Lu Zhi Is Professor Qi And Nourishing Yin On The Treatment Of Primary Sjogren's Syndrome Dry Mouth And Efficacy Study

Primary sicca syndrome (PSS) is considered to be a chronic inflammatory systemic autoimmune disease affecting the exocrine glands and predominantly the salivary and lacrimal glands. It is one of the stubborn diseases in clinical. Characterized by dryness of the mouth and eyeball, recurrent parotid gland swelling and joint pain, the patients usually have various of clinical features and varying severity. The PPS could affect many body systems, such as the skeleton and the muscle, the lung, the kidney, the enteron, the blood vessels, the nerves and other tissues and affecting the health of patients.In the treatment, the Western medicine treatment of the PSS is mainly symptomatic treatment. Glucocorticosteroid or immunosuppressant could be used if the patient shows the symptoms such as lung lesion, vasculitis or pseudo-lymphoma. However, these drugs have some side effects, and efficacy for the treatment of this disease is not yet sure. In conclusion, the effective treatment methods and medicines for the PPS are in shortage and further exploration is required.Traditional Chinese Medicine has significant effects on relieving the symptoms, controlling the severity of the disease and reducing side effects of glucocorticosteroid or immunosuppressant, and also it can reduce the recurrence rate of this disease and improve the quality of patients'life.Lu Zhizheng, a national famous experienced TCM doctor, firstly put up "dry Bi" as a disease name of TCM and treated the disease by syndrome differentiation very early. During the recent 20 years, he got a lot of precious experiences and good clinical effects. This research evaluated the clinical effects of the treating method of supplementing qi and nourishing yin and moistening the body by cool and sweet herbs through a scientific and reasonable way under the guidance of professor Luzhizheng to reveal the internal law of treating this disease with Chinese medicine.The clinical trial method of this program includes prospective, randomized, crossover treatment of drug, placebo controlled, and single blind.This study collects 66 patients who are consistent with the standard of Dry Bi which is Qi and Yin deficiency.66 cases are randomly divided the into treatment group and control group and 30 cases each group were given a two-stage treatment of drug (Lu's Dryness-Moistening Drink) and the contrast drug (simulated agent). The treatment is for 6 weeks and a washout period for 2 weeks time is between the two stage of treatment thus the total course of treatment is set to 14 weeks. Evaluating the total curative effect, the TCM pattern effect, the improvement and effect of dry mouth, the improvement of unstimulated mixed saliva flow rate, Laboratory improvement of the patient, the results are as follows: 1. It has been proved in the research that after 14 weeks'treatment, two groups of patients have gained a marked effect, the effective rates of the treatment group, the control group and the treatment group plus control group are all not less than 90%. The case number controlled in clinical in the treatment group is 4, and the control group 3. Totally 7 patients are completely controlled within the 2 groups.2. After the total period of treatment, the syndromes scores in the 2 groups are both markedly improved. The total effective rate of the treatment group is 86.67% while the control group 87.10%, and the treatment group plus the control group 86.89%, which proves that the Dryness-Moistening Drink has obvious treating effect especially the effect of improving the TCM syndrome scores of PSS.For the improvement of dry mouth symptom, the effective rate of the treatment group is 90.00% while the control group 90.32% and the treatment group plus the control group 90.16%, which shows that the dry mouth symptoms scores of patients from both group are obviously improved.After the treatment, there isn't obvious difference' of unstimulated mixed saliva flow rate between the treatment group and the control group, which means the degree of the effects on improving the saliva flow rate of the patients from the two groups by Dryness-Moistening Drink are quite the same. The comparison of unstimulated mixed saliva flow rate between 0 week treatment and 14 week treatment has obvious statistical significance which manifests the obvious effect of Dryness-Moistening Drink in improving the saliva flow rate of the patients from the treatment group. For the control group, the comparison of unstimulated mixed saliva flow rate between 0 week and 14 week does not show obvious statistical significance.After the treatment, the serum RF level of the treatment group is obvious lower than it of the control group while no significant differences of the other immune indices between the two groups is found. Compare with the baseline before treatment, the serum RF level is obviously lower 14 weeks after treatment while the changes are not obvious in the other indices.6. After the treatment, no significant differences in blood, urine, stool examination and biochemical index of the patients from both group have been found. It indicates that Ru' s Dryness-Moistening drink is safe and has no side effects in treating PSS.7. Treatment group:14 weeks after treatment the serum ESR and are significantly lower with p<0.05 which shows the statistical significance while no significant differences are found in the rest indices. Control group:serum ESR are significantly lower with p<0.05 while the serum CRP are not significantly changed.