In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
Objective To explore the change of particles of Shuanghuanglian Injection (SHLI) admixed with different infusion solutions, and provide a reference for selecting rational menstruum. Methods A comprehensive literature search was executed to collect all the studies on the compatibility of SHLI with different infusion solutions. The reporting quality of the included studies was assessed; particles-related data were extracted and analyzed systematically. Results A total of 338 studies were identified, and 24 studies were included after screening. The quality of the included studies were poor and had heterogeneous outcomes. Generally, the particles of mixture increased dramatically, and there were significant differences among different pharmaceuticals, drug batches and infusion solutions. The pH of solvent had a greater impact on the particles, and the concentration and storage time of prepared liquor were other important factors. The particles of SHLI admixed with Normal Saline were less than 5%, 10% glucose injection and other solvents. Conclusion The particles of SHLI admixed with Normal Saline are the fewest, and commonly can be the preferred solvent. Factors on rational drug use are worthy of further studies; and more attention is needed for the scientificalness of study design.
Objective Shuanghuanglian injection (SHLI) is a typical Chinese medicine injection which has been used for more than 20 years. This study aims to investigate the compatibility of SHLI with western intravenous agents. Methods An extensive literature search was executed to identify all experimental tests and clinical reports on the topics. Data on the types of infusion solutions and western medical injections, usage and dosage, outcome measures for physical and chemical properties, and changes of drug effect were searched for. The included data was analyzed and described by the category of included western drugs. Compatibility was tested through integrating the evaluations of physical properties, chemical composition, drug metabolism, and safety. Results Sixty articles (38 experimental tests and 22 clinical reports) were included after screening. Fifty–three western medical injections were identified from all the included articles. Most of the research was about the compatibility of SHLI with different types of antibiotics, including β-lactam, aminoglycoside, and quinolone etc. Thirty-one western medical injections were not recommended to be combined with SHLI. The quality of the experimental test design was low because of unbalanced evaluation indicators: more attention to physical changes than drug metabolism, effect, and safety. Conclusions A broad incompatibility exists in the combination of SHLI with western medical injections. Some results are still uncertain, but the combinations should still be avoided until researched clearly. The compatibility and interaction of Chinese herbal injections and western medicines is still a weak area. The pharmaceutical sector should strengthen post-market research to update evidence and improve its distribution.