Anticancer drugs – Participation of a capsule, (1) Composition: Participation of a capsule is extracted from Ginseng tetracyclic triterpenoid saponins A.
(2) Functions: Ginseng Dabu strength, solid off the fluid, since ancient times to the drug treatment of deficiency. Can be the yin yang in the yin within the yang, encouraged by the spleen and stomach, qi congestion. Qi deficiency of the drug for lung, liver and gastric cancer and breast cancer patients based variety.
484 cases of cancer patients by phase clinical trial conducted research, confirmed by statistical analysis, the Senate combined with chemotherapy drugs for a capsule attenuated the synergism effect on the tumor Qi deficiency symptoms significantly improved clinical effect, can improve immune function and quality of life, weight gain, protection of white, non-toxic side effect is a safe and effective medicine for a class of drugs.
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.
3. Need to pay attention to the problem
(1) test purposes to be clear: According to the clear positioning of drug prescriptions, which determine the treatment of cancer adjuvant treatment of drug or 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) patient selection:
the number of cases: synergistic antitumor and chemotherapy drugs, the treatment group of single disease (with tumor) 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.
Anticancer drugs – Participation of a capsule, (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.
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