Objective

2

To evaluate the short-term and long-term efficacy of Jingui Shenqiwan combined with three-stage syndrome differentiation on osteoporotic vertebral compression fractures (OVCFs) after operation

and its regulatory effect on biomarkers of bone metabolism.

Method

2

One hundred and thirty-five patients were randomly divided into control group (67 cases) and observation group (68 cases) by random number table. A total of 58 patients in control group completed the treatment (4 patients were exfoliated

2 patients were lost to follow-up

3 patients were eliminated); and 60 patients in observation group completed the treatment (3 patients were exfoliated

2 patients were lost to follow-up

3 patients were eliminated). Both groups patients were given calcitonin injection through intramuscular injection

20 u/time

1 time/week

for 12 weeks

calcium carbonate D3 chewable tablets (Ⅱ)

1 tablet/time

2 times/day

and alendronate sodium tablets

70 mg/time

1 time/week. Patients in control group got Bushen Jiangu capsule

4 grains/time

3 times/day. And patients in observation group got modified Jingui Shenqiwan combined with fracture three-stage symptom differentiation

1 dose/day. The courses of treatment in the two groups were 24 weeks

and a 24 week follow-up was provided. Before the operation and at the 12

th

and 24

th

week after operation

the short-term efficacy indexes

such as back pain

lumbar function

traditional Chinese medicine （TCM） syndromes and complications

were recorded. And the long-term efficacy indexes

such as recovery of responsible vertebral body

lumbar function

bone density and quality of life and incidence of 48 week re-fracture

were also recorded. Before and after operation

levels of bone alkaline phosphatase (BALP)

osteocalcin (BGP)

tartrate resistant acid phosphatase-5b (TRAP-5b)

type I collagen carboxy terminal prepeptide (PICP)

type I collagen cross-linked C-terminal peptide (

β

-CTX) and

N

-MID-OT were detected

and the safety was evaluated.

Result

2

The comprehensive efficacy in observation group was superior to that in control group (

Z

=2.026

P

<

0.05). At the 12

th

and 24

th

week after operation

scores of back pain

lumbar function and TCM syndromes were all lower than those in control group (

P

<

0.01)

and score of lumbar function at the 48

th

week after operation was also lower than that in control group (

P

<

0.01). Bone density was higher than that in control group at the 24

th

and 48

th

week after operation

and score of quality of life was lower than that in control group (

P

<

0.01). At the 24

th

and 48

th

week after operation

Cobb angles were less than those in control group

and heights of responsible centrums (anterior

central

posterior) were higher than those in control group. Cumulative incidence of complications in control group was 51.72% (30/58)

which was higher than 26.67% (16/60) in control group (

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=7.784

P

<

0.01). The levels of BGP were higher than those in observation group at the 24

th

and 48

th

week after operation

and the levels of BALP

TRAP-5b

PICP

β

-CTX and

N

-MID-OT were all lower than those in control group (

P

<

0.01). And there was no side effect relating to Jingui Shenqiwan.

Conclusion

2

Modified Jingui Shenqiwan combined with fracture three-stage symptom differentiation can reduce the symptoms of back pain and promote the recovery of lumbar function

with a significant short-term comprehensive efficacy. In the long term

it can improve the strength of responsible centrums

restore the anatomical structure of injured centrums

increase the bone density of centrums

further improve the lumbar function

reduce the occurrence of complications

regulate the markers of bone metabolism

and improve osteoporosis.