The Curative Effects, Security And Initial Investigation Of Mechanism About "Bushenguchiwan" Recipe To The Periodontitis

Periodontal diseases result from complex interplay between the etiologic agents. On the one hand, the specific bacteria i.n dental plaque and their products are initial factors for this disease. On the other hand, the occurrence and process of periodontal disease are regulated by some systemic host factors such as immune deficiency, endocrine disorder, etc. Traditional Chinese Medicine (TCM) believes, that the doctrine that "kidney deficiency and hyperfire is the intrinsic factor, and humid heat is the extrinsic factor" is. the etiology of periodontal disease. "BUSHENGUCHIWAN" is a kind of recipe to treat periodontitis specifically, advanced by Professor Ju-zhi ZHANG in 1980s, on the base of "LIUWEIDIHUANGWAN". With the history of about 20-year clinical application, it has been included by pharmacopeia of the People's Republic of China for five times, and been recorded as a kind of conservation spieces of TCM.Objective: The aim of this study is to elucidate the mechanism of "BUSHENGUCHIWAN" recipe, by evaluating the curative effects and security thoroughly, objectively, scientifically on "BUSHENGUCHIWAN" recipe to the patients with moderate or severe periodontitis (diagnosed as "Kidney deficiency and hyperfire" by TCM) through a 3-month and multicenter project, as well as investigating the impacts of "BUSHENGUCHIWAN" recipe and Gu-Sui-Bu (an ingredient of "BUSHENGUCHIWAN") on proliferation, alkaline phosphatase activity and ultrastructure of osteoblasts.Methods: This study involves two parts.The first one is a multicenter, randomized, blinded, parallel-controlled project. Four hundred and twenty-four patients with "Kidney deficiency and hyperfire"periodontitis, after supragingival scaling of full mouth and subgingival scaling of the index tooth and two adjacent teeth, were divided into two groups: the test group were given "BUSHENGUCHIWAN" treatment, while the control group were given "ZHIBAIDIHUANGWAN" (as the positive-control). Three months later, the curative effects of"BUSHENGUCHIWAN" were evaluated by investigating clinical indexes of periodontitis(GI,SBI,mobility degree,PD,AL), the symptoms of TCM and the density of alveolar bone. The security of "BUSHENGUCHIWAN" was estimated through comparing routine analysis of blood, routine analysis of urin, hepatic function, kidney function, blood-fasting sugar and the incidence of adverse effects.The second one is to observe the impacts of the concentrated "BUSHENGUCHIWAN" fluid and naringin (the effective ingredient of Gu-Sui-Bu) on proliferation, alkaline phosphatase activity and ultrastructure of osteoblasts. We separated and cultured osteoblasts in vitro from crinial bone of Spague-Dawley rats in tissue-culture ways, then evaluated the effects of the concentrated "BUSHENGUCHIWAN" fluid and naringin of Gu-Sui-Bu on the proliferation activity of osteoblasts with MTT, determined the alkaline phosphatase activity impacted by the concentrated "BUSHENGUCHIWAN" fluid and naringin of Gu-Sui-Bu with the methods recommended byIFCC, and surveyed the ultrastructure of osteoblasts under the high-resolution transmission electronic microscope.Results: In the first part of this study, the efficiency rate of clinical periodontal indexes was 83.49% in the test group, and 72.64% (by FAS analysis) in the control group, which implied that the former is better on this aspect(P＜0.05). There was no statistical significance on the efficiency rate of the symptoms of TCM, with 72.97% in the test group and 70.76% (by FAS analysis) in the control one. The data of imageology showed that both of them could increase the density of alveolar bone (P＜0.01) , but there is no statistical significance between two groups. There was also no statistical significance on the incidence of adverse effects.In the second part of this study, the cells gained from primary culture had the typical characteristic of osteoblasts, such as being positive in the stain of alkaline phosphatase. As for the concentrated BUSHENGUCHIWAN fluid, the results showed inhibitory action to the proliferation of osteoblasts, no promotion to the activity of alkaline phosphatase, even diminish when used with high concentration (0.1 g/L ) .The ultrastructure showed less organelle such as ribosomes and mitochondria, more vacuole of endochylema in the experimental group than in the control group, chromatin agglutination and augment in nucleus heteromorphism, which indicated the decrease in cell metabolism and protein synthesis of treated osteoblasts. While as for naringin of Gu-Sui-Bu, the results indicated inhibitory action to the proliferation of osteoblasts when used with high concentration (0.1 g/L-10g/L) , while promotion when low concentration (0.0001g/L- 0.01g/L) , and enhancement to the activity of alkaline phosphatase when used with concentration between 0.0001 g/L to 0.1 g/L. The ultrastructure showed more mitochondria, rough endoplasmic reticulum and ribosome in endochylema. The extremity of rough endoplasmic reticulum became a pool, and ribosome was on the surfaces of rough endoplasmic reticulum, which indicated apparent cell differentiation. On these grounds, we can draw a conclusion that cell metabolism and protein synthesis of osteoblasts were reinforced after treated by naringin of Gu-Sui-Bu.Conclusions; BUSHENGUCHIWAN had an advantage to ZHIBAIDIHUANGWAN on improving clinical indexes in "Kidney deficiency and hyperfire" periodontitis, and amending the symptoms of TCM. So its curative effect was sure, as well as the security. On the other hand, naringin of Gu-Sui-Bu reinforced the osteoblsast metabolism, which may play a critical role on the reparation and reconstruction of alveolar bone. But the concentrated BUSHENGUCHIWAN fluid has no promotion effect to the osteoblast metabolism. From above results, we can presume that BUSHENGUCHIWAN may generate the new active components after digestion and absorption, influence the immunity and endocrine network system by blood circulation.