Governor vessel moxibustion combined with western medication for mild to moderate depression with kidney-yang deficiency: a randomized controlled trial / 中国针灸

OBJECTIVE@#To compare the therapeutic efficacy of governor vessel moxibustion combined with fluoxetine hydrochloride capsule, simple fluoxetine hydrochloride capsule and placebo moxibustion combined with fluoxetine hydrochloride capsule for mild to moderate depression with kidney-yang deficiency.@*METHODS@#A total of 126 patients with mild to moderate depression with kidney-yang deficiency were randomized into a governor vessel moxibustion group (42 cases, 2 cases dropped off), a western medication group (42 cases, 1 case dropped off) and a placebo moxibustion group (42 cases, 1 case dropped off). The western medication group was given fluoxetine hydrochloride capsule orally, 20 mg a time, once a day. On the basis of the treatment in the western medication group, governor vessel moxibustion was applied from Dazhui (GV 14) to Yaoshu (GV 2) in the governor vessel moxibustion group, once a week; placebo moxibustion was applied in the placebo moxibustion group, once a week. Treatment of 8 weeks was required in the 3 groups. Before and after treatment, the scores of Hamilton depression scale-17 (HAMD-17), Asberg's rating scale for side effects (SERS) and TCM clinical symptom were compared, and the clinical efficacy was evaluated.@*RESULTS@#After treatment, the scores of HAMD-17, SERS and TCM clinical symptom were decreased compared before treatment in the 3 groups (P<0.05), the decrease ranges of above scores in the governor vessel moxibustion group were larger than those in the western medication group and the placebo moxibustion group (P<0.05). The total effective rate was 92.5% (37/40) in the governor vessel moxibustion group, which was higher than 75.6% (31/41) in the western medication group and 80.5% (33/41) in the placebo moxibustion group (P<0.05).@*CONCLUSION@#Governor vessel moxibustion combined with fluoxetine hydrochloride capsule can improve the degree of depression and relieve the clinical symptoms in mild to moderate depression patients with kidney-yang deficiency, the efficacy is superior to simple fluoxetine hydrochloride capsule, and can reduce the fluoxetine hydrochloride capsule-induced adverse effect to a certain extent.

Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly (version 2023) / 中华创伤杂志

Periarticular fracture of the shoulder is a common type of fractures in the elderly. Postoperative adverse events such as internal fixation failure, humeral head ischemic necrosis and upper limb dysfunction occur frequently, which seriously endangers the exercise and health of the elderly. Compared with the fracture with normal bone mass, the osteoporotic periarticular fracture of the shoulder is complicated with slow healing and poor rehabilitation, so the clinical management becomes more difficult. At present, there is no targeted guideline or consensus for this type of fracture in China. In such context, experts from Youth Osteoporosis Group of Chinese Orthopedic Association, Orthopedic Expert Committee of Geriatrics Branch of Chinese Association of Gerontology and Geriatrics, Osteoporosis Group of Youth Committee of Chinese Association of Orthopedic Surgeons and Osteoporosis Committee of Shanghai Association of Chinese Integrative Medicine developed the Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly ( version 2023). Nine recommendations were put forward from the aspects of diagnosis, treatment strategies and rehabilitation of osteoporotic periarticular fracture of the shoulder, hoping to promote the standardized, systematic and personalized diagnosis and treatment concept and improve functional outcomes and quality of life in elderly patients with osteoporotic periarticular fracture of the shoulder.

Motor imagery electroencephalogram classification based on sparse spatiotemporal decomposition and channel attention / 生物医学工程学杂志

Motor imagery electroencephalogram (EEG) signals are non-stationary time series with a low signal-to-noise ratio. Therefore, the single-channel EEG analysis method is difficult to effectively describe the interaction characteristics between multi-channel signals. This paper proposed a deep learning network model based on the multi-channel attention mechanism. First, we performed time-frequency sparse decomposition on the pre-processed data, which enhanced the difference of time-frequency characteristics of EEG signals. Then we used the attention module to map the data in time and space so that the model could make full use of the data characteristics of different channels of EEG signals. Finally, the improved time-convolution network (TCN) was used for feature fusion and classification. The BCI competition IV-2a data set was used to verify the proposed algorithm. The experimental results showed that the proposed algorithm could effectively improve the classification accuracy of motor imagination EEG signals, which achieved an average accuracy of 83.03% for 9 subjects. Compared with the existing methods, the classification accuracy of EEG signals was improved. With the enhanced difference features between different motor imagery EEG data, the proposed method is important for the study of improving classifier performance.

Isoflavones from Sojae Semen Praeparatum Regulate Lipid Metabolism in Atherosclerotic Mice Through PPARγ/LXRα/ABCA1 Signaling Pathway / 中国实验方剂学杂志

ObjectiveTo study the effect of isoflavones from Sojae Semen Praeparatum （ISSP） on lipid metabolism in atherosclerotic mice， and decipher the underlying mechanism via the peroxisome proliferator-activated receptor gamma/liver X receptor alpha/ATP-binding cassette transporter A1 （PPARγ/LXRα/ABCA1） signaling pathway. MethodFifty ApoE-/- mice were randomly assigned into the model group， western medicine （atorvastatin calcium， 3.03 mg·kg-1） group， and low-， medium-， and high-dose ISSP （2.5， 5， 10 mg·kg-1， respectively） groups， with 10 rats in each group. Atherosclerosis model mice were established by bilateral ovariectomy and feeding high-fat diet. Another 10 ApoE-/- mice receiving ovariectomy and high-fat diet were taken as the sham group. Some mice died of postoperative infection， and finally 6 mice were included in each group. One week after operation， each group was administrated with corresponding drugs or equivalent amount of normal saline. After 12 weeks， the levels of triglyceride （TG）， total cholesterol （TC）， high-density lipoprotein cholesterol （HDL-C）， low-density lipoprotein cholesterol （LDL-C）， and non-esterified fatty acids （NEFAs） in serum and liver tissue were measured. The levels of tumor necrosis factor-α （TNF-α） and interleukin-6 （IL-6） in serum were detected by enzyme-linked immunosorbent assay （ELISA）. Hematoxylin-eosin （HE） staining and oil red O staining were used for observation of aortic plaque formation and liver lipid deposition. The mRNA and protein levels of PPARγ， LXRα， ABCA1， and ATP-binding cassette transporter G1 （ABCG1） in liver were determined by real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） and Western blot. ResultCompared with the sham group， the modeling of atherosclerosis increased the aortic plaque area （P<0.01）， elevated the serum TC， TG， LDL-C， TNF-α， and IL-6 levels （P<0.01）， decreased the level of HDL-C （P<0.01）， increased the liver index （P<0.05） and the levels of TC， TG， and NEFAs in liver （P<0.01）， and caused obvious hepatic fat vacuoles and lipid deposition. In addition， the modeling down-regulated the mRNA levels of PPARγ， LXRα， ABCA1 in liver （P<0.05， P<0.01），and regulated the mRNA and protein levels of ABCG1（P<0.05， P<0.01）. Compared with the model group， atorvastatin calcium and middle-， high-dose ISSP reduced the serum TC， TG， LDL-C， TNF-α， and IL-6 levels （P<0.01）， decreased the liver index （P<0.01）， alleviated the liver fat vacuoles and lipid deposition， and increased the levels of TC， TG， and NEFAs in the liver （P<0.05， P<0.01）. Furthermore， they up-regulated the mRNA and protein levels of PPARγ， LXRα， ABCA1， and ABCG1 in the liver （P<0.05， P<0.01）. ConclusionISSP may regulate lipid metabolism through PPARγ/LXRα/ABCA1 signaling pathway to down-regulate the expression of inflammatory cytokines in serum and alleviate liver lipid deposition， thereby suppressing the formation of atherosclerotic plaque.

Research Progress on Mechanism of Tongxie Yaofang in Treating Diarrhea-Predominate Irritable Bowel Syndrome Based on Brain-gut Interaction Function / 中国实验方剂学杂志

Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the common functional gastrointestinal diseases in clinical practice, its pathogenesis is diverse. Because of its sudden and lingering intractable symptoms, it seriously affects patients' work and life. IBS-D patients suffer from repeated illnesses, which often affect their lives with mental symptoms such as anxiety and depression. Anxiety and depression can also affect visceral sensation, increase intestinal sensitivity, aggravated by interaction between physical symptoms and mental symptoms. The main pathogenesis of IBS-D such as visceral hypersensitivity, gastrointestinal motility disorders, intestinal infections, and psychosocial factors are all related to brain-gut interaction disorders. Patients with IBS-D are prone to brain-gut interaction disorders due to long-term chronic mental stress. Brain-gut interaction is the main mode of regulation of gastrointestinal function in the brain-gut axis. Traditional Chinese medicine （TCM） believes that the main syndrome type of IBS-D patients is liver stagnation and spleen deficiency, while liver stagnation will be unsatisfactory, and the secretion and content of various neurotransmitters in the brain are closely related to emotions. Tongxie Yaofang is a commonly basic prescription used for the clinical treatment of IBS-D liver stagnation and spleen deficiency syndrome. It has the functions of softening the liver and replenishing the spleen, removing dampness and stopping diarrhea, and has a significant clinical effect. At present, many animal experiments and clinical studies have explored the mechanism of Tongxie Yaofang in treating IBS-D and its effect on brain-gut interaction function and brain-gut peptide content, but the main liver drainage and brain-gut interaction have not been linked. The author took the correlation between liver liver govers regulating and brain-gut interaction as the starting point, explored the mechanism of Tongxie Yaofang in treating IBS-D based on brain-gut interaction disorder, and explained the correlation between the three. Based on the research literature of Tongxie Yaofang in the past 5 years and the interaction between Tongxie Yaofang and brain-gut interaction, the author explored the effect of Tongxie Yaofang in treating IBS-D by affecting the brain-gut axis and brain-gut peptides.

The mediating role of experiential avoidance and thought suppression between trait mindfulness and rumination in undergraduates / 中华行为医学与脑科学杂志

Objective To investigate the relationship between trait mindfulness( TM) and rumina-tion,as well as the mediating effects of experiential avoidance(EA) and thought suppression(TS) in under-graduates. Methods A sample of 1 219 undergraduates was recruited to complete Mindful Attention Aware-ness Scale,Acceptance and Action Questionnaire-Ⅱ,the White Bear Suppression Inventory and Rumination Response Style Questionnaire. Results (1) The significant positive correlations of each two different fac-tors were found among experiential avoidance (18. 020±7. 446),thought suppression (47. 769±10. 011) and rumination (47. 668±10. 497),and the correlation coefficients were 0. 466,0. 546 and 0. 525 respectively, all P<0. 01. TM (64. 977± 9. 623) was found to be significantly related with EA ( r=-0. 450),TS ( r=-0. 424) and rumination (r=-0. 527),all P<0. 01. (2) Partially mediating effect of EA ( effect value=-0. 132) and TS (effect value=-0. 073) were both found in TM and rumination,and the proportion of these two effects were 25. 0% and 13. 9%,respectively. The chain mediating effect of EA and TS (effect value=-0. 042 ) was also found between TM and rumination, whose indirect effect size was 8. 0%. Conclusion The relationship between TM and rumination in undergraduates can be mediated by EA and TS respectively,as well as their chain effect.

Improving Asymptomatic Left Ventricular Diastolic Dysfunction in Postmenopausal Hypertensive Women with Metabolic Syndrome: A Prospective, Open-Labeled, Randomized Controlled Trial / 中华医学杂志(英文版)

<p><b>Background</b>Postmenopausal women with metabolic syndrome (MetS) have increased cardiovascular morbidity and left ventricular diastolic dysfunction (LVDD). The various protective effects of astragalus membranaceus (AM) have been described in previous studies. Therefore, this study aimed to evaluate the effects of different doses of AM on diastolic function in postmenopausal hypertensive women with MetS.</p><p><b>Methods</b>This was a prospective, randomized controlled study. The postmenopausal hypertensive patients with MetS were enrolled from Lanzhou University Second Hospital from March 2014 to April 2015. Patients were divided into three groups: control group (received conventional medical treatment), AM Group 1 (received AM capsules at 5 g/d additionally), and AM Group 2 (received AM capsules at 10 g/d additionally). Echocardiographic and clinical characteristics were evaluated before and 12 months after treatment. Quantitative data were analyzed using unpaired t-test, analysis of variance, and multiple linear regression analysis.</p><p><b>Results</b>A total of 154 patients were subjected to final analysis. In the AM Group 2, significant improvements were noted in diastolic function 12 months after treatment than those of the control group, including the early diastolic mitral annular velocity (E'; 0.065 ± 0.007 m/s vs. 0.061 ± 0.008 m/s, P = 0.014), the ratio of the early diastolic mitral peak flow velocity to the late diastolic mitral peak flow velocity (E/A; 0.81 ± 0.05 vs. 0.80 ± 0.06, P = 0.012), the ratio of E' to the late diastolic mitral annular velocity (E'/A'; 0.56 ± 0.12 vs. 0.51 ± 0.13, P = 0.048), and the ratio of the early diastolic mitral peak flow velocity (E) to E' (E/E'; 10.70 ± 1.30 vs. 11.37 ± 1.73, P = 0.031). After treatment, E/E' (10.70 ± 1.30 vs. 11.24 ± 1.56, P = 0.021), deceleration time (DT; 261.49 ± 44.41 ms vs. 268.74 ± 53.87 ms, P = 0.046), and E'/A' (0.56 ± 0.12 vs. 0.52 ± 0.13, P = 0.019) values improved more significantly than those of AM Group 2 before treatment. Besides, waist circumference was positively correlated with E' (r = 0.472; P = 0.003) and E'/A' (r = 0.321; P = 0.047). In addition, the waist-to-hip ratio was a significant predictor of DT (r = 0.276; P = 0.041), E' (r = -0.590; P < 0.001), E/E' (r = 0.454; P = 0.004), and E'/A' (r = -0.377; P = 0.018).</p><p><b>Conclusions</b>Conventional medical plus AM therapy improved diastolic function. Moreover, WC and WHR might be risk factors for LVDD.</p><p><b>Chinese Clinical Trial Register</b>ChiCTR-TRC-11001747. http://www.chictr.org.cn/showprojen.aspx?proj=7798.</p>

New method for evaluating pharmacodynamics of traditional Chinese medicine compounds based on its moderate regulation and principle of balanced adjustment of immunity under pan-immunomic / 中国中药杂志

For the basic research on the traditional Chinese medicine(TCM), objective syndrome of traditional Chinese medicine and evaluation criteria of traditional Chinese medicine compounds are hardly to break though. While, the modern immunology points out that the body is a counterbalance state and immune imbalance is the root of sickness. The thinking mode of treating diseases in traditional Chinese medicine is also "balance", considering disease is the result of bias which present the imbalance of "Yin counters Yang", "exterior counters interior", "cold counters heat" and "weak counters strong". The Chinese herbal compound formula preparation was applied on disease therapy based on theory of Chinese medicine, which was confirmed by long period clinical application. It is composed of multi-compounds and has the characteristic of multi-targeting. Integrative medicine has spawned pan-immunomics, and the evaluation of immune function (immune balance) has become an important basis for diagnosis and treatment models of integrative medicine. In addition, balance is the core idea of whole-systemic conception of traditional Chinese medicine. Therefore, we speculate that immune balance under pan-immunomic can bridge the traditional Chinese medicine and modern integrative medicine and is the important basis for objective syndrome of traditional Chinese medicine and evaluation criteria of traditional Chinese medicine compounds. According to the bridging theory, we attempt to utilize informatics and statistical methods to construct an evaluation system for pharmacodynamics of traditional Chinese medicine based on its moderate regulation and the balanced adjustment of immunity under pan-immunomic, which further reveal the scientific essence of the whole-systemic view of traditional Chinese medicine. This research brings out a new valuable strategy and provides a theoretical basis for accelerating the transformation of traditional Chinese medicine, especially the exploitation of Chinese herbal compound formula, and constructing the new drug innovation and review system for traditional Chinese medicine. Besides as a reference for traditional Chinese medicine objective syndrome and pharmacodynamics of traditional Chinese medicine compounds, the evaluation system can screen the immunity of sub-health population also. With the continuous accumulation of clinical sample and data, the evaluation system will be more accurate and intelligent.

Clinical analysis of treating severe soft tissue defect on distal leg and foot with sural nerve nutrient vessels retrograde island flap / 局解手术学杂志

Objective To explore the clinical application of treating severe soft tissue defect on distal leg and foot with sural nerve nutrient vessels retrograde island flap.Methods A total of 34 cases of patients who were treated with sural nerve nutrient vessels retrograde island flap were regared as the observation group, and the other 12 cases who were treated with local rotation skin flap grafting were regared as the control group.The postoperative survival rate of skin flap,complications,functional recovery and local sensation of the two groups were evaluated.Results The transplanted skin flap of the observation group all survived after operation.There were 3 cases of partial necrosis of the skin flap distal edge which were cured with dressing change.A few tension vesicle occured in 3 patients and they were cured with dressing change.The transplanted skin flap of the control group all survived after operation,but there were different degree of scar contracture,flap deformation and flap atrophy 6 months after surgery.The postoperative function,local sensation,scar size of the observation group were better than those of the control group with statistically significant difference (P<0.05).Conclusion To treat severe soft tissue defect on distal leg and foot with sural nerve nutrient vessels retrograde island flap is a good method which can promote severe tissue defect repair on the lower extremity and foot.

Selection of Meridians and Acupoints of Tuina for Spastic Paralysis post Stroke:A Bibliometric Analysis / 中国康复理论与实践

Objective To investigate the meridians and acupoints selection in the treatment of post-stroke spastic paralysis with Tuina (Chinese massage). Methods The literatures about Tuina therapy for post-stroke spastic paralysis were retrieved. The frequency of meridi-ans and acupoints used was counted and analyzed. Results 99 papers were collected, which involved in 226 acupoints and 1602 times of ap-plication. The selected acupoints were distributed in all the fourteen meridians and 64.5% (1033/1602, 606 on upper limb, 427 on lower limb) of them were on the limbs. The acupoints of the Yang meridians was 75.0%(1200/1602) and the specific acupoints was 71.7%(1148/1602). Conclusion The acupoint selected was basically focused on the local areas in Tuina for post-stroke spastic paralysis, assisted with the involved meridians and distal acupoints. The acupoints of the Yang meridians were the first option, mainly on the extremities. The specific acupoints were the major components of the prescription, especially the Five-shu acupoints and the He acupoints.

Selection of Meridians and Acupoints of Tuina for Spastic Paralysis post Stroke: A Bibliometric Analysis / 中国康复理论与实践

@#Objective To investigate the meridians and acupoints selection in the treatment of post-stroke spastic paralysis with Tuina (Chinese massage). Methods The literatures about Tuina therapy for post-stroke spastic paralysis were retrieved. The frequency of meridians and acupoints used was counted and analyzed. Results 99 papers were collected, which involved in 226 acupoints and 1602 times of application. The selected acupoints were distributed in all the fourteen meridians and 64.5% (1033/1602, 606 on upper limb, 427 on lower limb) of them were on the limbs. The acupoints of the Yang meridians was 75.0% (1200/1602) and the specific acupoints was 71.7% (1148/ 1602). Conclusion The acupoint selected was basically focused on the local areas in Tuina for post-stroke spastic paralysis, assisted with the involved meridians and distal acupoints. The acupoints of the Yang meridians were the first option, mainly on the extremities. The specific acupoints were the major components of the prescription, especially the Five-shu acupoints and the He acupoints.

Expertise-based randomized controlled trials and its application in acupuncture clinical research / 中国针灸

Through introduction of the methodological mechanism and comparison with classic randomized controlled trial, the status and the applicability of the expertise-based randomized controlled trials in clinic are explored, and its characteristics in acupuncture clinical application are analyzed. It is held that expertise-based randomized controlled trial is more suitable for the acupuncture clinical research, especially for acupuncture practice which emphasizes manipulations and different schools.

An investigation of the statistical power of the effect size in randomized controlled trials for the treatment of patients with type 2 diabetes mellitus using Chinese medicine / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate whether the power of the effect size was based on adequate sample size in randomized controlled trials (RCTs) for the treatment of patients with type 2 diabetes mellitus (T2DM) using Chinese medicine.</p><p><b>METHODS</b>China Knowledge Resource Integrated Database (CNKI), VIP Database for Chinese Technical Periodicals (VIP), Chinese Biomedical Database (CBM), and Wangfang Data were systematically recruited using terms like "Xiaoke" or diabetes, Chinese herbal medicine, patent medicine, traditional Chinese medicine, randomized, controlled, blinded, and placebo-controlled. Limitation was set on the intervention course > or = 3 months in order to identify the information of outcome assessement and the sample size. Data collection forms were made according to the checking lists found in the CONSORT statement. Independent double data extractions were performed on all included trials. The statistical power of the effects size for each RCT study was assessed using sample size calculation equations.</p><p><b>RESULTS</b>(1) A total of 207 RCTs were included, including 111 superiority trials and 96 non-inferiority trials. (2) Among the 111 superiority trials, fasting plasma glucose (FPG) and glycosylated hemoglobin HbA1c (HbA1c) outcome measure were reported in 9% and 12% of the RCTs respectively with the sample size > 150 in each trial. For the outcome of HbA1c, only 10% of the RCTs had more than 80% power. For FPG, 23% of the RCTs had more than 80% power. (3) In the 96 non-inferiority trials, the outcomes FPG and HbA1c were reported as 31% and 36% respectively. These RCTs had a samples size > 150. For HbA1c only 36% of the RCTs had more than 80% power. For FPG, only 27% of the studies had more than 80% power.</p><p><b>CONCLUSIONS</b>The sample size for statistical analysis was distressingly low and most RCTs did not achieve 80% power. In order to obtain a sufficient statistic power, it is recommended that clinical trials should establish clear research objective and hypothesis first, and choose scientific and evidence-based study design and outcome measurements. At the same time, calculate required sample size to ensure a precise research conclusion.</p>

1,25-dihydroxyvitamin D₃ pretreatment enhances the efficacy of allergen immunotherapy in a mouse allergic asthma model / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Allergen-specific immunotherapy can induce immune tolerance to specific allergens by regulating immune status of individuals. However, its clinical application is limited due to individual differences in efficacy among patients and un-confirmed safety. 1,25 Dihydroxyvitamin D(3) (1,25(OH)(2)D(3)) has been shown to be involved in a variety of physiological processes, including immune response regulation. In the present study we explored the role of 1,25(OH)(2)D(3) pretreatment for immunotherapy.</p><p><b>METHODS</b>Seventy-five BALB/c mice were randomly divided into five groups (15 mice per group). The mouse allergic asthma model was established by intra-peritoneal injection of ovalbumin (OVA, 10 µg) and aluminium hydroxide (2 mg) as an adjuvant. Intra-peritoneal injection of 50 ng of 1,25(OH)(2)D(3) served as a pretreatment, subcutaneous injection of OVA (100 µg) as an immunotherapy, and 1% OVA inhalation as a challenge. Histopathological analysis was performed on four mice per group. The number of cells and their classification in bronchoalvolar lavage (BAL) fluid were assayed. Levels of serum OVA-specific immunoglobulin E (sIgE) and IFN-γ, IL-4, IL-5 and IL-10 in BAL fluid were measured by ELISA.</p><p><b>RESULTS</b>After 1,25(OH)(2)D(3) pretreatment, immunotherapy could significantly inhibit the infiltration of inflammatory cells into lung tissues and BAL fluid of mice with allergic asthma when compared with un-treated animals (eosinophils: (7.46 ± 1.34) × 10(4)/ml vs. (13.41 ± 1.67) × 10(4)/ml, P < 0.05). In addition, levels of IL-4 ((36.91 ± 7.87) pg/ml vs. (43.70 ± 6.42) pg/ml, P > 0.05) and IL-5 ((41.97 ± 7.93) pg/ml vs. (60.14 ± 8.35) pg/ml, P < 0.05) in BAL fluid and serum sIgE ((0.42 ± 0.05) vs. (0.75 ± 0.06) OD units, P < 0.05) were profoundly reduced. However, the IL-10 level in BAL fluid was significantly increased ((67.74 ± 6.57) pg/ml vs. (44.62 ± 8.81) pg/ml, P < 0.05).</p><p><b>CONCLUSIONS</b>These results indicated that 1,25(OH)(2)D(3) pretreatment enhanced the inhibitory effects of immunotherapy on allergic airway inflammation. In the treatment of allergic diseases, 1,25(OH)(2)D(3) pretreatment may be beneficial for improving the efficacy of immunotherapy.</p>

Guiding principles of clinical research on mild cognitive impairment (protocol) / 中西医结合学报

Mild cognitive impairment (MCI), as a nosological entity referring to elderly people with MCI but without dementia, was proposed as a warning signal of dementia occurrence and a novel therapeutic target. MCI clinical criteria and diagnostic procedure from the MCI Working Group of the European Alzheimer's Disease Consortium (EADC) may better reflect the heterogeneity of MCI syndrome. Beijing United Study Group on MCI funded by the Capital Foundation of Medical Developments (CFMD) proposed the guiding principles of clinical research on MCI. The diagnostic methods include clinical, neuropsychological, functional, neuroimaging and genetic measures. The diagnostic procedure includes three stages. Firstly, MCI syndrome must be defined, which should correspond to: (1) cognitive complaints coming from the patients or their families; (2) reporting of a relative decline in cognitive functioning during the past year by the patient or informant; (3) cognitive disorders evidenced by clinical evaluation; (4) activities of daily living preserved and complex instrumental functions either intact or minimally impaired; and (5) absence of dementia. Secondly, subtypes of MCI have to be recognized as amnestic MCI (aMCI), single non-memory MCI (snmMCI) and multiple-domains MCI (mdMCI). Finally, the subtype causes could be identified commonly as Alzheimer disease (AD), vascular dementia (VaD), and other degenerative diseases such as frontal-temporal dementia (FTD), Lewy body disease (LBD), semantic dementia (SM), as well as trauma, infection, toxicity and nutrition deficiency. The recommended special tests include serum vitamin B12 and folic acid, plasma insulin, insulin-degrading enzyme, Abeta40, Abeta42, inflammatory factors. Computed tomography (or preferentially magnetic resonance imaging, when available) is mandatory. As measurable therapeutic outcomes, the primary outcome should be the probability of progression to dementia, the secondary outcomes should be cognition and function, and the supplement outcome should be the syndrome defined by traditional Chinese medicine. And for APOE epsilon4 carrier, influence of the carrier status on progression rate to dementia and the effect of treatment should be evaluated.