| Primary sicca syndrome (pSS) is considered to be a chronic inflammatory systemic autoimmune disease predominantly affecting the exocrine glands. Dryness of the mouth and eyeball is commonly seeing, and the pSS could involve many body systems. The patients usually have various of clinical features and varying severity, affect patients'life seriously. This disease have slow progress, and the symptoms are not specific enough to take patients'attention to the hospital, even until when it appeared the system damages.The effective treatments and drugs for the pSS in the Western medicine are in shortage.And is mainly about symptomatic treatment. Glucocorticosteroid or immunosuppressant could be used if the patients have the symptoms such as lung lesion, vasculitis or pseudo-lymphoma. And these drugs have some side effects, and efficacy for the treatment of this disease is not yet sure.Traditional Chinese Medicine has significant effects not only on relieving the symptoms, controlling the severity of the disease and reducing side effects of western drugs, and also it can reduce the recurrence rate of this disease and could improve the quality of patients'life.This research summarized the clinical effects of professor Lu Zhi-zheng who firstly put up "Dry Bi" as a disease name of TCM, treating pSS with the methods of supplementing qi and nourishing yin and moistening the body by cool and sweet herbs 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 61 patients who are consistent with the standard of pSS which is Qi and Yin deficiency. There are two groups:treatment group 30 cases and control group 31 cases.Each group was given a two-stage treatment of drug (Dryness-Moistening Drink) and the contrast drug (simulated agent). The treatment period is 6 weeks and a elution period for 2 weeks time between the two stage of the treatment. The total course is 14 weeks. Evaluating the total cur at ive effect, the TCM pattern effects, the improvement and effects of dry eyes, the improvement of Schirmer I test and the laboratory improvement of patients, the results are as follows:(l)According to the standard, 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%, which proves that the Dryness-Moistening Drink has obvious treating effect in controling the pSS. (2)The syndromes scores in two groups are both markedly improved. The total effective rate of the treatment group is 86.67%, the control group is 87.10%, and the treatment group plus the control group is 86.89%.(3)For the improvement of dry eyes symptom, the effective rate of the treatment group is 86.67%while the control group is 83.87%and the treatment group plus the control group is 85.25%, which shows that the dry eyes symptoms scores of patients from both group are obviously improved. And through the comparison between different stages dry eye symptoms integral, after 2 weeks of elution period, there is no sign that the dry eye symptoms integral in treatment group had repea.tedly at the end of the research. It's mean that Dryness-Moistening Drink to patients'dry eye symptoms has the stable improvement action.(4)After the treatment, there isn't have obvious difference of Schirmer I test between the treatment group and the control group, which means the degree of the effects on improving the tear secretion of the patients from two groups by Dryness-Moistening Drink are quitely the same. The comparison of Schirmer I test between 0 week treatment and 14 week treatment has obvious statistical significance which means Dryness-Moistening Drink in improving the tear secretion of the patients from both groups.(5)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. In treatment group, compare with the basel ine before treatment, the serum RF level is obviously lower in 14 weeks whi le the changes are not obvious in other indices. So, Dryness-Moistening Drink have obviously improved function in lowing the serum RF level of the treatment group. And not have obviously improved in other indices, we need further observe.(6) After the treatment, there are no significant differences in blood, urine, stool examination and biochemical index have been found in the patients from both groups.It indicates that Dryness-Moistening drink is safe and has no side effects in treating pSS.This topic have confirmed that the herbs of strengthening the body resistance have obvious curative effect in treating pSS.Using the herbal treatment pSS should get further application and spread, and to regulate the clinical treatment of patients with pSS. This study really made a solid step for Chinese medicine go towards the world, also for further study in pSS and its Chinese patent medicine laid a good foundation. |
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