A continuous infusion of bupivacaine 0.5% at 4 ml/h is effective for decreasing pain and the need for opioid analgesic medication as well as for improving patient satisfaction with their pain management after cardiac surgery. Patients in the bupivacaine-0.5% group were able to ambulate earlier, leading to a reduced length of hospital stay.
When dosed in a similar manner, epsilon-aminocaproic acid seems to be as effective as aprotinin at reducing interleukin-6 and interleukin-8 levels in patients undergoing primary coronary artery bypass graft surgery. These data indicate that suppression of excessive plasmin activity or D-dimer formation or both may play an important role in the generation of proinflammatory cytokines during and after cardiopulmonary bypass.
As part of a cardiac fast-tracking program involving desflurane anesthesia, the use of intrathecal morphine in combination with a remifentanil infusion provided improved postoperative pain control, compared with IV sufentanil alone.
Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority’s websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors’ and the regulators’ perspectives.
Background
The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCMs were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China.
Methods
A mixed approach of documentary analysis of government policies, regulations and official information about TCMs regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCMs regulation was employed.
Results
Ten priority areas in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with a holistic approach; (2) advancing the methodology for the quality control of TCMs; (3) fostering the control mechanism of TCMs manufacturing process; (4) improving clinical evaluation of TCMs and leveraging real world data; (5) re-evaluation of TCMs injection; (6) developing evaluation standards for classic TCMs formula; (7) harnessing diverse data to improve pharmacovigilance of TCMs; (8) evaluating the value of integrative medicine in clinical practice with scientific research; (9) advancing the regulatory capacity to encourage innovation in TCMs; and (10) advancing a vision of collaboration for RS development in TCMs.
Conclusions
RS for TCMs in China encompasses revolution of operational procedures, advancement in science and technology, and cross-disciplinary collaborations. Such experiences could be integrated in the communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines.
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