臨床研究等提出・公開システム

Clinicopathological study on the efficacy of Cepharanthine for preventing salivary gland destruction in Sjogren's syndrome patients (Cepharanthine trial)

Cepharanthine trial (Cepharanthine trial)

14

The average age of the patients is 66.4 (10.3) years (53-89 years), and there are 3 males and 11 females. The mean salivary secretion was 5.20 (4.10) ml/10 min in the gum test and 0.60 (0.35) g/2 min in the Saxon test. From grade classification on the histopathology of the lower lip salivary glands, Grade 4 was found in 7 patients, Grade 3 in 1 patient, and unmeasurable in 1 patient. In many cases, the condition was relatively advanced.

Received therapy n=14 Stopped therapy n=4 Difficult to visit n=2 Poor compliance n=1 Refused futher tests n=1 Completed therapy n=10 Evaluable response to therapy n=10 Increased saliva n=10

During the study period, (1) 1 bone fracture, (2) 1 drug eruption, and (3) 1 hypersensitivity symptom were observed. They were hospitalized in the medical department (our hospital and other hospitals) and the symptoms improved. The symptoms of (1) was due to trauma, (2) occurred after oral administration of another drug (amoxicillin). Furthermore, the symptoms of (3) were diagnosed as the symptoms triggered by upper respiratory infection. These symptoms of (1)-(3) were not associated with oral administration of cepharanthine.

In this study, (1) improvement of salivary secretion, (2) decrease of CRP values, (3) decrease of lymphocyte infiltration, and (4) improvement of acinar structure of salivary gland were evaluated for comparison before and after the cephalanthine (6 mg / day) medication. (3) and (4) were evaluated from lower lip salivary gland histopathology of first time visit and 6 months after the cephalanthine medication. (1) the main evaluation item, the improvement of (2) (3) (4) was set as a secondary evaluation item. The analysis was carried out with Wilcoxon signed-rank test. (1) Improvement of salivary secretion. The gum test group was n = 8. The maximum saliva secretion after the cephalanthine medication was increased in all of these patiens compared to the first visit time, and significant improvement in saliva secretion was observed (P = 0.017). The study project expected 2.20 mL/10min as an increase in salivary secretion after the cephalanthine medication, but the increase of only 1.39 (1.14) mL/10min was observed. In the other hand, the Saxon test group was not analytical in only n = 2, but the maximum salivary secretion after the cephalanthine medication as compared to the first time visit was observed to increase. (2) Decrease of CRP values. No significant improvement was observed before and after the cephalanthine medication. (3) , (4) Decrease of lymphocyte infiltration and improvement of acinar structure of salivary gland It was observed to decrease the lymphocyte infiltration degree in 3 out of 10 patients. The improvement of the acinar structure destruction was not clear. No significant change was observed in 5 patients, and the exacerbation was observed in 2 patients.

This study suggests that cepharanthine may be effective in salivary glamd symptoms in patients with Sjogren's syndrome.

Sept. 09, 2020

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs061180072

Yamanoi Tomoko

Tokushima University

3-18-15 Kuramoto-tyo Tokushima-shi Tokushima, Japan

yamanoi.tomoko@tokushima-u.ac.jp

Yamanoi Tomoko

Tokushima University

3-18-15 Kuramoto-tyo Tokushima-shi Tokushima, Japan

+81-88-633-7352

yamanoi.tomoko@tokushima-u.ac.jp

Complete

Aug. 01, 2011

Interventional

non-randomized controlled trial

single blind

no treatment control/standard of care control

single assignment

treatment purpose

Outpatient 20 years or older who meets the diagnostic criteria of Sjogren's syndrome

1. History of hypersensitivity to cepharanthine
2. Serious ischemic heart disease
3. Bronchial asthma and chronic obstructive pulmonary disease
4. Blockade of gastrointestinal tract and bladder neck
5. Epilepsy
6. Parkinsonism or Parkinson's disease
7. Patients with iritis
8. Pregnant women, lactating women or possible pregnancy
9. Others inappropriate

Both

SjS

Cepharanthine (6 mg / day) administration

To evaluate (1) salivary secretion improvement after taking cepharanthine (6 mg / day) compared with the first time in patients with Sjogren's syndrome.

(2) Improvement of CRP value.
And in the histopathology (3) Improvement of lymphocyte infiltration, (4) Improvement of acinar structural destruction.

+81-88-633-7958

Mar. 11, 2019

none