Objective To analyze the level of 25-hydroxyvitamin D[25(OH)D]in patients with type 2 diabetes mellitus,and preliminarily investigate the correlation between serum 25(OH)D level and metabolic indicators such as glycosylated hemoglobin(HbA1c)and pancreatic islet function in patients with type 2 diabetes mellitus.Methods A total of 459 patients with type 2 diabetes mellitus who were hospitalized in the Department of Endocrinology,Xinxiang First People's Hospital from January 2020 to December 2020 were selected as the research subjects.Clinical data of the patients were collected,including gender,age,serum 25(OH)D,fasting insulin,C-peptide,HbA1c,fasting blood glucose,postprandial blood glucose,urinary microalbumin,urinary albumin-to-creatinine ratio,blood calcium,blood uric acid(UA),triglyceride(TG),total cholesterol(TCH),low-density lipoprotein(LDL),and high-density lipoprotein(HDL).According to the serum 25(OH)D level,the patients were divided into sufficient group[n=20,25(OH)D≥30 μg·L-1],insufficient group[n=95,20 μg·L-125(OH)D＜30 μg·L-1],deficient group[n=231,10 μg·L-1 ≤25(OH)D＜20 μg·L-1],and severely deficient group[n=113,25(OH)D＜10 μg·L-1].Differences in metabolic indicators of patients in the four groups were compared,and the correlation between 25(OH)D level and metabolic indicators was analyzed by using the Pearson correlation.Results The serum 25(OH)D level of patients with type 2 diabetes mellitus was 3.00-46.59(15.75±0.35)μg·L-1;the serum 25(OH)D level of male patients was significantly higher than that of female patients(P＜0.05).The prevalence of 25(OH)D deficiency in patients with type 2 diabetes mellitus was 74.9％(344/459).The 25(OH)D deficiency mainly occurred in January,February,March,April,November,and December.Patients in the insufficient,deficient,and severely deficient groups had significantly higher HbA1c levels than those in the sufficient group(P＜0.05),and the HbA1c levels of patients in the deficient and severely deficient groups were significantly higher than those in the insufficient group(P＜0.05);there was no statistically significant difference in the HbA1c level between the deficient group and the severely deficient group(P＞0.05).There was no statistically significant difference in fasting blood glucose between the sufficient group and insufficient group,and between the deficient group and severely deficient group(P＞0.05);fasting blood glucose of patients in the deficient and severely deficient groups was significantly higher than that in the sufficient and insufficient groups(P＜0.05).There was no statistically significant difference in fasting insulin,urinary microalbumin,daily total urinary albumin,and urinary albumin-to-creatinine ratio of patients among the sufficient,insufficient,and deficient groups(P＞0.05);the fasting insulin of patients in the severely deficient group was significantly lower than that in the sufficient,insufficient,and deficient groups(P＜0.05);the urinary microalbumin,daily total urinary albumin,and urinary albumin-to-creatinine ratio of patients in the severely deficient group were significantly higher than those in the sufficient,insufficient,and deficient groups(P＜0.05).There was no statistically significant difference in the homeostasis model assessment for insulin resistance(HOMA-IR),serum albumin,blood creatinine,1-hour postprandial blood glucose,2-hour postprandial blood glucose,3-hour postprandial blood glucose,fasting C-peptide,1-hour postprandial C-peptide,2-hour postprandial C-peptide,3-hour postprandial C-peptide,TG,TCH,LDL,HDL,blood UA,and blood calcium of patients among the four groups(P＞0.05).Pearson correlation analysis showed that serum 25(OH)D levels in patients with type 2 diabetes mellitus were negatively correlated with HbA1c,urinary microalbumin,and urinary albumin-to-creatinine ratio(r=-0.093,-0.166,-0.157;P＜0.05),and positively correlated with fasting insulin(r=0.089,P＜0.05).Serum 25(OH)D levels in patients with type 2 diabetes mellitus had no correlation with fasting blood glucose,HOMA-IR,serum albumin,blood creatinine,1-hour postprandial blood glucose,2-hour postprandial blood glucose,3-hour postprandial blood glucose,fasting C-peptide,1-hour postprandial C-peptide,2-hour postprandial C-peptide,3-hour postprandial C-peptide,TG,TCH,LDL,HDL,blood UA,and blood calcium(P＞0.05).Conclusion 25(OH)D deficiency and insufficiency are common in patients with type 2 diabetes mellitus,especially in female patients.In patients with type 2 diabetes mellitus,25(OH)D level is positively correlated with fasting insulin and negatively correlated with HbAlc,urinary microalbumin,and urinary albumin-to-creatinine ratio.25(OH)D deficiency in patients with type 2 diabetes mellitus is mainly distributed in January,February,March,April,November,and December.

Based on the pathogenesis of “tendon off-position and joint subluxation”， combined with modern ana-tomy and biomechanics， the characteristic manifestations of “tendon off-position” and “joint subluxation” of the knee and the intrinsic connection between them are clarified. Through sorting out the relationship between “tendon off-position and joint subluxation” and knee osteoarthritis （KOA） in modern research， it is believed that “tendon off-position and joint subluxation” is the key mechanism for the occurrence and development of KOA， and accordingly， it is proposed to take the diet as the guide， use bone manipulation for external diagnosis and treatment， use traditional Chinese medicine decoction for internal treatment， and use Daoyin exercise throughout the whole process as the strategy for KOA's comprehensive traditional Chinese medicine treatment to improve the clinical effectiveness.

This study aims to provide evidence for clinical practice by systematically reviewing the efficacy and safety of Gusongbao preparation in the treatment of primary osteoporosis(POP). The relevant papers were retrieved from four Chinese academic journal databases and four English academic journal databases(from inception to May 31, 2022). The randomized controlled trial(RCT) of Gusongbao preparation in the treatment of POP was included after screening according to the inclusion and exclusion criteria. The quality of articles was evaluated using risk assessment tools, and the extracted data were subjected to Meta-analysis in RevMan 5.3. A total of 657 articles were retrieved, in which 15 articles were included in this study, which involved 16 RCTs. A total of 3 292 patients(1 071 in the observation group and 2 221 in the control group) were included in this study. In the treatment of POP, Gusongbao preparation+conventional treatment was superior to conventional treatment alone in terms of increasing lumbar spine(L2-L4) bone mineral density(MD=0.03, 95%CI[0.02, 0.04], P<0.000 01) and femoral neck bone mineral density, reducing low back pain(MD=-1.69, 95%CI[-2.46,-0.92], P<0.000 1) and improving clinical efficacy(RR=1.36, 95%CI[1.21, 1.53], P<0.000 01). Gusongbao preparation was comparable to similar Chinese patent medicines in terms of improving clinical efficacy(RR=0.95, 95%CI[0.86, 1.04], P=0.23). Gusongbao preparation was inferior to similar Chinese patent medicines in reducing traditional Chinese medicine syndrome scores(MD=1.08, 95%CI[0.44, 1.71], P=0.000 9) and improving Chinese medicine syndrome efficacy(RR=0.89, 95%CI[0.83, 0.95], P=0.000 4). The incidence of adverse reactions of Gusongbao preparation alone or combined with conventio-nal treatment was comparable to that of similar Chinese patent medicines(RR=0.98, 95%CI[0.57, 1.69], P=0.94) or conventio-nal treatment(RR=0.73, 95%CI[0.38, 1.42], P=0.35), and the adverse reactions were mainly gastrointestinal discomforts. According to the available data, Gusongbao preparation combined with conventional treatment is more effective than conventional treatment alone in increasing lumbar spine(L2-L4) bone mineral density and femoral neck bone mineral density, reducing low back pain, and improving clinical efficacy. The adverse reactions of Gusongbao preparation were mainly gastrointestinal discomforts, which were mild.
Humans ; Bone Density ; Low Back Pain ; Medicine, Chinese Traditional ; Osteoporosis/drug therapy*

Objective To simultaneously collect and analyze the kinematic and dynamic parameters for two techniques of traditional Chinese cervical manipulation ( TCCM), and quantitatively describe its biomechanical characteristics. Methods A senior practitioner completed the TCCM (positioning and directional rotation pulling, lateral flexion, respectively) on 10 healthy subjects, and the fluorescent marker balls were pasted on the operator to capture manipulation movements. The dynamic parameters and the surface electromyography ( sEMG) signals were collected by pressure-sensitive gloves and wireless sEMG acquisition system. Results The upper arm muscle was the main force muscle during TCCM, and biceps brachii had the highest contribution rate. The range of motion (ROM), speed, pulling force, and time during cervical spine positioning and directional rotation pulling were all greater than those during cervical spine lateral flexion. The integrate electromyography ( iEMG) and root mean square (RMS) for each muscle of the operator during cervical spine positioning and directional rotation pulling were higher than those during cervical spine lateral flexion. Conclusions The overall ROM, three-dimensional (3D) motion angle, load intensity and time during CCTM have the characteristics of high speed, low amplitude and strong force, reflecting the biomechanical characteristics of ‘ cunjin ’ ( one-inch punch ) in traditional Chinese medicine. This study provides references for further standardizing manual teaching and training and improving clinical safety.

OBJECTIVE: To observe the clinical effect of single acupoint [Yaotu (extra)] electroacupuncture (EA) therapy on lumbar intervertebral disc herniation (LIDH) and its promotion and application in community medical institutions. METHODS: This research adopted a three-level promotion model, and used multi-center collaboration topics as a platform. A total of 240 patients with LIDH were divided into a group A (top three hospital, 80 cases, 3 cases dropped off), a group B (secondary hospital, 80 cases, 8 cases dropped off), and a group C (community health center, 80 cases, 7 cases dropped off). All groups were treated with EA at a single acupoint [Yaotu (extra)] under the guidance of a unified experimental protocol. The EA was given 60 min each time and performed 3 times a week for a total of 2 weeks. The changes of visual analogue scale (VAS) scores of three groups before and after each treatment were compared, and the clinical efficacy was evaluated. RESULTS: Compared with before each treatment, the VAS scores of three groups after each treatment decreased ( CONCLUSION The single acupoint EA therapy has a significant effect in the treatment of LIDH, can quickly relieve the pain symptoms, and has the characteristics of simple operation and easy control, suitable for promotion and application in primary hospitals.
Acupuncture Points ; Electroacupuncture ; Humans ; Intervertebral Disc ; Intervertebral Disc Degeneration ; Intervertebral Disc Displacement/therapy*

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.
Biomedical Research ; Clinical Trials as Topic ; Consensus ; Drugs, Chinese Herbal ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Multicenter Studies as Topic ; Pharmaceutical Preparations

By systematically sorting out the ancient medical books and modern clinical literature of Yiguanjian， the historical evolution of this formula， including its source， composition， origin， processing， dosage， preparation and usage， functions and indications， evolution of prescription meaning， is textual so as to clarify the historical evolution and clinical application of Yiguanjian. On the basis of fully considering the actual demand of development of famous classical formula preparation and the usage habit of modern clinical practice， the feasible development suggestions were put forward. Yiguanjian is composed of six herbs， which is derived from Yifang Jiedu (《医方絜度》) . It is an ancient book of traditional Chinese medicine edited by QIAN Min-jie in Qing dynasty. The original medicinal plants and medicinal parts of the formula were basically the same as those recorded in the 2020 edition of Chinese Pharmacopoeia. The raw products should be selected for decoction pieces and processed according to the methods recorded in the 2020 edition of Chinese Pharmacopoeia. The reference dose of the medicine in this formula is set out in Yifang Jiedu. According to dosage of one Qian（钱）=3.73 g， the dosages of Glehniae Radix， Ophiopogonis Radix and Angelicae Sinensis Radix were 5.60 g， the dosages of Lycii Fructus and Rehmanniae Radix were 11.19 g， the dosage of Toosendan Fructus was 7.46 g. These decoction pieces were boiled and warm decoction was taken. According to ancient medical records， the formula always has the effect of nourishing Yin and relieving Qi of liver. It is used to treat syndrome of stagnation of liver-Qi and deficiency of liver-Yin and kidney-Yin， which can be seen with pain in chest， stomach and flank， acerbity and vomiting， dry throat and mouth， red tongue， weak pulse or deficiency of string and hernia. Here， the source， processing and others of Yiguanjian were clarified， providing a literature reference for the development and application of this famous classical formula.

The histamine receptor antagonists in the treatment of allergic disease have limitations. The treatments of Chinese herbs have some curative effects on allergic skin lesions. Present research indicates that the mitogen-activated protein kinase (MAPK) signaling pathway might be equally important in allergic reactions. It was found that the inhibition of MAPK signaling pathways might relieve allergy symptoms, and some herbs can inhibit the MAPK pathway, which yields anti-allergy effects. Chinese medicines (CMs) have immense potential in the development of treatments for allergic disease.

Objective To investigate the correlation of variations of ABCB11 gene and primary intrahepatic stone (PIS).Methods The retrospective case-control study was conducted.The clinical data of 319 patients with PIS and 344 healthy controls who were admitted to the Southwest Hospital of the Third Military Medical University between December 2012 and December 2015 were collected.Three hundred and ninteen patients with PIS and 344 healthy controls were respectively allocated into the PIS and control groups.Twenty-seven exons in ABCB11 gene were detected via polymerase chain reaction (PCR) and DNA sanger sequencing.Observation indicators included:(1) variations and genotype frequency distribution of ABCB11 gene in the 2 groups;(2) correlation analysis between variations of ABCB11 gene and clinical data of patients with PIS:preoperative indicators of liver function test,recurrent episodes of cholangitis,preoperative obstructive jaundice,type and recurrence of stones.Comparison between groups in variations and genotype frequency distribution of ABCB11 gene was analyzed by the Logistic regression.The Kruskal-Wallis H test was performed to explore the correlation between genotype of ABCB11 gene and clinical test results of patients with PIS.Correlation between genotype of ABCB11 gene and clinicopathological data of patients with PIS was analyzed by the chi-square test.Results (1) Variations and genotype frequency distribution of ABCB11 gene in the 2 groups:whole-exome sequencing results showed that synonymous mutations of rs3815675,rs2287616 and rs497692 and missense mutations of rs2287617,rs2287622 and rs118109635 in the PIS group were respectively detected in exon 4,9,24 and 9,13,21.CT genotype frequency of rs118109635 was 4.70％(15/319) in the PIS group and 1.45％ (5/344) in the control group,respectively,with a statistically significant difference [OR=3.49,95％ confidence interval (CI):1.17-10.40,P＜0.05].GG and AG+GG genotype frequency of rs497692 were 46.08％ (147/319),87.46％ (279/319) in the PIS group and 37.79％ (130/344),79.36％ (273/344) in the control group,respectively,with a statistically significant difference (OR=1.73,1.65,95％ CI:1.05-2.83,1.04-2.61,P＜0.05).(2) Correlation analysis between variations of ABCB11 gene and clinical data of patients with PIS:levels of glutamyl-transpeptidase (GGT),alkaline phosphatase (ALP) and direct bilirubin (DBil) in the PIS group were 167 U/L (range,7-1 968 U/L),166 U/L (range,36-1 527 U/L),4 μmol/L(range,1-272 μmol/L) in the CC genotype of rs118109635 and 433 U/L(range,17-864 U/L),232 U/L (range,85-613 U/L),6 μmol/L(range,2-173 μmol/L) in the CT genotype of rs118109635,respectively,with a statistically significant difference (H=6.025,5.879,8.056,P＜0.05).Globulin level of PIS group was respectively 32 g/L (range,20-40 g/L),34 g/L(range,17-50 g/L) and 33 g/L(range,14-49 g/L) in the AA,AG and GG genotype of rs497692,respectively,with a statistically significant difference (H=12.119,P＜0.05).Of 81 patients with recurrence of PIS,GG and GA genotypes of rs2287617 were detected in 78 and 3 patients,respectively,with a statistically significant difference (x2=5.367,P＜0.05);TT,TC and CC genotypes of rs2287622 were detected in 12,39 and 30 patients,respectively,with a statistically significant difference (x2=6.153,P＜0.05).Of 127 patients with obstructive jaundice,116 and 11 patients had CC and CT genotypes of rs118109635,respectively,with a statistically significant difference (x2=7.381,P＜0.05);11,43 and 73 patients had AA,AG and GG genotypes of rs497692,respectively,with a statistically significant difference (x2 =11.364,P＜0.05).Conclusion There is a correlation between rs118109635 and rs497692 of ABCB11 gene and PIS,meanwhile,the above variation loci are associated with obstruction of biliary tract and cholestasis.

OBJECTIVE: To observe the early adverse effect index caused by short-term-repeated exposure to cadmium chloride via oral perfusion in male rats. METHODS: Forty specific pathogen free healthy male SD rats were randomly divided into four groups: control group,low-,middle-and high-dose groups. The rats of low-,middle-and high-dose groups were treated with cadmium chloride 1. 11,3. 51 and 11. 06 mg/kg body weight,respectively,and the control group rats was treated with the same volume of ultra pure water,by gavage once a day for four weeks. During the experimental duration,the body weights of the rats were taken and activity status of the rats was observed. After the experiment,the rats were executed,and some indicators of main organ coefficients,blood routine,serum biochemical indexes,urine related effect indexes and bone mineral density were measured. RESULTS: During the experimental duration,rats of high-dose group showed the symptoms such as decreased activity,increase repose,move slowly and skin duller. Comparing with control group at the same time points,the body masses of the high-dose group of the 1-4 weeks were lower(P < 0. 05).After the experiment,comparing with control group,the weights of kidney and spleen of the high-dose group decreased significantly(P < 0. 05) and the liver coefficient increased significantly(P < 0. 05). The cadmium levels in blood,urine,liver,kidney and thighbone of the middle-and high-dose groups were higher than those of the control group(P < 0. 05).The red blood cell counts of the low-and middle-dose groups increased significantly(P < 0. 05). The level of hemoglobin of middle-and high-dose groups decreased(P < 0. 05),and the activity of alanine aminotransferase in high-dose groups increased significantly(P < 0. 05). Comparing with control group,the levels of urine α_1-microglobulin and urine β_2-microglobulin in urine of the middle-dose group were decreased(P < 0. 05) and the level of urine urea nitrogen increased(P < 0. 05),but there were no significantly changes of the above three indexes in the high-dose group(P >0. 05). There were no significant difference of the levels of N-acetyl-beta-D glucosaminidase in urine between control and treatment groups(P > 0. 05). Simultaneously,in high-dose group,the weight of thighbone,the bone calcium content and bone mineral density reduced significantly than those of the control group(P < 0. 05). CONCLUSION: Skeletal effects can be used as an early toxic effect sensitive index of short-term-repeated experiments exposure to cadmium chloride via oral perfusion in male rats.