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Objective: To analyze the trend of epidemiological characteristics and spatiotemporal distribution of pulmonary tuberculosis (PTB) among smear-positive or other types of students in Guizhou Province from 2011 to 2020, and to provide a reference for improving prevention and control measures. Methods: Data were collected from the Chinese Information System's Notifiable Disease and Tuberculosis Management Information System for disease control and prevention, the Joinpoint 4.9.1.0 software was used to analyze the trend of registration rate; the ArcGIS 10.6 software was used to construct a ring map and to perform spatial autocorrelation analysis; the SaTScan 9.7 software was used for spatial-temporal scan statistics. Results: A total of 32 682 student PTB cases were reported in Guizhou Province from 2011 to 2020, including 5 949 (18.20%) smear-positive cases. Most cases occurred from high school students of 16 to 18 years old (43.99%, 14 376/32 682); the annual average registered rate was 36.22/100 000, the highest in 2018 (52.90/100 000), and the registration rate showed an increasing trend. Meanwhile, a similar trend of registration rate was observed among smear-positive or other types of students. The spatialtemporal heterogeneity was found that the "high-high" clustering patterns of smear-positive or other types were aggregated in Bijie City. Six spatialtemporal clusters with statistically significant (all P<0.001) were detected among smear-positive or other cases, respectively. Conclusions: Upward trend with spatial- temporal clusters of PTB cases reported in students from Guizhou Province from 2011 to 2020. Surveillance should be strengthened for high school students, and regular screening should be conducted in high-risk areas to control the source of infection and reduce the risk of transmission.
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Humans , Adolescent , Tuberculosis, Pulmonary/epidemiology , Asian People , Cluster Analysis , Software , StudentsABSTRACT
We prepared 15 batches of Kaixin Powder benchmark samples with the decoction pieces of different batches. Further, we established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples and analyzed the peaks and similarity of the chromatograms. With sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid as index components, the index component content determination method was established and 70%-130% of the mean content of each component was set as the range. The chromatograms of 15 batches of Kaixin Powder benchmark samples had a total of 22 characteristic peaks, among which 8 peaks were identified, which represented sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid, respectively. The chromatograms shared the similarity of 0.992-0.999. The 15 batches of benchmark samples had sibiricose A5 of 0.34-0.55 mg·g~(-1), sibiricose A6 of 0.43-0.57 mg·g~(-1), polygalaxanthone Ⅲ of 0.12-0.19 mg·g~(-1), 3,6'-disinapoyl sucrose of 1.08-1.78 mg·g~(-1), ginsenoside Rb_1 of 0.33-0.62 mg·g~(-1), β-asarone of 2.34-3.72 mg·g~(-1), α-asarone of 0.11-0.22 mg·g~(-1), and dehydropachymic acid of 0.053-0.079 mg·g~(-1). This study established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples, and the method was simple, feasible, reproducible, and stable. This study provides a scientific basis for further research on the key chemical properties of the benchmark samples and preparations of Kaixin Powder.
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Powders , Ginsenosides , Benchmarking , Drugs, Chinese Herbal/chemistry , Sucrose , Chromatography, High Pressure Liquid/methodsABSTRACT
The main clinical phenotypes, imaging features and genetic test results of a child with Joubert syndrome treated in Shenzhen Children′s Hospital in July 2020 were analyzed retrospectively, and the literature on Joubert syndrome was summarized.The main manifestations of the protester during infancy were respiratory abnormalities and developmental retardation.The brain magnetic resonance imaging (MRI) showed a " molar sign" , which was consistent with the diagnosis of Joubert syndrome.Genetic testing suggested that the protestor carried complex heterozygous variations of KIAA0586 gene.Two variants were not reported previously, one of which was synonymous mutation.The child is the first case of Joubert syndrome caused by KIAA0586 gene in China.Joubert syndrome is a rare congenital brain development malformation characterized by high clinical heterogeneity and MRI molar signs.It may involve multiple systems.Early identification and intervention can improve outcomes.
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To analyze the clinical characteristics, treatment and prognosis of mediastinal germ cell tumors (GCTs) with concurrent hematologic malignancy (HM). The clinical features, treatment and prognosis of 3 cases of HM associated with mediastinal GCTs treated in the Department of Medical Oncology, Beijing Children′s Hospital from November 2014 to September 2018 were retrospectively analyzed.Meanwhile, relevant cases were searched in the PubMed and Wanfang database from their establishment to December 2019.Three male cases of HM associated with mediastinal GCTs aged from 12 to 16 years.The pathogenesis of mediastinal masses suggested teratoma or yolk sac tumor.All of them were treated with surgery and chemotherapy.Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) was diagnosed respectively at 5 months, 9 months and 31 months after initial GCTs in the 3 cases.Two patients died and 1 child survived at the last follow-up.A total of 135 cases of concurrent GCTs and HM (or leukemia) were reviewed in online databases, involving 127 cases (94.1%) with the mediastinal GCTs associated with HM and 8 cases(5.9%) with GCTs related HM from another original sites.One hundred and twenty-six cases (99.2%) were male and the median age of GCTs diagnosis was 22 (10-48) years.Fifty-three cases (41.7%) were teratoma and 94 cases (74.0%) were GCTs containing teratoma with or without yolk sac tumor.Among the types of HM, 72 cases (56.7%) were AML and 31 cases (24.4%) were AML-M7.The median interval between GCTs and HM was 3 (0-122) months.Forty-six cases (36.2%) presented 2 malignancies simultaneously.HM were diagnosed within 12 months of GCTs in 85 cases (66.9%). The survival data were known in 107 cases, involving 94 (87.9%) deaths and 13 (12.1%) survivors.The median survival time after diagnosis of HM was 2 (0-48) months.The tendency of HM must be highly concerned in adolescent male patients with primary mediastinal GCTs, especially those with yolk sac tumor or teratoma.Their prognoses are very poor.Allogeneic hematopoietic stem cell transplantation is an alternative treatment.
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【Objective】 To understand the effect of long-term high-frequency platelet donation on the health, safety and platelet quality of blood donors. 【Methods】 From August 2020 to July 2022, blood donors who donated platelets for single collection in the station were selected as two groups: those who donated for 20-29 times and those who donated for 30-44 times. Such 14 test indexes as red blood cell count (RBC), hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), platelet count (Plt), white blood cell count (WBC), large platelet ratio (P-LCR), lymphocyte (LYM) , neutrophil (NE), mean hemoglobin content (MCH), mean hemoglobin concentration (MCHC), platelet specific volume (PCT), mean platelet volume (MPV) and platelet distribution width (PDW) were grouped and statistically analyzed for 5 times in each group. In addition, blood donors who have donated platelets more than 100 times in the station were chosen; the changes of their 5 parameters as RBC, Hb, Hct, PLT and WBC, as well as the correlation with the total number of platelet donations were analyzed through statistical analysis of the first 100 donations(10 donations/group). 【Results】 During 2 years, the hematological parameters were similar between 20-29 donation group(n=30) and 30-44 donation group(n=11) (P>0.05). For donors with donations≥100 occasions, RBC, Hb, Hct and WBC were negatively correlated with the number of blood donations, while Plt was positively correlated. There were significant differences in Hb, Hct, WBC and Plt among groups (P<0.05). Hb, Hct and WBC showed a downward trend, while Plt showed an upward trend. 【Conclusion】 With the increase of blood donations and units of blood donated, some changes in hematological parameters are observed among long-term high-frequency platelet donors. Monitoring and health education should be strengthened to ensure the safety and quality of blood donors.
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Objective:Gasless laparoscopic surgery using lifting device was first introduced in 1993 mainly for general surgery and gynecology. Here we report its application in bifid rib treatment and explore the feasibility and safety of the surgery.Methods:From July 2008 to December 2019, according to the enrollment criteria, 278 patients of bifid ribs were treated at the Department of Thoracic Surgery, Beijing Children’s Hospital, Capital Medical University, including 183 males and 95 females, the mean age was(5.7±2.5) years old. There were 242 cases of single bifid rib and 36 cases of multiple bifid ribs. The bifid ribs were more common on the right side, as 184 cases had bifid ribs on right side, while only 68 cases on the left side and 26 cases on both sides. Patients’ clinical data were retrospectively summarized and analyzed, including the patients’ gender, age, location and type of bifid rib, perioperative outcome, and follow-up.Results:All the 278 patients successfully completed the operation. The abnormality was most frequently found in the fifth rib(incidence ranking: fifth > fourth > third > sixth). The mean operation time was(64.5±16.1)min, and the mean blood loss was(4.8±2.1)ml. No serious complications occurred during the surgery. Follow-up was done for 7 to 120 months, and no recurrent patients were observed.Conclusion:Gasless endoscopy with lifting device has been used as a safe and effective method to treat bifid ribs in our hospital. This surgery leads to less injury, smaller incision, and no scars on the front chest. Gasless endoscopic surgery with lifting device can be one of the options for correcting bifid ribs.
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Objective:To summarize the clinical features, diagnosis and treatment experience of esophageal hamartoma in children.Methods:From December 2013 to December 2019, 3 cases of esophageal hamartoma were admitted to our hospital, and a retrospective analysis was conducted.Results:There were 1 male and 2 females, with an average age of 6.4 years old. The clinical manifestations were vomiting in 2 cases and dysphagia with esophageal foreign body sensation in 1 case. Esophagography, chest contrast-enhanced CT, and esophagoscopy showed esophageal stenosis or esophageal mass effectg, and esophageal dilatation above the affected segment. The tumor was found in upper esophagus in 1 case and lower esophagus in 2 cases. Tumors were complete resection in all 3 cases and the patients were discharged smoothly. All the 3 cases were followed up after surgery for 10-74 months(average 37 months), and 1 case had gastroesophageal reflux. No stenosis or recurrence was found in all the cases, and all the patients could eat normal diet.Conclusion:The main manifestations of esophageal hamartoma in children are vomiting and choking. Complete surgical resection is the main treatment method, and the prognosis is good.
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Objective:To systematically evaluate the correlation between C-reactive protein (CRP) and postmenopausal osteoporosis.Methods:PubMed, EMbase, Cochrane library, China biomedical literature database, China HowNet and Wanfang database were searched by computer to collect the clinical research literature related to CRP and postmenopausal osteoporosis. The retrieval period was from the establishment of the database to April 1, 2021. The two researchers screened the literature according to the inclusion and exclusion criteria, extracted the data and evaluated the quality, Revman5.3 software was used for meta-analysis.Results:A total of 12 studies were included, including 778 cases in postmenopausal osteoporosis group and 933 cases in non osteoporosis group. The results of combined analysis showed that the level of CRP in postmenopausal osteoporosis group was higher than that in non osteoporosis group, and the difference was statistically significant (standardized mean difference (SMD)=0.55, 95% CI (0.03, 1.07), P=0.04). Further subgroup analysis according to different grouping criteria and CRP detection methods showed that the level of CRP in patients with osteoporosis was higher than that in normal bone group ( SMD=0.88, 95% CI (0.07,1.69), P=0.03). There was no significant difference in CRP level between osteoporosis group and osteopenia Group (SMD=0.13, 95% CI (-0.05, 0.31), P=0.15). There was no correlation between CRP levels detected by automatic analyzer, chemiluminescence immunoassay and enzyme-linked immunosorbent assay and postmenopausal osteoporosis. The level of CRP in postmenopausal osteoporosis group detected by immunoturbidimetry was higher than that in non osteoporosis group (SMD=1.50, 95% CI (1.10,1.90), P<0.01). Conclusion:CRP level is related to postmenopausal osteoporosis. High CRP level may be a risk factor for postmenopausal osteoporosis.
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Objective:To summarize the clinical characteristics of single-center children with low and intermediate-risk neuroblastoma (NB), report the long-term follow-up results of the growth and survival quality, and provide a basis for further clinical research.Methods:Clinical characteristics, including the sex, age, stage, risk of disease, and metastatic site of 370 newly treated children with low and intermediate-risk NB admitted to Hematology Oncology Center, Beijing Children′s Hospital from March 2007 to June 2019 were retrospectively analyzed.Kaplan-Meier method was used for survival analysis.WHO Anthro Plus was used for calculating Z score.Results:A total of 370 eligible children with low and intermediate-risk NB were included, with the mean age at onset of 16.8 months (1-191 months). Among them, 148 cases (40%) were younger than 12 months old.Mediastinal region was the most common primary site of NB (47.8%, 177 cases), followed by retroperitoneum/adrenal gland (41.4%, 153 cases). The median follow-up time of 370 patients was 31 months (0.3-157.0 months), the 5-years event free survival (EFS) and 5-year overall survival (OS) were 86.2% and 96.9%, respectively.Thirty-seven cases had growth and deve-lopment problems, of which 22 cases had stunted growth, 6 cases had low body mass, 9 cases had wasting, and 7.3%(27/370 cases) had scoliosis.5.5% of them had heart damage and 5.0%(18/357 cases) had kidney damage, involving 12 cases related to the primary tumor and 6 cases were surgically related.30.2%(95/315 cases) of them had hair changed after chemotherapy, and curly hair was the most common change.Compared with before treatment, 14.9% of the children had a personality change, with an impatient being the most common.Conclusions:The 5-year overall survival rate of the single-center large sample of low and intermediate-risk NB was high, mediastinal was the most common primary site of tumor, and the long-term quality of life is good, but there were still treatment-related side effects, and further clinical monitoring and long-term follow-up were needed.
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Assessment of the status property(boiling time) is a challenge for the quality control of extraction process in pharmaceutical enterprises. In this study, the pilot extraction process of Phellodendron chinense was used as the research carrier to develop an online near-infrared(NIR) quality control method based on the status property(boiling time). First, the NIR spectra of P. chinense were collected during the two pilot-scale extraction processes, and the status property(boiling time) was assessed by observing the state of bubbles in the extraction tank using a transparent window during the extraction process, which was then used as a reference standard. Based on the moving block standard deviation(MBSD) algorithm, the assessment model using online NIR spectra for boiling time during extraction process was established. In addition, the model was optimized as follows: standard normal variable(SNV) for spectral pretreatment, modeling band of 800-2 200 nm, and window size of 4. The results showed that, with 0.002 0 as the MBSD model threshold, the boiling time can be accurately assessed using online NIR spectra during extraction process. Furthermore, the principal component analysis-moving block standard deviation(PCA-MBSD) model was developed by our group to reduce the influence of online NIR spectral noise and background signal on the model, and the number of principal components was optimized into 2 in the PCA-MBSD model. The results showed that, with 0.000 075 as the PCA-MBSD model threshold, the boiling time can be accurately assessed using online NIR spectra during extraction process, with improved reliability. This study can provide a assessment method for boiling time during extraction process using online NIR spectra, which can replace the empirical judgment in manual observation, and realize the digitalization of the extraction process for big brand traditional Chinese medicine.
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Medicine, Chinese Traditional , Principal Component Analysis , Quality Control , Reproducibility of Results , Spectroscopy, Near-InfraredABSTRACT
The physical properties of powder and granules are the critical quality attributes for the process control of Suhuang Zhike Capsules, a big brand traditional Chinese medicine. This paper took the production of 25 batches of real-world Suhuang Zhike Capsules dry extract powder and granules intermediates as the research object. Firstly, a method for testing the physical properties of Suhuang Zhike Capsules powder and granules with 19 physical indicators was established. The results showed that the granules of dry extract powder after granulation had a smaller particle size, wider particle size distribution range and poor fluidity, which easily caused the problem of over-limit capsule loading. Secondly, correlation analysis, principal component analysis and cluster analysis were used for mathematical statistics. The correlation analysis showed that the density of dry extract powder could affect the chroma and fluidity. At the same time, the particle size in the granules had a stronger effect on the chroma and fluidity than the density. The study also found that the particle size and hygroscopicity of dry extract powder were potentially key physical properties that affected the physical properties of granules. Furthermore, the results of principal component analysis and cluster analysis showed that the consistency of the physical properties between the dry extract powder and intermediate granules was relatively poor. To this end, similarity analysis was carried out, and the quality control method of powder and granules based on physical fingerprint was established. The results showed that the physical fingerprint similarity of 25 batches of dry extract powder was 0.639-0.976, and the physical fingerprint similarity of the gra-nules was 0.716-0.983. With the similarity of 0.85 as the threshold, the batches with abnormal physical properties could be identified. In this study, the process quality control method of Suhuang Zhike Capsules based on the physical properties of powder and granules was established finally, which realized the identification of abnormal batches, and provided a reference for the process quality control of Suhuang Zhike Capsules.
Subject(s)
Capsules , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality ControlABSTRACT
The chemical properties of characteristic components are significant to the manufacturing quality control of big brand traditional Chinese medicine. In this study, the Huangjing Zanyu Capsules were used as the research carrier to determine the content of five characteristic components including icraiin, emodin, schisandrin A, 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside, and osthole simultaneously by high-performance liquid chromatography(HPLC). The results showed that the chemical properties of five cha-racteristic components had a good linear relationship(r>0.999 9) within the quantitative range; the relative standard deviations(RSD) was 0.11%-2.0% and 0.25%-2.8% respectively for intra-day and inter-day precision; the RSD of repeatability was 1.8%-2.6%; the RSD of stability within 48 hours was 0.19%-2.8%, and the average recovery rate was 95.52%-100.1%, all meeting the requirements of pharmaceutical quantitative analysis. Additionally, the interval estimation method was used to directly reflect the distribution of samples with abnormal chemical properties of characteristic components, and the results showed ten samples were detected beyound the 95% control line of confidence level. Multivariate statistical process control(MSPC) method was used to monitor the abnormal samples of Huangjing Zanyu Capsules collectively, and the results showed that two samples were beyond the 95% control line of Hotelling's T~2 and three samples beyond the 95% control line of squared prediction error(SPE), indicating consistent quality control of Huangjing Zanyu Capsules. In conclusion, the proposed method is not only accurate and efficient but also a compensation for the traditional single-component quality control method, providing a scientific basis for the quality control in manufacturing process of Huangjing Zanyu Capsules. Furthermore, it could also serve as a reference method for the quality control in manufacturing big brand traditional Chinese medicine.
Subject(s)
Capsules , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality ControlABSTRACT
The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels. First, based on micromeritics evaluation method, a total of 29 physical attribute quality parameters in five dimensions were comprehensively characterized, with a total of 1 537 data points. Further, with use of physical fingerprinting technology combined with similarity evaluation, the powder physical properties of 53 batches of GLE showed obvious differences from an overall perspective, and the similarity of the physical fingerprints was 0.876 to 1.000. Secondly, hierarchical clustering analysis(HCA) and principal component analysis(PCA) models were constructed to realize the reliable identification and differentiation of real-world materials produced by GLE from different sources. Multivariate statistical process control(MSPC) model was used to create GLE material Hotelling T~2 and squared prediction error(SPE) control charts. It was found that the SPE score of B_(21) powder exceeded the 99% confidence control limit by 22.495 9, and the SPE scores of A_1 and C_(10) powder exceeded the 95% confidence control limit by 16.099 2, realizing the determination of abnormal samples in the materials of GLE from the production in real world. Finally, the physical quality control method of GLE in the production process of ginkgo leaves preparations was established in this study, providing a reference for the quality control methods of ginkgo leaves preparations in their manufacturing process.
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Drugs, Chinese Herbal , Ginkgo biloba , Medicine, Chinese Traditional , Plant Extracts , Plant Leaves , Powders , Quality ControlABSTRACT
Identification of critical quality attribute(CQA) is crucial in quality control of Tongren Niuhuang Qingxin Pills(TRNHQXP). In this study, 661 active components in TRNHQXP were selected by liquid chromatography-mass spectrometry(LC-MS) and network pharmacology based on reported data and TCMSP, BATMAN-TCM, and TCMID databases, as well as mass spectrometry data, and 1 413 targets of the active components were obtained through SwissTargetPrediction. The 152 potential targets obtained from the intersection of predicted targets with 456 stroke targets underwent functional enrichment analysis by Metascape. The 27 Chinese medicinals in TRNHQXP were divided into four sets according to efficacies. Thirty-seven key targets in the blood-activating and stasis-resolving set and 41 in the tonifying set were screened out. On the basis of these potential key targets, 137 potential key CQA of TRNHQXP for stroke were reversely predicted. This study revealed the possible mechanism of TRNHQXP in treating stroke and established a modular identification method for the potential CQA of big brand traditional Chinese medicine(TCM) based on efficacies and chemical properties. Consequently, the CQA of TRNHQXP were identified by this method, which has provided a reference for the following experimental studies of CQA.
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Chromatography, Liquid , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality ControlABSTRACT
Texture sensory attributes are the key items in quality control of Chinese medicinal honeyed pills. The purpose of this study is to develop a quality control method for assessing the texture sensory attributes of Chinese medicinal honeyed pills based on real-world Tongren Niuhuang Qingxin pilular masses and finished products. First, parameters of texture profile analysis(TPA) were optimized through single factor and central composite design(CCD) experiments to establish a detection method for texture sensory attri-butes of Tongren Niuhuang Qingxin Pills. The results showed that the established detection method was stable and reliable, with the optimal parameters set up as follows: deformation percentage of 70%, detection speed at 30 mm·min~(-1), and interval time of 15 s. Furthermore, 540 data points yielded form six texture sensory attributes of pills from 30 batches were subjected to multivariate statistical process control(MSPC) with Hotelling T~2 and squared prediction error(SPE) control charts to establish the quality control method of Tongren Niuhuang Qingxin Pills. This study is expected to provide a reference for improving the quality control system of Chinese medicinal honeyed pills.
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Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality ControlABSTRACT
For the field detection problems of critical quality attribute(CQA) of moisture content in traditional Chinese medicine(TCM) manufacturing process, big brand TCM Tongren Niuhuang Qingxin Pills were used as the carrier, to establish a moisture content NIR field detection model with or without cellophane in real world production with use of near infrared(NIR) spectroscopy combined with stoichiometry. With the moisture content determined by drying method as reference value, the partial least square method(PLS) was used to analyze the correlation between the spectrum and the moisture reference value. Then the spectral pretreatment methods were screened and optimized to further improve the accuracy and stability of the model. The results showed that the best quantitative model was developed by the spectral data pretreatment of standard normal variate(SNV) with the latent variable factor number of 2 and 7 of Tongren Niuhuang Qingxin Pills with or without cellophane samples. The prediction coefficient of determination(R_(pre)~2) and standard deviation of prediction(RMSEP) of the model with cellophane samples were 0.765 7 and 0.157 2%; R_(pre)~2 and RMSEP of the model without cellophane samples were 0.772 2 and 0.207 8%. The NIR quantitative models of moisture content of Tongren Niuhuang Qingxin Pills with and without cellophane both showed good predictive performance to realize the rapid, accurate and non-destructive quantitative analysis of moisture content in such pills, and provide a method for the field quality control of the critical chemical attributes of moisture in the manufacturing of big brand TCM.
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Drugs, Chinese Herbal , Least-Squares Analysis , Medicine, Chinese Traditional , Spectroscopy, Near-InfraredABSTRACT
The spatial distribution uniformity of valuable medicines is the critical quality attribute in the process control of Tongren Niuhuang Qingxin Pills. With the real world sample of the mixed end-point powder of Tongren Niuhuang Qingxin Pills as the research object, hyperspectral imaging technology was used to collect a total of 32 400 data points with a size of 180 pix×180 pix. Spectral angle matching(SAM), classical least squares and mixed tuned matched filtering(MTMF) were used to identify the spatial distribution of rare medicines. MTMF model showed higher identification accuracy, therefore the spatial distribution of the blended intermediates was identified based on the MTMF model. The histogram method was also used to evaluate the spatial distribution uniformity of rare medicines. The results showed that the standard deviation was 4.78, 6.5, 3.48, 1.96, and 3.00 respectively for artificial bezoar, artificial musk, Borneol, Antelope horn and Buffalo horn; the variance was 22.8, 42.3, 12.1, 3.82, and 9.00, and the skewness was 1.26, 1.71, 0.06,-0.86, and 1.04, respectively. The final results showed that the most even blending was achieved in concentrated powder of Borneol, Antelope horn and Buffalo horn, followed by artificial bezoar, and last artificial musk. A visualization method was established for quality attributes of distribution uniformity in blending process of Tongren Niuhuang Qingxin Pills. It could provide evidences of quality control methods in the mixing process of big brand traditional Chinese medicine.
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Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality ControlABSTRACT
Objective:To summarize the clinical features, treatment and outcomes of cervical neuroblastoma (NB) subjected to multi-disciplinary treatment.Methods:The clinical features of cervical NB patients who were admitted to Beijing Children′s Hospital, Capital Medical University from February 2015 to October 2018, were retrospectively analyzed.The tumor makers [lactate dehydrogenase(LDH), neuron-specific enolase(NSE), urine homovanillic acid/creatinine(HVA/Crn), and urine vanillyl-mandelic acid/creatinine(VMA/Crn)], index of tumor burden(KTB), bone marrow examination, histopathologic types, N- MYC, gene amplification and 11q23 depletion type, staging and grouping, treatment and outcomes were analyzed.Follow-up was ended on March 31 st, 2019. Results:The 13 cervical NB patients aged from 1 month to 47 months (median age: 10 months), and 8 patients (61.5%) were younger than 18 months old.The course of disease ranged from 0.5 to 24.0 months (median course: more than 1 month). Seven patients (53.8%) presented with cervical masses.According to International Neuroblastoma Staging System (INSS), 8 patients (61.5%) were identified as stage Ⅱ, 3 patients (23.1%) as stage Ⅲ, and 2 patients (15.4%) as stage Ⅳ.There were 8 patients (61.1%) at low risk, 4 patients (30.8%) at intermediate risk, 1 patient (7.7%) at high risk.As for the laboratory examinations, LDH was increased in 7 patients (53.8%), and normal in 5 patients (38.5%). NSE was increased in 9 patients (69.2%), and normal in 4 patients (30.8%). Urine VMA/Crn was increased in 5 patients (38.5%), and normal in 8 patients (61.5%). HVA/Crn was increased in 8 patients (61.5%), and normal in 5 patients (38.5%). KTB was increased in 5 patients (38.5%), and normal in 5 patients (38.5%). No NB cell was detected in bone marrow of 13 patients.The pathologic type was NB in 9 patients (69.2%), and ganglioneuroma in 4 patients (30.8%). N-MYC gene amplification and 11q depletion were not detected.All the 13 patients accepted regular chemotherapy, radiotherapy and primary tumor resection in accordance with the staging and clinical risk grouping.The range of follow-up time was 5 to 48 months (median: 24 months). All of the patients fi-nished their treatment and were followed up regularly.Nine patients (69.2%) achieved complete remission, 4 patients (30.8%) achieved partial remission, and none of the patients had progression of disease.Conclusions:Cervical NB subjected to multi-disciplinary treatment has a smaller age at admission, mostly presented with cervical masses and rarely accompanied with distant metastasis.They are mostly at low risk or intermediate risk, and can achieve good outcomes after regular treatment.
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Objective:To summarize the clinical features, therapeutic effects and prognostic factors of children with extracranial malignant germ cell tumor (MGCT), and further to improve the recognition of this disease.Methods:The clinical information and therapeutic effects of children patients diagnosed with MGCT and treated in Hematology-Oncology Center in Beijing Children′s Hospital, Capital Medical University from January 2008 to December 2018 were analyzed retrospectively, and the risk factors affecting the prognosis were discussed.Results:A total of 35 patients were collected in this study, including 19 girls and 16 boys, with a median age of 71 months.Forty-two point four percent (14/33 cases) of them were <3 year-old, and 39.3% (13/33 cases) of them were >6 year-old.The primary tumors were located at the gonad in 9 cases (6 cases in the ovary and 3 cases in the testis), and extragonadal sites in 26 cases (8 cases in the pelvic cavity, 8 cases in the mediastinum, and 10 cases in the sacrococcygeal region). Five cases were in stage Ⅱ, 16 cases in stage Ⅲ, and 14 cases in stage Ⅳ.Eleven cases were at intermediate risk, and 24 cases were at high risk.All children were followed up for (25.43±4.82) months, and given standard treatment of surgery plus chemotherapy.The 2-year overall survival (OS) rate and event-free survival (EFS) rate were 87.4% and 67.1%, respectively.The 2-year OS rate and EFS rate in patients at stage Ⅱ and Ⅲ (93.8% and 80.4%, respectively) were significantly higher than those at stage Ⅳ (66.7% and 45.1%, respectively) ( χ2=0.649, 0.739; P=0.021, 0.037). The 2-year EFS rate in patients with and without distant metastasis at the early stage of the disease was 43.8% and 86.9%, respectively, and the differences were significant ( χ2=0.694, P=0.028). The complete remission (CR) rates of intermediate-risk and high-risk children with tumor completely resected at the early stage of the disease were 100.0% (8/8 cases) and 71.4% (5/7 cases), respectively.The CR rate of patients who received 2-4 cycles of chemotherapy and had complete tumor resection after diagnosis by puncture was 72.7% (8/11 cases), and 40.0% (2/5 cases) of the children with incomplete resection got tumor progression.For eight patients with events, their alpha-fetoprotein (AFP) levels decreased slowly at the early stage of the disease and increased significantly as the disease progressed. Conclusions:The onset-age of MGCT is mainly <3 year-old and >6 year-old.The stan-dard treatment that combines surgery and chemotherapy can achieve a good overall prognosis.Incomplete surgical resection and a slow decline of AFP during treatment contribute to adverse prognosis.The outcomes of patients with tumor progression can be improved by increasing chemotherapy courses, secondary surgery and autologous stem cell transplantation.
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Objective:To follow up and clarify the prognosis of 670 pediatric patients with Dravet syndrome (DS).Methods:The clinical data of DS pediatric patients treated in the Department of Pediatrics, Peking University First Hospital from February 2005 to August 2016 were recorded, and genetic testing was carried out.DS pediatric patients were followed up via subsequent visits at the outpatient and telephone interview.Results:Among 670 cases with DS, 556 cases (556/670 cases, 83.0%) carried SCN1A mutations.In the follow-up, 608 cases were contacted (608/670 cases, 90.7%) and 62 cases (62/670 cases, 9.3%) were lost.The last follow-up median age was 8 years 5 months.Eighty-two cases (82/608 cases, 13.5%) were seizure-free for more than 1 year, with a median age of 9 years and 2 months.Thirty-eight cases relapsed (38/82 cases, 46.3%), mainly induced by fever (34 cases) or mi-ssing antiepileptic drugs (2 cases). Analysis of the relative factors of patients that were seizure-free for more than 1 year showed that children with missense SCN1A mutations, inherited mutations and an older age had a relatively good outcome for seizure control.Twenty-five cases (25/608 cases, 4.1%) were deceased, with a median age of 4 years.The mortality factors included multiple organ dysfunction syndromes after prolonged status epilepticus (12 cases), possible sudden unexpected death in epilepsy (7 cases), asphyxiation after vomiting with or without a seizure (2 cases), and an accidental injury (1 case). The fatal causes in the remaining 3 cases were unknown. Conclusions:DS is an intractable epileptic syndrome, but few patients may have a seizure remission (seizure free for more than 1 year). Patients with mi-ssense SCN1A mutations, inherited mutations and an older age have a relatively good outcome for seizure control.The mortality rate is high in DS patients.The causes of mortality include multiple organ dysfunction syndromes after prolonged status epilepticus, possible sudden unexpected death in epilepsy, and so on.