| Refractory acute leukemia (RAL) is a tough problem in clinical treating. The first causation lies in the formation of multidrug resistance (MDR) in leukemic cell during chemotherapy process. There are no satisfactory clinical treating drugs now to aim directly at MDR. Present reversal agents of drug resistance in Western medicine are limited in clinical application because their organ noxious property is serious and only have single effect target.Our recent basal research confirms that the alkaloid extracted from Thurberg Fritillary Bulb, a frequently used Chinese medicine with function of eliminating sputum and removing stasis, possess the biological activity of reversing MDR in some vitro and animal trials, can increase the density of chemotherapeutics in leukemic cell and degrade the expression of Pgp. Clinical preliminary experiment also confirms that the complete remission (CR) rate of treat group using routine chemotherapy combined with Thurberg Fritillary Bulb flour is notable higher than control group. Especially the clinical remission rate of refractoriness and palindromic AL patient are more excellent. Based on above-mentioned findings, in order to systematically evaluate the clinical curative effect of Thurberg Fritillary Bulb combined with chemotherapy in the treatment of RAL, we substituted Thurberg Fritillary Bulb crude drug powder with Thurberg Fritillary Bulb grains cut crude drug. Taking RAL patients as object and clinical remission rate as main evaluation indicatrix, we instituted consistent clinical research schema and curative effect appraisal denom and carried out multicentre clinical observation.Thesis data came from eight third class grade A hospitals including 72 RAL cases observed from 04, Jan to 05, Feb. Among them, 2 cases discontinued treating automatically, 6 cases had no complete data. There were 64 cases total that can calculate curative effect. This test adopting random, double-blind and ambi-imitation method. Both treat group and control group are taking Chinese medicine grains cut crude drug. Because the test is still not done, it's impossible to expose and it's hard to discriminate treat group and control group. So we can only calculate curative effect according to group. Preliminary clinical finding demonstrates that clinical CR rate is 34.4%, effective power rate is 62.5%. The result is alike to domestic documents about RAL (102 cases) and abroad documents (68 cases).Comparing with domestic and abroad records, this research has some innovations. One is that it's the first domestic study of clinical curative effectthat interferes mainly with Chinese medicine in RAL ambi-chemotherapy stage. At the same time, it systematically evaluates the clinical curative effect and adverse effect of Chinese medicine combined with chemotherapeutics in treating RAL. Another is that taking Pgp as an exploration detection target. Furthermore, using random, double-blind and multicentre method make this test possess conspicuous confidence. The third one is that its findings will show us the direction of our subsequent clinical research. If the test procures the expectant consequence, it will have significant practical importance and potential value of practicability in developing the theory of phlegmatic stagnation in the aspect of the occurrence of MDR in RAL, enhancing the curative effect of RAL and making more patents profit from it. All together, it's capable to change the passive appearance that there are no appropriate drugs aimed at RAL. |
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