RU2519120C1 - Method for prevention of skeletal complications in patients with lytic long and irregular bone metastases - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: osteo- and vertebroplasty are performed; introducing bone cement follows introducing a composition prepared as follows: Veroklast 4 mg dissolved in water for injections 1 ml with the prepared solution mixed with the osteoplastic material KollapAp-G 2 ml in the form of gel into a lytic lesion.

EFFECT: improving the patient's quality of life ensured by stabilising the involved segment, inhibiting the bone lysis and reducing the pain syndrome.

1 ex

Description

The invention relates to medicine, namely to oncology, and can be used in the complex treatment of patients with malignant tumors having lytic metastases in flat and mixed bones.

It is known that the skeletal system is one of the most affected in various oncological diseases, for example, with breast, prostate, kidney, thyroid, lung cancer. The course of the metastatic tumor process in the skeleton, especially with lytic forms, is often complicated by the occurrence of a pathological fracture. So, for example, with the localization of metastases in the spinal column, a pathological fracture may be accompanied by compression of the spinal cord, impaired function of the pelvic organs and, as a rule, there is a pronounced pain syndrome. These complications lead to impaired activity and significantly reduce the quality of life of patients.

Known methods of treating lytic and mixed tumor foci in the spinal column, pelvic bones are percutaneous vertebro and osteoplasty. The essence of these manipulations is the transdermal injection of bone cement based on polymethylmethacrylate into the lytic lesions of bone bones, which has the property of polymerization, thereby creating stability in the affected segment after its introduction, reducing the risk of pathological fracture and the degree of pain syndrome (Bukharov L.V. Abstract of dissertation for the degree of candidate of medical sciences. Minimally invasive methods in the treatment of patients with tumor lesions of the bones. Moscow, 2009, 24 pp.).

However, these methods do not have an antitumor effect, which reduces the time of the analgesic effect, leads to continued growth and further destruction of the bone segment.

The well-known "Method of local chemotherapy of spinal tumors" (patent No. 2448718, publ. 04/27/2012. Bull. No. 45), selected by us as an analogue, the patient is performed vertebroplasty, while the affected vertebra is punctured and cytostatics are incubated in single doses, incubated with autoplasma for 1 hour at a temperature of 37 ° C, and then bone cement is introduced. The use of the invention allows to increase the effectiveness of treatment due to local cytotoxic effects on the tumor, prevention of destruction of the vertebral body and compression of the spinal cord, reduction of toxicity of chemotherapy.

However, the local use of chemotherapy does not interfere with bone resorption and is not used in the present invention for lytic metastases to other bones.

The technical result of this invention is to improve the quality of life of patients by stabilizing the affected segment, reducing pain, reducing the risk of bone complications in osteolytic metastases.

This technical result is achieved by the fact that in the method for the prevention of skeletal complications in patients with lytic metastases in flat and mixed bones during osteo- or vertebroplasty, according to the invention, before administering bone cement, a composition for implantation prepared under aseptic conditions as follows is administered way: 4 mg of Veroclast dry concentrate is dissolved in 1 ml of water for injection, the resulting solution is mixed with 2 ml of Collapan-G osteoplastic material in the form of a gel.

The proposed method is as follows: the operation of vertebro- or osteoplasty is performed in the computed tomography (CT) room under local anesthesia sol.lidocaini 2% with sedation sol. promedoli 2% - 2ml and sol. relanii 0.5% -2 ml intramuscularly. After three times the treatment, a skin incision of 0.5 cm is made for trepan. Under CT control, a puncture site of lytic destruction is performed. The stylet is removed. Using a syringe, the contents of the focus are aspirated for verification. Then make the composition for implantation. Under aseptic conditions, a dry concentrate of 4 mg of Veroclast is diluted with 1 ml of water for injection and mixed with 2 ml of Collapan-G gel in a 5 ml syringe and injected into the destruction site through trepan. Further, under CT control, the cavity of the destruction center is filled with bone cement by 50-70%. Trepan is removed. 1 nodular suture, aseptic dressing are applied to the skin.

The use of osteo- or vertebroplasty in combination with the composition of Veroclast and Collapan-G provides a specific local antitumor effect, alleviates or completely relieves pain, and slows down tumor growth by suppressing bone resorption. Thus, stabilization of the affected segment is carried out, and the risk of developing bone complications with osteolytic metastases is also reduced, which improves the quality of life of patients.

The use of this method allows the prevention of skeletal complications in patients with lytic metastases in flat bones.

In available sources of information from Russia, the CIS countries and abroad, indications of a similar method for improving the results of prophylaxis of bone complications in patients with lytic metastases to flat bones were not found. Thus, the claimed invention meets the criterion of "novelty."

The studies of the authors found that before the introduction of bone cement, during vertebro- or osteoplasty, implantation of the composition prepared as follows: 4 mg of Veroclast is dissolved in 1 ml of water for injection, the resulting solution is mixed with 2 ml of osteoplastic material. G in the form of a gel improves the quality of life of patients by stabilizing the affected segment, reducing pain, suppressing bone lysis and reducing the risk of bone complications in osteolytic their metastases. Thus, the claimed invention meets the criterion of "inventive step".

We give an example of clinical use of the proposed method.

Patient O., 56 years old, and.b. No. s-8025 / b, was in the Department of General Oncology, RNII from 11/21/2011 to 11/25/2011 with the doctor: С-r of the right kidney St III, T3bN0М1 class. column 2. Condition after complex treatment. Generalization. Solitary pay in L4, severe pain. The threat of a pathological fracture. The patient performed percutaneous vertebroplasty. Before plastic surgery with bone cement, a composition consisting of 1 ml of a solution of 4 mg of Veroclast and 2 ml of Collapan-g gel was introduced into the destruction site. No complications were observed during and after the manipulation. On the 2nd day after the operation, a significant decrease in the pain syndrome of neurological symptoms was not observed. On a scale for assessing pain (according to Watkins), pain decreased from 3 points (not constant use of narcotic analgesics) to 0 points (no pain). With a dynamic observation of relapse of pain within 6 months was not observed. The level of outpatient activity and the quality of life of the patient according to the Karnofski scale increased from 70 (caring for himself, cannot work) to 90 (minimal symptoms).

This method treated 6 patients. The proposed method is easily reproducible in a hospital environment. Thus, the claimed invention meets the criterion of "industrial applicability".

Claims (1)

A method for the prevention of skeletal complications in patients with lytic metastases in flat and mixed bones, including osteo- or vertebroplasty, characterized in that before the introduction of bone cement, a composition for implantation prepared under aseptic conditions as follows: 4 mg of Veroclast are dissolved in 1 ml of water for injection, the resulting solution is mixed with 2 ml of osteoplastic material Collanan-G in the form of a gel.