Review considerations on the design and evaluation of the oral sensory features in pediatric medications / 药学学报

Recent years, China has released a series of policies to encourage drug research and development in pediatric populations, aiming to meet pediatric populations' medical needs. Because of the physical and psychological developmental characteristics, tolerance of aversive feelings when taking medications are different between pediatric population and adults. So pediatric populations are at a relatively higher risk of not taking medications as prescribed when the medication tasted unpleasant. Therefore, sound design and evaluation of oral sensory features have important clinical significance and value in developing pediatric medications. "Technical guidance for the design and evaluation of the oral sensory features of pediatric drugs (trial version) " was released in November 2022, by Centre for Drug Evaluation, National Medical Products Administration of China. Based on the guidance, this article will introduce the drafting background and review considerations, hoping to provide reference for the design and evaluation of oral sensory features, and promote drug developing in pediatric population.

Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported / 中华肿瘤杂志

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.

Free anterolateral thigh flap with superficial temporal vessels as recipient vessels for reconstruction of defect after maxillectomy in malignant tumor / 中华耳鼻咽喉头颈外科杂志

Objective: To study the effects of superficial temporal artery and vein as recipient vessels for the free anterolateral thigh flap on the appearance and functions after maxillectomy. Methods: Clinical data of 21 patients with malignant maxillary tumors in Department of Oral and Maxillofacial Surgery, the Second Xiangya Hospital of Central South University from January 2014 to November 2019, who were treated by free anterolateral thigh flap with temporal superficial vessels as the recipient vessels were analyzed retrospectively. There were 18 males and 3 females, with the age ranging from 29 to 73 years old, including 19 cases of squamous carcinoma, 1 case of adenoid cystic carcinoma and 1 case of osteosarcoma. Of those 7 patients underwent primary surgery, 14 patients received resurgery, and 6 patients had a history of postoperative radiotherapy and chemotherapy. Among 14 patients with resurgery, 13 had recurrent ipsilateral second site tumor and 1 had recurrent tumor, and all of them received the maxillectomy and reconstructive surgery with the free anterolateral thigh flap. Patients were evaluated with water swallow test and speech intelligibility score in 1, 3 and 6 months after operation. The data were statistically analyzed with SPSS 22.0 statistical software. Water swallow test results before and after operation were compared using the Wilcoxon rank sum test. The mean speech intelligibility scores before and after operation were compared by the paired t test. Results: Patients were followed up for 10-60 months. All free flaps survived after operation. No diplopia occurred. Breathing, swallowing and speaking functions were normal. No movement disorders caused by the donor of thigh flap. Water swallow test showed no phenomenon of water flowing into the nasal cavity or oral and nasal leakage with level Ⅰ for 4 cases, level Ⅱ for 13 cases, level Ⅲ for 3 cases and level Ⅳ for 1 case. The mean speech intelligibility scores before surgery and 1, 3 and 6 months after surgery were 4.31±0.13, 1.46±0.21, 2.15±0.45 and 2.87±0.76 respectively. There was statistically significant difference in the mean speech intelligibility scores between 1 and 6 months after surgery (F=78.456, P<0.05). Conclusion: It is safe and reliable to use the superficial temporal vessels as recipient vessels for free anterolateral thigh flap in the reconstruction of defect after maxillectomy in malignant tumors, with good outcomes of functions and a satisfactory restoration of outward appearance.

Effect of Dilong on expression of fibrogenic factors TGF-β1 and α-SMA in lung tissue of mice with pulmonary fibrosis / 中国中药杂志

The aim of this paper was to investigate the effect of Dilong( geosaurus) on the expressions of fibrotic factors TGF-β1 and α-SMA in bleomycin-induced pulmonary fibrosis mice. The binding ability of Dilong to fibrotic factor TGF-β1 was initially detected by Biacore technology and verified by in vivo pharmacodynamics. A total of 60 SPF C57 mice were randomly divided into 6 groups. Except the blank group( injecting 0. 08 m L·kg-1 sodium chloride in the trachea),the other five groups were given bleomycin( 4 mg·kg-1) to replicate the pulmonary fibrosis model. After 14 days of drug treatment,the expressions of TGF-β1 and α-SMA were detected by Masson staining,immunohistochemistry and RT-PCR. The results of Biacore experiment showed that the extract of Dilong was well bound to TGF-β1 protein in vitro,and the binding value reached 619. 3. Compared with the model group,Masson's results showed that cellulose deposition in high-dose,medium-dose and low-dose Dilong groups decreased to varying degrees. RT-PCR results showed that different doses of Dilong could reduce protein and mRNA expressions of TGF-β1 and α-SMA to a certain extent in a dose-dependent manner. In conclusion,Dilong could delay the process of pulmonary fibrosis by binding to target protein TGF-β1 and inhibiting the expression of α-SMA.

Analysis of treating syndrome by I-Ching navel acupuncture / 中国针灸

Based on the theories of I-Ching and umbilicus-hologram, the navel acupuncture is considered as a new acupuncture therapy that only acupuncture at Shenque (CV 8). It has a good effect on the treatment of syndrome and provides a new treatment idea for syndrome. This article presents the definition, etiology and treatment of syndrome, and introduces the application of umbilical-holographic, the principle and method of positioning and needle-inserting, the adjustment of therapies and the analysis of cases, in order to introduce the idea of treating syndrome by I-Ching navel acupuncture.

Effects of acute lymphoblastic leukemia children bone marrow mesenchymal stem cells on drug resistance of K562/A02 cell line / 中国实验血液学杂志

The aim of study was to investigate the effect of acute lymphoblastic leukemia (ALL) children bone marrow mesenchymal stem cells (MSC) on resistance of K562/A02 cells and its mechanism. MSC obtained from bone marrow of AL children were cultured and identified. The co-culture of MSC and K562/A02 and the culture of K562/A02 cell suspension alone was performed, of which 2 kinds of cells were treated with same concentration of adriamycin (ADM), and the rate of apoptosis was detected by flow cytometry, bcl-2 and bax of K562/A02 were detected by RT-PCR, while mdr1 gene level was detected by FQ-PCR. The results indicated that the MSC separation and proliferation were viable and steady. The apoptosis rate of the K562/A02 cells co-cultured with MSC was 1.97 ± 0.11%, while apoptosis rate of the K562/A02 cells cultured alone was 8.38 ± 0.29%, there was significant difference (p < 0.05). As compared with the K562/A02 cells cultured alone, the bcl-2 gene expression in K562/A02 cells co-cultured with MSC obviously increased; ratio of bcl-2/bax was obviously enhanced. The mdr1 gene level in K562/A02 co-cultured with MSC was no statistical different from K562/A02 cultured alone (p > 0.05), which suggested that adhesion co-cultured with MSC did not induce mdr1 expression higher than the culture of suspension. It is concluded that the MSC of ALL children can escape the leukemia cells from proapoptotic effect of drugs, the resistance of K562/A02 to ADM may be involved in enhancement of bcl-2 gene expression of K562/A02 cells co-cultured with MSC, but not in relation to mdr1 gene in K562/A02 cells themselves.

A literature review on the conceptual framework of sub-health / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To further articulate the conceptual framework of sub-health by way of literature review.</p><p><b>METHODS</b>Published papers and relevant literature about sub-health were collected, the representative publishing about theoretical exploration and practical surveys were focused for analyzing and assessing the category of sub-health, investigative objects, assessing tools, conceptual framework, diagnostic criteria and its operability, foundation support, etc.</p><p><b>RESULTS</b>Sub-health conditions were categorized into three kinds in most documents, namely, the somatic, the mental and the social adaptative sub-health, and the relevant symptoms were classified into three levels. However, contents regarding the homogeneous issues, such as meaning and definition of sub-health, its diagnostic criteria and operability, in different documents were discrepant.</p><p><b>CONCLUSION</b>Discrepancy exists between the theoretical and practical studies of sub-health. And detailed description is needed to articulate the problems respectively on specific and non-specific sub-health. The perspicuity of conceptual framework is the basis of sub-health researches. The authors recommended that to form the framework the four-level hierarchic structure should be adopted; in developing the assessing tool for sub-health diagnosis, besides the basic assessment on concrete conditions, the differential evaluation on the belonging of overall manifestations, subjective complain or objective symptom, should also be paid attention to.</p>

Efficacy of intravenous Acehytisine Hydrochloride versus propafenone on terminating paroxysmal supraventricular tachycardia: a double-blinded, randomized multi-center study / 中华心血管病杂志

<p><b>OBJECTIVE</b>In this double-blinded, randomized, parallel study, we investigated the clinical efficacy of intravenous Acehytisine Hydrochloride (AHH) and propafenone on terminating paroxysmal supraventricular tachycardia (PSVT).</p><p><b>METHODS</b>Patients (18 - 70 years old) with either spontaneous or induced sustained supraventricular tachycardia lasted at least 15 min were recruited in this study. Exclusion criteria included sick sinus syndrome, atrial ventricular block or intraventricular block, etc. Eligible patients were randomly assigned to receive intravenously AHH (n=101) or propafenone (n=100) according to a proportion of 1:1 in a double-blinded manner. AHH (4 mg/kg, iv.) or propafenone (PRO, 1 mg/kg, iv.) was administered in 5 min followed by the same dose if no response was observed. Conversion times, vital signs, electrocardiograms were documented before and after drug administration.</p><p><b>RESULTS</b>Except for age, the demographic characteristics and clinical features were comparable between the two groups. Efficacy on PSVT termination was comparable between AHH (72/101, 71.3%) and PRO group (73/100, 73.0%, P=0.6368). The average time from drug administration to conversion was also similar [AHH: (9.62 +/- 8.39) min vs. PRO: (10.61 +/- 9.47) min, P=0.5035]. In the AHH group, 59/72 episodes of PSVT were terminated by the first dose, and 66/72 were terminated prematurely. The average AHH dose in the 72 converted patients was (273.7 +/- 111.2) mg. In the PRO group, 54/73 episodes of PSVT were terminated by the first dose. The electrocardiographic parameters, such as sinus recovery time, longest PP and RR interval, PR interval, QRS interval, QT interval after conversion were similar between the two groups. Transient adverse events were reported in 11/101 (10.9%) patients in the AHH group and in 18/100 (18.0%,) in the PRO group (P=0.1653).</p><p><b>CONCLUSION</b>With the dosage used in the present study, the efficacy on terminating PSVT was comparable between AHH and PRO.</p>

Systematic evaluation on clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To analyze the quality of scientific research design of clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine, so as to objectively evaluate the therapeutic effect of TCM.</p><p><b>METHODS</b>According to principles of evidence-based medicine, clinical epidemiology/design measurement evaluation (DME), the "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature" were established and used to evaluate clinical control trial literature related with treatment of Parkinson's disease with TCM published during 1979 to 2000.</p><p><b>RESULTS</b>The method of randomization was not described in 66.7% of the literature. Although randomized design was declared in 33.3 %, problems or mistakes of randomized allocation still existed in them. No record about the state of dropped out or absconded cases in follow-up study and without any record of samples screening presented in all literature. There were some problems of key links concerning samples' homogeneity, outcome indexes selection, conclusion deduction and so on, which could also influence the quality and reliability of randomized controlled trials.</p><p><b>CONCLUSION</b>Methodological design of clinical research of TCM on Parkinson's disease should be strengthened.</p>

Clinical observation on 103 patients of severe acute respiratory syndrome treated by integrative traditional Chinese and Western Medicine / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the effect of 103 patients of severe acute respiratory syndrome (SARS) treated by integrative traditional Chinese and western medicine.</p><p><b>METHODS</b>Alimentotherapy, respiratory auxiliaring ventilation, anti-infective and glucocorticoid methods were used in western medicine; Chinese herbal medicine was used according to syndrome differentiation in traditional Chinese medicine. Descriptive statistical analyses were performed.</p><p><b>RESULTS</b>Of the 103 patients, 77 were identified as severe cases and 29 were admitted to the intensive care unit. A total of 96 patients (93.2%) were cured, 7 patients died (6.8%). The mean time between onset of feverishness and improvement was 6.72 +/- 3.95 days; 94 successful responses to therapy could be demonstrated by serial chest radiographs showing the resolution of lung opacities during 18.13 +/- 8.99 days, 2 of whom showed fibroid cord-like changes.</p><p><b>CONCLUSION</b>In terms of traditional Chinese medicine theory, SARS is referred to "infectious febrile disease", the therapeutic strategies of integrative traditional Chinese and western on SARS have been shown effective, and traditional Chinese medicine played a positive role in it.</p>