Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male ; Female ; Humans ; Aged ; Natriuretic Peptide, Brain ; Simendan/therapeutic use* ; Non-ST Elevated Myocardial Infarction ; Heart Failure/drug therapy* ; Peptide Fragments ; Arrhythmias, Cardiac ; Biomarkers ; Prognosis

Objective:To evaluate the residual risk (RR) of transfusion transmitted HIV (TT-HIV) after the implementation of nucleic acid amplification test (NAT) in blood screening test among blood centers in China.Methods:The data of blood donors and HIV infection markers from 2017 to 2020 were collected from 28 blood centers via the Platform of Comparison of blood establishments Practice in Chinese Mainland. The new infection rate/window period mathematical model was used for two types of blood screening strategies, namely, two rounds ELISA plus individual NAT take turn with pooling NAT (2ELISA+ ID-NAT/MP-NAT) and two ELISA plus one round pooling NAT (2ELISA+ MP-NAT), and the RR of HIV infection was estimated also based on first donors (FDs) and repeated donors (RDs) in different blood donation years. T-test analyses were conducted for comparing TT HIV RR among FDs and RDs in different blood donation years with two blood screening strategies, and the variation trend of RR in HIV test was observed.Results:From 2017 to 2020, the RR of FDs in 2ELISA+ ID-NAT/MP-NAT blood screening strategy was 2.869/10 6 person-year, 3.795/10 6 persons-year, 3.879/10 6 person-year, and 2.890/10 6 person-year respectively. The RR of RDs was 1.797/10 6 person-year, 1.502/10 6 person-year, 1.857/10 6 person-year, and 1.483/10 6 person-year respectively. Significant difference exists between RR of FDs and RDs, with F=9.898 and p<0.05. In 2ELISA+ MP-NAT strategy, the RR of FDs was 3.508/10 6 person-year, 1.868/10 6 person-year, 2.204/10 6 person-year, and 1.765/10 6 person-year respectively. The RR of RDs was 0.948/10 6 person-year, 0.926/10 6 person-year, 0.748/10 6 person-year, and 0.682/10 6 person-year respectively. Statistical difference existed between RR of FDs and RDs, with F=17.126 and P<0.05. There was no significant difference between the RR of FDs in these two strategies with F=3.493 and P>0.05, while there was a difference between the RR of RDs in these two strategies with F=24.516 and P<0.05, and a difference between the RR of total donors (TDs) in these two strategies F=20.216 and P<0.05. Conclusions:The RR of TT HIV significantly decreased after the introduction of NAT into blood test among blood centers in China. There were some differences in the RR of HIV testing among different blood screening strategies. There could be significant differences in the RR of HIV testing among different groups of blood donors. Compared with FDs, RDs is the low risk group for HIV.

Objective: To select the preferred flaps for the reconstruction of different maxillary defects and to propose a new classification of maxillary defects. Methods: A total of 219 patients (136 males and 83 females) underwent the simultaneous reconstruction of maxillary defects in the Beijing Tongren Hospital, Capital Medical University, between January 2005 and December 2018 were reviewed. Age ranged from 16 to 78 years. Based on the proposed new classification of the maxillary defects, 22 patients with class Ⅰ defects (inferior maxillectomy), 44 patients with class Ⅱ defects (supperior maxillectomy), 132 patients with class Ⅲ defects (total maxillectomy) and 21 patients with class Ⅳ defects (extensive maxillectomy) were enrolled. Survival rate, functional and aesthetic outcomes of flaps were evaluated. Survival analysis was performed in 169 patients with malignant tumor, Kaplan-Meier method was used to calculate the survival rate, and Log-rank method was used to compare the difference of survival rate in each group. Results: A total of 234 repairs for maxillary defects were performed in 219 patients. Fibula flaps were used in 4/13 of class Ⅰ defects; temporal muscle flaps (11/24, 45.8%) and anterolateral thigh flaps (6/24, 25.0%) used in class Ⅱ defects; temporal muscle flaps (71/128, 55.5%), anterolateral thigh flaps (6/24, 25.0%) and fibula flaps (12/128, 9.4%) used in class Ⅲ defects; and anterolateral thigh flaps (8/20, 40.0%) and rectus abdominis flaps (8/20, 40.0%) used in class Ⅳ defects. The success rate of local pedicled flaps was 95.6% (109/114) and that of free flaps was 95.8% (115/120). Thrombosis(10/234,4.3%) was a main reason for repair failure. Among the followed-up 88 patients, swallowing and speech functions recovered, 82 (93.2%) of them were satisfied with appearance, and 75 (85.2%) were satisfied with visual field. The 3-year and 5-year overall survival rates were 66.5% and 63.6%, and the 3-year and 5-year disease-free survival rates were 57.1% and 46.2%, respectively, in the 169 patients with malignant tumors. Conclusion: A new classification of maxillary defects is proposed, on which suitable flaps are selected to offer patients good functional and aesthetic outcomes and high quality of life.
Adolescent ; Adult ; Aged ; Female ; Free Tissue Flaps ; Humans ; Male ; Maxilla/surgery* ; Middle Aged ; Quality of Life ; Reconstructive Surgical Procedures ; Young Adult

Objective: To investigate the treatment outcomes and risk factors of postoperative recurrence in T4a papillary thyroid carcinoma (PTC). Methods: A total of 185 patients with locally advanced T4a PTC treated in Beijing Tongren Hospital, Capital Medical University from January 2006 to December 2019 were retrospectively analyzed, including 127 females and 58 males, aged between 18 and 80 years, with 74 patients aged over 55 years. According to AJCC thyroid tumor staging, 111 cases were stage I (T4aN0M0 26 cases, T4aN1aM0 35 cases, and T4aN1bM0 50 cases) and 74 cases were stage Ⅲ (T4aN0M0 29 cases, T4aN1aM0 19 cases, and T4aN1bM0 26 cases). Kaplan-Meier method was used to calculate the overall survival and the recurrence-free rate, and univariate and multivariate logistic regression analyses on the clinical data were performed. Results: Recurrent laryngeal nerve invasion was observed in 150 cases, trachea invasion in 61 cases, esophagus invasion in 30 cases, and laryngeal structure invasion in 10 cases. Postoperative follow-up periods were 24-144 months, with an average of 68.29 months. Of the 185 patients, 18 (9.73%) had recurrences or metastases, including 9 cases (4.86%) died of recurrences or metastases. The 5-year and 10-year overall survival rates were respectively 95.21% and 93.10%. The 5-year and 10-year disease-free survival rates were respectively 89.65% and 86.85%. Univariate analysis showed that age of onset, tumor diameter, preoperative recurrent laryngeal nerve palsy, esophageal invasion and cervical lymph node metastasis were the risk factors for postoperative recurrence of T4a PTC(all P<0.05). Multivariate analysis showed that preoperative recurrent laryngeal nerve palsy (OR=3.27, 95%CI: 1.11-9.61, P=0.032) and lateral cervical lymph node metastasis (OR=4.71, 95%CI: 1.19-18.71, P=0.027) were independent risk factors for T4a PTC recurrence. Survival rate of patients with T4a PTC involving only the recurrent laryngeal nerve or the outer tracheal membrane was significantly better than that of patients with tracheal invasion (P<0.05). Conclusions: T4a PTC patients with R0 resection can still achieve good efficacy. Preoperative recurrent laryngeal nerve palsy and lateral cervical lymph node metastasis are independent risk factor for postoperative recurrence in the patients.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Carcinoma/pathology* ; Carcinoma, Papillary/surgery* ; Female ; Humans ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local/surgery* ; Retrospective Studies ; Risk Factors ; Survival Analysis ; Thyroid Cancer, Papillary/surgery* ; Thyroid Neoplasms/pathology* ; Thyroidectomy/adverse effects* ; Vocal Cord Paralysis/etiology* ; Young Adult

OBJECTIVES: To study the value of functional echocardiographic parameters in predicting refractory septic shock in neonates. METHODS: A total of 72 neonates with septic shock were enrolled. According to the highest value of septic shock score, they were divided into two groups: refractory (n=30) and non-refractory (n=42). The two groups were compared in terms of clinical data, laboratory findings, and functional echocardiographic parameters. The receiver operating characteristic (ROC) curve was used to evaluate the performance of functional echocardiographic parameters in predicting refractory septic shock. RESULTS: Compared with the non-refractory group, the refractory group had significantly lower cardiac output and cardiac index (CI) and a significantly higher mean arterial pressure (MAP)/CI ratio (P<0.05). CI had a cut-off value of 2.6 L/(min·m²), a sensitivity of 79%, a specificity of 83%, and an area under the ROC curve (AUC) of 0.841 in predicting septic shock-related death (P<0.05), and MAP/CI ratio had a cut-off value of 11.4, a sensitivity of 83%, a specificity of 73%, and an AUC of 0.769 (P<0.05). CI had a cut-off value of 2.9 L/(min·m²), a sensitivity of 69%, a specificity of 69%, and an AUC of 0.717 in predicting all-cause death within 28 days (P<0.05). CONCLUSIONS CI and MAP/CI ratio can be useful for early prediction of septic shock-related death in neonates.
Infant, Newborn ; Humans ; Shock, Septic/diagnostic imaging* ; Echocardiography ; ROC Curve

Objective: To investigate the characteristics of thyroid invasion and central lymph node metastasis of hypopharyngeal carcinoma, and the impact on survival rate and quality of life. Methods: A retrospective analysis of 124 cases (122 males and 2 females with age range from 36 to 78 years old) with laryngopharyngeal squamous cell carcinoma who were initially treated in the Department of Head and Neck Surgery, Beijing Tongren Hospital Affiliated to Capital Medical University from January 2014 to December 2017 was performed. The clinical data included tumor location, pathological T stage, pathological N stage, invasion of thyroid gland, central lymph node metastasis, surgical procedures and so on. Patients were grouped according to if presence of thyroid invasion and central lymph node metastasis. With follow-up, the survival was analyzed by Kaplan-Meier method, and tumor recurrence and metastasis were evaluated. Results: Of the patients, 12 patients had thyroid involvement and 5 patients had central lymph node metastasis. The incidence of thyroid involvement was 8.16% (8/98) in pyriform sinus, 1/18 in posterior pharyngeal wall and 3/8 in posterior cricoid wall, with statistically significant difference (χ²=15.076,P=0.008). The incidence of central lymph node metastasis was 1.02% (1/98) in pyriform sinus, 3/18 in posterior pharyngeal wall and 1/8 in posterior cricoid wall, also with statistically significant difference (χ²=11.205, P=0.008). There was no statistical correlation between thyroid invasion or central lymph node metastasis and gender, smoking or alcohol exposure history and tumor pathological differentiation (all P>0.05). The 3-year overall survival rate was 80.65% and the 3-year recurrence free rate was 85.48%. Totally 24 patients died in 3 years, including 4 cases in thyroid invasion group and 1 case in central lymph node metastasis group. Local recurrence occurred in 18 patients, including 4 cases in thyroid invasion group and 1 case in central lymph node metastasis group. There was no significant difference in survival between patients with and without thyroid invasion and central lymph node metastasis (all P>0.05). There were significantly difference in 3-year overall survival and relapse-free survival among the groups with different T stages, N stages, pathological stages and tumor pathological differentiation levels (all P<0.05). There were significantly differences in the levels of serum calcium and FT3 between the groups with or without thyroid invasion and central lymph node metastasis (all P<0.05). Conclusion: The incidences of thyroid invasion and central lymph node metastasis of hypopharyngeal carcinoma are rare, and the risk of occurrence is related to the primary site of tumor. Comprehensive evaluation, correct decision-making and accurate treatment could be helpful to cure radically the tumor, to prevent recurrence and to improve the quality of life of patients.
Adult ; Aged ; Carcinoma, Squamous Cell/surgery* ; Female ; Head and Neck Neoplasms ; Humans ; Lymph Nodes ; Lymphatic Metastasis ; Male ; Middle Aged ; Neck Dissection ; Neoplasm Recurrence, Local ; Quality of Life ; Retrospective Studies ; Thyroid Gland ; Thyroid Neoplasms/surgery*

Objective: To compare the clinical application results of the FPTF (free posterior tibial artery perforator flap) and RFFF (radial forearm free flap) for reconstruction of head and neck defects. Methods: A retrospective analysis of 27 cases treated with FPTF (19 males and 8 females, aged 14-69 years) and 24 cases with RFFF (11 males and 13 females, aged 22-69 years) for head and neck defect reconstruction at Beijing Tongren Hospital of Capital Medical University from January 2015 to December 2020 was conducted. Flap size, vascular pedicle length, matching degree of recipient area blood vessels, preparation time, total operation time, hospital stay, recipient area complications, donor area complications and scale-based patient satisfaction were compared between two groups of patients with FTPF and RFFF. SPSS 26.0 statistical software was used for statistical analysis. Results: There was no statistically significant difference between the two groups of patients in tumor T staging (P=0.38), primary sites (P=0.05) and mean flap areas ((53.67±29.84) cm² vs. (41.13±11.08) cm², t=-1.472, P=0.14). However the mean vascular pedicle length of FPTF was more than that of RFFF ((11.15±2.48)cm vs. (8.50±1.69)cm, t=-4.071, P<0.01). The donor sites of 4 patients in FPTF group could be sutured directly, while all the 24 patients in RFFF group received skin grafts from the donor sites. There was no statistically significant difference in the recipient area arteries between two groups of flaps (P=0.10), with more commonly using of the facial artery (RFFF: FPTF=21∶27), but there was significant difference in the recipient area veins (P<0.01), with more commonly using of the external jugular vein in RFFF (14/24) than FPTF (4/32) and the posterior facial vein in FPTF (27/32) than RFFF (9/24). There were 10 recipient complications and 3 donor complications in RFFF group; no recipient complication and 3 donor complications occurred in FPTF group. With patient's subjective evaluation of the donor site at 12 months after surgery, FPTF was better than RFFF (χ²=22.241, P<0.01). Conclusions: FPTF is an alternative to RFFF in head and neck reconstruction and has unique advantages in aesthetics and clinical application.
Female ; Forearm/surgery* ; Free Tissue Flaps ; Humans ; Male ; Perforator Flap ; Reconstructive Surgical Procedures ; Retrospective Studies ; Skin Transplantation ; Tibial Arteries/surgery*

Wolfberry has important unique medical values as well as edible and commerce values. In this paper,we analyze the characteristics and problems of international trade of wolfberry based on the customs data between 2008 and 2017. During periods of these ten years,the wolfberry was mainly exported with a small proportions of imports. The total export volume increased steadily,reached 82 182. 08 tons and 696. 622 million dollars respectively. Wolfberry came from 31 provinces/autonomous regions and exported to 105 countries and regions through 21 ports. Most of the total exports of wolfberry flew to markets of Asia and Europe,the Ningxia autonomous region was the major export province. Large amount of wolfberry exported through Tianjin port. Compared with the export volume,the import is almost negligible,mainly coming from North Korea,almost all through Changchun port,Jilin province to enter the domestic market. There is a situation of"import of domestic goods". To enhance the international competitiveness of wolf berry industry,we must rely on the fundamental research of wolfberry,speed up the standardization process,strengthen the scientific and technological innovation in wolfberry products,improve the added value and profit of wolfberry.
Asia ; China ; Commerce ; Europe ; Lycium

Pulmonary infections are the most common complications in immunocompromised host (ICH).The immune system of ICH was in inhibitory condition because of long-term use of immunosuppressive agents,such as glucocorticoids,antimetabolite medicine and alkylating agents.Therefore,compared with the immunocompetent host,the condition is more critically serious in ICH with more difficult diagnosis and treatment,and higher motality after pulmonary infections.Early identification of pathogens and early treatment are helpful for improving the prognosis and decreasing mortality.