| ObjectiveTo measure the LD50 of the Re Bi Granule and the safety and Side effect of the prescription. Investigating the therapeutic effect of the Re Bi Granule in treatment rheumatoid arthritis (Traditional Chinese Medicine consider that the damp-heat accumulated in the body).To evaluate the effect of the prescription on decreasing tumefaction, relieving pain, and improving the joint function. It will afford the basis of function about the Re Bi Granule in the clinical therapy. MethodThe acute toxicity experiment: The Re Bi Granule decoction is condensed and its density is 200%. The mouse can accept the biggest physical volume that is 0.4ml/10g(40ml/kg), so it was the biggest dosage (maximum dosage) of the decoction to infuse about 80g/kg. Preparing 30 mice (18g-22g), amount of male and female is equal .The decoction were infused the stomach of mouse, tow times a day , total amount measures 160g/ kg in 24 hours, Observing 7 days continuously, and recording the symptom of mice ,such as death, activity, erection of hair, weight diarrhea etc.Clinical observation: The 60 Rheumatoid arthritis patients that belongs to the damp-heat type divided into 2 groups randomly as follows: Experimental group(Re Bi Granule p.o 2g t.i.d ), comparative group(Loxoprofen Sodium Tablets, p.o 60mg t.i.d ). After 4 weeks treatment, examining patients' blood routine, urine routine, stool routine, liver function, kidney function, electrocardiogram, the blood sink( ESR), rheumatism factor( RF), the C respond protein( CRP) etc. Observing the main clinical symptom, and recording the side effect. Evaluating result and comparing the curative effect and the safety of two medicines. Result1. Its toxicity is very low. But didn't determine the LD50, its maximum dosage is 160g/kg/d that is of 800 times of human, and showing that the drug is safety.2. Curative effect: the total effective rate of experimental group and comparative group was 76.67% and 83.33%, respectively after 8 week treatment. There were no statistically differences between two groups (P>0.05).3. Symptom: the total effective rate of experimental group and comparative group was 76.67% and 83.33%, respectively after 8 week treatment. There were no statistically differences between two groups (P>0.05).4. It improved about the main clinical symptoms and physical including count of joint swollen, rest pain, average grasp force of both hands of 2 groups. The result of each index before and after therapy was significantly different between tow groups after weeks (P<0.05).5. Result of indexes in laboratory test was improved after 4 weeks. The change rates of blood sedimentation rate between 2 groups were significantly different (P<0.05).6. Both medicines had no obvious effect to the heart function, hepatic function, renal function, Blood-Rt, Urine-Rt and Stool-Rt of all patients. All adverse reaction could be recovered by discontinuation or keeping on treatment. the adverse reactionoccurring rate of experimental group and comparative group was 20.00% and 3.33%.The differences of incidence rate of adverse reaction between two groups were no statistically significant (P<0.05). ConclusionThe Re Bi Granule is safe and nontoxic. It can improve the clinical symptom, physical signs and laboratory test indexes of patients with active rheumatoid arthritis. The incidence rate of adverse reaction of Re Bi Granule is obvious low in comparative group .That advantage of the Chinese herbal medicine is obvious, and it is worth generalizing to clinical use. |
PDF Full Text Request