Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine：Fibromyalgia Syndrome / 中国实验方剂学杂志

Fibromyalgia syndrome （FMS） is a refractory， chronic non-articular rheumatic disease characterized by widespread pain throughout the body， for which there are no satisfactory therapeutic drugs or options. There are rich Chinese medical therapies， and some non-drug therapies， such as acupuncture， Tai Chi， and Ba-Duan-Jin， have shown satisfactory efficacy and safety and definite advantages of simultaneously adjusting mind and body. FMS is taken as a disease responding specifically to traditional Chinese medicine （TCM） by the National Administration of Traditional Chinese Medicine in 2018. In order to clarify the research progress in FMS and the clinical advantages of TCM/integrated Chinese and Western medicine， the China Academy of Chinese Medicine organized a seminar for nearly 20 experts in Chinese and Western medicine， including rheumatology， psychology， acupuncture and moxibustion， and encephalopathy， with the topic of difficulties in clinical diagnosis and treatment of FMS and advantages of TCM and Western medicine. The recommendations were reached on the difficulties in early diagnosis and solutions of FMS， mitigation of common non-specific symptoms， preferential analgesic therapy， TCM pathogenesis and treatment advantages， and direction of treatment with integrated Chinese and Western medicine. FMS is currently facing the triple dilemma of low early correct diagnosis， poor patient participation， and unsatisfactory benefit from pure Western medicine treatment. To solve the above problems， this paper suggests that rheumatologists should serve as the main diagnostic force of this disease， and they should improve patient participation in treatment decision-making， implement exercise therapy， and fully utilize the holistic and multidimensional features of TCM， which is effective in alleviating pain， improving mood， and decreasing adverse events. In addition， it is suggested that FMS treatment should rely on both TCM and Western medicine and adopt multidisciplinary joint treatment， which is expected to improve the standard of diagnosis and treatment of FMS in China.

Gallic Acid Ameliorates Cognitive Impairment Caused by Sleep Deprivation through Antioxidant Effect

Sleep deprivation (SD) has a profound impact on the central nervous system, resulting in an array of mood disorders, including depression and anxiety. Despite this, the dynamic alterations in neuronal activity during sleep deprivation have not been extensively investigated. While some researchers propose that sleep deprivation diminishes neuronal activity, thereby leading to depression. Others argue that short-term sleep deprivation enhances neuronal activity and dendritic spine density, potentially yielding antidepressant effects. In this study, a two-photon microscope was utilized to examine the calcium transients of anterior cingulate cortex (ACC) neurons in awake SD mice in vivo at 24-hour intervals. It was observed that SD reduced the frequency and amplitude of Ca2+ transients while increasing the proportions of inactive neurons. Following the cessation of sleep deprivation, neuronal calcium transients demonstrated a gradual recovery. Moreover, whole-cell patch-clamp recordings revealed a significant decrease in the frequency of spontaneous excitatory post-synaptic current (sEPSC) after SD. The investigation also assessed several oxidative stress parameters, finding that sleep deprivation substantially elevated the level of malondialdehyde (MDA), while simultaneously decreasing the expression of Nuclear Factor erythroid 2-Related Factor 2 (Nrf2) and activities of Superoxide dismutase (SOD) in the ACC. Importantly, the administration of gallic acid (GA) notably mitigated the decline of calcium transients in ACC neurons. GA was also shown to alleviate oxidative stress in the brain and improve cognitive impairment caused by sleep deprivation. These findings indicate that the calcium transients of ACC neurons experience a continuous decline during sleep deprivation, a process that is reversible. GA may serve as a potential candidate agent for the prevention and treatment of cognitive impairment induced by sleep deprivation.

Advantages of Chinese Medicine in Treating Dominant Disease： Benign Prostatic Hyperplasia / 中国实验方剂学杂志

China Association of Chinese Medicine organized specialists in andrology of Chinese and western medicine to explore the population and treatment stage of benign prostatic hyperplasia （BPH） with Chinese medicine as the leading therapy. Chinese medicine has great advantages in the treatment of benign prostatic hyperplasia. However， it is necessary to make clear the stage when Chinese medicine or modern medical treatment can be used as the leading therapy， and the conditions under which Chinese and western medicine can be combined to achieve the best treatment efficacy. The specialists agreed Chinese medicine as the leading therapy for the treatment of BPH in the following populations or conditions： the elderly and weak patients with basic diseases， BPH symptoms， and cannot tolerate anesthesia and surgery， the patients with BPH symptoms and cannot tolerate the adverse reactions or the possible adverse reactions of western medicine； the patients with mild ［international prostatic symptom score （IPSS） ≤ 7］ or moderate lower urinary tract symptoms （IPSS ≥ 8） and the quality of life not significantly affected， the patients with bladder detrusor hypofunction， bladder dysfunction and cannot be treated surgically， or with incomplete bladder emptying after surgical treatment； the BPH patients with prostatitis as the main clinical manifestation， the patients with non-acute complications after operation. BPH is one of the dominant diseases in urology and andrology of Chinese medicine， and the symptoms， complications， and prognosis of BPH patients need to be fully considered during the clinical treatment. When Chinese medicine is taken as the leading therapy， it is essential to regularly review the serum level of prostate-specific antigen to exclude the possibility of prostate cancer， and apply Chinese medicine for full treatment course and cycle. At the same time， Chinese and western medicine can be combined to achieve the most effective， convenient， economical， and satisfactory treatment， which can carry forward the advantages of Chinese medicine in treating this disease.

Protective Effect of Huangqi Guizhi Wuwutang Combined with Shengmaiyin on Cardiac Function of Diabetic Cardiomyopathy / 中国实验方剂学杂志

Objective:To observe the protective effect of Huangqi Guizhi Wuwutang combined with Shengmaiyin on the heart function in patients with diabetic cardiomyopathy and explore its anti-myocardial fibrosis and anti-inflammatory effects. Method:The 96 patients were randomly divided into observation group （48 cases） and control group （48 cases）. Both groups were given comprehensive measures to control blood sugar， blood lipids， blood pressure and heart failure. Patients in control group took Tongmai Jiangtang capsule， 3 granules/time， 3 times/day. Patients in observation group took Huangqi Guizhi Wuwutang combined with modified Shengmaiyin， 1 dose/day. The treatment courses were three months in both groups. Left ventricular ejection fraction （LVEF）， early diastolic peak velocity E peak/late diastolic peak velocity A peak （E/A）， left ventricular end diastolic diameter （LVEDd） and cardiac output per stroke （SV） through echocardiography were recorded before and after therapy. Cardiac troponin-I （cTn I）， troponin T （cTn-T）， creatine kinase isoenzyme -MB （CK-MB）， lactate dehydrogenase （LDH）， transforming growth factor-<italic>β</italic>₁ （TGF-<italic>β</italic>₁） before and after treatment ， matrix metalloproteinase-2 （MMP-2）， insulin-like growth factor-1 （IGF-1）， interleukin-6 （IL-6）， IL-1， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， N-terminal pro-B-type natriuretic peptide （NT-proBNP）， soluble ST2 （sST2） and galectin-3 （Gal-3） levels were detected. Symptom of cardiac insufficiency and traditional Chinese medicine （TCM） syndrome score were evaluated before and after treatment. Result:The LVEF and E/A data in observation group were higher than those in control group （<italic>P</italic><0.01）. The levels of cTn-I， cTn-T， LDH and CK-MB in the observation group were lower than those in the control group （<italic>P</italic><0.01）. After treatment， the levels of TGF-<italic>β</italic>₁， MMP-2， IGF-1， IL-6， IL-1， TNF-<italic>α</italic>， NT-proBNP， sST2 and Gal-3 in the observation group decreased and were lower than those in the control group （<italic>P</italic><0.01）. The clinical efficacy of the observation group was better than that of the control group （<italic>Z</italic>=1.974，<italic>P</italic><0.05）. Conclusion:On the basis of conventional intervention of western medicine， Huangqi Guizhi Wuwutang combined with modified Shengmaiyin has anti-inflammatory and anti-myocardial fibrosis effects， with inhibitory effect on myocardial remodeling， and can reduce myocardial tissue damage to improve ventricular diastolic function and protect heart function. With such high clinical efficacy， it is worthy of clinical use.

Effect of Xihuangwan on NLRP3 Inflammatory Bodies and Their Products and Tumor Proliferation of Lung Cancer A549 Bearing Nude Mice in Inflammatory Microenvironment / 中国实验方剂学杂志

Objective:To study the antitumor effect of Xihuangwan on A549 lung cancer nude mice in inflammatory microenvironment, and explore the effect of Xihuangwan on the expressions of nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammatory bodies and their products in serum and tumor tissue of A549 lung cancer nude mice. Method:The lung cancer A549 cell model was established in nude mice with lung cancer, and the lung cancer A549 cell model was established in inflammatory microenvironment by adding lipopolysaccharide (LPS) + adenosine triphosphate (ATP) to the culture medium. After modeling, the rats were randomly divided into blank group (equal volume of normal saline), positive drug control group (MCC950 solution, 0.79 g·kg-1), and low, medium, high-dose Xihuangwan groups (0.39, 0.78, 1.95 g·kg-1). The rats were administered orally once a day for 21 days, and then sacrificed. The tumor tissues were stripped to measure the tumor body. The expressions of NLRP3, malondialdehyde（MDA）, interleukin (IL)-1β, IL-18 and NLRP3 were detected by Western blot, and the levels of IL-1β, IL-18 and MDA were detected by enzyme linked immunosorbent assay（ELISA）. Result:Compared with the blank group, the tumor inhibition rates in the positive drug control group and the low, medium and high dose Xihuangwan group were 39.21%, 31.72%, 42.24% and 55.68%. ELISA showed that the high-dose Xihuangwan group could significantly reduce the expressions of MDA, IL-1β and IL-18 in the serum of nude mice (P<0.05). Western blot showed that the high-dose Xihuangwan group could effectively reduce the protein expressions of MDA, IL-1β, IL-18 and NLRP3 in tumor of nude mice (P<0.05), the results of immunohistochemistry showed that the expression rate of NLRP3 in the tumor tissues of nude mice was reduced in the positive drug group and each dose of Xihuangwan group (P<0.05). Conclusion:Xihuangwan can inhibit the growth of tumor tissue of A549 cells bearing lung cancer in nude mice. The mechanism may be that it can inhibit the growth of tumor cells by inhibiting the expression of NLRP3 inflammatory bodies, IL-1β, IL-18, MDA tables, and then inhibiting the inflammatory microenvironment of tumor cells.

Reporting standards for expert consensus on clinical practice of Chinese patent medicines of China Association of Chinese Medicine / 中国中药杂志

In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.

Guidance of instructions for compiling expert consensus on clinical practice of Chinese patent medicine of China Association of Chinese Medicine / 中国中药杂志

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.

Manual for the clinical experts consensus of Chinese patent medicine / 中国中药杂志

Chinese patent medicine is widely used in clinical practice, but improper use will not only weaken the efficacy of drugs, but even cause adverse consequences. Evidence-based medicine provides guidance for clinical practice based on the best available evidence, experience of experts and needs of patients. However, considering the situation of "insufficient evidence" or "very low quality" in Chinese medicine research, experts consensus is the main basis for clinical decision-making, but expert opinions on which the consensus depends are susceptible to various subjective biases. Therefore, a reliable and scientific consensus-making process is needed to maximally avoid bias on consensus. Unlike the clinical practice guidelines, there is no unified formulating process for consensus in the world today. This article learns from a set of formulating processes from some international consensus formulating institutions/associations, combined with the characteristics and current situation of traditional Chinese medicine, and draws up a set of standard process that is suitable for the clinical experts consensus on Chinese patent medicine, with the expect of providing evidence and reference for consensus makers, and then bringing evidence-based assistance for the clinical standardized application of Chinese patent medicines.

Recent advances in study of long β2-adrenoceptor agonist / 药学学报

β2-Adrenoceptor agonists are highly effective bronchodilators and are widely used in the treatment of both chronic obstructive pulmonary disease (COPD) and asthma. In the last 15 years, there has been great interest within the pharmaceutical industry in the discovery of a long β2-adrenoceptor agonist for a mono-therapy or combination therapy. The search for new long-acting β2-adrenoreceptor agonists (LABA's), for the treatment of asthma and COPD, has become a very active area of drug discovery. This article reviews the mechanisms, potential candidates and research advances of long β2-adrenoceptor agonists.

Comparative proteomics study of different processing technology for pilose antler using iTRAQ technology coupled with 2D LC-MS / 药学学报

This study was designed to use iTRAQ technology coupled with 2D LC-MS/MS to study the comparative proteomics of different processing technology for pilose antler. 1015 proteins were identified with 2D LC combined with MOLDI TOF/TOF mass spectrometry. Comparative analysis with Protein Pilot (Version 4.5) revealed that 87 proteins were changed (P ≤ 0.05, the ratio of > 1.50 or < 0.60 as the threshold selection of difference proteins), of which 24 were up regulated and 33 were down regulated in the traditional frying process (TFP) compared with the fresh pilose antler (P ≤ 0.05). 7 significant different proteins (P ≤ 0.001), most of these significantly changed proteins were found to be involved in calcium ion binding and ATP binding associated with human healthy. Freeze drying with protective agent (FDP) (Trehalose) can improve the content of significantly different proteins (P ≤ 0.001) including Collagen alpha-1 (XII) chain (COL12A1) and Collagen alpha-1 (II) chain (COL2A1). The significant function involves in platelets activating, maintenance of spermatogonium, and disorder expression in tumor cells. The functional annotation by Hierarchical clustering and GO (gene ontology) showed that the main molecule functions of the proteins significantly changed in these processes were involved in binding (52.7%), catalytic (25.3%), structural molecule and transporter (6.6%).

Studies and reports of impact indicators on big brand Chinese medicine cultivation / 中国中药杂志

Questionnaire survey was conducted among thirty traditional Chinese pharmaceutical companies nationwide. We studied the following factors and how they impose the significance on the culture of big brands, namely, the policies, the access to market, the specialty of the product, the foundation of research, the market, the salesmanship, the resource insurance of product and the security. And these could be referred when the enterprises cultivate the big brands. The findings show that interviewees and different firms hold various opinions on the factors of culture of the big brands. The policies and the access to market always attract the most attention for the enterprises, and whether the product is classified into the catalogue of health insurance or into the basic medicinal directory plays a pivotal role in the development of big brand. The uniqueness of the product can be regarded as a natural advantage, the construction of team of academic experts is more and more emphasized on the development of the product, and the security of the product deserves increasing attention.

Comparative proteomics study of different processing technology for pilose antler using iTRAQ technology coupled with 2D LC-MS / 药学学报

This study was designed to use iTRAQ technology coupled with 2D LC-MS/MS to study the comparative proteomics of different processing technology for pilose antler. 1015 proteins were identified with 2D LC combined with MOLDI TOF/TOF mass spectrometry. Comparative analysis with Protein Pilot (Version 4.5) revealed that 87 proteins were changed (P ≤ 0.05, the ratio of > 1.50 or < 0.60 as the threshold selection of difference proteins), of which 24 were up regulated and 33 were down regulated in the traditional frying process (TFP) compared with the fresh pilose antler (P ≤ 0.05). 7 significant different proteins (P ≤ 0.001), most of these significantly changed proteins were found to be involved in calcium ion binding and ATP binding associated with human healthy. Freeze drying with protective agent (FDP) (Trehalose) can improve the content of significantly different proteins (P ≤ 0.001) including Collagen alpha-1 (XII) chain (COL12A1) and Collagen alpha-1 (II) chain (COL2A1). The significant function involves in platelets activating, maintenance of spermatogonium, and disorder expression in tumor cells. The functional annotation by Hierarchical clustering and GO (gene ontology) showed that the main molecule functions of the proteins significantly changed in these processes were involved in binding (52.7%), catalytic (25.3%), structural molecule and transporter (6.6%).

Effects of dujieqing oral liquid on the promoter methylation of the MGMT gene in middle-and-late stage tumor patients receiving chemotherapy / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the effects of Dujieqing Oral Liquid (DJQ) on the promoter methylation of the O6-methylguanine-DNA methyltransferase (MGMT) gene in the plasma DNA samples from middle-and-late stage tumor patients receiving chemotherapy.</p><p><b>METHODS</b>Recruited 60 patients were randomly assigned to the treatment group (treated by conventional chemotherapy combined DJQ, 20 mL each time, three times daily) and the control group (treated by chemotherapy alone), 30 in each group. The therapeutic course was 8 weeks. The promoter methylation of the MGMT gene in the plasma DNA samples form middle-and-late stage tumor patients receiving chemotherapy was detected before and after treatment using nested methylation-specific polymerase chain reaction (MSP). Meanwhile, the peripheral hemogram was detected. The clinical efficacy and toxic/adverse reactions were assessed using Karnofsky performance scale (KPS).</p><p><b>RESULTS</b>Results of the promoter methylation of MGMT genes showed that methylation rate was 20.00% in the treatment group and 46.67% in the control group (P<0.05). Compared with before treatment, the KPS was significantly improved in the treatment group after treatment, while it significantly decreased in the control group after treatment (both P<0.05). There was statistical difference in the KPS between the two groups after treatment (P<0.01). The toxic/adverse reactions were milder in the treatment group than in the control group (P<0.01).</p><p><b>CONCLUSIONS</b>DJQ showed efficiency synergism and toxicity reducing effects, but with no effect on the hematopoietic function of the bone marrow. MGMT gene was indicated as DJQ's target point for efficiency synergism and toxicity reducing. The efficiency synergism and toxicity reducing effects were achieved by regulating the activities of MGMT gene.</p>

A novel mutation in β-globin gene of a patient with β-thalassemia / 中国实验血液学杂志

This study was aimed to analyze the β-globin gene mutations in a patient with β-thalassemia minor. Genomic DNA was extracted from peripheral blood cells of the patient. The full-length DNA sequence coding for β-globin was amplified by polymerase chain reaction, and the gene mutation was determined by DNA sequencing. The results indicated that a heterogeneous A→G mutation was found at position 129 in intron 1 of the β-thalassemia minor patient. It is concluded that the IVS-I-129(A→G) mutation is a splicing site mutation leading to a splicing error in immature messenger RNA and a protein translation error for the β-globin gene. Thus, the IVS-I-129(A→G) is a novel mutation.

Correlation between hemoglobin F levels and single nucleotide polymorphism at BCL11A gene rs11886868 locus in β-thalassemia patients / 中国实验血液学杂志

This study was aimed to analyze hemoglobin F (HbF) level and single nucleotide polymorphisms at rs11886868 locus of BCL11A gene in β-thalassemia patients, and to explore correlation between them. 89 mild β-thalassemia patients with known mutations were registered, and HbF levels were determined by capillary electrophoresis. Genomic DNA was extracted from peripheral leukocytes, fragment including rs11886868 locus in BCL11A gene was amplified by PCR, and polymorphism was determined by DNA sequencing. The results showed that 2 polymorphisms including C and T were found at rs11886868 locus in BCL11A gene among 89 mild β-thalassemia patients. HbF levels in red blood cells were (4.47 ± 3.42)% and (2.79 ± 2.21)% for β-thalassemia patients carrying C/C and C/T haplotypes, respectively. There was difference between 2 haplotype groups. It is concluded that the C and T polymorphisms are found at rs11886868 locus in the BCL11A gene for β-thalassemia patients. C polymorphism may be related to high HbF expression in red blood cells.

Acute toxicity of CCR5 antagonist C25P polypeptide in mice and its carcinogenicity in vitro / 南方医科大学学报

<p><b>OBJECTIVE</b>To study the acute toxicity of C25P polypeptide, a CCR5 antagonist, in mice and its carcinogenic effect in vitro.</p><p><b>METHODS</b>The acute toxicity of C25P polypeptide in mice was assessed by determining the maximum tolerated dose (MTD). The mice were given C25P at the dose of 3.64 g/kg by tail vein injection, and the control mice received saline (40 ml/kg) injection. The mice were continuously observed for 14 days after the administration and sacrificed on day 14 for routine blood test, examination of the blood biochemistry and pathological examination. The carcinogenicity of C25P polypeptide in vitro was evaluated in cultured cell lines by chromosome aberration test, cell transformation test and non-anchorage dependent growth test.</p><p><b>RESULTS</b>No mice died following administration of the drug, but 3 mice showed mild adverse reactions. The rats in both groups showed an increase in the body weight at a comparable rate. GPT increased and ALP decreased significantly in C25P polypeptide group (P<0.05). Most of the organs of the rats treated with in C25P polypeptide remained normal, but 3 mice showed pathologies in the lung, spleen and liver. Chromosome aberration test, cell transformation test and non-anchorage-dependent growth test all yielded negative results for C25P polypeptide.</p><p><b>CONCLUSION</b>C25P polypeptide is a low-toxicity drug that produces no apparent acute toxicity in mice or obvious carcinogenicity in vitro.</p>

The Interaction Between Human TRIM5? Chimera and HIV-1gag Protein in Vitro / 中国生物工程杂志

Objective:To express and purify the TRIM5? chimaera[TRIM5? H(R328-332)] protein and to explore the interaction between the TRIM5? H(R328-332)and HIV-1gag. Methods:The plasmid pET28aTRIM5? H(R328-332) was transformed to E.coli BL21 (DE3) strain ,and the expression of TRIM5? H(R328-332) protein was induced by IPTG,purified with Ni2+ chromatography.The expression and purification of TRIM5? H(R328-332) were analyzed by SDS-PAGE and Western blot,and the interaction between TRIM5? H(R328-332) and HIV-1gag was detected by co-immunoprecipitation,His pull-down and ELISA. Results:The recombinant plasmid pET28aTRIM5? H(R328-332) was successfully expressed in E.coli. The results showed that the purified full length TRIM5? H(R328-332) interacted with HIV-1gag protein. Conclusion:The human TRIM5? chimaera was expressed successfully in vitro,and the study demonstrates that the human TRIM5? chimaera interacts with HIV-1 gag in vitro.

Effect of eradication of Helicobacter pylori with quadruple therapy on posthepatitic cirrhosis accompanied with peptic ulcer / 第三军医大学学报

Objective To explore the clinical characteristics of posthepatitic cirrhosis accompanied with peptic ulcer (called as hepatogenic ulcer, HU) and the effect of quadruple therapy in this event Methods A total of 105 cases of PU were subjected in this study, and 126 patients with simple peptic ulcer (PU) served as control Endoscopy was carried out to observe the peptic ulcer, bleeding, and healing after treatment Urease testing was employed to detect Helicobacter pylori (Hp) in gastric mucosa All patients were followed up for 2 years Results Most cases of PU were confirmed to have duodenal ulcer The positive rate of Hp was 72 4% in HU group before treatment Ulcer healing rates of quadruple therapy were 65 7% and 88 5% respectively in HU group and PU group During the follow up, the rates of recurrence and rebleeding were 68 4% and 30 2% in HU group, and 48 9% and 16 6% in PU group,with very significant difference between them ( P