OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*

Objective To explore the application effect of 3D printed individualized model in the treatment of complex ankle fractures(AF).Methods Patients with complex AF admitted to our hospital from July 2021 to October 2022 were selected and divided into the control group and the observation group using a random number table method,with 50 cases in each group.Patients in the control group were received minimally invasive reduction and internal fixation,while these in the observation group were given minimally invasive reduction and internal fixation under the guidance of 3D printed individualized model.The surgical conditions,ankle joint reduction,stress indicators[norepinephrine(NE)and angiotensin Ⅱ(AngⅡ)],ankle function and postoperative complications were compared between the two groups.Results There were 2 patients in the observation group and 3 patients in the control group were lost to follow-up 12 months after surgery.Compared with the control group,the observation group showed a decrease in the intraoperative blood loss,shortened surgical time,hospitalization time,and weight-bearing activity time,and an increase in the anatomical reduction rate(P<0.05).The observation group had lower serum levels of NE and AngⅡ 1 and 3 days after surgery(P<0.05)and higher Kofoed score and American Orthopedic Foot and Ankle Society(AOFAS)scores 1,6,and 12 months after surgery(P<0.05),as well as lower incidence of postoperative complications(P<0.05)than those in the control group.Conclusion For the treatment of complex AF,3D printed individualized model assisted the formulation of minimally invasive reduction and fixation surgical plans before surgery can shorten surgical time,reduce stress injury,decrease the risk of complications,and simultaneously increase the anatomical reduction rate and improve ankle joint function,thereby accelerating postoperative recovery of patients.

Objective To analyze the changes of intestinal microbiota in patients with nonalcoholic fatty liver disease(NAFLD)and healthy controls so as to explore the relationship between intestinal microbiota and NAFLD.Methods A total of 353 samples from the National Center for Biotechnology Information were included,including 110 healthy controls and 243 NAFLD patients(127 NASH and 116 NAFLD).Macrogenome sequencing data were extracted to obtain data on intergroup flora diversity changes and analyze the potential correlation between alterations in gut microbes and NAFLD.Results Alpha diversity analysis showed no significant differences in Invsimpson index(P=0.57)or Simpson index(P=0.57)between NAFLD patients and healthy controls,while there was a trend of decreasing Shannon index(P=0.084),but with no significant difference.β-diversity analysis showed significant differences between the two groups(P=0.002).Species composition analysis showed that at the genus level,NAFLD patients and healthy controls had the same species types,with Bacteroidetes and Firmicutes being the dominant phyla in both groups.However,compared to Control group,NAFLD group had significantly lower Firmicutes,Synergistetes,and Candidatus_Melainabacteria.At the species level,there were significant differences between NAFLD group and Control group for 10 bacterial species,including Bacteroides_uniformis and Faecalbacterium_prausnitzil.Intergroup difference analysis showed that Phocaeicola dorei,Parabacteroides_distasonis,Bilophila_wadsworthia,and Dysosmobacter_welbionis were significantly enriched in NAFLD patients(LDA score＞2.0,P＜0.05),while Prevotella_stercorea,Faecalibacterium prausnitzii,and others were negatively associated with NAFLD.A disease detection model was constructed based on metagenomic data,and 26 intestinal microorganisms related to NAFLD were selected,including Pyramidobacter piscolens and Citrobacter freundii,etc.The diagnostic accuracy of NAFLD was judged by ROC curve discriminant model,and the AUC of the ROC curve was 0.743 8,indicating that the model has a certain accuracy in diagnosing NAFLD.Conclusion This study revealed differences in gut microbial diversity between NAFLD patients and healthy controls and identified key bacterial groups associated with NAFLD.In addition,the disease detection model constructed based on metagenomic data provides a new method and idea for the diagnosis of NAFLD,which is conducive to further study of the disease and the early diagnosis and treatment of clinical patients.

Objective To explore the application effect of 3D printed individualized model in the treatment of complex ankle fractures(AF).Methods Patients with complex AF admitted to our hospital from July 2021 to October 2022 were selected and divided into the control group and the observation group using a random number table method,with 50 cases in each group.Patients in the control group were received minimally invasive reduction and internal fixation,while these in the observation group were given minimally invasive reduction and internal fixation under the guidance of 3D printed individualized model.The surgical conditions,ankle joint reduction,stress indicators[norepinephrine(NE)and angiotensin Ⅱ(AngⅡ)],ankle function and postoperative complications were compared between the two groups.Results There were 2 patients in the observation group and 3 patients in the control group were lost to follow-up 12 months after surgery.Compared with the control group,the observation group showed a decrease in the intraoperative blood loss,shortened surgical time,hospitalization time,and weight-bearing activity time,and an increase in the anatomical reduction rate(P<0.05).The observation group had lower serum levels of NE and AngⅡ 1 and 3 days after surgery(P<0.05)and higher Kofoed score and American Orthopedic Foot and Ankle Society(AOFAS)scores 1,6,and 12 months after surgery(P<0.05),as well as lower incidence of postoperative complications(P<0.05)than those in the control group.Conclusion For the treatment of complex AF,3D printed individualized model assisted the formulation of minimally invasive reduction and fixation surgical plans before surgery can shorten surgical time,reduce stress injury,decrease the risk of complications,and simultaneously increase the anatomical reduction rate and improve ankle joint function,thereby accelerating postoperative recovery of patients.

Objective To analyze the changes of intestinal microbiota in patients with nonalcoholic fatty liver disease(NAFLD)and healthy controls so as to explore the relationship between intestinal microbiota and NAFLD.Methods A total of 353 samples from the National Center for Biotechnology Information were included,including 110 healthy controls and 243 NAFLD patients(127 NASH and 116 NAFLD).Macrogenome sequencing data were extracted to obtain data on intergroup flora diversity changes and analyze the potential correlation between alterations in gut microbes and NAFLD.Results Alpha diversity analysis showed no significant differences in Invsimpson index(P=0.57)or Simpson index(P=0.57)between NAFLD patients and healthy controls,while there was a trend of decreasing Shannon index(P=0.084),but with no significant difference.β-diversity analysis showed significant differences between the two groups(P=0.002).Species composition analysis showed that at the genus level,NAFLD patients and healthy controls had the same species types,with Bacteroidetes and Firmicutes being the dominant phyla in both groups.However,compared to Control group,NAFLD group had significantly lower Firmicutes,Synergistetes,and Candidatus_Melainabacteria.At the species level,there were significant differences between NAFLD group and Control group for 10 bacterial species,including Bacteroides_uniformis and Faecalbacterium_prausnitzil.Intergroup difference analysis showed that Phocaeicola dorei,Parabacteroides_distasonis,Bilophila_wadsworthia,and Dysosmobacter_welbionis were significantly enriched in NAFLD patients(LDA score＞2.0,P＜0.05),while Prevotella_stercorea,Faecalibacterium prausnitzii,and others were negatively associated with NAFLD.A disease detection model was constructed based on metagenomic data,and 26 intestinal microorganisms related to NAFLD were selected,including Pyramidobacter piscolens and Citrobacter freundii,etc.The diagnostic accuracy of NAFLD was judged by ROC curve discriminant model,and the AUC of the ROC curve was 0.743 8,indicating that the model has a certain accuracy in diagnosing NAFLD.Conclusion This study revealed differences in gut microbial diversity between NAFLD patients and healthy controls and identified key bacterial groups associated with NAFLD.In addition,the disease detection model constructed based on metagenomic data provides a new method and idea for the diagnosis of NAFLD,which is conducive to further study of the disease and the early diagnosis and treatment of clinical patients.

Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P＜0.05).After continuation treatment,the remission rate was 54.59％(202 cases/370 cases),and the recurrence rate was 6.49％(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35％(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.

Objective To investigate the effect and mechanism of rhubarb Tangluo pill on liver injury in type 2 diabetic rats.Methods ZDF(fa/fa)rats were given high-fat diet to induce type 2 diabetes model,and were randomly divided into model group,positive control group(0.18 g·kg-1 metformin)and experimental-L,-M,-H groups(0.54,1.08 and 2.16 g·kg-1 rhubarb Tangluo pill),with 8 rats in each group.Eight ZDF(fa/+)rats were selected as control group.The control group and model group were given equal volume of pure water once a day for 12 weeks.An oral glucose tolerance test(OGTT)was performed after administration.Fasting blood glucose level,body mass and liver mass of rats were measured and liver index was calculated.The contents of glutamic-pyruvic transaminase(GPT),glutamic oxalacetic transaminase(GOT),triglyceride(TG)and total cholesterol(TC)in serum were detected.The histomorphologic changes of liver were observed by hematoxylin-eosin(HE)staining and Masson staining.The protein expression of phosphorylated insulin receptor substrate 1(p-IRS1),phosphorylated protein kinase B(p-Akt)and glucose transporter 4(GLUT4)were detected by Western blotting.Results After administration,the fasting blood glucose levels of control group,model group,positive control group and experimental-H group were(4.71±0.45),(29.9±2.97),(15.28±4.52)and(13.84±1.55)mmol·L-1,respectively;the liver index were 2.31±0.46,4.03±0.18,3.37±0.23 and 3.38±0.24;the relative expression level of p-IRS1 protein were 1.00±0.36,4.00±0.11,1.62±0.27 and 1.90±0.17,respectively;the relative expression levels of p-Akt protein were 1.00±0.25,0.21±0.04,0.73±0.15 and 0.54±0.04,respectively;GLUT4 protein relative expression levels were 1.00±0.11,0.40±0.08,0.86±0.04 and 0.70±0.06,respectively.Compared with the model group,the above indexes in the experimental-H group were statistically significant(P＜0.01,P＜0.05).Conclusion Rhubarb Tanglu pill can effectively improve glycolipid metabolism and liver injury in type 2 diabetes mellitus,and its mechanism may be related to the activation of IRS1/Akt signaling pathway.

Objective To compare clinical effect between open reduction and fixation with cannulated screw and threaded rivet via posteromedial approach versus arthroscopic Endobutton plate fixation in treating posterior cruciate ligament avulsion fractures.Methods Clinical data of 38 patients with posterior cruciate ligament avulsion fractures from July 2020 to December 2021 were analyzed retrospectively,and divided into open reduction and internal fixation group(posterior medial approach hollow anchor system fixation)and arthroscopic fixation group(Endobutton with loop plate fixation under arthroscopy).There were 20 patients in open reduction and internal fixation group,including 16 males and 4 females,aged from 26 to 74 years old with an average of(42.9±18.8)years old;13 patients on the left side and 7 patients on the right side;12 patients were classi-fied to type Ⅱ and 8 patiens with type Ⅲ according to Meyers-McKeever fractures classification;14 patients were grade Ⅱ and 6 patients were grade Ⅲ in back drawer test.There were 18 patients in arthroscopic fixation group,including 11 males and 7 fe-males;aged from 24 to 70 years old with an average of(53.5±13.4)years old;11 patients on the left side and 7 patients on the right side;10 patients were classified to type Ⅱ and 8 patiens with type Ⅲ according to Meyers-McKeever fractures classifica-tion;11 patients were grade Ⅱ and 7 patients were grade Ⅲ in back drawer test.Operation time,blood loss,and quality of im-mediate reduction were compared between two groups.Knee range of motion,knee back drawer test,and International Knee Documentation Committee(IKDC)grading,KT2000 stability evaluation and Lysholm function score of knee joint were com-pared at 6 months after operation.Results All patients were followed up for 8 to 16 months with an average of(12.3±1.9)months.There were no complications such as incision infection,fracture malunion or non-union,and internal fixation loosening occurred.The avulsion fractures of knee joint were reached to imaging healing standard at 6 months after operation.Operation time and blood loss in open reduction and internal fixation group were(56.4±7.1)min and(63.2±10.2)ml,while(89.9±7.4)min and(27.7±8.7)ml in arthroscopic fixation group,respectively,and had significant difference between two groups(P＜0.05).There were no differences in immediate reduction quality(x2=0.257,P=0.612),knee joint range of motion at 6 months after opertaion(t=0.492,P=0.626),knee joint rear drawer test(x2=0.320,P=0.572),IKDC classification of knee joint(x2=0.127,P=0.938),KT2000stability evaluation(x2=0.070,P=0.791),and knee Lysholmfunction score(t=0.092,P=0.282)between two groups.Conclusion Posterior medial approach with hollow anchoring system fixation and arthroscopic Endobutton with loop plate fixa-tion for the treatment of posterior cruciate ligament tibial occlusion avulsion fracture could achieve satisfactory clinical results,and arthroscopic surgery has less bleeding,but also has a longer learning curve and longer operation time than traditional inci-sion surgery.The surgeon needs to make a choice according to clinical situation of patient and their own surgical inclination.

Osteoporosis(OP)is a bone-related disease characterized by an imbalance between bone resorption and bone formation.Recent studies have shown that endoplasmic reticulum stress(ERS)plays an important role in the pathogenesis of OP.On the one hand,moderate ERS can regulate the differentiation of mesenchymal stem cells,osteoblasts and osteoclasts through multiple signaling pathways to promote bone homeostasis.On the other hand,excessive ERS can induce apoptosis of bone-related cells through various ways to disrupt bone homeostasis.Traditional Chinese medicine monomer and compound have significant therapeutic effect on OP.Recent studies have found that regulating ERS is one of the important mechanisms of effective treatment of OP by traditional Chinese medicine.From the perspective of ER stress,many studies have explored the mechanism of action in the treatment of OP by Chinese medicine.In this paper,through analyzing and summarizing the literature at home and abroad in recent years,the relevant studies on the involvement of ERS process in osteoporosis and the studies on the treatment of OP by Chinese medicine ERS process were reviewed.To further reveal the involvement of ERS process in the pathogenesis of osteoporosis and the regulatory role of traditional Chinese medicine.

Osteoporosis(OP)is a bone-related disease characterized by an imbalance between bone resorption and bone formation.Recent studies have shown that endoplasmic reticulum stress(ERS)plays an important role in the pathogenesis of OP.On the one hand,moderate ERS can regulate the differentiation of mesenchymal stem cells,osteoblasts and osteoclasts through multiple signaling pathways to promote bone homeostasis.On the other hand,excessive ERS can induce apoptosis of bone-related cells through various ways to disrupt bone homeostasis.Traditional Chinese medicine monomer and compound have significant therapeutic effect on OP.Recent studies have found that regulating ERS is one of the important mechanisms of effective treatment of OP by traditional Chinese medicine.From the perspective of ER stress,many studies have explored the mechanism of action in the treatment of OP by Chinese medicine.In this paper,through analyzing and summarizing the literature at home and abroad in recent years,the relevant studies on the involvement of ERS process in osteoporosis and the studies on the treatment of OP by Chinese medicine ERS process were reviewed.To further reveal the involvement of ERS process in the pathogenesis of osteoporosis and the regulatory role of traditional Chinese medicine.