Study of anti-tumor medicine drugs

By | October 27, 2011

Anti-tumor medicine rapid progress in drug research and development, China is also an important feature of cancer treatment. At present, anti-cancer traditional Chinese medicine research and development of new drugs is divided into the following categories:
Chinese anti-tumor drug research is the first agents, mainly based on: tumor regression-based, symptom improvement, quality of life and immune function improved as supplementary indicators;
Chinese Anti-Cancer Drug Research The second type is the tumor an adjuvant, such as radiotherapy and chemotherapy efficiency (increased efficacy of radiotherapy and chemotherapy) or attenuated (reduced chemotherapy toxicity) of drugs, advanced cancer drugs (to improve symptoms, improve quality of life and prolong survival time) and immunotherapy drugs, etc.; The third category is for drugs that cancer patients symptoms such as pain, hair loss, leukopenia, etc.; The fourth category of drugs for complications of cancer patients.
Currently, the class of drug development there are still some problems, such as mixed therapeutic purposes, can not clearly be synergistic, attenuated, or anti-tumor, often of several both; Chinese lack of uniform evaluation indicators, and indicators of the main study not clear; otherwise observed number of cases of confusion, the range of treatment and treatment of such diseases is not clear.
(1) test purposes to be clear: According to the clear positioning of drug prescriptions, which determine the treatment of drug or adjuvant therapy drugs. To distinguish between the main effect of treatment and a secondary role, a drug generally can not be both drug treatment (cancer) and a supplementary drug. The indexes should be based on objective test to determine the corresponding.
(2) double-blind trial design should be emphasized, particularly in Phase clinical trial application process compared to the exact description of blind patients.
(3) The choice of cases: the number of cases: synergistic anticancer drugs and radiotherapy and chemotherapy, the treatment of single disease group (with tumors) should not be less than 100 cases, in order to clarify efficacy evaluation. Medication in improving symptoms in patients with the symptoms of the tumor can be included (eg, leukopenia, pain, etc.), diseases should be relatively concentrated, the treatment group and control group should be equal. diagnostic criteria: Western diagnostic criteria commonly used Ministry of Health, Medical Administration compiled the "diagnosis and treatment of common malignant tumors in China norms" and the international standard, can also be appropriate, authoritative reference books at home and abroad. treatment: chemotherapy and adjuvant chemotherapy should be the same period, the treatment should be synchronized with the chemotherapy treatment, as an objective description of the problem, usually not less than 2 cycles of chemotherapy (42-56 days). Pain or symptoms of blood and other drugs should improve the mechanism of drug action and the effective dose, as the case may be.
(4) observations: determination of drug treatment efficacy should be based on the primary purpose and secondary purpose to the establishment of key indicators and secondary indicators. Observed indicators should be emphasized authority, impartiality, specificity and objectivity. Recommendation: a more mature immune indicators and recognized indicators, such as NK cells, T cell subsets; evaluation of the anticancer drugs divided by the change of the main indicators of tumor may be associated with tumor detection Zhuojia indicators, such as CEA, CA19-9, CA port 5, etc. for reference, evaluation of living conditions in addition to using Kanorfsky, PS and other rating criteria, should pay attention to the subjects of self-evaluation.
(5) control drug: control drug commonly used positive control, positive control, randomized, double-blind, and should be known, effective, proven, safe drug. If, as radiotherapy and chemotherapy adjuvant in the absence of drugs of similar syndromes can be considered with placebo controls.
(6) administration of the program: the principles of cancer treatment drugs are not less than six weeks of observation in order to make a proper evaluation of efficacy, therapeutic efficacy should be determined in accordance with WHO tumor response criteria.
(7) Evaluation: anti-tumor medicine and the evaluation of chemotherapy drugs should be based on efficiency change is mainly on the tumor target. Chemotherapy to radiotherapy and chemotherapy to reduce poison damage caused by the human body as the main observation of indicators to assess. Advanced cancer patients with medication should be emphasized that comprehensive assessment should primarily depend on the outcome indicators, such as quality of life, survival, survival, etc., the observation of a greater degree of difficulty, but it does reflect the comprehensive effect of Chinese medicine.
(8) Study TCM: traditional Chinese medicine syndromes of antineoplastic agents should pay attention to distinguish the main symptoms second disease, particularly in conjunction with the syndrome should be treated in the main symptoms of the disease. Because Western medicine treatment of cancer patients often cancer patients will bring some damage caused by the production of a number of syndromes, such as post-operative blood loss, spleen and stomach after chemotherapy and radiotherapy heat Poison Yam, and thus these auxiliary agents can be replenishing qi and blood, spleen and stomach, while the traditional Chinese medicine and other treatment, "has died of disease, treating disease." The adjuvant may also be known as the prevention of drug use, drug use against damage by drugs to reduce the appearance of these syndromes.
(9) adverse drug reactions observed: anti-cancer drug research traditional Chinese medicine, oncology and chemotherapy side effects can be attenuated response to anti-cancer drug developed by WHO in acute sub-acute toxicity grading standards for reference, but also application of radiotherapy and chemotherapy the drug should pay attention to the toxicity of the chemotherapy drug adverse reactions and observations to distinguish as far as possible, therefore recommended that a separate group of 30-50 cases of simple drug to identify adverse drug reactions.
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