The principle of anti-tumor synthetic drugs

By | April 24, 2012

The principle of anti-tumor synthetic drugs, anti-tumor drug in clinical trials, new drugs before the trial method is not national unity, or misjudge the efficacy of a drug to give up too early and effective new drugs are not rare. With nearly 20 years, recommended to the increasing number of clinical drugs, clinical trials of new drugs in many countries have norms, WHO and the European and American countries have begun ICH try, but there are still many problems to be solved and needs attention:
1. Drug test required drug testing of single, clear its real effect, so that is covered by other therapies in the late 50's, Japanese scholars were dissolved sarcoma adriamycin (sarcomycin) study, combined with radiotherapy applications, and that very effective , but soon proved no objective effect of the drug, only symptomatic treatment. In fact, the drug should be based on the drug-sensitizing agents to verify the design of clinical trials in need of special design, the role of positioning is very important.
2. To overcome the toxicity of cancer chemotherapy chemotherapy drugs are often abandoned because of toxicity. Cisplatin as the first listing of platinum drugs, may cause kidney damage because of its more than 10 years but can not be used, in a later treatment by strong hydration to prevent kidney damage after becoming one of the basic anticancer drugs. The same heterocyclic amines and phosphoric acid with doxorubicin are also measures for the prevention of adverse reactions after being widely used in clinical.
The principle of anti-tumor synthetic drugs 3. Should not be based on objective indicators of feelings of efficacy by the private sector to develop as many anticancer drugs because the majority of patients believe that "effective" and to draw attention, but must be verified through clinical trials and in clinical trials should be to observe the effect as the main indicators of the objective. As the late 70 century, foreign to amygdalin (vitamin B17 or Laetrile, Amygdalin) as an effective anti-cancer drug approved in 27 countries, the drug's legitimate use of the U.S. National Cancer Institute (NCI) organizations in 1978 multi-center clinical trials, clinical trials through the observation of 178 cases, there is no proof of efficacy of the drug. Concluded that "the United States today amygdalin is a serious shortage of safe and effective to ensure that health-damaging counterfeit drugs."
4. Note that exclude the impact of prior treatment in the treatment of malignant tumors, its efficacy is often needed between the intervals shown, especially radiation therapy, in clinical trials of observation with particular attention. 50 of the last century, the late Shen pill is the treatment of esophageal cancer patients after radiotherapy applications, and its "effective" radiation is markedly time. General requirements for clinical trials of new drugs, at least in radiotherapy, chemotherapy, biological therapy 1-2 months after the interval before the start.
5. Seriously I clinical trial phase I clinical trial is a new drug for safety and tolerability study of phase clinical trials for the dose of the basis, it is very important and the most easily overlooked. Hydroxyl (base) application of camptothecin Although more than 15 years, but because I did not do clinical trials, clinical drug metabolism insufficient information, the conventional dosage is 200 tons, IV every other day, but applied to 40 tons, IV, 1 times / week, it seems not yet reached the MTD (maximum tolerated dose or minimum toxic dose). Some foreign anticancer drugs in Phase I clinical trial, or even years after listing, re-I clinical trials, such as cyclophosphamide gaze intently gum, initially recommended dose is 200 tons, IV, every other day, and the current is generally 400-600mg / m2, a, 1 times / week. Card uranium originally recommended dose is 300mg/m2, iv, every 3 weeks. The recommended initial administration of taxanes is 135 -175mg/m2, administered once every 3 weeks; and found that in practice 1 time per week dosing adverse reactions decreased, while the effect of a certain improvement of taxane week administration as an important issue currently being studied.
The principle of anti-tumor compound classes, 6. New drug should be effective against cancer tumor spectrum of Test Most scholars believe that in order to determine the value of the clinical use of cancer drugs should be used for broad-spectrum, reported in the literature should also be clear that in certain conditions The following results, and not necessarily conclusive, and some yet to be further research and evaluation. Such as methotrexate, has been considered effective only for acute leukemia, breast cancer was found accidentally in the human chorionic gonadotropin in urine of patients affected, began to try and get the treatment choriocarcinoma outstanding results. While the high dose methotrexate therapy in osteosarcoma also occupies an important position, the efficacy of a wide range of tumors that are found in the spectrum of tests.

Leave a Reply

Your email address will not be published. Required fields are marked *