Performance of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) in Chinese Population with Primary Prevention Indications: A Prospective Observational Cohort Study.

BACKGROUND International studies have shown that use of a subcutaneous implantable cardioverter defibrillator (S-ICD) could reduce lead-related complications while maintaining adequate defibrillation performance; however, data from the Chinese population or other Asian groups are limited. MATERIAL AND METHODS SCOPE is a prospective, multicenter, observational cohort study. Two hundred patients with primary prevention indication for sudden cardiac death (SCD), who are candidates for S-ICD, will be enrolled. From the same population, another 200 patients who are candidates for transvenous implantable cardioverter defibrillator (TV-ICD) will be enrolled after being matched for age, sex, SCD high-risk etiology (ischemic cardiomyopathy, and non-ischemic cardiomyopathy, ion channel disease, and other) and atrial fibrillation in a 1: 1 ratio with enrolled S-ICD patients. All the patients will be followed for 18 months under standard of care. RESULTS The primary endpoint is proportion of patients free from inappropriate shock (IAS) at 18 months in the S-ICD group. The lower 95% confidence bound of the proportion will be compared with a performance goal of 90.3%, which was derived from the previous meta-analysis. The comparisons between S-ICD and TV-ICD on IAS, appropriate shock, and complications will be used as secondary endpoints without formal assumptions. CONCLUSIONS This is the first prospective multicenter study focusing on the long-term performance of S-ICD in a Chinese population. By comparing with the data derived from international historical studies and a matched TV-ICD group, data from SCOPE will allow for the assessment of S-ICD in the Chinese population in a contemporary real-world implantation level and programming techniques, which will help us to further modify the device implantation and programming protocol in this specific population in the future.

Classification of regulatory T cells and their role in myocardial ischemia-reperfusion injury.

Myocardial ischemia-reperfusion injury (MIRI) is closely related to the final infarct size in acute myocardial infarction (AMI). Therefore, reducing MIRI can effectively improve the prognosis of AMI patients. At the same time, the healing process after AMI is closely related to the local inflammatory microenvironment. Regulatory T cells (Tregs) can regulate various physiological and pathological immune inflammatory responses and play an important role in regulating the immune inflammatory response after AMI. However, different subtypes of Tregs have different effects on MIRI, and the same subtype of Tregs may also have different effects at different stages of MIRI. This article systematically reviews the classification and function of Tregs, as well as the role of various subtypes of Tregs in MIRI. A comprehensive understanding of the role of each subtype of Tregs can help design effective methods to control immune reactions, reduce MIRI, and provide new potential therapeutic options for AMI.

Application of locally responsive design of biomaterials based on microenvironmental changes in myocardial infarction.

Morbidity and mortality caused by acute myocardial infarction (AMI) are on the rise, posing a grave threat to the health of the general population. Up to now, interventional, surgical, and pharmaceutical therapies have been the main treatment methods for AMI. Effective and timely reperfusion therapy decreases mortality, but it cannot stimulate myocardial cell regeneration or reverse ventricular remodeling. Cell therapy, gene therapy, immunotherapy, anti-inflammatory therapy, and several other techniques are utilized by researchers to improve patients' prognosis. In recent years, biomaterials for AMI therapy have become a hot spot in medical care. Biomaterials furnish a microenvironment conducive to cell growth and deliver therapeutic factors that stimulate cell regeneration and differentiation. Biomaterials adapt to the complex microenvironment and respond to changes in local physical and biochemical conditions. Therefore, environmental factors and material properties must be taken into account when designing biomaterials for the treatment of AMI. This article will review the factors that need to be fully considered in the design of biological materials.

Prognosis of patients with familial hypertrophic cardiomyopathy: A single-center cohort study with ten-year follow-up by propensity score matching analysis.

Objectives: Hypertrophic cardiomyopathy (HCM) is the most common hereditary cardiomyopathy. However, few studies have investigated the prognosis of familial HCM (FHCM) through clinical data. The purpose of this study was to compare the clinical outcomes of FHCM and non-FHCM through propensity score matching analysis. Methods and results: The cohort study included 1243 patients with HCM between 1996 and 2013 in Fuwai Hospital, Chinese Academy of Medical Sciences, among whom 125 patients had FHCM. During a mean follow-up of 7.6 ± 3.8 years (interquartile range: (IQR) 5.0-10.0 years), 217 (16.57%) of the 1243 patients had died, including 3 patients who underwent cardiac transplantation. Using 30 demographic and clinical variables, a 4:1 propensity score matched cohort for FHCM was established. The stepwise variable selection procedure for the Cox proportional hazards model was performed to identify the factors associated with mortality and competing risk regression analysis was performed to analyze the competitive risk of cardiovascular and non-cardiovascular mortality. The results showed that FHCM patients had a higher risk of cardiovascular mortality/cardiac transplantation (log-rank χ2 = 6.8, P = 0.0084) and an increased tendency of sudden cardiac death (SCD) (log-rank χ2 = 3.2, P = 0.074) compared with non-FHCM patients, but there was no difference in all-cause mortality (log-rank χ2 = 2.7, P = 0.1) between the two groups. Moreover, the Cox model showed that FHCM was an independent prognostic predictor for cardiovascular mortality/cardiac transplantation in HCM patients. Conclusion: FHCM patients had a higher risk of cardiovascular mortality/cardiac transplantation and a higher tendency of SCD than non-FHCM patients, but there was no difference in all-cause mortality. Moreover, FHCM was an independent prognostic predictor for cardiovascular mortality/cardiac transplantation in HCM patients.

Simplified Rapid Hydration Prevents Contrast-Associated Acute Kidney Injury Among CKD Patients Undergoing Coronary Angiography.

BACKGROUND: Patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) are at high risk of contrast-associated acute kidney injury (CA-AKI) and mortality. Therefore, there is a clinical need to explore safe, convenient, and effective strategies for preventing CA-AKI. OBJECTIVES: This study sought to assess whether simplified rapid hydration is noninferior to standard hydration for CA-AKI prevention in patients with CKD. METHODS: This multicenter, open-label, randomized controlled study was conducted across 21 teaching hospitals and included 1,002 patients with CKD. Patients were randomized to either simplified hydration (SH) (SH group, with normal saline from 1 hour before to 4 hours after CAG at a rate of 3 mL/kg/h) or standard hydration (control group, with normal saline 12 hours before and 12 hours after CAG at a rate of 1 mL/kg/h). The primary endpoint of CA-AKI was a ≥25% or 0.5-mg/dL rise in serum creatinine from baseline within 48 to 72 hours. RESULTS: CA-AKI occurred in 29 of 466 (6.2%) patients in the SH group and in 38 of 455 (8.4%) patients in the control group (relative risk: 0.8; 95% CI: 0.5-1.2; P = 0.216). In addition, the risk of acute heart failure and 1-year major adverse cardiovascular events did not differ significantly between the groups. However, the median hydration duration was significantly shorter in the SH group than in the control group (6 vs 25 hours; P < 0.001). CONCLUSIONS: In CKD patients undergoing CAG, SH is noninferior to standard hydration in preventing CA-AKI with a shorter hydration duration.

Prognosis for patients with apical hypertrophic cardiomyopathy: A multicenter cohort study based on propensity score matching.

BACKGROUND: Apical hypertrophic cardiomyopathy (AHCM) is a subtype of HCM, and few studies on the prognosis in AHCM are available. AIMS: This study aimed to explore the clinical prognosis for AHCM and non-AHCM patients through clinical data based on propensity score matching (PSM) in a large cohort of Chinese HCM patients. METHODS: The cohort study included 2268 HCM patients, 226 AHCM and 2042 non-AHCM patients from 13 tertiary hospitals, who were treated between 1996 and 2021. Fifteen demographic and clinical variables of 226 AHCM patients and 2042 non-AHCM patients were matched using 1:2 PSM. A Cox proportional hazard regression model was constructed to assess the effect of AHCM on mortality. RESULTS: During a median follow-up of 5.1 (2.4-8.4) years, 353 (15.6%) of the 2268 HCM patients died, of whom 205 died due to cardiovascular mortality/cardiac transplantation and 94 experienced sudden cardiac death (SCD). In the matched cohort, the ACHM patients had lower rates of all-cause mortality (P = 0.003), cardiovascular mortality/cardiac transplantation (P = 0.03), and SCD (P = 0.02) than the non-AHCM patients. Furthermore, the Cox proportional hazard regression model showed that AHCM was an independent prognostic predictor of all-cause HCM mortality (P = 0.004) and a univariable prognostic predictor of cardiovascular mortality/cardiac transplantation (P = 0.03) and for SCD (P = 0.03). However, AHCM was not significant in multivariable Cox regression models in relation to cardiovascular mortality/cardiac transplantation and SCD. CONCLUSION: AHCM had a favorable prognosis both before and after matching, with lower all-cause mortality, cardiovascular mortality/cardiac transplantation, and SCD than non-AHCM.

Esophageal cervical spondylosis complicated with cervical disc herniation: A rare case report.

RATIONALE: Esophageal cervical spondylosis is rare in clinical practice, and the patients with cervical disc herniation are more rare. PATIENT CONCERNS: A 56 year old male patient had dysphagia for 2 years, which was more obvious in the last month, and presented with pain and numbness in the right shoulder and upper arm. DIAGNOSIS: The patient suffered from dysphagia. Gastroscope showed that the inner membrane of the esophagus was intact, chronic esophagitis, local smooth swelling, and no new organisms. DR shows a huge osteophyte in front of the cervical spine. INTERVENTION: Anterior approach of cervical 4 and 5 anterior osteophyte resection, cervical 4/5 intervertebral disc resection, interbody fusion and internal fixation. OUTCOMES: Three days after operation, the dysphagia of the neck was significantly improved, and the numbness and pain of the right limb disappeared. The patient was very satisfied with the treatment. CONCLUSION: Anterior cervical anterior osteophyte resection, cervical disc resection, interbody fusion and internal fixation can effectively solve esophageal cervical spondylosis with cervical disc herniation. LESSONS: Through the understanding of the disease, we can better understand the disease. It provides a treatment scheme for similar diseases.

Associations of Serum and Red Blood Cell Folate With All-Cause and Cardiovascular Mortality Among Hypertensive Patients With Elevated Homocysteine.

Objectives: This study aims to explore the associations between serum and red blood cell (RBC) folate as indicators of short- and long-term folate status, respectively, and all-cause as well as CVD mortality among hypertensive patients with elevated homocysteine. Methods: A prospective cohort study of the National Health and Nutrition Examination Survey (1999-2006) and 2015 Linked Mortality File was performed. All-cause and CVD mortality risk estimated using Cox proportional hazards models with adjusting for multiple potential covariates. Results: A total of 1,753 hypertensive patients with elevated homocysteine [mean (SD) age, 68.5 (13.1)] were included in the analysis. During a median follow-up of 10.0 years, a total of 899 all-cause and 257 CVD deaths occurred. Compared the highest with the lowest quartile of RBC folate, the multivariable adjusted hazard ratios and 95% confidence intervals for all-cause and CVD death were 1.13 (0.92-1.39) and 1.47 (1.01-2.16) respectively. There was a significant and positive trend between RBC folate and the risk of CVD death (p for trend = 0.0196). No significant association was found between serum folate and mortality risk among the study sample. Conclusions: High level of RBC folate is associated with an increased risk of cardiovascular mortality among hypertensive patients with elevated homocysteine while serum folate has no such effects.

Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.

BACKGROUND: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. METHODS: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; P=0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; P=0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points. CONCLUSIONS: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02270242.

Amelioration of acute myocardial infarction injury through targeted ferritin nanocages loaded with an ALKBH5 inhibitor.

The roles of m6A RNA methylation and mitochondrial metabolism in acute myocardial infarction (AMI) remain unclear. In this study, we demonstrated that m6A RNA methylation affected ischemia/reperfusion (I/R) injury in AMI through the "Erasers" protein ALKBH5-related metabolic reprogramming, characterized by the inhibition of enzyme activities of the tricarboxylic acid cycle; moreover, a surface-modified bioengineered ferritin nanocage was obtained from Archaeoglobus fulgidus, with a chimeric structure containing 8 lysine residues, SpyTag/SpyCatcher, and the C1q ligand Scarf1, which could disassemble and self-assemble in neutral solutions according to different Mg2+ concentrations. The surface-modified bioengineered ferritin nanocage targeted the dying cells in the infarct area under the guidance of Scarf1. These cells were then phagocytosed through recognition of their TfR1 receptor. Lysosomal escape was achieved through the 8 lysine residues on the nanocage, and the nanocage disassembled based on the differences in intracellular and extracellular Mg2+ concentrations. Finally, the ALKBH5 inhibitor IOX1 was loaded onto the ferritin nanocage and used in the AMI model, and it was found to effectively improve cardiac function. These results provide a potential strategy for the treatment of AMI in the future. STATEMENT OF SIGNIFICANCE: In acute myocardial infarction (AMI) induced by ischemia/reperfusion injury, m6A RNA methylation aggravates the injury through the "Erasers" protein ALKBH5-related metabolic reprogramming. To achieve precise treatment, genetic engineering-based recombinant expression technology was used to obtain a ferritin from Archaeoglobus fulgidus. The obtained ferritin was designated as HAfFtO, and it can disassemble and self-assemble in a neutral solution under different Mg2+ concentrations and achieve lysosomal escape. Three G4S linkers were used to connect SpyTag with HAfFtO to synthesize HAfFtO-ST and recombination Scarf1 containing SpyCatcher structure, namely SC-Sf. According to the SpyTag/SpyCatcher technique, HAfFtO-ST and SC-Sf can form a gentle and firm combination, namely HSSS. The ALKBH5 inhibitor IOX1 was loaded on HSSS to form HSSS-I. HSSS-I effectively improved the cardiac function and decreased the infarct size in AMI.

Predictors of Quality of Life in Patients With Myocardial Infarction Combined With Dyslipidemia.

Background: Dyslipidemia is an important risk factor for myocardial infarction (MI). This study aimed to examine the health-related quality of life (HRQoL) and its predictors of patients with MI combined with dyslipidemia in China. Methods: Information on patients' sociological characteristics, lifestyle, clinical characteristics, and quality of life were collected by electronic medical records and questionnaires. Tobit regression model was used to investigate the predictors of quality of life. Results: There were 756 patients responded. The average EQ-5D score of all the patients was 0.95 (SD: 0.11). For all patients, factors such as age, high-fat and high-cholesterol diet, sports, family history of dyslipidemia, history of peripheral artery disease significantly affected HRQoL. Conclusions: Post-discharge care of the elderly group should be paid more attention to and suggestions on the healthy lifestyle (fat control) of the patients should be encouraged to improve the quality of life of these population.

Systemic Lupus Erythematosus Complicated with Hypertrophic Cardiomyopathy: A Case Report and Literature Review.

A 32-year-old female with systemic lupus erythematosus (SLE) for more than 7 years, and long-term treatment with cyclophosphamide, cyclosporine, methotrexate, and tacrolimus, later found to be combined with hypertrophic cardiomyopathy (HCM) for one year. The patient denied a family history of cardiomyopathy and sudden cardiac death (SCD). Echocardiography suggested that uneven thickening of the left ventricle (LV), mainly in the lower middle segment. Cardiac magnetic resonance (CMR) showed that the walls of the left ventricular (LV) were significantly thickened, as about 21 mm, mainly in the middle and lower segments. Genetic tests showed no known or suspected pathogenic variations were found and no significant enhancement in CMR, so secondary HCM was diagnosed clinically. After symptomatic treatment, the patient was discharged, and long-term follow-up was conducted. The diagnosis of HCM, which combined with SLE or second to usage of tacrolimus, was based on symptoms, echocardiography, and CMR; no endomyocardial biopsies were performed.

Economic Burden of Myocardial Infarction Combined With Dyslipidemia.

Background: Dyslipidemia is a common comorbidity and an important risk factor for myocardial infarction (MI). This study aimed to examine the economic burden of MI combined with dyslipidemia in China. Methods: Patients who were hospitalized due to MI combined with dyslipidemia in 2016 were enrolled. Costs were measured based on electronic medical records and questionnaires. The annual costs were analyzed by conducting descriptive statistics, univariable, and multivariable analyses. Results: Data of 900 patients were analyzed, and 144 patients were dead during the follow-up. The majority of patients were aged 51-70 years (n = 563, 62.55%) and males (n = 706, 78.44%). For all-cause costs, the median annual direct medical costs, direct non-medical costs, indirect costs, and total costs were RMB 13,168 (5,212-29,369), RMB 600 (0-1,750), RMB 676 (0-1,787), RMB 15,361 (6,440-33,943), respectively; while for cardiovascular-related costs, the corresponding costs were RMB 12,233 (3,795-23,746), RMB 515 (0-1,680), RMB 587 (0-1,655), and RMB 14,223 (4,914-28,975), respectively. Lifestyle and complications significantly affected both all-cause costs and cardiovascular-related costs. Conclusions: Increasing attention should be paid to encourage healthy lifestyle, and evidence-based medicine should focus on optimal precautions and treatments for complications, to reduce the economic burden among MI patients with a comorbid dyslipidemia.

Comparison of intravascular ultrasound-guided with angiography-guided double kissing crush stenting for patients with complex coronary bifurcation lesions: Rationale and design of a prospective, randomized, and multicenter DKCRUSH VIII trial.

BACKGROUND: Double kissing (DK) crush approach for patients with coronary bifurcation lesions, particularly localized at distal left main or lesions with increased complexity, is associated with significant reduction in clinical events when compared with provisional stenting. Recently, randomized clinical trial has demonstrated the net clinical benefits by intravascular ultrasound (IVUS)-guided implantation of drug-eluting stent in all-comers. However, the improvement in clinical outcome after DK crush treatment guided by IVUS over angiography guidance for patients with complex bifurcation lesions have never been studied in a randomized fashion. TRIAL DESIGN: DKCRUSH VIII study is a prospective, multicenter, randomized controlled trial designed to assess superiority of IVUS-guided vs angiography-guided DK crush stenting in patients with complex bifurcation lesions according to DEFINITION criteria. A total of 556 patients with complex bifurcation lesions will be randomly (1:1 of ratio) assigned to IVUS-guided or angiography-guided DK crush stenting group. The primary end point is the rate of 12-month target vessel failure, including cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. The secondary end points consist of the individual component of primary end point, all-cause death, myocardial infarction, and in-stent restenosis. The safety end point is the incidence of definite or probable stent thrombosis. An angiographic follow-up will be performed for all patients at 13 months and clinical follow-up will be continued annually until 3 years after the index procedure. CONCLUSIONS: DKCRUSH VIII trial is the first study designed to evaluate the differences in efficacy and safety between IVUS-guided and angiography-guided DK crush stenting in patients with complex true bifurcation lesions. This study will also provide IVUS-derived criteria to define optimal DK crush stenting for bifurcation lesions at higher complexity.

Effect of N-acetylcysteine on prevention of contrast-associated acute kidney injury in patients with STEMI undergoing primary percutaneous coronary intervention: a systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: Several studies evaluating the preventive effect of N-acetylcysteine (NAC) on contrast-associated acute kidney injury (CA-AKI) among patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) have suggested inconsistent results and that a systematic review and meta-analysis should be performed. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, MEDLINE, EMBASE, ClinicalTrials.gov and the Cochrane Central databases were searched from inception to 15 November 2019. ELIGIBILITY CRITERIA: Randomised controlled trials assessing use of NAC compared with non-use of NAC (eg, placebo) in preventing CA-AKI in patients with STEMI following PPCI were included. DATA SYNTHESIS: Relative risks with 95% CIs were pooled using a random-effects model. Evidence level of conclusions was assessed by Cochrane GRADE measure. RESULTS: Seven trials including 1710 patients were identified. Compared with non-use of NAC, use of NAC significantly reduced the incidence of CA-AKI by 49% (risk ratio (RR) 0.51, 95% CI 0.31 to 0.82, p<0.01) and all-cause in-hospital mortality by 63% (RR 0.37, 95% CI 0.17 to 0.79, p=0.01). The estimated effects on the requirement for dialysis (RR 0.61, 95% CI 0.11 to 3.38, p=0.24) were not statistically significant. Trial sequential analysis confirmed the true positive of NAC in reducing risk of CA-AKI. Subgroup analyses suggested that the administration of NAC had greater benefits in patients with renal dysfunction and in those receiving oral administration and higher dosage of NAC. CONCLUSIONS: NAC intake reduces the risk of CA-AKI and all-cause in-hospital mortality in patients with STEMI undergoing PPCI. The estimated potential benefit of NAC in preventing dialysis was ambiguous, and further high-quality studies are needed. PROSPERO REGISTRATION NUMBER: CRD42020155265.

Myocardial caspase-3 and NF-κB activation promotes calpain-induced septic apoptosis: The role of Akt/eNOS/NO pathway.

AIMS: To explore the potential mechanism that the role of the Akt/eNOS/NO pathway in calpain-induced caspase-3 and NF-κB activation during septic apoptosis. MAIN METHODS: Septic rats were stimulated by LPS (8 mg/kg, i.p.). Myocardial calpain, caspase-3, NO, TNF-α and IL-1ß levels were detected by ELISA. The levels of Akt/p-Akt, eNOS/p-eNOS, iNOS proteins and number of apoptotic cells were evaluated by immunohistochemistry, western blot and TUNEL method. KEY FINDINGS: Compared with sham, LPS treatment resulted in 4.1-fold and 1.8-fold increases in myocardial calpain activity and caspase-3 activation, respectively, and a significant increase (6.8-fold) in apoptotic cardiomyocytes was observed. The administration of calpain inhibitors (calpain inhibitor-IV, PD150606 and PD151746) showed that p-Akt and p-eNOS protein levels were correlated with the levels of LPS-induced myocardial calpain and caspase-3 activity. In addition, the quantity of p-Akt protein and NO content were markedly attenuated by wortmannin, a phosphoinositide 3-kinase (PI3K) inhibitor. Pretreatment with L-NAME, an NOS inhibitor, induced a decrease in p-eNOS proteins and apoptosis in myocardial tissues, while iNOS proteins were strongly increased in septic rats. SIGNIFICANCE: This study suggests that the Akt/eNOS/NO pathway might lead to a novel pharmacological therapy for cardiomyocytes apoptosis in sepsis.

Analysis of the Current Situation of Antibiotics Use in China: A Hospital-Based Perspective.

OBJECTIVE: To investigate the present situation of antibiotics use in selected hospitals in China according to 2 indicators: hospital-based market sales and frequency of usage; based on this information, to assess the government's containment policies toward antibiotics overuse. METHODS: Marketing and clinical usage data of antibiotics in 420 selected hospitals from 21 major cities and 1 district in China during 2008-2011 were collected and analyzed. Usage frequency was measured by the defined daily dose (DDD) analytic approaches recommended by World Health Organization (WHO), and the growth rate of DDDs per patient was compared for 3 categories of antibiotics: nonlimited (first line), limited (second line), and specially controlled (third line). RESULTS: During the period studied, an obvious slowdown was observed in both sales value and the growth of sales volume for the 3 categories. With respect to frequency, both limited-level and specially controlled level antibiotics with high cost and low safety and effectiveness showed an evident decline in the growth rate of DDDs per patient ( P < .05). However, no significant decline was found for nonlimited antibiotics ( P > .05). CONCLUSION: The Chinese government's containment policies toward antibiotics overuse are beginning to take effect, and antibiotics usage has become more measured in major cities. However, China still has a long way to go before it can win the battle against antibiotics overuse and drug resistance.

Approvals of Pharmaceutical Drugs in China in the Post-Drug Registration Regulation II Era.

OBJECTIVE: To delineate the impact of the revised Drug Registration Regulation (DRR II) issued in 2007 on drug approval in China and reveal the change in approval situations for new drugs and generic drugs in the post-DRR II era (2007-2011). METHODS: Data of drug approvals were collected from the database of the China Food and Drug Administration (CFDA) and were analyzed by introducing 3 ratio indicators and utilizing statistical analysis tools. RESULTS: In the post-DRR II era, the drug approvals showed a general trend of the following: (1) a statistically significant rise in both the absolute number and proportion of new drugs, (2) a nonsignificant change for drugs in new dosage forms, and (3) a statistically significant drop in both the absolute number and proportion of generic drugs. On the other hand, Class 1 (new chemical entities) drugs accounted for an extremely small proportion in new drugs. Except for the rise in gastrointestinal and cardiovascular new drugs, no significant changes were found in other therapeutic categories. CONCLUSIONS: Thanks to the DRR II, the aberration in Chinese drug registration has been terminated. Approvals for new drugs and high-quality generics are the main trends. Because of the severe paucity of Class 1 drugs, innovation and collaboration will be the main 2 themes for the Chinese pharmaceutical industry as well as the upcoming version of the DRR III in the near future.

[Chemical constituents from Corydalis humosa].

OBJECTIVE: To study the chemical constituents of Corydalis humosa Migo. METHODS: Some chromatography methods were used to separate the chemical constituents of this plant. Their structures were determined by NMR and MS spectral data. RESULTS: Six compounds were isolated from the 95% ethanolic extract of the tubers of C. humosa. The structures of these compounds were identified as tetrahydropalmatine (1), jatrorrhizine (2), berberine (3), tetrahydroberberine (4), palmaline (5) and (-)-tetrahydrocoptisine (6) respectively. CONCLUSIONS: Compounds 1-3 were isolated from this plant for the first time.