Analysis of Structural Heterogeneity in Low-Rank Coal and Its Pyrolyzed Char Using Multi-Point Scanning Micro-Raman Spectroscopy.

Understanding the changes in carbon structure during the mid-low-temperature pyrolysis of low-rank coal is important for efficient utilization. Raman spectroscopy is commonly used to analyze the structural order of carbonaceous materials, but traditional methods may overlook the heterogeneity of coal/char. This research explores the heterogeneity of char structure derived from low-rank coal at 700 °C through multi-point micro-Raman analysis. The analysis of parameters such as area (A), intensity (I), full width at half maximum (FWHM/W), and peak position (P) reveals that the carbon structure becomes less ordered as coal transforms into char due to the deposition of small molecules on the surface. The study emphasizes the benefits of multi-point detection for gaining in-depth insights into the structural evolution of carbonaceous materials. The increased standard deviation of Raman parameters indicates diverse structural characteristics resulting from pyrolysis at this temperature, which traditional methods may not capture effectively. The mapping method used in this research visually illustrates the distribution of carbon structures in the region.

[Technical points of human use experience of ethnic medicine].

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.

[Expert consensus on human use experience research of traditional Chinese medicine].

Human use experience(HUE) is important for the research and development of Chinese medicine. For the sake of more reliable data, the Professional Committee for Clinical Evaluation of Chinese Medicine of Chinese Pharmaceutical Association drafted the Expert Consensus on Human Use Experience Research of Traditional Chinese Medicine. It highlights that the research on HUE should have clear purposes, describe the theoretical basis of traditional Chinese medicine(TCM) for the clinical indications and prescriptions and the clinical value of prescriptions, especially the advantages or characteristics in clinical orientation and target population, evaluate the dosages and number of medicinals of prescriptions, verify the accordance with the preparation process of new Chinese medicine, analyze feasibility of the process for large-scale production and the rationality of the dosage form, and assess the medicinal material resources. Moreover, such research should have reasonable protocol and the collection of clinical data on HUE must comply with medical ethics and avoid conflicts of interest. The collection method should be selected depending on the characteristics of clinical data. Quality control measures should be formulated to ensure the authenticity, accuracy, completeness, reliability, and traceability of clinical data. The definitions on the clinical data should be uniform and clear, and methods should be adopted to avoid bias. The data can be statistically analyzed after the processing. Through the study of HUE, the clinical orientation, target population, commonly used dosage, course of treatment, preliminary efficacy and safety of Chinese medicine prescriptions will be clarified. On this basis, the data on the HUE should be discussed and conclusions will be drawn. Finally, a standardized report will be formed.

[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

Absent atherosclerotic risk factors are associated with carotid stiffening quantified with ultrafast ultrasound imaging.

OBJECTIVES: To evaluate carotid stiffening in participants without conventional cardiovascular risk factors (CVRFs) by using ultrafast pulse wave velocity (ufPWV). METHODS: The present study enrolled 517 participants without conventional CVRFs (CVRF-Free total population). Subjects in this population were defined as current non-smokers with untreated blood pressure < 140/90 mmHg, fasting blood glucose (FBG) < 7.0 mmol/L, total cholesterol (TC) < 6.2 mmol/L, low-density lipoprotein cholesterol < 4.1 mmol/L, and high-density lipoprotein cholesterol ≥ 1.0 mmol/L. Participants in the subgroup with optimal CVRFs (CVRF-Optimal subgroup; n = 188) were defined as having blood pressure < 120/80 mmHg, TC < 5.2 mmol/L, and FBG < 5.6 mmol/L. Clinical interviews, physical examinations, serum draw, carotid intima-media thickness (cIMT), and ufPWV were evaluated. Adjusted odds ratios (ORs) with 95% confidence intervals and ordinal logistic regression models were used. RESULTS: Carotid stiffening was present in 46.2-54.5% of CVRF-Free subjects. Age, male sex, and body mass index (BMI) were independently associated with carotid stiffening in both the CVRF-Free total population and CVRF-Optimal subgroup (OR for age = 1.10-1.11, OR for male sex = 2.65-7.19, OR for BMI = 1.34-1.62; p < 0.05). Carotid stiffening was associated with TC only in the CVRF-Free total population (OR for TC = 1.84; p = 0.034). CONCLUSIONS: Many CVRF-Free individuals have carotid stiffening. ufPWV for atherosclerotic stiffening aids the assessment of early atherogenesis and may further clarify the true status of healthy adults without CVRFs. KEY POINTS: • CVRF-Optimal individuals have a lower carotid stiffness than CVRF-Free populations. • ufPWV is a quantitative predictor for the early assessment of AS. • Absent major CVRFs cannot be considered low risk for carotid stiffening and atherosclerosis.

The bioequivalence of a single dose of a generic solifenacin succinate tablet or Vesicare in fasting or postprandial healthy Chinese adults.

OBJECTIVE: The present study evaluated the bioequivalence of the test preparation (5 mg generic solifenacin succinate tablet, produced by Jiangsu Deyuan Pharmaceutical Co., Ltd.) or the reference preparation (5 mg solifenacin succinate tablets with the trade name Vesicare, produced by Astellas Pharma Europe B.V.) in either fasting or postprandial states in healthy Chinese subjects. MATERIALS AND METHODS: The present study was designed as an open-label, randomized, single-center, single-dose, dual-cycle, dual-crossover, fasting/postprandial study. 56 healthy Chinese subjects (28 each in the fasting and postprandial groups) were enrolled. WinNolin software (version 7.0 or above) was used to calculate the pharmacokinetic parameters. RESULTS: In the fasting and postprandial group, pharmacokinetic analysis and bioequivalence analysis were carried out based on the blood concentration-time data. The 90% confidence interval of the geometric mean ratio of Cmax, AUC0-t, and AUC0-∞ of the test preparation and the reference preparation were both within the acceptance range of 80.00 - 125.00%. CONCLUSION: A single administration of a 5-mg tablet of either the test preparation, generic solifenacin succinate, or the reference preparation, solifenacin succinate with the brand-name Vesicare, was safe and bioequivalent in healthy Chinese subjects in either fasting or postprandial states according to the criteria of bioequivalence of the State Drug Administration of China.

Bioequivalence of daclatasvir hydrochloride tablets in healthy Chinese subjects.

OBJECTIVE: The aim of the present study was to evaluate the bioequivalence and safety of two types of daclatasvir hydrochloride tablets administered to healthy Chinese subjects under fasting and postprandial conditions. MATERIALS AND METHODS: A total of 72 healthy Chinese subjects were randomly divided into two groups: the fasting group (n = 36) and the postprandial group (n = 36). A dose of 60 mg of both the test and reference preparations of the daclatasvir hydrochloride tablets was taken orally under fasting and postprandial conditions. RESULTS: The main plasma pharmacokinetic parameters of the test and reference preparations in the fasting group were as follows: T1/2 was 9.82 ± 1.00 and 9.67 ± 0.99 hours, respectively; tmax was 1.00 hour in both; Cmax was 1,528.25 ± 428.80 and 1,504.25 ± 414.50 ng/mL-1, respectively; AUC0-t was 14,553.04 ± 4,013.26 and 14,391.97 ± 4,078.18 h/ng/mL-1, respectively; the AUC0-∞ was 14,660.80 ± 4,018.37 and 14,494.85 ± 4,095.57 ng/mL-1, respectively. Meanwhile, the main plasma pharmacokinetic parameters of the test and reference preparations in the postprandial group were as follows: T1/2 was 10.18 ± 1.38 and 10.18 ± 1.69 hours, respectively; tmax was 2.00 and 1.75 hours, respectively; Cmax was 974.92 ± 248.50 and 981.44 ± 237.11 ng/mL-1, respectively; AUC0-t was 9,597.00 ± 3,094.28 and 9,982.83 ± 3,512.07 h/ng/mL-1, respectively; AUC0-∞ was 9,712.92 ± 3,130.43 and 10,113.97 ± 3,593.47 ng/mL-1, respectively. CONCLUSION: Both types of daclatasvir hydrochloride tablets demonstrated good safety levels in healthy Chinese subjects under both fasting and postprandial conditions. Moreover, the two preparations were bioequivalent.

[Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs].

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

[Data collection, quality and evidence formation for human use experience of traditional Chinese medicine].

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.

[Theoretical thinking on guiding research and development of new drugs of traditional Chinese medicine].

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.

[Expert consensus on key issues of quality control in clinical trials of new drugs of traditional Chinese medicine].

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.

[Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0)].

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.

Vertical Midface Lifting: An Improved Technique for Asians.

BACKGROUND: Treatment of the aging midface is increasingly deemed a key part of facial and periorbital rejuvenation. Compared with Westerners, Asians tend to have a relatively prominent zygoma and mandibular angle, thicker dermis, and greater propensity for scar formation. OBJECTIVE: This study was performed to review our surgical method of vertical midface lifting in Asian patients and evaluate the clinical outcomes. METHODS AND MATERIALS: This retrospective observational study involved 116 Asian women who complained of an aged midface. All patients underwent midface rejuvenation surgery with one lower eyelid incision and 2 small frontal-temporal incisions. Clinical results were assessed objectively using photographs and subjectively by a patient satisfaction survey. RESULTS: All patients recovered well without major complications. High patient satisfaction (94%) was attained. The improvement scores as evaluated by the panel demonstrated a higher level of improvement for the malar eminence (8.3 ± 0.6), nasojugal groove (8.0 ± 0.8), and nasolabial fold (7.9 ± 0.7) than for the lower face (6.2 ± 1.0). CONCLUSION: Our vertical midface lift technique is safe and effective for older Asian patients with a midface aging appearance. LEVEL OF EVIDENCE: Therapeutic IV.

Study on Temperature and Synthetic Compensation of Piezo-Resistive Differential Pressure Sensors by Coupled Simulated Annealing and Simplex Optimized Kernel Extreme Learning Machine.

As a high performance-cost ratio solution for differential pressure measurement, piezo-resistive differential pressure sensors are widely used in engineering processes. However, their performance is severely affected by the environmental temperature and the static pressure applied to them. In order to modify the non-linear measuring characteristics of the piezo-resistive differential pressure sensor, compensation actions should synthetically consider these two aspects. Advantages such as nonlinear approximation capability, highly desirable generalization ability and computational efficiency make the kernel extreme learning machine (KELM) a practical approach for this critical task. Since the KELM model is intrinsically sensitive to the regularization parameter and the kernel parameter, a searching scheme combining the coupled simulated annealing (CSA) algorithm and the Nelder-Mead simplex algorithm is adopted to find an optimal KLEM parameter set. A calibration experiment at different working pressure levels was conducted within the temperature range to assess the proposed method. In comparison with other compensation models such as the back-propagation neural network (BP), radius basis neural network (RBF), particle swarm optimization optimized support vector machine (PSO-SVM), particle swarm optimization optimized least squares support vector machine (PSO-LSSVM) and extreme learning machine (ELM), the compensation results show that the presented compensation algorithm exhibits a more satisfactory performance with respect to temperature compensation and synthetic compensation problems.

Reduction Malarplasty With Face-Lift for Older Asians With Prominent Zygoma.

BACKGROUND: In Asian culture, overly prominent zygomas are undesirable because they give a masculine and severe appearance. Thus, reduction malarplasty is now becoming one of the most popular procedures among Asian women. However, older patients present sagging facial soft tissue and have high incidence of cheek descent after surgery. To overcome these issues and achieve better cosmetic surgical outcomes, we performed a reduction malarplasty combined with a face-lift to achieve an oval and youthful midface. METHODS: It was a retrospective observational study of 22 older Asian women who complained of prominent zygoma and aged midface. All of them had undergone reduction malarplasty combined with cheek-lift. Clinical results were assessed with photographs and patient satisfactory rates. RESULTS: The L-shaped reduction malarplasty with face-lift was performed successfully in all cases. All of the patients recover successfully without major complications. Malar prominence and midface aging was improved, and the natural midface contour was preserved. One hundred percent of the patients thought that the shape of their midface had improved, and 95.5% were satisfied with the rejuvenation of midface. CONCLUSIONS: The reduction malarplasty combined with face-lift effectively addressed the malar prominence and midface aging issues simultaneously. Therefore, this can be a useful technique to restore the youthful and proportionate facial relationships in older Asian patients.

A Temperature Compensation Method for Piezo-Resistive Pressure Sensor Utilizing Chaotic Ions Motion Algorithm Optimized Hybrid Kernel LSSVM.

A piezo-resistive pressure sensor is made of silicon, the nature of which is considerably influenced by ambient temperature. The effect of temperature should be eliminated during the working period in expectation of linear output. To deal with this issue, an approach consists of a hybrid kernel Least Squares Support Vector Machine (LSSVM) optimized by a chaotic ions motion algorithm presented. To achieve the learning and generalization for excellent performance, a hybrid kernel function, constructed by a local kernel as Radial Basis Function (RBF) kernel, and a global kernel as polynomial kernel is incorporated into the Least Squares Support Vector Machine. The chaotic ions motion algorithm is introduced to find the best hyper-parameters of the Least Squares Support Vector Machine. The temperature data from a calibration experiment is conducted to validate the proposed method. With attention on algorithm robustness and engineering applications, the compensation result shows the proposed scheme outperforms other compared methods on several performance measures as maximum absolute relative error, minimum absolute relative error mean and variance of the averaged value on fifty runs. Furthermore, the proposed temperature compensation approach lays a foundation for more extensive research.

[Safety and Tolerance of Healthy People to Injection of Astragalosides-a New Drug for Coronary Heart Disease].

OBJECTIVES: To assess the safety and tolerance of healthy volunteers to as tragalosides injection (AGI), and to determine a safe dose range for phase II clinical trial. METHODS: A total of 62 healthy volunteers participated in this study, with 26 being given a single AGI of 100 mL, 200 mL, 300 mL, 400 mL, 500 mL, or 600 mL and 36 subjects being given 500 mL, 400 mL, 200 mL or 300 mL of AGI once a day for 7 d. Discomfortsymptoms, vital signs and safety problems were recorded 3 d and 7 d after the administration of AGI. The results were analyzed. RESULTS: Of the 62 participants, 40 adverse events (AEs) were reported by 31 participants, which included 23 mild adverse reactions (ADRs) and 4 moderate ADRs. Nine AEs were reported by 9 participants with single AGI, including 7 ADRs. Fourteen AEs were reported by 10 participants with 500 mL and 400 mL multiple AGI, including 12 ADRs occurred in 9 participants.Seventeen AEs were reported by 12 participants with 300 mL and 300 mL multiple AGI, including 3 mild ADRs. The main ADRs included abnormal liver function [slightly elevated glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST),and serum total bilirubin (TBil)], low blood potassium, increased urine red blood cell count, rash, and phlebitis. CONCLUSIONS: The maximum tolerance is 600 mL for single-dose treatment, and 400 mL for multiple-dose (7 d). The dose guidance given in this study should be examined its effects and safety in patients with coronary heart disease in phase II clinical trial.

Zygomatic Complex Change After Reduction Malarplasty and Its Geometric Model: A Retrospective Clinical Study.

PURPOSE: To achieve optimal outcomes in reduction malarplasty, the amount of removed zygomatic bone must be planned accurately. This study aimed to analyze the associations between the width of bony resection and changes in zygomatic bony parameters, to propose a geometric model to guide surgical planning, and to objectively evaluate the surgical outcomes of reduction malarplasty based on computed tomographic (CT) images. PATIENTS AND METHODS: This was a retrospective observational study of patients who underwent reduction malarplasty. Digitized CT images were used to evaluate the bony parameters of the zygomatic complex. A geometric model was proposed to guide surgical planning for malar reduction. The primary predictor variable was the width of the bony segment to be resected. The primary outcome variables were changes in malar prominence and attractiveness. Other variables included gender, age, and other bony parameters of the zygoma. Bivariate correlation analysis and multiple linear regression analyses were performed between predictor and outcome variables. Presurgical and postsurgical data were analyzed with paired-samples t test to evaluate surgical outcomes. Differences were considered statistically significant at a P value less than .05. RESULTS: Fifty-one patients who underwent reduction malarplasty with an L-shaped osteotomy from 2012 through 2014 were included in the study. Statistical analysis showed a significant decrease in malar prominence and increased attractiveness between presurgical and postsurgical images (P < .001). The width of bony resection was statistically associated with all outcome variables after adjusting for potential confounders. CONCLUSIONS: Reduction malarplasty with a modified L-shaped osteotomy resulted in a notable decrease in malar prominence and a statistical decrease in the zygomatic arch width. The amount of bone that must be removed from the zygoma to achieve a desired reduction can be calculated with geometric equations. The proposed methodology could assist surgical design and improve surgical accuracy.

Application of Computer Techniques in Correcting Mild Zygomatic Assymetry With Unilateral Reduction Malarplasty.

Zygomatic assymetry is common in the population, which often requires surgical correction for aesthetic concerns. Previously, surgeons performed the surgery often based on their personal experience and visual evaluation. The purpose of this study was to apply computer techniques in patients with mild zygomatic asymmetry treated with unilateral reduction malarplasty to improve surgical accuracy and reduce preoperative risks. The authors used computer techniques to plan osteotomies, to produce surgical template, and to evaluate the surgical outcome. Postoperative follow-up demonstrated that zygomatic asymmetry was corrected in all the patients without complications. The proposed methodology was considered to be helpful in improving the surgical accuracy and efficiency for treatment of zygomatic asymmetry, while greatly minimizing operative risk.

Titanium screw entered into maxillary sinus: a rare incident during rigid fixation of the porous polyethylene implant in enophthalmos correction.

Screw fixation is used for accurate augmentation by porous polyethylene implant in traumatic enophthalmos correction to avoid complications such as migration and protrusion. We report an incident of titanium screw entered into the maxillary sinus during enophthalmos correction with porous polyethylene implant. Such incident could be avoided by standard manipulation. We here present the rare case and offer proposals for the screw fixation of porous polyethylene implant during traumatic enophthalmos correction.