Производство лекарственных средств и ИМН соответствует международным требованиям стандартов GMP, ISO 13485

Научная публикация

Zhao Hongbin1, Hu Min2, Qiu Zhixing3, Li Linzhi1

(1. First Affiliated Hospital of Kunming Medical College, Orthopedics dept., Kunming 650032, China; 2. Kunming Health School, Kunming 650000; 3. First Affiliated Hospital of Yunnan Institute of Traditional Chinese Medicine, Massage dept., Kunming 650200)

Abstract: objective: to evaluate the long term therapeutic effect of Osteoking against protrusion of lumbar intervertebral disc. Method: adopt prospect and self control method, 37 cases of protrusion of lumbar intervertebral disc patients are taken take Osteoking, during the follow up of 4 years and 10 months, evaluate according to the VAS and National seminar summary clinical standard. Results: the goodness rate excellent ratefor follow up is 86.5%; VAS grade is less than before administration, the results are handled by statistics are brought through statistic test(P<0.05), the difference has statistic meaning statistic significance. Conclusion: the long term therapeutic effect of Osteoking against protrusion of lumbar intervertebral disc is satisfied.

Key words: protrusion of lumbar intervertebral disc; Osteoking, therapeutic effect.

Classification number: R681.5

Document code: B

Article ID: 1007-2349 (2006) 05-0003-02

Osteoking is originated from Yunnan province, the approval licensepermitNo. is Z20025103, formulated from pseudo-ginseng, ginseng, carthamus tinctorius and eucommia ulmoides.it is made from notoginseng, ginseng, safflower flower, eucommia bark and other ingredients according to the formula. Osteoking was used for the treatment of protrusion of lumbar intervertebral disc from 1997 and got the satisfied therapeutic effect, the completed report of 37 cases for 4 years follow up. The writer began to use Osteoking to treat protrusion of lumbar intervertebral disc from 1997 and received satisfied therapeutic effects.

1. Data and method

1.1 General data

Totally 37 cases, 16 cases for male, 21 cases for female; ages from 41 to 72 years old, 58.7 years old averagely; course of disease 8 months - 16a, 3 years and 2 months averagely. Among one case for L3-1, 20 cases for L4-5, 14 cases forL6 – S1, 2 cases for L1-5 combining L6 – S1. 5 cases for central type, 32 cases for lateral type, no free prolapsed. 37 cases are not nerve root canals narrow. 33 cases are lumbago with unilateral lower limbs pain, 4 cases are bilateral lower limbs pain. All of the cases are diagnosed with medical history, clinical physical examination, CT or MRI iconography examination. 37 cases have no mental disease, heart, lung, kidney insufficiency, no tumor medical history. All of the cases have been treated by 1 – 2 conservative treatments such as  traction, physical exercise therapy (massage), physiotherapy, sports therapy and block therapy and have been invalid. 4 years and one month – 6a for follow up time, 4 years and 10 months averagely.

1.2 Therapeutic method

Osteoking, manufactured by Yunnan Crystal Natural Pharmaceutical CO., Ltd., 25ml/bottle. Medication Directions: take orally 25mg once, shake well and take, take medicine once every other day, 12 days as a course of treatment, totally 24 days for 2 courses of treatment. One or two therapeutic methods can be assisted when taking medicine, such as traction, physical exercise therapy (massage) and waist back muscle practice.

1.3 Statistical method

VAS score value is indicated as`x±s, tested with t for difference before and after treatment, handled with SPSS10.0 statistical software.

2. Therapeutic effect criterion and therapeutic outcome

2.1 Therapeutic effect criterion

(1) Evaluated with VAS: according to the method of visual analogue scale, VAS, the score range is 0 – 10cm, 0cm indicates no pain, 10cm indicates the most severe pain. Record the score before administration and with follow-up visit.

(2) According to the clinical criterion of national symposium summary for lumbar instability and lumbar spinal stenosis, record the follow-up classification.

2.2 Therapeutic result

2.2.1 Evaluated with VAS, refer to table 1.

Table 1.  Change of VAS score before administration and when following up



VAS score

Before administration


7.6± 2.3

When following up


3.3± 0.9

We can see the score when following up is lower than before administration, the result is tested by t, t=2.935, p=0.032, P<0.05, the difference has the statistical significance.

2.2.2 Clinical effect

4 cases are excellent, 28 cases are good, 5 cases are bad. The excellent and good rate is 86.5%.

3. Discussion

Protrusion of lumbar intervertebral disc is normal clinically, the pathogenesis is mainly the mechanical compression by nerve root, inflammatory stimulation and autoimmune response, most patients can obtain the good therapeutic effect by non-surgical treatment, only partial patients can be considered the surgical treatment for no improvement after conservative treatment or repeated attack. There are lots of surgical treatment methods, such as lumbar nucleus pulposus enucleation, minimally invasive treatment, chemonucleolysis and intervertebral disc prostretic replacement. Except for the inherent risk, the surgical treatment can cause the compression of lumbar segment, obvious decrease of shear and torsional rigidity, and torsional strength by removal of nucleus pulposus and laminectomy, after microendoscopic discectomy, may cause the more severe sequela such as spine segment instability, obvious increased every direction activity of lumbar vertebra, decreased stability, small joint degeneration hyperplasia, narrowing and quickening of intervertebral space, vertebra small joint degeneration in advance, degenerative spondylolisthesis or spinal stenosis.

Non-surgical treatment plays a major role in the treatment of protrusion of lumbar intervertebral disc, with which 80% - 85% patients can be cured or respited temporarily. There are lots of non-surgical treatments for protrusion of lumbar intervertebral disc, traditional Chinese medicine has showed the unique effect for the treatment, and been safe, less adverse reaction, can be accepted by patients easily. Traditional Chinese medicine considers the pathogenesis is from liver-kidney deficiency, blood weakness, cold attack, blood stagnation, blocked main and collateral channels, loss of blood moistening and nourishing, stagnation leading to pain. Mostly applying the drug of promoting blood circulation to remove blood stasis and promoting qi circulation to relieve pain, compatibility of medicines of nourishing liver and kidney and promoting blood circulation to remove meridian obstruction. The drugs are researched by modern pharmacology research to have the action of anti-inflammatory, analgesia, spasmolysis, dilating vessel and reducing immunoreactivity. The clinical effect for protrusion of lumbar intervertebral disc by traditional Chinese medicine is definite, but the clinical effect evaluation for the treatment by traditional Chinese medicine reported by most literature, the result hasn’t handled with statistics, the follow-up visit after treatment is short term, seldom is medium and long term.

Osteoking, the new approval approved drug creativemedication originated for Yunan, called quick-acting bone fracture consolidant mixture before, based on the theory of Yi medicine aibu, bagong, baji, base, sky five elements, land five elements, human five elements and “qi producing everything”, formulated with pseudo-ginseng, ginseng, safflower carthamus and eucommia ulmoides,notoginseng, ginseng, safflower flower, eucommia bark  conform with the dialectical therapy of Chinese medicine treatment fracture activating blood circulation and supplementing qi, have the better curative effect for patients by clinical observation. With our 4 years and 10 months follow-up visit, the excellent and good rate can reach 86.5%. Analyzing the mechanism of the treatment for lumbar disc herniation, ginseng, pseudo-ginseng, safflower carthamus and eucommia ulmoides notoginseng, ginseng, safflower flower, eucommia bark can promote the microcirculation, add capillary permeability, be good for eliminating local metabolite, quicken the textile damage repair and edema absorption, reduce the inflammatory exudates stimulation to nerve endings, so that reach the effect of relieving swelling and pain. The long term reason for treatment of lumbar disc herniation should be studied furtherly.


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