Zheng Zhiwen1 Zhu Junchen 2
(1 An Hui University of Traditional Chinese Medicine, Hefei City, Anhui Province 230038; 2 Department 1 of Orthopaedics, 2nd Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei City, Anhui Province, 230061)
Abstract: Objective e: To explore the effect on serous inflammatory cytokines IL-1β、TNF-α of 34 patients with knee osteoarthritis （KOA）by acupotome lysis. Method: Randomly divided 65 KOA patients into the treatment group and control group. Through comparison, test clinical effect of Acupotome Lysis on KOA. Result: IL-1β、TNF-α of treatment group and control group decreased after treatment（p<0.01，p<0.05）, in which treatment group decreased distinctly（p<0.01）. Compared treatment group with control group after treatment, and the differentiation is distinct（p<0.01）. Conclusion: Acupotome lysis is able to decrease effectively serous IL-1β, TNF-α of KOA patients, thus having more favorable efficacy than that of traditional treatment.
Key words: knee osteoarthritis; acupotomy lLysis; IL-1β; TNF-α ;content
Chinese Library Classification: R246.2 R363 Document code: B
KOA is a chronic arthritis featured articular cartilage degeneration and loss and joint edge and the subchodral bone regenereation, whose starting position is cartilage. This is the frequently-occurring and stubborn disease among the old. Epidemic investigation shows that KOA occurrence rate in the group over age 55 was 80% according to general X ray survey.  The clinical manifestations are knee pain, stiffness, moving limitation, friction noise while moving. KOA belongs to knee paralysis disease in TCM and is treated with nonsteroidal anti-inflammatory drugs, intra-articular injection of lubricant, aupuncture, moxibustion and tuina. But it has long course, repeated symptoms and unfavorable efficacy. Treatment with operation will produce heavy trauma and expensive cost, which cannot be accepted by many patients. A great number of clinical cases of acupotome effectively applied to this disease were reported lately and the mechanism has been under basic research and clinical exploration. But mechanisms are various and lack objective scientific data. The experiments showed IL-1β、TNF-α could stimulate the synovial cell to secret prostaglandin E2, which generated MMPs to inhibit the synthesis of collagen type II, playing key role in the onset and progress of osteoarthritis.  34 cases of acupotome Lysis applied to KOA in the Orthopaedics Department 1 of 2nd Affiliated Hospital under An Hui TCM University were contrasted to 31 cases of sodium hyaluronate injection group. Through observing variation of serious IL-1β、TNF-α, the report were made as follows:
1.Data and Method
1.1 General data
65 KOA cases were from the Orthopaedics Department 1 of the 2nd Affiliated Hospital under An Hui TCM University during Oct. 2012 to Oct. 2013. The patients involved agreed to participate in this research and signed the Inform Consent Form. 65 KOA cases who are appropriate to the inclusion criteria were randomly divided into 2 groups: 34 cases in the acupotome treatment group, 19 male cases and 1 5female cases, aged between 41 and 76, and the averaged age is 57.6±13.4. The disease courses were 0.3-15 years, with averaged years of 8.0±5.9. 31 cases in the control group, 14 male cases and 17 female cases, aged between 40 and 74, and the averaged age is 56.2±14.1. The disease courses were 0.5-14 years, with averaged years of 7.2±4.6. The sex, age and disease course contrast between 2 groups showed no significant difference（P>0.05）, which is comparable.
1.2 Diagnosis, Inclusion and Exclusion criteria
This research applied KOA Diagnosis, Inclusion, Exclusion and curative effect criteria in 2007 < Guide for diagnosis and treatment of osteoarthritis>
1.2.1 Diagnosis Criteria
（1）persistent knee pain for one month；（2）cool, refreshing and sticky synovial fluid（more than twice），WBC<2000/ml；（3）X ray（standing or weight load）indicated the narrowing in inter-joint space, subchondral bone sclerosis and（or）cystic degeneration, formation of joint marginal osteophyte；（4）middle-aged and old patients（≥40years）；（5）morning stiffness≤30min；（6）Bone fricative（feeling）while moving combined with clinical, laboratory and X ray test，and if the symptoms fits into 1+3 or 1+2+5+6 or 1+4+5+6, KOA could been confirmed.
1.2.2 Inclusion Criteria
（1）fit into the above diagnosis criteria；（2）patients aged between 40 and75;（3）Not treated by drugs or other therapies for 2 recent weeks；（4）patients who signed the Research Inform Consent Form。
1.2.3 Exclusion Criteria
（1）acute knee joint injury, knee tuberculosis, tumors, rheumatic and rheumatoid arthritis, etc；（2）women who had lactation, pregnancy or were prepared to have pregnancy；（3）allergic constitution and (or) allergy to varied drugs；（4）patients with serious primary diseases of cardiovascular, cerebrova-scular, liver, kidney, hematopoietic or endocrine system and psycho- tics；（5）patients who were not able to insist on completing this research or accepting other therapies, thus affecting the efficacy.
1.3.1 Acupotome treatment group
The patients took supine body-position with their knees flexed at 60°. Pillows were put under the knees. Search for the pain spots for acupotome at affected patellar fabricius, inside and outside of the patellar ligaments, fat pads under the patellars, patellar lateral retinaculum, phil side and tibial collateral ligaments, goose foot capsule, check points of patellar ligament, inside and outside attachments of the gastrocnemius muscle, attachment points of biceps femoris, WeiZhong acupoint, inside and outside the edge of the starting point of anterior cruciate ligament and cruciate ligament. Marked pain points with markers. Selected 5-7 points for manipulation. After the conventional aseptic operation, sterile drapes were used. Applied 0.5% lidocaine to make local infiltration anesthesia. Select disposable HanZhang needle knife (4#, type I). According to the 4-step insertion, let the knife edge line to insert the acupoints with pressure along the parallel direction of muscle fibers. Longitudinal dredge stripping supplemented by transverse stripping. 2-3 cuts on scleroma, cords and slippery bursa. Withdrew needle knife when there is loose sense. After stopping bleeding with pressure, apply needle knife surgery paste to cover the operation region. Once for a week, 3 times a period.
1.3.2 Control Group
Knee joint cavity was intentioned with sodium hyaluronate. Patients sat or lied with supine body-position. After the strict aseptic operation and local infiltration anesthesia with 1% lidocaine, executed arthrocentesis, inserted until empty feeling occurred and withdrew without blood. If there was no resistance on push, withdrew hydrops articuli as much as possible, retained the needle position, 2 ml sodium hyaluronate was intentioned into cavity, then slowly and passively moved knee joint for several times to distribute sodium hyaluronate evenly on the surface of articular cartilage and synovial membrane. One injection in a week, 3 times in a period.
1.3.3 Test Serious IL-1β、TNF-α
To evaluate patients so as to assess the efficacy before treatment and after 3 times of acupotomes (made injections for 3 times). Made a follow-up visit in 3 months after treatment, reevaluated patients to observe the long term efficacy and to see whether there were subsequent adverse reactions. Before treating, fasting venous blood 5 ml was taken in the morning and was stored at -20℃ after the serum was segregated. Tested serious IL-1β、TNF-α with ELISA, which was made by JinMei Biology Lit. Cop. The test was strict consistent with ELISA instructions. Retest the patients in the same way 2 days after treatment.
1.3.4 Statistical Methods
Took the universal international statistic software SPSS17.0 to process the Data, and all the results were indicated with average ± standard deviation（±S）. First used homogeneity variance to test the data, and the Homogeneity test level α=0.10. Applied T-test to the data before and after treatment, and analyzed the data with factor analysis of variance after treatment, and the significance level α=0.05.
Before treatment, the comparison of IL-1β、TNF-α between 2 groups was no statistical significance(P>0.05), which showed that there was comparability between the groups. IL-1β、TNF-α of the acupotome treatment group and control group descended (P<0.01)and(P<0.05) after treatment, particularly the treatment group(P<0.01).
Table 1 IL-1β、TNF-α（x±s,pg/ml）before/ after treatment
Before treatment After treatment Before treatment After treatment
acupotome 20 57.20±11.18# 22.16±4.85★△ 84.44±15.37# 35.26±9.87★△
Control 20 52.17±12.77 40.01±6.42☆ 85.64±15.50 66.63±12.27☆
Note： # compare to control group before treatment p>0.05，★ acupotome treatment group before treatment compared to itsself after treatment p<0.01，△ control group before treatment compared to itself after treatment p<0.05，☆compare to control group after treatment p<0.01。
This research showed: Serious IL-1β、TNF-α were positively correlated with KOA symptoms; acupotome lysis group reduced serious IL-1β、TNF-α more effectively than sodium hyaluronate injection group.
As one of the earliest cytokines that has been researched, IL-1β belongs to hormonal peptides with target cells distributed widely throughout humanbody. IL-1β could play various roles in evoked response under the conditions of trauma, infectious inflammation, stress etc. There is little IL-1β in normal articular synovial fluid, while IL-1βcontent in arthrosis synovia of patients with knee osteoarthritis increased abnormally . IL-1 β is a powerful proinflammatory cytokine that is produced by activated macrophages, and it inhibits generation of osteoblast and stimulates regeneration of osteoclast. As an important inflammatory and immune cytokine, TNF-αprompts inflammatory cells to adhere and swim out and stimulates the release of TNF-α and adhesion molecules.
Therefore, IL-1β and TNF-α are essential media of destroying depredating inflammation of osteoarthritis cartilage. IL-1β and TNF-α not only restrain the synthesis of cartilage tissue components but involves in the destruction and decomposition of cartilaginous tissue, whose content is positively correlated with reaction extent of inflammation.
Comprehensive analysis, acupotome lysis could reduce the content of IL-1β and TNF-α in knee articular cavity and inflammation and prolong cartilage degeneration, which is significant in curing KOA and its recovery. Compared to traditional therapies, acupotome lysis is feasible and practicable, which has advantages of light trauma, less risk, improving the repair of cartilage, better long term effect. Acupotome lysis has TCM features of easiness, convenience, cheapness and effectiveness. It is expected that acupotome lysis will be one of significant KOA therapies and will widely spread in clinical application.
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