Clinical Obseravation And Experimental Research On Tongbi 2 Mixture Toxicity Of The Liver, Kidney And Gastrointestinal Tract

Rheumatoid arthritis is a disabling autoimmune disease, it can damage joints, its features mainly caused synovitis of the joint chamber, exudate, cell proliferation, granuloma formation, cartilage and bone destruction , caused the occurrence of irreversible damage, resulting in loss of joint function. Chinese medicine treatment of rheumatoid arthritis is effective, but its drug safety has not been widespread concerned, because of this, this study through clinical observation and experimental research on Tongbi 2 Mixture toxicity of the liver, kidney and gastrointestinal tract, provided some evidence for its safty use in clinic.Objective: To evaluate the Tongbi 2 Mixture toxicity of liver, kidney and gastrointestinal tract.Methods: This study is divided into two parts, clinical observation and experimental research, including:Clinical observations: Select 40 cases of RA patients, are in line with diagnostic criteria which was resived by the United States Institute of Rheumatology (ACR) in 1987 and the formulate criteria for inclusion, exclusion criteria of this study. Giving oral Tongbi 2 Mixture decoction to the patients for eight weeks, to record laboratory examination of the patients before and after medication, including erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, aspartate aminotransferase, alanine transarninase, urea nitrogen, creatinine, leucocytes, Platelets, hemoglobin, and observed the gastrointestinal discomfort and pigmentation of the patients.Experimental research: A total of 90 rats, no specific pathogens (SPF level) of pure SD mature male, divided into the normal control group, the high-dose mixture group and low-dose mixture group, the high-dose Celastrus group and low-dose Celastrus group, each with 18, each group was killed half rats after administration and drug withdrawal, observed the changes of the laboratory examination and the liver,kidney and gastrointestinal tract biopsy pathological changes between administration and drug withdrawal.Result:Clinical observations: After eight weeks of treatment, to compare the liver function (AST, ALT), renal function (BUN, CREA) and blood analysis (WBC, HGB, PLT) of 40 patients between before and after the treatment , there was no significant statistical difference (P> 0.05). Clinical observations found two cases of patients with AST, ALT increased which could return to normal after treatment, kidney function and blood analysis were normal; statistical analysis was consistent with the clinical observation, which indicated that Tongbi 2 Mixture has a high liver and kidney security. There was a total of 12 patients with different degrees of gastrointestinal reactions or gastrointestinal reactions increased, about 30 percent, which shows that Tongbi 2 Mixture has a certain gastrointestinal toxicity.Experimental Research: This experimental research showed that Tongbi 2 Mixture has no kidney toxicity. There was a certain toxicity on the liver and gastrointestinal tract, which could cause liver cells fatty degeneration and gastrointestinal mucosa erosion(P<0.05), but there was no significantly different between the high-dose and low-dose mixture groups(P>0. 05), and there was also no significantly different between the high-dose Celastrus and low-dose Celastrus group (P > 0.05), which indicated that there was no significant toxicity of the drug dose response relationship. Compared to the high-and-low-dose Celastrus groups and the high-and-low-dose mixture group, the former has more damage (P < 0.05), indicated that the compatility of dipsacus asper could reduce the Celastrus toxicity of the liver and gastrointestinal tract.Comprehensive clinical and experimental results, experimental pathology in the kidney biopsy found no obvious abnormalities, in line with the result of clinical observation. Experimental pathology in the liver could be found a mild fatty degeneration of the liver cells, but there was no significant statistical difference of liver function in rats, which was in line with the clinical observation result, indicated that liver toxicity should be alerted by clinicians. Because in the presence of mild liver cell degeneration, the indicators of liver function may be normal, which can be neglected by Clinical doctors easily. There was mucosa erosion in the gastrointestinal tract of experiment rats, in line with the clinical observation which show some patients have gastrointestinal reaction.Conclusion: Tongbi 2 mixture has no kidney toxicity , it can cause mild fatty degeneration of the liver cells and mucosa erosion of the gastrointestinal tract. Because of this, liver toxicity should arouse the vigilance of doctors, gastrointestinal tract toxicity should be cause our common concern. The compatility of dipsacus asper can reduce the Celastrus toxicity of the liverand gastrointestinal tract.