[Construction of quality evaluation strategy for Chinese medicine based on ambient mass spectrometry].

Quality is the guarantee for the clinical safety and effectiveness of Chinese medicine. Accurate quality evaluation is the key to the standardization and modernization of Chinese medicine. Efforts have been made in improving Chinese medicine quality and strengthening the quality and safety supervision in China, but rapid and accurate quality evaluation of complex Chinese medicine samples is still a challenge. On the basis of the development of ambient mass spectrometry and the application in quality evaluation of complex Chinese medicine systems in recent years, the authors developed the multi-scenario Chinese medicine quality evaluation strategies. A systematic methodology was proposed in specific areas such as real-time monitoring of the quality of complex Chinese medicine decoction system, rapid toxicity grading of compound Chinese patent medicine, and evaluation of bulk medicinals of Chinese patent medicine. Allowing multi-scenario analysis of Chinese medicine, it is expected to provide universal research ideas and technical methods for rapid and accurate quality evaluation of Chinese medicine and boost the high-quality development of Chinese medicine industry.

Construction of quality evaluation strategy for Chinese medicine based on ambient mass spectrometry / 中国中药杂志

Quality is the guarantee for the clinical safety and effectiveness of Chinese medicine. Accurate quality evaluation is the key to the standardization and modernization of Chinese medicine. Efforts have been made in improving Chinese medicine quality and strengthening the quality and safety supervision in China, but rapid and accurate quality evaluation of complex Chinese medicine samples is still a challenge. On the basis of the development of ambient mass spectrometry and the application in quality evaluation of complex Chinese medicine systems in recent years, the authors developed the multi-scenario Chinese medicine quality evaluation strategies. A systematic methodology was proposed in specific areas such as real-time monitoring of the quality of complex Chinese medicine decoction system, rapid toxicity grading of compound Chinese patent medicine, and evaluation of bulk medicinals of Chinese patent medicine. Allowing multi-scenario analysis of Chinese medicine, it is expected to provide universal research ideas and technical methods for rapid and accurate quality evaluation of Chinese medicine and boost the high-quality development of Chinese medicine industry.

Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research.

BACKGROUND: Clinicians are the standard source for adverse event (AE) reporting in oncology trials, despite the subjective nature of symptomatic AEs. The authors designed a pediatric patient-reported outcome (PRO) instrument for symptomatic AEs to support the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) (the Pediatric PRO-CTCAE). The current study developed a standardized algorithm that maps all possible Pediatric PRO-CTCAE response patterns to recommended CTCAE grades to improve the accuracy of AE reporting in pediatric oncology trials. METHODS: Two rounds of surveys were administered to experienced cancer clinicians across 9 pediatric hospitals. In round 1, pediatric oncologists assigned CTCAE grades to all 101 possible Pediatric PRO-CTCAE response patterns. The authors evaluated clinician agreement of CTCAE grades across response patterns and categorized each response pattern as having high or low agreement. In round 2, a survey was sent to a larger clinician group to examine clinician agreement among a select set of Pediatric PRO-CTCAE response patterns, and the authors examined how clinical context influenced grade assignment. RESULTS: A total of 10 pediatric oncologists participated in round 1. Of the 101 possible patterns, 89 (88%) had high agreement. The Light weighted kappa was averaged across the 10 oncologists (Light kappa = 0.73; 95% CI, 0.66-0.81). A total of 139 clinicians participated in round 2. High clinician agreement remained for the majority of generic response patterns and the clinical context did not typically change grades but rather improved agreement. CONCLUSIONS: The current study provides a framework for integrating child self-reported symptom data directly into mandated AE reporting in oncology trials. Translating Pediatric PRO-CTCAE responses into clinically meaningful metrics will guide future cancer care and toxicity grading.

Grading Dysphagia as a Toxicity of Head and Neck Cancer: Differences in Severity Classification Based on MBS DIGEST and Clinical CTCAE Grades.

Clinician-reported toxicity grading through common terminology criteria for adverse events (CTCAE) stages dysphagia based on symptoms, diet, and tube dependence. The new dynamic imaging grade of swallowing toxicity (DIGEST) tool offers a similarly scaled five-point ordinal summary grade of pharyngeal swallowing as determined through results of a modified barium swallow (MBS) study. This study aims to inform clinicians on the similarities and differences between dysphagia severity according to clinical CTCAE and MBS-derived DIGEST grading. A cross-sectional sample of 95 MBS studies was randomly selected from a prospectively-acquired MBS database among patients treated with organ preservation strategies for head and neck cancer. MBS DIGEST and clinical CTCAE dysphagia grades were compared. DIGEST and CTCAE dysphagia grades had "fair" agreement per weighted κ of 0.358 (95% CI .231-.485). Using a threshold of DIGEST ≥ 3 as reference, CTCAE had an overall sensitivity of 0.50, specificity of 0.84, and area under the curve (AUC) of 0.67 to identify severe MBS-detected dysphagia. At less than 6 months, sensitivity was 0.72, specificity was 0.76, and AUC was 0.75 while at greater than 6 months, sensitivity was 0.22, specificity was 0.90, and AUC was 0.56 for CTCAE to detect dysphagia as determined by DIGEST. Classification of pharyngeal dysphagia on MBS using DIGEST augments our understanding of dysphagia severity according to the clinically-derived CTCAE while maintaining the simplicity of an ordinal scale. DIGEST likely complements CTCAE toxicity grading through improved specificity for physiologic dysphagia in the acute phase and improved sensitivity for dysphagia in the late-phase.

Induction Analysis of Toxic Herbs and Decoction Pieces in Chinese Pharmacopoeia( 2015 Edition,Part 1) / 中国药房

OBJECTIVE:To provide reference for clinical use of toxic herbs and decoction pieces contained in Chinese Pharma-copoeia (2015 edition,part 1)(referred to Chinese Pharmacopoeia). METHODS:The contents in"taste and meridian""usage and dosage""note"for herbs and decoction pieces contained in Chinese Pharmacopoeia were summed up. Varieties and toxicity grading of toxic herbs and decoction pieces and precautions for clinical use were summarized. It was compared with Shennong Ben-caojing and Zhongyao Dacidian,and examined whether there were differences in the presence or absence of toxicity and toxicity grading in Chinese Pharmacopoeia. RESULTS:Chinese Pharmacopoeia contained 83 kinds of toxic herbs and decoction pieces,in which,10 had great toxicity,42 had general toxicity and 31 had small toxicity. There were restrictive provisions for the use of tox-ic TCM,in which,30 were forbidden for pregnant women,1 should be contraindicated for pregnant women,16 should be avoid-ed for pregnant women,3 should be avoided for athletes,6 can't be taken orally,8 should be avoided when taken orally,3 were inappropriate for using with crude drugs,5 were used by pills,and 13 were often used by pills. There were 30 toxic TCM in Chi-nese Pharmacopoeia,which were recorded in Shennong Bencaojing as well. 3 were recorded as toxic drugs in Chinese Pharmaco-poeia while non-toxic drugs in Shennong Bencaojing,14 had the same toxicity grading and 13 had not. And there were 80 toxic TCM in Chinese Pharmacopoeia,which were recorded in Zhongyao Dacidian as well. 6 were recorded as toxic drugs in Chinese Pharmacopoeia while non-toxic drugs in Zhongyao Dacidian,60 had the same toxicity grading and 14 had not. CONCLUSIONS:Chinese Pharmacopoeia shows differences with Shennong Bencaojing and Zhongyao Dacidian in the presence or absence of TCM toxicity and toxicity grading. It is necessary to set up unified grading standards for toxic TCM to avoid doubts in clinical use.

Induction Analysis of Toxic Herbs and Decoction Pieces in Chinese Pharmacopoeia( 2015 Edition,Part 1) / 中国药房

OBJECTIVE:To provide reference for clinical use of toxic herbs and decoction pieces contained in Chinese Pharma-copoeia (2015 edition,part 1)(referred to Chinese Pharmacopoeia). METHODS:The contents in"taste and meridian""usage and dosage""note"for herbs and decoction pieces contained in Chinese Pharmacopoeia were summed up. Varieties and toxicity grading of toxic herbs and decoction pieces and precautions for clinical use were summarized. It was compared with Shennong Ben-caojing and Zhongyao Dacidian,and examined whether there were differences in the presence or absence of toxicity and toxicity grading in Chinese Pharmacopoeia. RESULTS:Chinese Pharmacopoeia contained 83 kinds of toxic herbs and decoction pieces,in which,10 had great toxicity,42 had general toxicity and 31 had small toxicity. There were restrictive provisions for the use of tox-ic TCM,in which,30 were forbidden for pregnant women,1 should be contraindicated for pregnant women,16 should be avoid-ed for pregnant women,3 should be avoided for athletes,6 can't be taken orally,8 should be avoided when taken orally,3 were inappropriate for using with crude drugs,5 were used by pills,and 13 were often used by pills. There were 30 toxic TCM in Chi-nese Pharmacopoeia,which were recorded in Shennong Bencaojing as well. 3 were recorded as toxic drugs in Chinese Pharmaco-poeia while non-toxic drugs in Shennong Bencaojing,14 had the same toxicity grading and 13 had not. And there were 80 toxic TCM in Chinese Pharmacopoeia,which were recorded in Zhongyao Dacidian as well. 6 were recorded as toxic drugs in Chinese Pharmacopoeia while non-toxic drugs in Zhongyao Dacidian,60 had the same toxicity grading and 14 had not. CONCLUSIONS:Chinese Pharmacopoeia shows differences with Shennong Bencaojing and Zhongyao Dacidian in the presence or absence of TCM toxicity and toxicity grading. It is necessary to set up unified grading standards for toxic TCM to avoid doubts in clinical use.

Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.

The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal-fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed.