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

Objective: To investigate the efficacy and safety of liver venous deprivation (LVD) before secondary resection of primary liver cancer. Methods: 56 patients with advanced primary liver cancer who were not suitable for primary resection in Liver Surgery Department of Xinxiang Central Hospital from January 2018 to January 2019 were analyzed retrospectively. They were divided into liver vein deprivation group (LVD group: LVD+ PVE, n=26) and portal vein embolization group (PVE group, n=30). The dynamic changes of liver reserve function and future liver remnant volume (FLR-V), R0 resection rate, surgical complications, postoperative recurrence rate and overall survival rate of two groups before and after LVD/PVE were compared. Results: The success rate of puncture and embolization in LVD group and PVE group was 100%. There were no grade Ⅳ complications, and there was no significant difference of grades Ⅰ, Ⅱ and Ⅲ complications between the groups (P=0.808). The FLR-V of LVD group before embolization, 7, 14 and 21 days after embolization was (493.1±25.8), (673.2±56.1), (779.5±81.6) and (853.3±85.2) cm(3), respectively. The FLR-V of PVE group before embolization, 7, 14 and 21 days after embolization were (502.4±20.1), (688.6±43.9), (656.8±73.7) and (563.5±69.1) cm(3), respectively. There was no significant difference in FLR-V between the two groups before and 7 days after embolization (P>0.05). The FLR-V of LVD group was higher than that of PVE group at 14 and 21 days after embolization (P<0.01). The preparation time of LVD group was (20.4±6.3) days, which was shorter than that of PVE group [(31.5±8.8) days, P=0.045]. The rate of secondary hepatectomy was 92.3% (24/26), which was higher than that of PVE group [70.0% (21/30), P=0.036]. The R0 resection rate was 87.5% (21/24), which was higher than that of the PVE group [57.1% (12/21), P=0.022]. However, there were no significant differences in surgical methods, operation time, intraoperative blood loss, Clavien-Dindo complication grade and length of hospital stay between the two groups (P>0.05). After hepatectomy, the median recurrence time and median survival time of LVD group were 12.6 months and 21.3 months, respectively, which were longer than those of PVE group (9.4 months and 13.5 months, respectively, P<0.01). Conclusions: For patients with advanced liver cancer who are not suitable for primary hepatectomy, preoperative LVD can significantly increase FLR-V, improve the resection rate of secondary surgery, shorten the preparation time of two operations, and do not increase surgical complications. Moreover, patients with LVD can improve the R0 resection rate of secondary surgery. The postoperative recurrence time and overall survival rate of patients with LVD are better than those of patients with PVE, and LVD has a good long-term effect.
Humans ; Portal Vein ; Retrospective Studies ; Hepatectomy/methods* ; Liver/surgery* ; Liver Neoplasms/surgery* ; Embolization, Therapeutic/methods* ; Treatment Outcome

Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ²=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent ; Brain Abscess ; Child ; Child, Preschool ; Escherichia coli ; Female ; Humans ; Hydrocephalus ; Infant ; Infant, Newborn ; Male ; Meningitis, Bacterial/epidemiology* ; Retrospective Studies ; Streptococcus agalactiae ; Streptococcus pneumoniae ; Subdural Effusion ; beta-Lactamases

Objective: To understand the relationship between female breast cancer and occupational risk factors in Beijing, and provide scientific basis for the formulation of prevention strategies and measures. Methods: From June to December 2019, A 1: 1 case-control study was adopted, eight medical institutions in Beijing were selected as the research objects. Patients with breast cancer diagnosed by medical institutions were selected as case group and non breast cancer patients in the same medical institution as control group. A total of 973 subjects were included, including 495 in the case group and 478 in the control group. A one-to-one survey was conducted using a questionnaire uniformly compiled by the Beijing Centers for Disease Control and Prevention. The survey content mainly includes basic demographic characteristics and occupational risk factors. The Trait Coping Style Questionnaire (TCSQ) was used to investigate the corresponding methods, including two aspects: positive coping and negative coping. First, chi square test or Wilcoxon rank sum test were used for univariate analysis. Then Lasso regression was used to screen the risk factors of breast cancer. Finally, the risk factors were screened by multivariate logistic regression analysis. Results: Education lovel was 49.64%, body mass index (BMI) was 18.4~23.9 kg/m(2), accounting for 48.82%, marital status ws 84.48%. Compared with no night shift history, there was a significant increase in risk of breast cancer at night shift history (OR=1.70, 95% CI: 1.25~2.30, P<0.05) . Compared with most of the sitting posture and sometimes standing, the risk of breast cancer was increased, and the difference was statistically significant (OR=2.01, 95%CI: 1.40~2.90, P<0.05) . Conclusion: In the occupation risk factors, night shift work and working posture are related to the incidence of breast cancer in women, establishing a good schedule and avoiding long standing can effectively prevent and reduce the occurrence of breast cancer.
Beijing ; Breast Neoplasms/epidemiology* ; Case-Control Studies ; Female ; Humans ; Logistic Models ; Risk Factors

OBJECTIVE: To explore the clinical efficacy of reconstruction the anterior talofibular ligament and calcaneofibular ligament with autologous peroneus brevis tendon for the treatment of chronic lateral ankle instability. METHODS: The clinical data of 42 patients with chronic lateral ankle instability treated by anatomical reconstruction of anterior talofibular ligament and calcaneofibular ligament with autologous peroneus brevis tendon from July 2016 to July 2019 was retrospectively analyzed. Including 30 males and 12 females, age ranged from 25 to 46 years old with an average of (37.6±12.4) years. There were 15 cases of left foot and 27 cases of right foot, the time from injury to operation was 3 to 12 months with a mean of (7.4±2.8) months. And 14 patients had tenderness in lateral collateral ligament area, 28 patients complained of multiple ankle sprains while walking on the flat ground. At 12 months after operation, the talar tilt angle and visual analogue scale(VAS)were observed, ankle joint varus stress and anterior drawer test were performed to check the mechanical stability of the ankle joint, American Orhopaedic Foot and Ankle Society(AOFAS) was used to score the ankle and hindfoot functions and evaluate the curative effect. RESULTS: Forty patients were followed up for 12 to 48 months with an average of (28.3±10.0) months, 2 cases were lost. The VAS decreased from(4.50±0.93) scores before surgery to (1.10±0.30) scores at 12 months after surgery;the talar tilt angle was reduced from (12.26±1.13)° before operation to (4.60±0.45)° at 12 months after operation;the AOFAS score increased from (65.10±7.50)scores before surgery to (84.40±3.95) scores at 12 months after surgery;all the differences were statically significant(P<0.05). According to the AOFAS score, 27 cases got excellent results, 7 good, 5 fair, and 1 poor. One patient had the symptoms of sural nerve injury after operation, and the symptoms were relieved after oral Mecobalamin for 3 months. The remaining patients had no complications such as nerve injury, infection, and skin necrosis. There was no instability of ankle joint, and both ankle varus stress test and drawer test were negative. CONCLUSION Autologous peroneal brevis tendon with double bone channel pass through the tendon (modified Chrisman-Snook operation) can anatomically reconstruct the anterior talofibular ligament and the calcaneofibular ligament, restore the stability of the patient's ankle joint, reduce postoperative complications, and restore ankle joint function well.
Adult ; Ankle ; Ankle Joint/surgery* ; Female ; Humans ; Joint Instability/surgery* ; Lateral Ligament, Ankle/surgery* ; Male ; Middle Aged ; Retrospective Studies ; Tendons

Objective: To investigate the impact of different levels of systolic blood pressure on all-cause, cardiovascular and cerebrovascular mortality in patients with nonvalvular atrial fibrillation (AF). Methods: This is a prospective cohort study. Patients with AF or atrial flutter diagnosed by 12 lead electrocardiogram during physical examination of Kailuan Group employees from July 2006 to December 2017 or previously diagnosed with AF in an inpatient setting at a level 2A hospital or above were eligible for the study. Baseline clinical characteristics including age, gender, systolic blood pressure were collected. According to the level of systolic blood pressure, patients were divided into systolic blood pressure<120 mmHg (1 mmHg=0.133 kPa)group, 120 mmHg ≤ systolic blood pressure<140 mmHg group, and systolic blood pressure ≥140 mmHg group. The time of first diagnosis with AF was defined as the start of follow-up and the final follow-up ended at December 2018. Primary endpoint was all-cause death. Related information was obtained through the social security system or inpatient medical records. The cause of death was defined according to the International Classification of Diseases disease (ICD-10) codes by professional medical stuffs. Multifactorial Cox proportional risk model was used to analyze the relative risk ratios for the occurrence of death in different systolic blood pressure level groups. The relationship between systolic blood pressure levels and mortality in the patients with AF was analyzed by using natural spline function curves. Results: A total of 1 721 patients with AF were enrolled (average age=(67.0±9.0) years), patients were followed up for (6.3±3.8) years. 544 out of 1 721 patients with AF died during the follow-up period (31.61%). The cumulative incidence rate of all-cause mortality, cardiovascular and cerebrovascular death was 26.13%, 25.59%, 36.96% and 14.86%, 11.87%, 19.76% respectively in the systolic blood pressure<120 mmHg, 120 mmHg ≤ systolic blood pressure<140 mmHg and systolic blood pressure ≥140 mmHg groups. The cumulative incidence rate of all-cause, cardiovascular and cerebrovascular death was significantly higher in the group with systolic blood pressure ≥140 mmHg than in 120 mmHg ≤ systolic blood pressure<140 mmHg group (P<0.05). Compared with 120 mmHg ≤ systolic blood pressure<140 mmHg group, multivariable Cox proportional hazards regression models showed that the HRs (95%CI) for all-cause, cardiovascular and cerebrovascular death were 1.47 (1.20 to 1.79) and 1.69 (1.27 to 2.26) for the group with systolic blood pressure ≥ 140 mmHg (P<0.05). In contrast, the HRs (95%CI) for all-cause, cardiovascular and cerebrovascular death in the systolic blood pressure<120 mmHg group were 0.99 (0.73-1.35) and 1.24 (0.82-1.89), respectively, with no statistically significant differences between the two groups (P>0.05). The natural spline curve showed that there was a "U" relationship between systolic blood pressure levels and all cause death and cardiovascular and cerebrovascular death in this patient cohort. Systolic blood pressure greater than or less than 123 mmHg was associated with increased risk of death of AF patients in this cohort. Conclusion: Compared with systolic blood pressure<120 mmHg and systolic blood pressure≥140 mmHg group, the risk of all-cause and cardiovascular and cerebrovascular death is the lowest in AF patients with 120 mmHg ≤ systolic blood pressure<140 mmHg in this cohort.

OBJECTIVE: To evaluate the effect of Danhong Injection (, DH) on the index of microcirculatory resistance (IMR) and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention (PCI). METHODS: Seventy-eight patients with unstable angina were randomly divided into DH group (39 cases) and the control group (39 cases) during elective PCI. Randomization was performed using a random-number table. The DH group received DH at a dosage of 40 mL (mixed with 250 mL saline, covered by a light-proof bag, intravenous drip) during PCI and daily for 7 consecutive days, while the control group only received the same dosage of saline. Both groups received standardized treatment. The IMR and fractional flow reserve (FFR) were measured at maximal hyperemia before and after PCI. Myocardial markers, including myoglobin, creatine kinase (CK), creatine kinase MB (CK-MB), and coronary troponin T (cTnT) values were measured at baseline and 24 h after PCI. RESULTS: Among the 78 patients enrolled, the baseline and procedural characteristics were similar between the two groups. There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups. However, post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group (111.97 ± 80.97 vs. 165.47 ± 102.99, P=0.013; 13.08 ± 6.90 vs. 19.75 ± 15.49, P=0.016). Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance (88.07 ± 52.36 vs. 108.13 ± 90.94, P=0.52; 2.56% vs.7.69%, P=0.065). Compared with the control group, the post-IMR levels of the DH group tended to decrease, but there was no statistical difference (20.73 ± 13.15 vs. 26.37 ± 12.31, P=0.05). There were no statistical differences in post-FFR in both groups. The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group (2.56% vs. 15.38%, P=0.025). During the 30-d follow-up period, no major adverse cardiovascular events occurred in either group. CONCLUSION This study demonstrated benefit of DH in reducing myocardial injury and potential preserving microvascular function in patients with unstable angina undergoing elective PCI.
Angina, Unstable/drug therapy* ; Drugs, Chinese Herbal ; Fractional Flow Reserve, Myocardial ; Humans ; Microcirculation ; Percutaneous Coronary Intervention ; Pilot Projects ; Treatment Outcome

BACKGROUND: Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease. OBJECTIVE: This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m MAIN OUTCOME MEASURES: The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment. RESULTS: A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group. CONCLUSION: SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone. TRIAL REGISTRATION NUMBER NCT02063100 on ClinicalTrials.gov.

OBJECTIVE: To study the clinical features of coronavirus disease 2019 (COVID-19) in children aged <18 years. METHODS: A retrospective analysis was performed from the medical data of 23 children, aged from 3 months to 17 years and 8 months, who were diagnosed with COVID-19 in Jiangxi, China from January 21 to February 29, 2020. RESULTS: Of the 23 children with COVID-19, 17 had family aggregation. Three children (13%) had asymptomatic infection, 6 (26%) had mild type, and 14 (61%) had common type. Among these 23 children, 16 (70%) had fever, 11 (48%) had cough, 8 (35%) had fever and cough, and 8 (35%) had wet rales in the lungs. The period from disease onset or the first nucleic acid-positive detection of SARS-CoV-2 to the virus nucleic acid negative conversion was 6-24 days (median 12 days). Of the 23 children, 3 had a reduction in total leukocyte count, 2 had a reduction in lymphocytes, 2 had an increase in C-reactive protein, and 2 had an increase in D-dimer. Abnormal pulmonary CT findings were observed in 12 children, among whom 9 had patchy ground-glass opacities in both lungs. All 23 children received antiviral therapy and were recovered. CONCLUSIONS COVID-19 in children aged <18 years often occurs with family aggregation, with no specific clinical manifestation and laboratory examination results. Most of these children have mild symptoms and a good prognosis. Epidemiological history is of particular importance in the diagnosis of COVID-19 in children aged <18 years.
Adolescent ; Betacoronavirus ; Child ; Child, Preschool ; China ; Coronavirus Infections ; Humans ; Infant ; Pandemics ; Pneumonia, Viral ; Retrospective Studies

Objective: To evaluate the outcomes of myelodysplastic syndromes (MDS) patients who received HLA-matched sibling donor allogeneic peripheral blood stem cell transplantation (MSD-PBSCT) . Methods: The clinical data of 138 MDS patients received MSD-PBSCT from Sep. 2005 to Dec. 2017 were retrospectively analyzed, and the overall survival (OS) rate, disease-free survival (DFS) rate, relapse rate (RR) , non-relapse mortality (NRM) rate and the related risk factors were explored. Results: ①After a median follow-up of 1 050 (range 4 to 4 988) days, the 3-year OS and DFS rates were (66.6±4.1) % and (63.3±4.1) %, respectively. The 3-year cumulative incidence of RR and NRM rates were (13.9±0.1) % and (22.2±0.1) %, respectively. ②Univariate analysis showed that patients with grade Ⅲ-Ⅳ acute graft-versus-host disease (aGVHD) or hematopoietic cell transplantation comorbidity index (HCT-CI) ≥2 points or patients in very high-risk group of the Revised International Prognostic Scoring System (IPSS-R) had significantly decreased OS[ (42.9±13.2) %vs (72.9±4.2) %, χ(2)=8.620, P=0.003; (53.3±7.6) %vs (72.6±4.7) %, χ(2)=6.681, P=0.010; (53.8±6.8) %vs (76.6±6.2) %vs (73.3±7.7) %, χ(2)=6.337, P=0.042]. For MDS patients with excess blasts-2 (MDS-EB2) and acute myeloid leukemia patients derived from MDS (MDS-AML) , pre-transplant chemotherapy or hypomethylating agents (HMA) therapy could not improve the OS rate[ (60.4±7.8) %vs (59.2±9.6) %, χ(2)=0.042, P=0.838]. ③Multivariate analysis indicated that the HCT-CI was an independent risk factor for OS and DFS (P=0.012, HR=2.108, 95%CI 1.174-3.785; P=0.008, HR=2.128, 95%CI 1.219-3.712) . Conclusions: HCT-CI was better than the IPSS-R in predicting the outcomes after transplantation. The occurrence of grade Ⅲ-Ⅳ aGVHD is a poor prognostic factor for OS. For patients of MDS-EB2 and MDS-AML, immediate transplantation was recommended instead of receiving pre-transplant chemotherapy or HMA therapy.
Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Leukemia, Myeloid, Acute ; Myelodysplastic Syndromes ; Retrospective Studies ; Siblings ; Transplantation Conditioning ; Transplantation, Homologous