Chronic bone and joint infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ( 1 ) Western medicine diagnostic criteria for chronic bone and joint infection : acute limb infection or history of open trauma ; the course of disease was more than 3 weeks ; local redness and swelling, sinus ulceration can be accompanied by pus or exudate after prolonged unhealed ; white blood cells, CRP may be elevated or normal ; x-ray showed dead bone, dense bone formation or dead space, cladding. ( 2 ) Chronic bone and joint infection ( Fugu gangrene ) damp heat stasis syndrome TCM diagnostic criteria : course of not less than 3 weeks ; limb ( place ) pain, inability to move ; local swelling, burning, obvious tenderness and percussion pain, pus viscosity ; red tongue, yellow fur, pulse number. Patients with a single bone or joint non-specific infection of the lower extremity should meet the following inclusion criteria : ? In line with the above western medicine diagnostic criteria; ? In line with the clinical syndrome differentiation of damp-heat intrinsic in traditional Chinese medicine; ? Patients aged between 18-70 years old, men and women are not limited. ? Subjects informed consent, voluntary subjects, informed consent process in line with the provisions of the GCP.
Exclusion criteria
Exclusion criteria: ? Patients in critical condition ( such as complicated with specific infection, sepsis and sepsis, etc. ) or with surgical indications ; ? Special population : extremely obese people, pregnant women or lactating women, mental illness, long-term smoking population ; ? Special diseases : malignant tumor, immunodeficiency, allergic reaction and limb vascular disease ; ? Patients with severe primary diseases such as heart, cerebrovascular and blood system, liver function alanine aminotransferase ( ALT ) greater than 2 times the upper limit of normal value, renal function creatinine ( Cr ) greater than the upper limit of normal value ; ? Patients who had used the relevant Chinese and Western medicine for the treatment of this disease within 1 month before the group, which made it difficult to judge the efficacy of the drug ; ? Allergic constitution or known to be allergic to the drugs and their components used in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-36 quality of life score was used to evaluate the therapeutic effect.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The curative effect of TCM symptoms to determine the therapeutic effect;Laboratory parameters;Local infection recurrence and swelling and pain of the affected area; | — |
Countries
China
Contacts
Shanghai Jiao Tong University Affiliated Sixth People's Hospital