The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order ...The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.展开更多
Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing...Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.展开更多
Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OS...Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.展开更多
基金Supported by the Ninth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Seventh Science Foundation of China Academy of Chinese Medical Sciences(No.ZZ070817)+1 种基金National Natural Science Foundation of China(General Program,No.81202776)China Postdoctoral Science Foundation project(No.2014T70202)
文摘The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.
基金Supported by Research on Key Techniques of Reevaluation of Postmarketing Chinese Medicines,the Ministry of Science and Technology(No.2009ZX09502-030)the Seventh-Science Foundation of China Academy of Chinese Medical Sciences(No.ZZ070817)National Natural Science Foundation of China(General program,No.81202776)
文摘Pharmacoeconomics is an important part of the postmarketing Chinese medicine (CM) evaluation, and postmarketing pharmacoeconomic evaluation can reveal the clinical and market value of CM. The purpose of establishing the guideline for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines both scientific and fair. Every country's guidelines for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the guideline that takes into account the special characteristics of CM; and these are in preparation for the postmarketing CM pharmacoeconomic evaluation.
文摘Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.