Objective

2

To investigate the clinical efficacy of Shashen Maidongtang plus total glucosides of paeony capsule on primary Sjogren's syndrome (pSS) based on the theory of fluid metabolism.

Method

2

In this study

84 patients of Qi-Yin deficiency type pSS admitted in Zhengzhou Chinese Medicine Hospital from January 2018 to January 2019 were divided into observation group (42 cases) and control group (42 cases) on the basis of random number table. The control group was orally given total glucosides of paeony capsule and iguratimod tablet

while the observation group was orally given Shashen Maidongtang combined with glucosides of paeony capsule. After 3 months of continuous treatment to all subjects

the clinical efficacy was evaluated

and side effects were recorded. Before and after the treatment

the saliva flow rate and basal tear secretion Schirmer I test (SIt) value were measured

European League Against Rheumatism Sjogren's syndrome patient reported index and Sjogren's syndrome disease activity index (ESSPRI and ESSDAI) were scored

the erythrocyte sedimentation rate (ESR) was determined by Westergren

and the levels of serum rheumatoid factor (RF) and immunoglobulin (Ig) G were tested by immunoturbidimetry and rate scattering turbidimetry

respectively.

Result

2

The overall effective rate of the observation group was 90.48% (38/42)

which was much higher than 69.05% (29/42) of the control group (

χ

2

=5.974，

P

<

0.05). After treatment

the saliva flow rates and SIt values of both groups got significantly increased compared with those before the treatment (

P

<

0.05)

but the saliva flow and SIt of the observation group were significantly better than those of the control group over the same period after treatment (

P

<

0.05). After treatment

both groups had a great decrease in ESSPRI and ESSDAI scores compared with those before the treatment (

P

<

0.05)

and the above scores of the observation group were dramatically lower than those of the control group over the same period (

P

<

0.05). After treatment

ESR

serum RF

and IgG levels of both groups were significantly lower than those before the treatment (

P

<

0.05)

and the observation group showed higher levels of ESR

serum RF and IgG than the control group over the same period after treatment (

P

<

0.05). Side effects were few and mild in both groups.

Conclusion

2

In treating patients of Qi-Yin deficiency type pSS

Shashen Maidongtang plus total glucosides of paeony capsule was proven to be effective generally. It could significantly inhibit excessive inflammation and hyperhumoral immunity in patients

and control their disease activity. This may be related to the effect of Shashen Maidong decoction and its decomposed recipes in correcting body fluid infusion and metabolic disorder in patients of Qi-Yin deficiency type pSS.