Abstract Objective : To confirm the role of a new drug-"Gu Chisan" in the treatment of adult periodontitis (AP). Methods : This study investigated 130 AP patients. In which, 100 cases constituted the experimental group and 30 cases were control group. Two weeks after basic periodontal treatment, the AP patients began to use the drug, twice a day, for 30 days. The clinical parameters were recorded at study 0 day, 30day and 90day. At the same time, investigated the side effects of Gu Chisan in 20 AP patients. Results: The use of Gu Chisan for 30 days, effected improvement in the extent of tooth mobility (TM) and in the bite force (BF). In the experimental group the results were significantly greater than in the control group (P<0.001), and these results maintained at 90 days. 30 days after treatment, the BF in experimental group was higher 2.26 Kg/tooth than in the control group. 60 days after discontinuation of drug therapy, the BF in experimental group was still higher 1.02 Kg/tooth than in the control group. During the study, Gu Chisan had no significant side effects to the heart、liver、kidney and blood system; and there were no visible changes on mucosal membrane. Conslusion: Gu Chisan was a safe and effective new drug to treat adult periodontitis.
Key words Gu Chisan, treatment, periodontitis

摘要 目的： 为了进一步验证固齿散治疗成人牙周炎的作用。方法： 本研究将130例成人牙周炎患者随机分为实验组(100例)和对照组(30例)。在牙周基础治疗结束后2周开始用药，每日两次，连续30天。记录用药前、用药30天和停药60天时的各项临床观察指标。同时观察了固齿散对20例成人牙周炎患者全身的影响。结果： 用药30天，试验组牙动度和咬合力的改善程度显著大于对照组(P<0.001)。这些结果一直保持至停药60天后。用药30天后，齿散组平均比对照组咬合力增加2.26公斤/牙，停药60天后仍比对照组增加1.02公斤/牙。临床试验过程中未发现该药对心、肝、肾及血液系统有明显的毒副作用，口腔粘膜也无明显的改变。结论： 固齿散用于治疗成人牙周炎安全、有效。
Periodontitis is a chronic destructive disease. It usually occurs in most teeth of an individual. The destruction of periodontal tissue is irreversible. The progress of disease can be blocked by currently used periodontal therapy. But the destroyed periodontal tissue is hard to fully recover. How to more effectively treat periodontitis has been the major problem encountered by clinical doctors. Gu Chisan is a new Chinese medicine, which has been produced by the college of stomatology, Hubei Medical University and Hubei Shennong's pharmaceutics Co. LTD. In the animal experiment and the primary clinical study^[1～3] , this drug had roles of antiinflammation、stanching and promoting reconstitution of bone. This study was designed to confirm the clinical efficacy of Gu Chisan treating adult periodontitis.

Material and methods
Patient selection: A total of 130 patients with adult periodontitis (AP) were followed longitudinally for 3 months. All patients met the following entry criteria:① 18～60 years old and at least 8 teeth with periodontitis. ② 4 teeth were selected in one patient and the teeth were at intervals. Two or more quadrants were needed. One or more teeth were molar. ③ The pocket depth on probing (PD) was 4～8mm, attachment loss(AL)≥2mm, Plaque index (PLI)≤2,Tooth mobility (TM)≥1. ④ The absence of any systemic medical problem. The woman was not pregnant or was not baby nursing. ⑤ No current use of drugs that could potentially affect the periodontal status and no antibiotic usage during the study. ⑥ Willingness to take part in the tests.
Clinical protocol: The 130 AP patients were divided into two groups: experimental group (55 males and 45 females, mean age 42.2 years) and control group (13 males and 17 females, mean age 42.6 years). All par-ticipants in the study gave informed consent to the experiment procedures.
Subgingival scaling two weeks later, the subjects were asked to use Gu Chisan powder or placebo (tooth powder). The powder was applied to the teeth, 0.5 gram, twice a day for 30 days. During the study, the patient was given ultrasonic scaling once a month, and used the same toothpaste and toothbrush.
Safeness:20 AP patients were randomly selected from the experimental group to confirm the safeness of Gu Chisan. Before and after using the drug, the white blood cell (WBC)、hemoglobin(HB)、glutamic-pyruvic transaminase enzyme (GPT) and blood urea nitrogen (BUN) were measured. 7 AP patients in the experimental group has an electrocardiogram (ECG) taken.
Clinical parameters: Oral hygiene was assessed using a plaque index^[4] . Gingival recession (RC) and probing depths were measured using a William periodontal probe. The tooth was probed four sites (mesiobuccal, direct buccal, distobuccal and direct lingual). The deepest site of the periodontal pocket was study site and recorded. The RC was recorded at same site. The tooth mobility (TM) was documented as outlined by Lindhe^[5] . The electronic bite force instrument (made in Japan) examined the bite force. The maximal bite force of the examined tooth was recorded. All the clinical parameters were recorded at study 0, 1 and 3 months. Table 1 shows the clinical parameters of subjects before study.

Table 1 The periodontal conditions of
the teeth before study (±s)

Statistical analysis：The statistical analysis of clinical data was performed using statistical package SPSS. The differences of clinical parameters between two groups were sought using independent samples t-test.

Results
At the end of study, all patients, including experimental group and control group, improved their clinical parameters significantly. When on comparing the extent of improvement of clinical parameters between two groups, the extent of improvement of clinical parameters in experimental group was significantly greater than in the control group. The detailed results are shown in table 2.

Table 2 The comparing of the improving extent of clinical parameters
between two groups. (±s)

* 0, Baseline; 1, First month; 3, Third month
a, P<0.05; b, P<0.01; c, P<0.001

30 days after application Gu Chisan, there were no significant changes in the patients' WBC、HB、GPT、BUN and ECG. In the experimental group ( 100 cases ), there also were neither any visible changes on the mucosal membrane, nor disorder in taste. Only two cases were excluded from the study because they could not stand the taste of the drug.

Discussion
Gu Chisan is a new Chinese medicine. It is refined from several traditional Chinese herbs. Our previous study showed that Gu Chisan had an anti-inflammatory role in treating adult periodontitis^[3] . This study, confirmed the previous results and further found that: although the TM of all patients reduced after treatment 30 days, the extent of improvement of TM and BF in the experimental group is significantly greater than in the control group (P<0.001). And these results maintained at 90 days. 30 days after treatment, The BF in the experimental group was higher 2.26 Kg/tooth than in the control group. On stopping using the drug 60 days later, the BF in the experimental group was still higher 1.02 Kg/tooth than in the control group. The rising BF in experimental group was significant.
The mechanism that Gu Chisan could reinforce teeth was unknown. In a laboratory study, Fan et al.^[2] found that there were some components in the Gu Chisan, which could stimulate the mitosis and enhance the DNA synthesis of human gingival fibroblast. It's well known that the fibroblast could take part in the reconstitution of bone. This may be the biological basis of Gu Chisan reinforcing teeth.
The baseline of this study was the time when subgingival scaling two weeks later performed. The subgingival scaling itself had a role in reducing inflammation. So, all patients showed the inflammation reaction lightened after treatment. In this case, the extent of improvement of PD and RC in the experimental group was still greater than in the control group. It is shown again that Gu Chisan had a function of anti-inflammation.
Fan et al.^[2] found that Gu Chisan had no cytotoxicity on human gingival fibroblast. In this study, the safeness of Gu Chisan in clinical application was investigated. During the study, the drug had not significant side-effect to the heart、liver、kidney and blood system. And also there were no visible changes on mucosal membrane. Most patients (98%) could stand the taste of the drug.
From the above results, it is demonstrated that Gu Chisan is a safe and effective new drug to treat adult periodontitis.

Reference
1 Fan Mingwen, Ling Junqi, Cheng Xiangrong, et al. A study of Zeng-Gu-San and observation of its primary clinical effects. Journal of comprehensive stomatology, 1994; 10(4): 195～198
2 Fang Mingwen，Peng bin，Luo Lingli. Effects of Gu Chisan on cultured human gingival fibroblasts. Chinese journal of stomatology, 1995; 30(5): 298～300
3 Xie Hao, Su Xia, Huang Zhiqiang, et al. The anti-inflammatory role of Gu Chisan in treatment of adult periodontitis. Journal of comprehensive stomatology, 1998; 14(1): 14～15
4 Silness J, Loe H. Periodontal disease in pregnancy: Ⅱ. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand 1964; 22:125～135
5 Lindhe J. Textbook of clinical periodontology. ed. 2. Munksgaard, Copenhagen, 1989; 317

[收稿：1999-05-28]