Fibrosis of skeletal muscle following acupuncture is an iatrogenic disorder. The present case illustrates a patient with a unilateral fibrotic formation on a thumb muscle after acupuncture injection therapy with red sage. The patient in the present case was a counter-terrorism police officer with right-handedness; he noted a palpable nodule three months after injection therapy at his left first dorsal interosseous in which the acupuncture point LI4 (He Gu) is located. He also found a reduction in the strength of his left pinch grip that noticeably affected his left handgun marksmanship. However, being ambidextrous in single-hand pistol shooting is an essential requirement for counter-terrorism police officers. Based on the patient's medical history and claims, no underlying disease or trauma was found to be associated with his current complaint. During physical examination, a fibrotic formation in his left first dorsal interosseous muscle was visualized by using diagnostic ultrasound; also, as confirmed with dynamometry, the strength of his left pinch grip was significantly lower than that of the right counterpart. Because acupuncture injection therapy has three components, antiseptic practices, the mechanical action of syringe insertion, and the pharmacological effect of the sterile herb extract, any one of the components may have contributed to the present adverse event. The first dorsal interosseous muscle is small in dimension and rather vascular; thus, it is not an ideal site for intramuscular injection. When a clinician needs to treat a patient by performing acupuncture at the LI4 acupoint and injecting a herbal extract simultaneously, the clinician should only mechanically stimulate the LI4 acupoint while injecting the herbal medicine into the LI14 (Bi Noe) acupoint on the same meridian, the LI14 acupoint being located in the distal portion of the deltoid muscle and being fairly close to the universally agreed upon site on the upper arm for safe administration of an injection.
Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.
Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water- soluble ginseng pharmacopuncture (GP) intramuscular injections in rats. Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech. Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.
Objectives: This study was carried out in order to find both the single-dose intramuscular injection toxicity and the approximate lethal dose of samjeong pharmacopuncture (SP) in Sprague-Dawley (SD) rats. Methods: The SD rats in this study were divided into four groups, one control group (1.0 mL/animal, normal saline) and three experimental groups (0.25, 0.5, and 1.0 mL/animal, SP). All groups consisted of five male and five female rats. SP was injected as a single-dose intramuscularly at the thigh. After the injection, general symptoms and weight were observed for 14 days. After the observations had ended, hematologic and serum biochemical examinations, necropsy and a local tolerance test at the injection site were performed. The experiments were carried out at the Good Laboratory Practice firm, Biotoxtech Co. (Cheongwon, Chungbuk). Animal experiments were approved by the Ethics Committee (Approval Number: 130379). Results: No deaths occurred in any of the three experimental groups. The injection of SP had no effects on the general symptoms, body weights, results of the hematologic, and serum biochemical examinations, and necropsy findings. In local tolerance tests at the injection sites, mild inflammation was observed in the experimental group, but it did not appear to be a treatment related effect. Conclusion: Under the conditions of this test, the results from the injection of SP suggest that the approximate lethal dose of SP is above 1.0 mL/animal for both male and female SD rats. Therefore, the clinical use of SP is thought to be safe.
Objectives: Neuralgia-pharmacopuncture (NP) was recently developed as a water-soluble type of pharmacopuncture inspired by CS (care special pain)-pharmacopuncture. I aimed to evaluate the toxic response and approximate lethal dose of when NP when administered intramuscularly to Sprague Dawley rats. Methods: The experimental group was divided into the NP test substance group and the saline control group and administered at a dose of 1.0 mL/animal to the posterior thigh muscles on both sides using a 1 mL syringe; each group consisted of five males and five females. Each rat was monitored for clinical signs and changes in body weight for 14 days after a single intramuscular injection. After completing observation, necropsy findings and localized tolerance at the injection site were assessed via gross necropsy and histopathological examination. Results: No deaths occurred in the NP or control group, regardless of sex. During the observation period, no changes (such as general symptoms, weight change, or visual observation results at the time of autopsy) were judged to be due to the test substance. Histopathological examination showed no changes at the administration site judged to be caused by the test substance in either the male or female test substance administration groups. In addition, mononuclear cell infiltration of the outer membrane of the femoris muscle at the administration site was observed at the same frequency and extent in the control and NP groups, and was judged to be caused by physical stimulation by the injection needle; therefore, it had no toxicological significance. Conclusion: Based on the above results, the approximate lethal dose for a single intramuscular administration of the test substance NP in Sprague-Dawley rats was judged to be > 1.0 mL/animal, and there were no findings that were judged to be due to the test substance at the administration site.
Objectives : This study was conducted to carry out quantitative evaluation and safety of Sweet Bee Venom. Methods : Content analysis was done using HPLC, measurement of LD$^{50}$ was conducted intravenous, subcutaneous, and intramuscular injection to the ICR mice. Results : 1. According to HPLC analysis, removal of the enzymes containing phospholipase A2 was successfully rendered on Sweet Bee Venom. And analyzing melittin content, Sweet Bee Venom contained 12% more melittin than Bee Venom. 2. LD$^{50}$ of ICR mice with Sweet Bee Venom was more than 20mg/kg in subcutaneous injection and intravenous injection, between 15mg/kg and 20mg/kg in muscular injection. 3. LD$^{50}$ of ICR mice with Bee Venom was between 6 and 9mg/kg in subcutaneous injection and intravenous injection, and more than 9mg/kg in muscular injection. Conclusion : Above results indicate that Sweet Bee Venom was more safe than Bee Venom and the process of removing enzymes was well rendered in Sweet Bee Venom.
Objectives: Bufonis venonum (BV) is the dried white secretions of the auricular and skin glands of the toads Bufo bufo gargarizans or Bufo melanosticus Schneider. This study was performed to evaluate the toxicity of intramuscularly-administered Bufonis venonum pharmacopuncture (BVP) and to calculate its approximate lethality through a single-dose test with Sprague-Dawley (SD) rats. Methods: Twenty male and 20 female 6-week-old SD rats were injected intramuscularly with BVP or normal saline. The animals were divided into four groups with five female and five male rats per group: the control group injected with normal saline at 0.5 mL/animal, the low-dosage group injected with 0.125 mL/animal of BVP, the medium-dosage group injected with 0.25 mL/animal of BVP and the high-dosage group injected with 0.5 mL/animal of BVP. All injections were in the left thighs of the rats. After administration, we conducted clinical observations everyday and body weight measurements on days 3, 7 and 14 after the injection. We also carried out hematology, serum biochemistry, and histological observations on day 15 after treatment. Results: No mortalities were observed in any experimental group. No significant changes in weight, hematology, serum biochemistry, and histological observations that could be attributed to the intramuscular injection of BVP were observed in any experimental group. Conclusion: Lethal dose of BVP administered via intramuscular injection in SD rats is over 0.5 mL/animal.
According to the North Korean documents , North Korean government have emphasized the development of the Koryo medicine (traditional korean medicine) and encouraged the combination of the Koryo and the modern medicine. It is regarded that this attitude arose from the ruler's will toward independency in the medical field and at the same time the lack of modern medical resources . Combinations of the Koryo medicine and the modern medicine in the clinical textbooks are classified as follows: first, mixed medication of the Koryo and the modern medicine. Second, combination of the traditional acupuncture(or moxibustion) and the medication of modern medicines. Third, injection of modern medicines at acupoints. Forth, an intramuscular or an intravenous injection of the Koryo medicine. Fifth, anesthesia using Koryo medicine. Sixth, simple surgery at the acupoints. Lastly, combination of injection and the traditional therapy(eg. acupuncture, moxibustion and cupping) Despite of many achievements in the field of combined medical treatment, recent economic failure and severe famine for several years caused collapse of the health care delivery system in North Korea, and it is hard to find combined practices actually.
Objectives : This study was performed to investigate the effects of anti-cancer and changes In immune response of Lonicerge Flos Herbal-acupuncture. Methods Experimental studies were evaluated through the anti-cancer and immune response activities such as, cell viability, BNA fragmentation, Apoptosis, survival time, pulmonary colonization, and productivity of interleukins & $interferon-{\gamma}$. In order to study the effects of anti-cancer and changes in immune response of Lonicerae Flos Herbal-acupuncture, the groups were divided into five groups ; Normal group(non treated group), Control A group(0.2ml Normal saline for oral administration), Control B group(administration of intramuscular injection with 0.2ml Lonicerae Flos Herbal-acupuncture solution), Acupuncture group(AT, administration of acupuncture at Chungbu(L1)), and Herbal-Acupuncture group(HAT, administration of Lonicerae Flos Herbal-acupuncture at Chungbu(L1)). Results : 1. Lonicerae Flos Herbal-acupuncture(>300mg/ml) could lead cancer cell to cell death. 2. Lonicerae Flos Herbal - acupuncture (40mg/ml) caused DNA cleavage. 3. Lonicerae Flos Herbal-acupuncture(400mg/ml) caused apoptosis in the cancer cell line. 4. In mouse survival time, all of experimental groups didn't show any significant compared to the control group. 5. In pulmonary colonization assay, Lonicerae Flos Herbal-acupuncture group was less than Control A group at 7 days after induction of cancer. 6. In comparison Control A group, there was significant decrease of Interleukin-2 level in Lonicerae Flos Herbal-acupuncture group. 7. In comparison Control group, there was decrease of Interleukin-4 level in the Acupuncture group. 8. In comparison Control group, there was decrease of Interleukin-10 level in the Acupuncture group. 9. In comparison Control group, there was significant increase of Interleukin-12 level in Acupuncture group and Lonicerae Flos Herbal-acupuncture group. 10. In comparison Control group, there was significant increase of $Interferon-{\gamma}$ level in Acupuncture group. Conclusion : According to above mentioned results, Lonicerae Flos Herbal- acupuncture is expected to be effective for anticancer and improvement in immune response.
Objectives: This study was carried out to analyze the single dose toxicity of Mecasin(Gami-Jakyak Gamcho buja Decoction) pharmacopuncture in muscle of Sprague-Dawley rats. Methods: All experiments were performed at the Medvill, an institution acknowledged to conduct non-clinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. The reason Sprague-Dawley rats were chosen is that they have been widely used in safety test in the field of medicine, so the results can be easily compared with many other databases. Doses of Mecasin pharmacopuncture, 0, 500, 1,000, and 2,000mg/kg, were registered to the experimental groups, and a dose of normal saline solution, 10 ml/kg, was registered to the control group. Mecasin pharmacopuncture and normal saline were injected into the thigh of the rats by disposable syringes at intervals of six hours twice a day. This study was performed under the approval of the Institutional Animal Ethic Committee. Results: There is no death or abnormality in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To inspect abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with Mecasin pharmacopuncture is relatively safe. Further evaluations and studies on this subject are needed to prove more concrete evidence.
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