the vessel wall. HR-VWI demonstrated that changes in vessel wall inflammation were closely correlated with changes in brain parenchymal lesions and symptoms. This study underscores the diagnostic value of HR-VWI in CNSV assessment and treatment monitoring, offering a quantitative evaluation of CNSV in children.

A retrospective study of occlusal reconstruction in patients with old jaw fractures and dentition defects

PurposeThis study evaluated the methods and clinical effects of multidisciplinary collaborative treatment for occlusal reconstruction in patients with old jaw fractures and dentition defects. MethodsPatients with old jaw fractures and dentition defects who underwent occlusal reconstruction at the Third Affiliated Hospital of Air Force Military Medical University from January 2018 to December 2022 were enrolled. Clinical treatment was classified into 3 phases. In phase I, techniques such as orthognathic surgery, microsurgery, and distraction osteogenesis were employed to reconstruct the correct three-dimensional (3D) jaw position relationship. In phase II, bone augmentation and soft tissue management techniques were utilized to address insufficient alveolar bone mass and poor gingival soft tissue conditions. In phase III, implant-supported overdentures or fixed dentures were used for occlusal reconstruction. A summary of treatment methods, clinical efficacy evaluation, comparative analysis of imageological examinations, and satisfaction questionnaire survey were utilized to evaluate the therapeutic efficacy in patients with traumatic old jaw fractures and dentition defects. All data are summarized using the arithmetic mean and standard deviation and compared using independent sample t-tests. ResultsIn 15 patients with old jaw fractures and dentition defects (an average age of 32 years, ranging from 18 to 53 years), there were 7 cases of malocclusion of single maxillary fracture, 6 of malocclusion of single mandible fracture, and 2 of malocclusion of both maxillary and mandible fractures. There were 5 patients with single maxillary dentition defects, 2 with single mandibular dentition defects, and 8 with both maxillary and mandibular dentition defects. To reconstruct the correct 3D jaw positional relationship, 5 patients underwent Le Fort I osteotomy of the maxilla, 3 underwent bilateral sagittal split ramus osteotomy of the mandible, 4 underwent open reduction and internal fixation for old jaw fractures, 3 underwent temporomandibular joint surgery, and 4 underwent distraction osteogenesis. All patients underwent jawbone augmentation, of whom 4 patients underwent a free composite vascularized bone flap (26.66%) and the remaining patients underwent local alveolar bone augmentation. Free gingival graft and connective tissue graft were the main methods for soft tissue augmentation (73.33%).The 15 patients received 81 implants, of whom 11 patients received implant-supported fixed dentures and 4 received implant-supported removable dentures. The survival rate of all implants was 93.82%. The final imageological examination of 15 patients confirmed that the malocclusion was corrected, and the clinical treatment ultimately achieved occlusal function reconstruction. The patient satisfaction questionnaire survey showed that they were satisfied with the efficacy, phonetics, aesthetics, and comfort after treatment. ConclusionOcclusal reconstruction of old jaw fractures and dentition defects requires a phased sequential comprehensive treatment, consisting of 3D spatial jaw correction, alveolar bone augmentation and soft tissue augmentation, and implant-supported occlusal reconstruction, achieving satisfactory clinical therapeutic efficacy.

Methods for traditional Chinese medicine syndrome-based efficacy evaluation: a review

Traditional Chinese medicine(TCM) syndrome-based efficacy is an evaluation index which is unique to TCM and can reflect the advantages of TCM. The development of the methods and measurement tools for evaluating TCM syndrome-based efficacy can provide objective and quantitative evidence for the clinical efficacy evaluation of TCM and the development of new Chinese medicine preparations, being the exploration direction of innovative methods and technologies for evaluating TCM efficacy. The conventional evaluation methods are subjective and limited to the mitigation of symptoms and the improvement of physical signs, which make it difficult to form a unified evaluation standard. In addition, the evaluation methods lack unity, objectivity, and quantitative research. The scientific connotation, evaluation ideas and methods, and key technologies of the evaluation for the therapeutic effect on syndromes remain unclear, which leads to diverse evaluation modes, methods, and indexes. The syndrome-based efficacy scale provides a new idea for the objective quantification and standardization of TCM syndromes. This review systematically summarizes the methods and problems, introduces the research progress in the evaluation scales, and puts forward some thoughts on the characteristics of TCM syndrome-based efficacy evaluation, aiming to provide insights for the research in this field.

Correction of Cleft Lip Sequelae by Hyaluronic Acid Injections: Clinical and Ultrasonographic Evaluation of Efficacy and Safety in a Series of 7 Patients.

Correction of Cleft Lip Sequelae by Hyaluronic Acid Injections: Clinical and Ultrasonographic Evaluation of Efficacy and Safety in a Series of 7 Patients.

Unilateral percutaneous vertebroplasty in osteoporotic vertebral compression fractures: A clinical efficacy evaluation.

Osteoporotic vertebral compression fractures, often resulting from low-energy trauma, markedly impair the quality of life of elderly individuals. The present retrospective study focused on the clinical efficacy of unilateral percutaneous vertebroplasty (PVP) in the treatment of osteoporotic compression fractures. A total of 68 patients, representing 92 vertebral bodies, who underwent the unilateral PVP technique from March 2020 to January 2023 were evaluated. Key parameters such as visual analogue scale (VAS) values, Oswestry disability index (ODI) scores, Cobb angle measurements, and anterior vertebral height (AVH) were documented pre- and post-surgery. The mean follow-up period was 15.41±3.74 months. The mean pre-operative VAS score was 8.08±0.79, which was significantly reduced to 2.25±0.71 by 24 h post-surgery and stabilized at 1.58±0.51 by the final follow-up. The ODI showed a significant improvement from a pre-operative average of 67.75±7.91 to 19.74±2.90 post-surgery, and was maintained at a low level of 28.00±4.89 at the last assessment. Radiological evaluations revealed significant alterations in Cobb angle and AVH post-operation. Notably, during the follow-up, eight patients developed new compression fractures in different vertebral segments. In conclusion, the unilateral PVP method is safe and efficient for the management of osteoporotic vertebral compression fractures.

The safety and efficacy of Houtou Jianweiling tablet in patients with chronic non-atrophic gastritis: a double-blind, non-inferiority, randomized controlled trial.

Background: Common symptoms of Chronic Non-atrophic Gastritis (CNAG) include nausea, stomach distension, and abdominal pain. The Houtou Jianweiling Tablet (HTJWT) is a chinese patent medicine (CN1368229A) and it has been used clinically for more than 20years with proven clinical efficacy in treating CNAG, prompted us to establish the clinical efficacy and safety of HTJWT on patients with mild to moderate CNAG symptoms in Pakistani population. Methods: This phase II, double-blind, randomized, parallel-controlled trial was conducted in a single center between November 2022 and February 2023 in Pakistan. In a ratio of 1:1, total 240 CNAG patients with erosion identified by pathological biopsy and gastroscopy were randomly assigned to control (Omeprazole) group (n = 120) and the treatment (HTJWT) group (n = 120). Patients in the treatment group received orally four HTJWT (0.38g/tablet), three times a day and one placebo of Omeprazole enteric-coated tablet prior to breakfast, daily. On the other hand, patients in the control group received one Omeprazole enteric-coated tablet (20 mg/tablet) prior to breakfast and four placebo of HTJWT, thrice a day. The patients consumed the investigated drugs (i.e., treatment and control) treatment regimen was followed for a duration of 28days. The safety of the patients were evaluated through adverse events, serious adverse events and laboratory tests such as blood biochemistry, urine analysis, liver and renal function tests. Vital signs like; blood pressure, pulse rate, body temperature, respiratory rate for all the patients were recorded. The cardiac status of the patients were assessed through electrocardiogram (ECG). The primary efficacy indicators were the improvement rate of gastric distention and gastralgia as the main clinical symptoms. Secondary indicators were visual analogue score (VAS); improvement rate of secondary clinical symptoms and signs; improvement rate of total clinical signs and symptoms; the disappearance/remission rate of Gastric pain and, remission/disappearance time of gastric distension; and the negative conversion rate of Helicobacter pylori (H. pylori). The outcomes among each group were compared using the chi-square test. Results: Patients in both groups had good drug compliance (80%-120%), and there was no statistically significant difference in the patients' baseline characteristics. The clinical improvement rate was found to be 91.1% in the treatment group and 91.0% in the control group with negligible variation among the two groups (p = 0.9824; 95% confidence interval: -0.0781-0.0798). Similarly, hardly no difference was found in the negative conversion rate of H. pylori between the treatment group and the control group (i.e., 70.1% and 71.8% respectively, p = 0.8125). There were no significant differences in respiratory rate, vital signs, blood pressure, laboratory results for blood biochemistry, urine analysis, liver and renal function tests between the two groups. The ECG assessment carried out for the treatment and control group revealed no considerable difference. Margin variation in the disappearance time of gastric pain (p = 0.1860) and remission rate (p = 0.5784) between the two groups were observed. The control group exhibited a faster remission period for gastrointestinal discomfort indications as compared to treatment group (p = 0.0430). Only one patient in the control group experienced mild to moderate adverse events, namely,; epigastric pain and dyspepsia. The results were consistent with the intention-to-treat and per-protocol analysis that included patients who were 100% compliant to the assigned therapy. Conclusion: The lower limit of confidence interval (CI, 95%) for the differences in the effective rate between the treatment and the control groups was found to be -0.0781 which is greater than -0.15, hence the treatment group is non-inferior to the control group. The therapeutic dosage used in the trial and treatment period did not cause any significant adverse event, and there were no obvious changes in the ECG profile, vital signs and biochemistry of the patients. Based on the clinical efficacy evaluation and reported adverse events, it can be concluded that the HTJWT is a safe and effective traditional chinese medicine for the treatment of patients suffering from chronic non-atrophic gastritis with mild to moderate symptoms. Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT04672018].

A nonadditive rough set model for long-term clinical efficacy evaluation of chronic diseases in real-world settings

The pursuit of clinical effectiveness in real-world settings is at the core of clinical practice progression. In this study, we address a long-term clinical efficacy evaluation decision-making problem with temporal correlation hybrid attribute characteristics. To address this problem, we propose a novel approach that combines a temporal correlation feature rough set model with machine learning techniques and nonadditive measures. Our proposed approach involves several steps. First, over the framework of granular computing, we construct a temporal correlation hybrid information system, the gradient method is employed to characterize the temporal attributes and the similarity between objects is measured using cosine similarity. Second, based on the similarity of gradient and cosine, we construct a composite binary relation of temporal correlation hybrid information, enabling effective classification of this information. Third, we develop a rough set decision model based on the Choquet integral, which describes temporal correlation decision process. We provide the ranking results of decision schemes with temporal correlation features. To demonstrate the practical applications of our approach, we conduct empirical research using an unlabeled dataset consisting of 3094 patients with chronic renal failure (CRF) and 80,139 EHRs from various clinical encounters. These findings offer valuable support for clinical decision-making. Two main innovations are obtained from this study. First, it establishes general theoretical principles and decision-making methods for temporal correlation and hybrid rough sets. Second, it integrates data-driven clinical decision paradigms with traditional medical research paradigms, laying the groundwork for exploring the feasibility of data-driven clinical decision-making in the field.

Research and development strategy of new traditional Chinese medicine drugs for syndromes based on human use experience

Chinese drug registration laws and regulations have always reserved a place for the new traditional Chinese medicine(TCM) drugs for syndromes, but so far no such new drugs have been approved for registration. This paper expounded on the relevant policies, regulations, and technologies of new TCM drugs for syndromes in China and pointed out that the application of the animal model of TCM syndromes to carry out pharmacodynamics research and clinical efficacy evaluation criteria of TCM syndromes were the main technical difficulties in the research and development of new TCM drugs for syndromes. Not all syndromes are suitable for developing new drugs, and the indications for new TCM drugs should be constant syndromes. Among the three research and development models of simple syndrome, syndrome-unified disease, and combined disease and syndrome, the research and development model of combined disease and syndrome is recommended. Clinical positioning is the key to new TCM drugs for syndromes. It is encouraged to conduct high-quality human use experience studies to determine the clinical positioning of new TCM drugs for syndromes, as well as the target population, dose, course of treatment, and initial therapeutic and safety, and apply for exemption from non-clinical effectiveness studies. Clinical trials of new TCM drugs for syndromes should take the target symptoms or signs as the main efficacy index and the efficacy of TCM syndromes as the secondary efficacy index. Clinical research program design should implement the "patient-centered" concept and introduce clinical outcome evaluation indicators. In the clinical safety evaluation, special conditions such as characteristic syndromes and changes should be considered. With the construction of the human use experience technology system and the promotion of the TCM registration and evaluation evidence system featuring the "combination of TCM theory, human use experience, and clinical trials", it is believed that many high-quality new TCM drugs for syndromes will be developed in the future.

Clinical Efficacy Evaluation of a Novel Negative Pressure Ureteroscopic Lithotripsy for Ureteral Stones

ObjectiveTo evaluate the clinical efficacy of a novel negative pressure ureteroscopic lithotripsy (NP-URL) compared to standard ureteroscopic lithotripsy (S-URL) for treating ureteral stones. MethodsA total of 284 patients diagnosed with ureteral stones and who underwent ureteroscopic lithotripsy between December 2020 and May 2022 at our hospital were included in the study. Among them, 146 cases underwent NP-URL and 138 cases underwent S-URL. The negative pressure device used in NP-URL consists of a 5F ureteric catheter and a tee joint. We evaluated the operative duration, stone-free rate, incidence of postoperative complications, stone retropulsion rate, and adjunct procedure rate between the two groups. ResultsThe mean operative duration was significantly shorter in the NP-URL group compared to the S-URL group (30.17±5.84 mins vs. 34.84±6.62 mins; P＜0.05). Additionally, the NP-URL group had a lower incidence of postoperative fever (1.4% vs. 8.7%; P＜0.05), reduced stone retropulsion rate (3.4% vs. 11.6%; P＜0.05), and a statistically lower rate of adjunct procedures (5.5% vs. 14.5%, P＜0.05). The NP-URL group also demonstrated a higher primary stone-free rate (91.8% vs. 81.9%; P＜0.05). However, there was no significant difference in the final stone-free rate between the NP-URL and S-URL groups (P＞0.05). ConclusionsNP-URL potentially reduces operative duration, significantly decreases the incidence of postoperative complications, and achieves better primary stone-free rates compared to S-URL.

Clinical and ultrasonographic evaluation of efficacy and safety of intralesional injection of autologous platelet-rich plasma in morphea: A comparative case series.

To evaluate the efficacy and safety of platelet-rich plasma to restore skin changes in morphea by ultrasound and Localized Scleroderma Cutaneous Assessment Tool. Nine morphea patients (21 lesions) were diagnosed clinically and by histopathology. Intradermal platelet-rich plasma was injected into morphea lesion once weekly for 12 sessions. The disease severity and damage were evaluated at baseline, after the last session (3 months later), and at 6 months follow-up using the LoSCAT and a high-resolution ultrasound. The healthy corresponding side was considered as a control. The Localized Scleroderma Cutaneous Assessment Tool score showed a significant improvement starting from 13 ± 7.28 up to 7.33 ± 6.82 after the therapeutic endpoint, reaching to 6.44 ± 7.09 after 6 months of follow-up with p value = 0.008 and 0.014, respectively. There was a significant positive correlation between the duration of the lesion and the improvement assessed by the ultrasound, with p value = 0.01. Regarding adverse effects, all patients reported having pain during platelet-rich plasma injection; transient edema of the face was reported by four patients (45%), and only two patients showed transient erythema. Autologous platelet-rich plasma is a safe technique with great aesthetic outcomes for filling up the contour defects and correcting both hyper and hypopigmentation, in addition to softening the indurated lesions.