The thinking of research on developing Chinese herbal medicine (CHM) has turned from the traditional exploration for active ingredients to develop microcosmic compound drug based on TCM and/or modern medical theories, which leads to the emerge of combination of effective components (CEC), a new pattern of developing modern Chinese herbal medicine. Meanwhile its researching targets and methods, including objectivization of treated diseases, optimization of compatibility proportion, standardization of component types, definition of synergistic and antagonistic effects, and minimization of toxic and side effects, have also been renewed. The existent problems in need of improvement were put forward on the basis of current researching situation of CEC pattern in order to construct new drugs, enrich the theoretical connotation of TCM and promote the process of TCM modernization.
Drug Combinations ; Drug Synergism ; Drugs, Chinese Herbal ; adverse effects ; chemistry ; therapeutic use ; Drugs, Investigational ; adverse effects ; chemistry ; therapeutic use ; Humans ; Phytotherapy ; methods ; Research Design

PURPOSE: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). We expected to obtain same results as with ReoPro(R) in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI). PATIENTS AND METHODS: Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab(TM) was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(R)(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events. RESULTS: The number of Clotinab(TM) patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro(R) group. The probability of MACE onset in Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables. CONCLUSION: Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
Acute Coronary Syndrome/surgery ; Adult ; Aged ; Aged, 80 and over ; *Angioplasty, Transluminal, Percutaneous Coronary ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Drugs, Investigational/adverse effects/therapeutic use ; Female ; Humans ; Immunoglobulin Fab Fragments/adverse effects/*therapeutic use ; Male ; Middle Aged ; Myocardial Ischemia/prevention & control ; Platelet Aggregation Inhibitors/adverse effects/*therapeutic use ; Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors ; Prospective Studies ; Risk Factors ; Treatment Outcome